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Roxicet Oral Solution

30/06/10

Generic Name: oxycodone hydrochloride and acetaminophen
Dosage Form: tablets, oral solution

ROXICET™ CII
Oxycodone 5 mg and Acetaminophen 325 mg Tablets, USP
Oxycodone 5 mg and Acetaminophen 325 mg Oral Solution per 5 mL

Rx only

Roxicet Oral Solution Description

Each tablet for oral administration contains:

Oxycodone Hydrochloride……………………………………………………………… 5 mg+

(+5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)

Acetaminophen………………………………………………………………………….. 325 mg

Each 5 mL of oral solution for oral administration contains:

Oxycodone Hydrochloride……………………………………………………………… 5 mg+

(+5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)

Acetaminophen………………………………………………………………………….. 325 mg

Alcohol ………………………………………………………………………………………… 0.4%

Inactive Ingredients

The tablets contain colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose and stearic acid.

The solution contains alcohol (0.4%), citric acid, disodium edetate, FD&C Red #40, flavors, fructose, polyethylene glycol, potassium sorbate, sodium saccharin and water.

ROXICET™ contains oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white, odorless, crystalline powder having a saline, bitter taste. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 381.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:

C18H21NO4 ·HCl MW 381.82

ROXICET™ contains acetaminophen, 4′-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. The molecular formula for acetaminophen is C8H9NO2 and then molecular weight is 151.17. It may be represented by the following structural formula:

C8H9NO2 MW 151.17

Roxicet Oral Solution – Clinical Pharmacology

Central Nervous System

Oxycodone is a semisynthetic pure opioid agonist whose principal therapeutic action is analgesia. Other pharmacological effects of oxycodone include anxiolysis, euphoria and feelings of relaxation. These effects are mediated by receptors (notably µ and ĸ) in the central nervous system for endogenous opioid-like compounds such as endorphins and enkephalins. Oxycodone produces respiratory depression through direct activity at respiratory centers in the brain stem and depresses the cough reflex by direct effect on the center of the medulla.

Acetaminophen is a non-opiate, non-salicylate analgesic and antipyretic. The site and mechanism for the analgesic effect of acetaminophen has not been determined. The antipyretic effect of acetaminophen is accomplished through the inhibition of endogenous pyrogen action on the hypothalamic heat-regulating centers.

Gastrointestinal Tract and Other Smooth Muscle

Oxycodone reduces motility by increasing smooth muscle tone in the stomach and duodenum. In the small intestine, digestion of food is delayed by decreases in propulsive contractions. Other opioid effects include contraction of biliary tract smooth muscle, spasm of the Sphincter of Oddi, increased ureteral and bladder sphincter tone, and a reduction in uterine tone.

Cardiovascular System

Oxycodone may produce a release of histamine and may be associated with orthostatic hypotension, and other symptoms, such as pruritus, flushing, red eyes, and sweating.

Pharmacokinetics

Absorption and Distribution

The mean absolute oral bioavailability of oxycodone in cancer patients was reported to be about 87%. Oxycodone has been shown to be 45% bound to human plasma proteins in vitro. The volume of distribution after intravenous administration is 211.9 ±186.6 L.

Absorption of acetaminophen is rapid and almost complete from the GI tract after oral administration. With overdosage, absorption is complete in 4 hours. Acetaminophen is relatively uniformly distributed throughout most body fluids. Binding of the drug to plasma proteins is variable; only 20% to 50% may be bound at the concentrations encountered during acute intoxication.

Metabolism and Elimination

A high portion of oxycodone is N-dealkylated to noroxycodone during first-pass metabolism. Oxymorphone, is formed by the O-demethylation of oxycodone. The metabolism of oxycodone to oxymorphone is catalyzed by CYP2D6. Free and conjugated noroxycodone, free and conjugated oxycodone, and oxymorphone are excreted in human urine following a single oral dose of oxycodone. Approximately 8% to 14% of the dose is excreted as free oxycodone over 24 hours after administration. Following a single, oral dose of oxycodone, the mean ± SD elimination half-life is 3.51 ± 1.43 hours.

Acetaminophen is metabolized in the liver via cytochrome P450 microsomal enzyme. About 80% to 85% of the acetaminophen in the body is conjugated principally with glucuronic acid and to a lesser extent with sulfuric acid and cysteine. After hepatic conjugation, 90% to 100% of the drug is recovered in the urine with in the first day.

About 4% of acetaminophen is metabolized via cytochrome P450 oxidase to a toxic metabolite which is further detoxified by conjugation with glutathione, present in a fixed amount. It is believed that the toxic metabolite NAPQI (N acetyl-p-benzoquinoneimine, N-acetylimidoquinone) is responsible for liver necrosis. High doses of acetaminophen may deplete the glutathione stores so that inactivation of the toxic metabolite is decreased. At high doses, the capacity of metabolic pathways for conjugation with glucuronic acid and sulfuric acid may be exceeded, resulting in increased metabolism of acetaminophen by alternate pathways.

Indications and Usage for Roxicet Oral Solution

ROXICET is indicated for the relief of moderate to moderately severe pain.

ï»¿CONTRAINDICATIONS

ROXICET should not be administered to patients with unknown hypersensitivity to oxycodone, acetaminophen, or any other component of this product.

Oxycodone is contraindicated in any situation where opioids are contraindicated including patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia. Oxycodone is contraindicated in the setting of suspected or known paralytic ileus.

Warnings

Misuse, Abuse and Diversion of Opioids

Oxycodone is an opioid agonist of the morphine-type. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.

Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing ROXICET in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Concerns about misuse, addiction, and diversion should not prevent the proper management of pain.

Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

Administration of ROXICET (Oxycodone and Acetaminophen) should be closely monitored for the following potentially serious adverse reactions and complications:

Respiratory Depression

Respiratory depression is a hazard with the use of oxycodone, one of the active ingredients in ROXICET, as with all opioid agonists. Elderly and debilitated patients are at particular risk for respiratory depression as are non-tolerant patients given large initial doses of oxycodone or when oxycodone is given in conjunction with other agents that depress respiration. Oxycodone should be used with extreme caution in patients with acute asthma, chronic obstructive pulmonary disorder (COPD), cor pulmonale, or pre-existing respiratory impairment. In such patients, even usual therapeutic doses of oxycodone may decrease respiratory drive to the point of apnea. In these patients alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose.

In case of respiratory depression, a reversal agent such as naloxone hydrochloride may be utilized (see OVERDOSAGE).

Head Injury and Increased Intracranial Pressure

The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure, and may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Oxycodone produces effects on pupillary response and consciousness which may obscure neurologic signs of worsening in patients with head injuries.

Hypotensive Effect

Oxycodone may cause severe hypotension particularly in individuals whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs which compromise vasomotor tone such as phenothiazines. Oxycodone, like all opioid analgesics of the morphine-type, should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure. Oxycodone may produce orthostatic hypotension in ambulatory patients.

Hepatotoxicity

Precaution should be taken in patients with liver disease. Hepatotoxicity and severe hepatic failure occurred in chronic alcoholics following therapeutic doses.

Precautions

General

Opioid analgesics should be used with caution when combined with CNS depressant drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension.

Acute Abdominal Conditions

The administration of ROXICET (Oxycodone and Acetaminophen) or other opioids may obscure the diagnosis or clinical course in patients with acute abdominal conditions.

ROXICET should be given with caution to patients with CNS depression, elderly or debilitated patients, patients with severe impairment of hepatic, pulmonary, or renal function, hypothyroidism, Addison’s disease, prostatic hypertrophy, urethral stricture, acute alcoholism, delirium tremens, kyphoscoliosis with respiratory depression, myxedema, and toxic psychosis.

ROXICET may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Oxycodone may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings.

Following administration of ROXICET, anaphylactic reactions have been reported in patients with a known hypersensitivity to codeine, a compound with a structure similar to morphine and oxycodone. The frequency of this possible cross-sensitivity is unknown.

Interactions with Other CNS Depressants

Patients receiving other opioid analgesics, general anesthetics, phenothiazines, other tranquilizers, centrally-acting anti-emetics, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with ROXICET may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced.

Interactions with Mixed Agonist/Antagonist Opioid Analgesics

Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, and butorphanol) should be administered with caution to a patient who has received or is receiving a course of therapy with a pure opioid agonist analgesic such as oxycodone. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of oxycodone and/or may precipitate withdrawal symptoms in these patients.

Ambulatory Surgery and Postoperative Use

Oxycodone and other morphine-like opioids have been shown to decrease bowel motility. Ileus is a common postoperative complication, especially after intra-abdominal surgery with use of opioid analgesia. Caution should be taken to monitor for decreased bowel motility in postoperative patients receiving opioids. Standard supportive therapy should be implemented.

Use in Pancreatic/Biliary Tract Disease

Oxycodone may cause spasm of the Sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis. Opioids like oxycodone may cause increases in the serum amylase level.

Tolerance and Physical Dependence

Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and tolerance are not unusual during chronic opioid therapy.

The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.

In general, opioids should not be abruptly discontinued (see DOSAGE AND ADMINISTRATION: Cessation of Therapy).

Information for Patients/Caregivers

The following information should be provided to patients receiving ROXICET by their physician, nurse, pharmacist, or caregiver:

Patients should be aware that ROXICET contains oxycodone, which is a morphine-like substance.
Patients should be instructed to keep ROXICET in a secure place out of the reach of children. In the case of accidental ingestions, emergency medical care should be sought immediately.
When ROXICET is no longer needed, the unused tablets or oral solution should be destroyed by flushing down the toilet.
Patients should be advised not to adjust the medication dose themselves. Instead, they must consult with their prescribing physician.
Patients should be advised that ROXICET may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating heavy machinery).
Patients should not combine ROXICET with alcohol, opioid analgesics, tranquilizers, sedatives, or other CNS depressants unless under the recommendation and guidance of a physician. When co-administered with another CNS depressant, ROXICET can cause dangerous additive central nervous system or respiratory depression, which can result in serious injury or death.
The safe use of ROXICET during pregnancy has not been established; thus, women who are planning to become pregnant or are pregnant should consult with their physician before taking ROXICET.
Nursing mothers should consult with their physicians about whether to discontinue nursing or discontinue ROXICET because of the potential for serious adverse reactions to nursing infants.
Patients who are treated with ROXICET for more than a few weeks should be advised not to abruptly discontinue the medication. Patients should consult with their physician for a gradual discontinuation dose schedule to taper off the medication.
Patients should be advised that ROXICET is a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.

Laboratory Tests

Although oxycodone may cross-react with some drug urine tests, no available studies were found which determined the duration of detectability of oxycodone in urine drug screens. However, based on pharmacokinetic data, the approximate duration of detectability for a single dose of oxycodone is roughly estimated to be one to two days following drug exposure.

Urine testing for opiates may be performed to determine illicit drug use and for medical reasons such as evaluation of patients with altered states of consciousness or monitoring efficacy of drug rehabilitation efforts. The preliminary identification of opiates in urine involves the use of an immunoassay screening and thin-layer chromatography (TLC). Gas chromatography/mass spectrometry (GC/MS) may be utilized as a third-stage identification step in the medical investigational sequence for opiate testing after immunoassay and TLC. The identities of 6-keto opiates (e.g., oxycodone) can further be differentiated by the analysis of their methoximetrimethylsilyl (MO-TMS) derivative.

Drug/Drug Interactions with Oxycodone

Opioid analgesics may enhance the neuromuscular-blocking action of skeletal muscle relaxants and produce an increase in the degree of respiratory depression.

Patients receiving CNS depressants such as other opioid analgesics, general anesthetics, phenothiazines, other tranquilizers, centrally-acting anti-emetics, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with ROXICET may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced. The concurrent use of anticholinergics with opioids may produce paralytic ileus.

Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, naltrexone, and butorphanol) should be administered with caution to a patient who has received or is receiving a pure opioid agonist such as oxycodone. These agonist/antagonist analgesics may reduce the analgesic effect of oxycodone or may precipitate withdrawal symptoms.

Drug/Drug Interactions with Acetaminophen

Alcohol, ethyl: Hepatotoxicity has occurred in chronic alcoholics following various dose levels (moderate to excessive) of acetaminophen.

Anticholinergics: The onset of acetaminophen effect may be delayed or decreased slightly, but the ultimate pharmacological effect is not significantly affected by anticholinergics.

Oral Contraceptives: Increase in glucuronidation resulting in increased plasma clearance and a decreased half-life of acetaminophen.

Charcoal (activated): Reduces acetaminophen absorption when administered as soon as possible after overdose.

Beta Blockers (Propanolol): Propranolol appears to inhibit the enzyme systems responsible for the glucuronidation and oxidation of acetaminophen. Therefore, the pharmacologic effects of acetaminophen may be increased.

Loop diuretics: The effects of the loop diuretic may be decreased because acetaminophen may decrease renal prostaglandin excretion and decrease plasma renin activity.

Lamotrigine: Serum lamotrigine concentrations may be reduced, producing a decrease in therapeutic effects.

Probenecid: Probenecid may increase the therapeutic effectiveness of acetaminophen slightly.

Zidovudine: The pharmacologic effects of zidovudine may be decreased because of enhanced non-hepatic or renal clearance of zidovudine.

Drug/Laboratory Test Interactions

Depending on the sensitivity/specificity and the test methodology, the individual components of ROXICET (Oxycodone and Acetaminophen) may cross-react with assays used in the preliminary detection of cocaine (primary urinary metabolite, benzoylecgonine) or marijuana (cannabinoids) in human urine. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The preferred confirmatory method is gas chromatography/mass spectrometry (GC/MS). Moreover, clinical considerations and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

Acetaminophen may interfere with home blood glucose measurement systems; decreases of > 20% in mean glucose values may be noted. This effect appears to be drug, concentration and system dependent.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Animal studies to evaluate the carcinogenic potential of oxycodone and acetaminophen have not been performed.

Mutagenesis

The combination of oxycodone and acetaminophen has not been evaluated for mutagenicity. Oxycodone alone was negative in a bacterial reverse mutation assay (Ames), an in vitro chromosome aberration assay with human lymphocytes without metabolic activation and an in vivo mouse micronucleus assay. Oxycodone was clastogenic in the human lymphocyte chromosomal assay in the presence of metabolic activation and in the mouse lymphoma assay with or without metabolic activation.

Fertility

Animal studies to evaluate the effects of oxycodone on fertility have not been performed.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproductive studies have not been conducted with ROXICET. It is also not known whether ROXICET can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. ROXICET should not be given to a pregnant woman unless in the judgment of the physician, the potential benefits outweigh the possible hazards.

Nonteratogenic Effects

Opioids can cross the placental barrier and have the potential to cause neonatal respiratory depression. Opioid use during pregnancy may result in a physically drug-dependent fetus. After birth, the neonate may suffer severe withdrawal symptoms.

Labor and Delivery

ROXICET is not recommended for use in women during and immediately prior to labor and delivery due to its potential effects on respiratory function in the newborn.

Nursing Mothers

Ordinarily, nursing should not be undertaken while a patient is receiving ROXICET because of the possibility of sedation and/or respiratory depression in the infant. Oxycodone is excreted in breast milk in low concentrations, and there have been rare reports of somnolence and lethargy in babies of nursing mothers taking an oxycodone/acetaminophen product. Acetaminophen is also excreted in breast milk in low concentrations.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Special precaution should be given when determining the dosing amount and frequency of ROXICET for geriatric patients, since clearance of oxycodone may be slightly reduced in this patient population when compared to younger patients.

Hepatic Impairment

In a pharmacokinetic study of oxycodone in patients with end-stage liver disease, oxycodone plasma clearance decreased and the elimination half-life increased. Care should be exercised when oxycodone is used in patients with hepatic impairment.

Renal Impairment

In a study of patients with end stage renal impairment, mean elimination half-life was prolonged in uremic patients due to increased volume of distribution and reduced clearance. Oxycodone should be used with caution in patients with renal impairment.

Adverse Reactions

ï»¿Serious adverse reactions that may be associated with ROXICET use include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock (see OVERDOSAGE).

The most frequently observed non-serious adverse reactions include lightheadedness, dizziness, drowsiness or sedation, nausea, and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down. Other adverse reactions include euphoria, dysphoria, constipation, and pruritus.

Hypersensitivity reactions may include: Skin eruptions, urticarial, erythematous skin reactions. Hematologic reactions may include: Thrombocytopenia, neutropenia, pancytopenia, hemolytic anemia. Rare cases of agranulocytosis has likewise been associated with acetaminophen use. In high doses, the most serious adverse effect is a dose-dependent, potentially fatal hepatic necrosis. Renal tubular necrosis and hypoglycemic coma also may occur.

Other adverse reactions obtained from postmarketing experiences with ROXICET are listed by organ system and in decreasing order of severity and/or frequency as follows:

Body as a Whole

Anaphylactoid reaction, allergic reaction, malaise, asthenia, fatigue, chest pain, fever, hypothermia, thirst, headache, increased sweating, accidental overdose, non-accidental overdose

Cardiovascular

Hypotension, hypertension, tachycardia, orthostatic hypotension, bradycardia, palpitations, dysrhythmias

Central and Peripheral Nervous System

Stupor, tremor, paraesthesia, hypoaesthesia, lethargy, seizures, anxiety, mental impairment, agitation, cerebral edema, confusion, dizziness

Fluid and Electrolyte

Dehydration, hyperkalemia, metabolic acidosis, respiratory alkalosis

Gastrointestinal

Dyspepsia, taste disturbances, abdominal pain, abdominal distention, sweating increased, diarrhea, dry mouth, flatulence, gastro-intestinal disorder, nausea, vomiting, pancreatitis, intestinal obstruction, ileus

Hepatic

Transient elevations of hepatic enzymes, increase in bilirubin, hepatitis, hepatic failure, jaundice, hepatotoxicity, hepatic disorder

Hearing and Vestibular

Hearing loss, tinnitus

Hematologic

Thrombocytopenia

Hypersensitivity

Acute anaphylaxis, angioedema, asthma, bronchospasm, laryngeal edema, urticaria, anaphylactoid reaction

Metabolic and Nutritional

Hypoglycemia, hyperglycemia, acidosis, alkalosis

Musculoskeletal

Myalgia, rhabdomyolysis

Ocular

Miosis, visual disturbances, red eye

Psychiatric

Drug dependence, drug abuse, insomnia, confusion, anxiety, agitation, depressed level of consciousness, nervousness, hallucination, somnolence, depression, suicide

Respiratory System

Bronchospasm, dyspnea, hyperpnea, pulmonary edema, tachypnea, aspiration, hypoventilation, laryngeal edema

Skin and Appendages

Erythema, urticaria, rash, flushing

Urogenital

Interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency and failure, urinary retention

Drug Abuse and Dependence

ROXICET is a Schedule II controlled substance. Oxycodone is a mu-agonist opioid with an abuse liability similar to morphine. Oxycodone, like morphine and other opioids used in analgesia, can be abused and is subject to criminal diversion.

Drug addiction is defined as an abnormal, compulsive use, use for non-medical purposes of a substance despite physical, psychological, occupational or interpersonal difficulties resulting from such use, and continued use despite harm or risk of harm. Drug addiction is a treatable disease, utilizing a multi-disciplinary approach, but relapse is common. Opioid addiction is relatively rare in patients with chronic pain but may be more common in individuals who have a past history of alcohol or substance abuse or dependence. Pseudoaddiction refers to pain relief seeking behavior of patients whose pain is poorly managed. It is considered an iatrogenic effect of ineffective pain management. The health care provider must assess continuously the psychological and clinical condition of a pain patient in order to distinguish addiction from pseudoaddiction and thus, be able to treat the pain adequately.

Physical dependence on a prescribed medication does not signify addiction. Physical dependence involves the occurrence of a withdrawal syndrome when there is sudden reduction or cessation in drug use or if an opiate antagonist is administered. Physical dependence can be detected after a few days of opioid therapy. However, clinically significant physical dependence is only seen after several weeks of relatively high dosage therapy. In this case, abrupt discontinuation of the opioid may result in a withdrawal syndrome. If the discontinuation of opioids is therapeutically indicated, gradual tapering of the drug over a 2-week period will prevent withdrawal symptoms. The severity of the withdrawal syndrome depends primarily on the daily dosage of the opioid, the duration of therapy and medical status of the individual.

The withdrawal syndrome of oxycodone is similar to that of morphine. This syndrome is characterized by yawning, anxiety, increased heart rate and blood pressure, restlessness, nervousness, muscle aches, tremor, irritability, chills alternating with hot flashes, salivation, anorexia, severe sneezing, lacrimation, rhinorrhea, dilated pupils, diaphoresis, piloerection, nausea, vomiting, abdominal cramps, diarrhea and insomnia, and pronounced weakness and depression.

“Drug-seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor Shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated infection.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Oxycodone, like other opioids, has been diverted for non-medical use. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.

Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Like other opioid medications, ROXICET is subject to the Federal Controlled Substances Act. After chronic use, ROXICET should not be discontinued abruptly when it is thought that the patient has become physically dependent on oxycodone.

Interactions with Alcohol and Drugs of Abuse

Oxycodone may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression.

Overdosage

ï»¿Signs and Symptoms

Serious overdose with ROXICET (Oxycodone and Acetaminophen) is characterized by signs and symptoms of opioid and acetaminophen overdose. Oxycodone overdosage can be manifested by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, pupillary constriction (pupils may be dilated in the setting of hypoxia), and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur.

In acute acetaminophen overdosage, dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma and thrombocytopenia may also occur.

In adults, hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams and fatalities with less than 15 grams. Plasma acetaminophen levels > 300 mcg/mL at 4 hours post-ingestion were associated with hepatic damage in 90% of patients; minimal hepatic damage is anticipated if plasma levels at 4 hours are < 120 mcg/mL or < 30 mcg/mL at 12 hours after ingestion.

Importantly, young children seem to be more resistant than adults to the hepatotoxic effect of an acetaminophen overdose. Despite this, the measures outlined below should be initiated in any adult or child suspected of having ingested an acetaminophen overdose.

Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.

Treatment

Primary attention should be given to the re-establishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. Supportive measures (including oxygen, intravenous fluids, and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation.

The opioid antagonist naloxone hydrochloride is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to opioids including oxycodone. Therefore, an appropriate dose of naloxone hydrochloride should be administered (usual initial adult dose 0.4 mg to 2 mg) preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. Since the duration of action of oxycodone may exceed that of the antagonist, the patient should be kept under continued surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to oxycodone overdose. In patients who are physically dependent on any opioid agonist including oxycodone, an abrupt or complete reversal of opioid effects may precipitate an acute abstinence syndrome. The severity of the withdrawal syndrome produced will depend on the degree of physical dependence and the dose of the antagonist administered. Please see the prescribing information for the specific opioid antagonist for details of their proper use.

Gastric emptying and/or lavage may be useful in removing unabsorbed drug. This procedure is recommended as soon as possible after ingestion, even if the patient has vomited spontaneously. After lavage and/or emesis, administration of activated charcoal, as a slurry, is beneficial, if less than three hours have passed since ingestion. Charcoal adsorption should not be employed prior to lavage and emesis.

If an acetaminophen overdose is suspected, the stomach should be promptly emptied by lavage. A serum acetaminophen assay should be obtained as soon as possible, but no sooner than 4 hours following ingestion. Liver function studies should be obtained initially and repeated at 24-hour intervals. The antidote N-acetylcysteine (NAC) should be administered as early as possible, preferably within 16 hours of the overdose ingestion, but in any case within 24 hours. As a guide to treatment of acute ingestion, the acetaminophen level can be plotted against time since ingestion on a nomogram (Rumack-Matthew). The upper toxic line on the nomogram is equivalent to 200 mcg/mL at 4 hours while the lower line is equivalent to 50 mcg/mL at 12 hours. If serum level is above the lower line, and entire course of N-acetylcysteine treatment should be instituted. NAC therapy should be withheld if the acetaminophen level is below the lower line.

The toxicity of oxycodone and acetaminophen in combination is unknown.

Roxicet Oral Solution Dosage and Administration

Dosage should be adjusted according to the severity of the pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effect of opioids. If pain is constant, the opioid analgesic should be given at regular intervals on an around-the-clock schedule. ROXICET is given orally.

ROXICET Tablets:

The usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams. (Maximum daily dose is 12 tablets.)

Roxicet Oral Solution:

The usual adult dosage is 5 mL (one teaspoonful) every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams. (Maximum daily dose is 12 teaspoonfuls or 60 mL.)

Cessation of Therapy

In patients treated with ROXICET for more than a few weeks who no longer require therapy, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

How is Roxicet Oral Solution Supplied

ROXICET™ Tablets, Oxycodone and Acetaminophen Tablets, USP (Oxycodone Hydrochloride 5 mg and Acetaminophen 325 mg)

White, round, scored tablets

(Identified 54 543)

NDC 0054-8650-24: Unit dose, 25 tablets per card (reverse numbered),

4 cards per shipper.

NDC 0054-4650-25: Bottles of 100 tablets.

NDC 0054-4650-29: Bottles of 500 tablets.

Storage

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight light-resistant container, as defined in the USP/NF.

ROXICET™ Oral Solution, Oxycodone and Acetaminophen Oral Solution (Oxycodone Hydrochloride 5 mg and Acetaminophen 325 mg Oral Solution per 5 mL)

Clear, dark red solution

NDC 0054-8648-16: Unit dose Patient Cups™ filled to deliver 5 mL (Oxycodone Hydrochloride 5 mg, Acetaminophen 325 mg), ten 5 mL Patient Cups™ per shelf pack, four shelf packs per shipper.

NDC 0054-3686-63: Bottles of 500 mL.

Storage

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight light-resistant container, as defined in the USP/NF.

DEA Order Form Required.

4073402//03 Revised May 2008

©RLI, 2008

Package Label – ROXICET™ Tablets, Oxycodone and Acetaminophen Tablets, USP (Oxycodone Hydrochloride 5 mg and Acetaminophen 325 mg)

NDC 0054-8650-24: Unit dose

Rx Only

Roxane Laboratories, Inc.

NDC 0054-4650-25: Bottles of 100 tablets.

Rx Only

Roxane Laboratories, Inc.

NDC 0054-4650-29: Bottles of 500 tablets.

Rx Only

Roxane Laboratories, Inc.

Package Label – ROXICET™ Oral Solution, Oxycodone and Acetaminophen Oral Solution (Oxycodone Hydrochloride 5 mg and Acetaminophen 325 mg Oral Solution per 5 mL)

NDC 0054-8648-16: Unit dose Patient Cups™

Rx Only

Roxane Laboratories, Inc.

NDC 0054-3686-63: Bottles of 500 mL.

Rx Only

Roxane Laboratories, Inc.

ROXICET
oxycodone and acetaminophen tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0054-4650
Route of Administration	ORAL	DEA Schedule	CII

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYCODONE HYDROCHLORIDE (OXYCODONE)	OXYCODONE HYDROCHLORIDE	5 mg
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CELLULOSE, MICROCRYSTALLINE
STEARIC ACID

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND (biconvex)	Size	11mm
Flavor		Imprint Code	54;543
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0054-4650-25	100 TABLET In 1 BOTTLE, PLASTIC	None
2	0054-4650-29	500 TABLET In 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA087003	02/01/1991

ROXICET
oxycodone and acetaminophen solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0054-3686
Route of Administration	ORAL	DEA Schedule	CII

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYCODONE HYDROCHLORIDE (OXYCODONE)	OXYCODONE HYDROCHLORIDE	5 mg in 1 mL
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	325 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
FD&C RED NO. 40
FRUCTOSE
POLYETHYLENE GLYCOL
POTASSIUM SORBATE
SACCHARIN SODIUM
WATER

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0054-3686-63	500 mL In 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA089351	12/03/1986

ROXICET
oxycodone and acetaminophen tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0054-8650
Route of Administration	ORAL	DEA Schedule	CII

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYCODONE HYDROCHLORIDE (OXYCODONE)	OXYCODONE HYDROCHLORIDE	5 mg
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CELLULOSE, MICROCRYSTALLINE
STEARIC ACID

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND (biconvex)	Size	11mm
Flavor		Imprint Code	54;543
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0054-8650-24	4 BLISTER PACK In 1 BOX	contains a BLISTER PACK
1		25 TABLET In 1 BLISTER PACK	This package is contained within the BOX (0054-8650-24)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA087003	03/11/1987

ROXICET
oxycodone and acetaminophen solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0054-8648
Route of Administration	ORAL	DEA Schedule	CII

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYCODONE HYDROCHLORIDE (OXYCODONE)	OXYCODONE HYDROCHLORIDE	5 mg in 1 mL
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	325 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
FD&C RED NO. 40
FRUCTOSE
POLYETHYLENE GLYCOL
POTASSIUM SORBATE
SACCHARIN SODIUM
WATER

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0054-8648-16	10 CUP In 1 CARTON	contains a CUP, UNIT-DOSE
1		5 mL In 1 CUP, UNIT-DOSE	This package is contained within the CARTON (0054-8648-16)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA089351	01/17/1991

Labeler - Roxane Laboratories, Inc. (058839929)

Registrant - Roxane Laboratories, Inc. (058839929)

Establishment
Name	Address	ID/FEI	Operations
Boehringer Ingelheim Roxane Inc		128407710	MANUFACTURE

Revised: 11/2009Roxane Laboratories, Inc.

Professional,R

Comments (0)

Roxicodone

30/06/10

Generic Name: oxycodone (ox i KOE done)
Brand Names: ETH-Oxydose, OxyContin, Oxyfast, OxyIR, Percolone, Roxicodone, Roxicodone Intensol

What is Roxicodone (oxycodone)?

Oxycodone is in a group of drugs called narcotic pain relievers. It is similar to morphine.

Oxycodone is used to treat moderate to severe pain. The extended-release form of this medication is for around-the-clock treatment of pain. Oxycodone is not for treating pain just after a surgery unless you were already taking oxycodone before the surgery.

Oxycodone may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Roxicodone (oxycodone)?

Oxycodone may be habit-forming and should be used only by the person it was prescribed for. Oxycodone should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Do not drink alcohol while you are taking oxycodone. Dangerous side effects or death can occur when alcohol is combined with a narcotic pain medicine. Check your food and medicine labels to be sure these products do not contain alcohol. Never take more than your prescribed dose of oxycodone. Tell your doctor if the medicine seems to stop working as well in relieving your pain. Oxycodone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Do not stop using oxycodone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

What should I discuss with my healthcare provider before using Roxicodone (oxycodone)?

Do not use this medication if you have ever had an allergic reaction to a narcotic medicine (examples include methadone, morphine, Oxycontin, Darvocet, Percocet, Vicodin, Lortab, and many others), or to a narcotic cough medicine that contains codeine, hydrocodone, or dihydrocodeine.

You should also not take oxycodone if you are having an asthma attack or if you have a bowel obstruction called paralytic ileus.

Before using oxycodone, tell your doctor if you are allergic to any drugs, or if you have:

asthma, COPD, sleep apnea, or other breathing disorders;
liver or kidney disease;
underactive thyroid;
curvature of the spine;
a history of head injury or brain tumor;
epilepsy or other seizure disorder;
low blood pressure;
gallbladder disease;
Addison’s disease or other adrenal gland disorders;
enlarged prostate, urination problems;
mental illness; or
a history of drug or alcohol addiction.

FDA pregnancy category C. This medication may be harmful to an unborn baby, and could cause addiction or withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Oxycodone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more sensitive to the effects of this medicine.

How should I use Roxicodone (oxycodone)?

Take this medication exactly as it was prescribed for you. Never take oxycodone in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Take the pill form of this medicine with a full glass of water. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It will release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Measure the liquid form of oxycodone with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Drink plenty of water daily to help prevent constipation while you are using oxycodone. Ask your doctor about ways to increase the fiber in your diet. Do not use a stool softener (laxative) without first asking your doctor. Do not stop using oxycodone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Never crush a tablet or other pill to mix into a liquid for injecting the drug into your vein. This practice has resulted in death with the misuse of oxycodone and similar prescription drugs.

Store this medication at room temperature, away from heat, moisture, and light.

Keep track of how many pills have been used from each new bottle of this medicine. Oxycodone is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

After you have stopped using this medication, flush any unused pills down the toilet.

Throw away any unused liquid oxycodone that is older than 90 days.

What happens if I miss a dose?

Since oxycodone is sometimes used as needed, you may not be on a dosing schedule. If you are using the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

Extended-release oxycodone is not for use on an as-needed basis for pain.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of oxycodone can be fatal.

Overdose symptoms may include extreme drowsiness, muscle weakness, confusion, cold and clammy skin, pinpoint pupils, shallow breathing, slow heart rate, fainting, or coma.

What should I avoid while using Roxicodone (oxycodone)?

Do not drink alcohol while you are taking this medication. Dangerous side effects or death can occur when alcohol is combined with oxycodone. Check your food and medicine labels to be sure these products do not contain alcohol. Oxycodone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Roxicodone (oxycodone) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

shallow breathing, slow heartbeat;
seizure (convulsions);
cold, clammy skin;
confusion;
severe weakness or dizziness; or
feeling light-headed, fainting.

Less serious side effects are more likely to occur, such as:

nausea, vomiting, constipation, loss of appetite;
dizziness, headache, tired feeling;
dry mouth;
sweating; or
itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Roxicodone (oxycodone)?

Do not take oxycodone with alcohol, other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

Before taking oxycodone, tell your doctor if you are using pentazocine (Talwin), nalbuphine (Nubain), butorphanol (Stadol), or buprenorphine (Buprenex, Subutex). If you are using any of these drugs, you may not be able to use oxycodone, or you may need dosage adjustments or special tests during treatment.

This list is not complete and there may be other drugs that can interact with oxycodone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about oxycodone.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,R

Comments (0)

Roxanol

30/06/10

Generic Name: morphine (MOR feen)
Brand Names: Avinza, Kadian, Morphine IR, MS Contin, MSIR, Oramorph SR, Roxanol

What is Roxanol (morphine)?

Morphine is in a group of drugs called narcotic pain relievers.

Morphine is used to treat moderate to severe pain. Short-acting morphine is taken as needed for pain. Extended-release morphine is for use when around-the-clock pain relief is needed.

Morphine is not for treating pain just after surgery unless you were already taking morphine before the surgery.

Morphine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Roxanol (morphine)?

You may not be able to take this medicine unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

Morphine may be habit-forming and should be used only by the person it was prescribed for. Morphine should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Do not drink alcohol while you are using morphine. Dangerous side effects or death can occur when alcohol is combined with morphine. Check your food and medicine labels to be sure these products do not contain alcohol.

Never take more than your prescribed dose of morphine. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Do not stop taking morphine suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

What should I discuss with my healthcare provider before using Roxanol (morphine)?

Do not use this medication if you have ever had an allergic reaction to a narcotic medicine (examples include codeine, methadone, Oxycontin, Darvocet, Percocet, Vicodin, Lortab, and many others). You should also not take morphine if you are having an asthma attack or if you have a bowel obstruction called paralytic ileus. Morphine may be habit-forming and should be used only by the person it was prescribed for. Morphine should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Before using morphine, tell your doctor if you are allergic to any drugs, or if you have:

asthma, COPD, sleep apnea, or other breathing disorders;
liver or kidney disease;
underactive thyroid;
curvature of the spine;
a history of head injury or brain tumor;
epilepsy or other seizure disorder;
low blood pressure;
gallbladder disease;
Addison’s disease or other adrenal gland disorders;
enlarged prostate, urination problems;
mental illness; or
a history of drug or alcohol addiction.

You may not be able to take morphine unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant. FDA pregnancy category C. This medication may be harmful to an unborn baby, and could cause addiction or withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Morphine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more sensitive to the effects of this medicine.

How should I use Roxanol (morphine)?

Use this medication exactly as it was prescribed for you. Never take morphine in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Too much morphine could be very harmful. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It will release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

To make swallowing easier, you may open the extended-release capsule and sprinkle the medicine into a spoonful of applesauce. Swallow this mixture right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Measure the liquid form of morphine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Do not stop using morphine suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Store this medication at room temperature, away from heat, moisture, and light.

Keep track of how many pills have been used from each new bottle of this medicine. Morphine is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

After you have stopped using this medication, flush any unused pills down the toilet. Throw away any unused liquid morphine that is older than 90 days.

What happens if I miss a dose?

Since morphine is sometimes used as needed, you may not be on a dosing schedule. If you are using the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

Extended-release morphine is not for use on an as-needed basis for pain.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of morphine can be fatal.

Overdose symptoms may include extreme drowsiness, pinpoint pupils, confusion, cold and clammy skin, weak pulse, shallow breathing, fainting, or breathing that stops.

What should I avoid while using Roxanol (morphine)?

Do not drink alcohol while you are taking this medication. Dangerous side effects or death can occur when alcohol is combined with morphine. Check your food and medicine labels to be sure these products do not contain alcohol. Morphine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Roxanol (morphine) side effects

shallow breathing, slow heartbeat;
seizure (convulsions);
cold, clammy skin;
confusion;
severe weakness or dizziness; or
feeling light-headed, fainting.

Less serious side effects are more likely to occur, such as:

constipation;
warmth, tingling, or redness under your skin;
nausea, vomiting, stomach pain, diarrhea, loss of appetite;
dizziness, headache, anxiety;
memory problems; or
sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Roxanol (morphine)?

Avoid taking morphine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Side effects can be more severe if you use morphine before the MAO inhibitor has cleared from your body. Do not take morphine with other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

Before taking morphine, tell your doctor if you are using pentazocine (Talwin), nalbuphine (Nubain), butorphanol (Stadol), or buprenorphine (Buprenex, Subutex). If you are using any of these drugs, you may not be able to use morphine, or you may need dosage adjustments or special tests during treatment.

This list is not complete and there may be other drugs that can interact with morphine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about morphine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,R

Comments (0)

Roxanol Concentrate

30/06/10

Generic Name: Morphine (MORE-feen)
Brand Name: Roxanol

Roxanol Concentrate is used for:

Treating moderate to severe pain.

Roxanol Concentrate is a narcotic pain reliever. It works by dulling the pain perception center in the brain. It may also affect other body systems (eg, respiratory and circulatory systems) at higher doses.

Do NOT use Roxanol Concentrate if:

you are allergic to any ingredient in Roxanol Concentrate
you have known or suspected paralysis of the intestines or antibiotic-associated colitis
you have diarrhea due to poisoning
you are taking cimetidine, sodium oxybate (GHB), or a tricyclic antidepressant (eg, amitriptyline), or you drink alcohol
you have slowed breathing or severe asthma or are having an asthma attack

Contact your doctor or health care provider right away if any of these apply to you.

Before using Roxanol Concentrate:

Some medical conditions may interact with Roxanol Concentrate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems, or you have a history of drug abuse or dependence
if you have increased pressure in the head, a recent head injury, or lesions in the head
if you have difficulty urinating; heart, liver, or thyroid disease; hypercapnia (abnormally increased carbon dioxide tension in your arteries); curvature of the spine; seizures; or a history of suicidal thoughts or behaviors
if you have low blood volume, a stomach blockage or inflammatory bowel disease, have had stomach tract surgery, or are in shock

Some MEDICINES MAY INTERACT with Roxanol Concentrate. Tell your health care provider if you are taking any other medicines, especially any of the following:

Fluoxetine, naltrexone, narcotic agonists/antagonists (eg, pentazocine), rifampin, or risperidone because they may decrease Roxanol Concentrate’s effectiveness
Barbiturate anesthetics (eg, thiopental), cimetidine, ethanol, ketorolac, sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects (eg, disorientation, respiratory depression, seizures) may occur
Barbiturate anesthetics (eg, thiopental) or sodium oxybate (GHB) because the risk of their side effects may be increased by Roxanol Concentrate
Mexiletine or trovafloxacin because their effectiveness may be decreased by Roxanol Concentrate

This may not be a complete list of all interactions that may occur. Ask your health care provider if Roxanol Concentrate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Roxanol Concentrate:

Use Roxanol Concentrate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Roxanol Concentrate by mouth with or without food.
Use the dropper that comes with Roxanol Concentrate to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
Take Roxanol Concentrate on a regular schedule to get the most benefit from it. It is more effective in preventing pain than in treating pain after it occurs.
If you also take trovafloxacin, do not take it within 4 hours before or after taking Roxanol Concentrate. Check with your doctor if you have questions.
If you miss a dose of Roxanol Concentrate, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Roxanol Concentrate.

Important safety information:

Roxanol Concentrate may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Roxanol Concentrate with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Roxanol Concentrate; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
Roxanol Concentrate may cause constipation. Constipation may be avoided by using a stool softener or fiber laxative.
The risk of Roxanol Concentrate becoming habit-forming may be greater if you take it in high doses or for a long time. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
Tell your doctor or dentist that you take Roxanol Concentrate before you receive any medical or dental care, emergency care, or surgery.
Do not take Roxanol Concentrate if you have had a severe allergic reaction to morphine or hydromorphone (eg, MS Contin, Roxanol, Dilaudid). If you have a question about whether you are allergic to Roxanol Concentrate or if a certain medicine contains morphine or hydromorphone, contact your doctor or pharmacist.
Lab tests, including liver function, kidney function, lung function, and complete blood cell counts, may be performed while you use Roxanol Concentrate. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Roxanol Concentrate with caution in the ELDERLY; they may be more sensitive to its effects.
Roxanol Concentrate should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Roxanol Concentrate while you are pregnant. Roxanol Concentrate is found in breast milk. Do not breast-feed while taking Roxanol Concentrate.

When used for long periods of time or at high doses, Roxanol Concentrate may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Roxanol Concentrate stops working well. Do not take more than prescribed.

Some people who use Roxanol Concentrate for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Roxanol Concentrate suddenly, you may have WITHDRAWAL symptoms. These may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Roxanol Concentrate:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; exaggerated sense of well-being; headache; lightheadedness; nausea; restless mood; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); excessive drowsiness; hallucinations; pounding in the chest; seizures; shock; shortness of breath; sudden chest pain; sweating.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include cold and clammy skin; convulsions; deep sleep; dizziness; drowsiness; lightheadedness; loss of consciousness; low body temperature; slowed breathing; slowed heartbeat.

Proper storage of Roxanol Concentrate:

Store Roxanol Concentrate between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Roxanol Concentrate out of the reach of children and away from pets.

General information:

If you have any questions about Roxanol Concentrate, please talk with your doctor, pharmacist, or other health care provider.
Roxanol Concentrate is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Roxanol Concentrate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,R

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Roxanol-T

30/06/10

Generic Name: morphine (Oral route)

MOR-feen

Injection routeSolution

Duramorph(TM)
- Because of the risk of severe adverse effects when the epidural or intrathecal route of administration is employed, patients must be observed in a fully equipped and staffed environment for at least 24 hours after the initial dose.
- Naloxone injection and resuscitative equipment should be immediately available for administration in case of life-threatening or intolerable side effects and whenever Duramorph(TM) therapy is being initiated.
- Note: Intrathecal dosage is usually 1/10 that of epidural dosage.
- Duramorph(TM) is supplied in sealed ampuls. Accidental dermal exposure should be treated by the removal of any contaminated clothing and rising the affected area with water.
- Each ampul of Duramorph(TM) contains a potent narcotic which has been associated with abuse and dependence among health care providers. Due to the limited indication for this product, the risk of overdosage and the risk of its diversion and abuse, it is recommended that special measures be taken to control this product within the hospital or clinic.
- Duramorph(TM) should be subject to rigid accounting, rigorous control of wastage and restricted access.
- Parenteral drug products should be inspected for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if color is darker than pale yellow, if it is discolored in any other way or it contains a precipitate .

Duramorph(TM): There is a risk of severe adverse effects when the epidural or intrathecal route of administration is employed. Monitor patients closely and have naloxone injection and resuscitative equipment immediately available. The intrathecal dosage is usually 1/10 that of epidural dosage. Duramorph(TM) contains a potent narcotic which has been associated with abuse and dependence among health care providers .

Oral routeCapsule, Extended Release

Kadian(R)
- Kadian(R) contains morphine sulfate, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. Kadian(R) can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Kadian(R) in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion. Kadian(R) capsules are an extended-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Kadian(R) capsules are NOT for use as a prn analgesic. Kadian(R) 100 mg and 200 mg capsules are for use in opioid-tolerant patients only. Ingestion of these capsules or of the pellets within the capsules may cause fatal respiratory depression when administered to patients not already tolerant to high doses of opioids. Kadian(R) capsules are to be swallowed whole or the contents of the capsules sprinkled on applesauce. The pellets in the capsules are not to be chewed, crushed, or dissolved due to the risk of rapid release and absorption of a potentially fatal dose of morphine .

Kadian(R): contains morphine sulfate, an opioid agonist and Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. Kadian(R) is indicated for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The 100-mg and 200-mg capsules are for use in opioid-tolerant patients only. Kadian(R) capsules should be swallowed whole or the contents sprinkled on applesauce. Do not crush, chew, or dissolve capsule pellets due to the risk of rapid release and absorption of a potentially fatal dose of morphine .

Oral routeCapsule, Extended Release, 24 HR

Avinza(R)
- Avinza(R) capsules are a modified-release formulation of morphine sulfate indicated for once daily administration for the relief of moderate to severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time. AVINZA(R) capsules are to be swallowed whole or the contents of the capsules sprinkled on applesauce. The capsule beads are not to be chewed, crushed, or dissolved due to the risk of rapid release and absorption of a potentially fatal dose of morphine. Patients must not consume alcoholic beverages while on Avinza(R) therapy. Additionally, patients must not use prescription or non-prescription medications containing alcohol while on Avinza(R) therapy. Consumption of alcohol while taking Avinza(R) may result in the rapid release and absorption of a potentially fatal dose of morphine .

Avinza(R): capsules are a modified-release formulation of morphine sulfate indicated for once daily administration for the relief of moderate to severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time. Avinza(R) capsules should be swallowed whole or the contents sprinkled on applesauce. Do not crush, chew, or dissolve capsule beads due to the risk of rapid release and absorption of a potentially fatal dose of morphine. Avoid alcohol and alcohol-containing medications as consumption of alcohol may result in the rapid release and absorption of a potentially fatal dose of morphine .

Oral routeSolution

Risk of Medication Errors
- Morphine oral solution is available in 10 mg per 5 mL, 20 mg per 5 mL and 100 mg per 5 mL (20 mg/mL) concentrations.
- The 100 mg per 5 mL (20 mg/mL) concentration is indicated for use in opioid-tolerant patients only.
- Take care when prescribing and administering morphine oral solution to avoid dosing errors due to confusion between different concentrations and between mg and mL, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed.
- Keep morphine oral solution out of the reach of children. In case of accidental ingestion, seek emergency medical help immediately .

Morphine oral solution is available in 10 mg/5 mL, 20 mg/5 mL and 100 mg/5 mL (20 mg/mL) concentrations. The 100 mg/5 mL (20 mg/mL) concentration is indicated for use in opioid-tolerant patients only. Take care to avoid dosing errors due to confusion between different concentrations and between mg and mL, which could result in accidental overdose and death. Keep morphine oral solution out of the reach of children .

Oral routeTablet, Extended Release

MS Contin(R)
- MS Contin(R) contains morphine sulfate, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics.
- Morphine can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing MS Contin(R) in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.
- MS Contin(R) tablets are a controlled-release oral formulation of morphine sulfate indicated for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
- MS Contin(R) tablets are NOT intended for use as a prn analgesic.
- MS Contin(R) 100 and 200 mg tablets are for use in opioid-tolerant patients only. These tablet strengths may cause fatal respiratory depression when administered to patients not previously exposed to opioids.
- MS Contin(R) tablets are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed. Taking broken, chewed, dissolved, or crushed MS Contin(R) tablets leads to rapid release and absorption of a potentially fatal dose of morphine .
Oramorph(R) SR
- Oramorph(R) SR is a sustained-release dosage form. Patients should be instructed to swallow the tablet whole. The tablet should not be broken in half, nor should it be crushed or chewed. The sustained release of morphine from Oramorph(R) SR should be taken into consideration in the event of adverse reactions or overdosage .

MS Contin(R): 100 mg and 200 mg tablets are for use in opioid-tolerant patients only. MS Contin(R) tablets are a controlled-release formulation, should be swallowed whole and are not to be broken, chewed, dissolved, or crushed due to the risk of rapid release and absorption of a potentially fatal dose of morphine . Oramorph(R) SR: is a sustained-release dosage form. Swallow the tablet whole; the tablet should not be broken in half, nor should it be crushed or chewed .

Commonly used brand name(s):

In the U.S.

Avinza
Kadian
Kadian ER
MS Contin
MSIR
Oramorph SR
Roxanol
Roxanol-T

Available Dosage Forms:

Capsule, Extended Release
Capsule, Extended Release, 24 HR
Tablet, Extended Release
Capsule
Tablet
Powder for Suspension, Extended Release
Solution
Capsule, Delayed Release
Syrup

Therapeutic Class: Analgesic

Chemical Class: Opioid

Uses For Roxanol-T

Morphine is used to relieve moderate to severe pain. It belongs to the group of medicines called narcotic analgesics (pain medicines). Morphine acts on the central nervous system (CNS) to relieve pain.

When morphine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only with your doctor’s prescription.

Before Using Roxanol-T

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of morphine in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of morphine in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving morphine.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Brofaromine
Clorgyline
Furazolidone
Iproniazid
Isocarboxazid
Lazabemide
Linezolid
Moclobemide
Naltrexone
Nialamide
Pargyline
Phenelzine
Procarbazine
Rasagiline
Selegiline
Toloxatone
Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Adinazolam
Alfentanil
Alprazolam
Amobarbital
Anileridine
Aprobarbital
Bromazepam
Brotizolam
Buprenorphine
Butabarbital
Butalbital
Butorphanol
Carisoprodol
Chloral Hydrate
Chlordiazepoxide
Chlorpromazine
Chlorzoxazone
Cimetidine
Clobazam
Clonazepam
Clorazepate
Codeine
Dantrolene
Dezocine
Diazepam
Estazolam
Ethchlorvynol
Fentanyl
Flunitrazepam
Fluphenazine
Flurazepam
Halazepam
Hydrocodone
Hydromorphone
Ketazolam
Levorphanol
Lorazepam
Lormetazepam
Medazepam
Meperidine
Mephenesin
Mephobarbital
Meprobamate
Metaxalone
Methocarbamol
Methohexital
Midazolam
Morphine
Morphine Sulfate Liposome
Nalbuphine
Nitrazepam
Nordazepam
Opium
Oxazepam
Oxycodone
Oxymorphone
Pentazocine
Pentobarbital
Perphenazine
Phenobarbital
Prazepam
Prochlorperazine
Promazine
Promethazine
Propoxyphene
Quazepam
Remifentanil
Secobarbital
Sodium Oxybate
Sufentanil
Tapentadol
Temazepam
Thiethylperazine
Thiopental
Thioridazine
Triazolam
Trifluoperazine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Cyclosporine
Esmolol
Rifampin
Somatostatin
Yohimbine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Proper Use of morphine

This section provides information on the proper use of a number of products that contain morphine. It may not be specific to Roxanol-T. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).

You may take this medicine with or without food.

Morphine extended-release capsules and tablets should only be used by patients who have already been taking narcotic pain medicines, also called opioids. These patients are called opioid-tolerant. If you are uncertain whether or not you are opioid-tolerant, check with your doctor before using this medicine.

Swallow the extended-release capsules and tablets whole. Do not break, crush, dissolve, or chew them. Do not use extended-release tablets that are broken.

If you cannot swallow the extended-release capsule, you may open it and pour the medicine into a small amount of applesauce. Stir this mixture well and swallow it right away without chewing.

While taking the extended-release tablet, part of the tablet may pass into your stool. This is normal and nothing to worry about.

Morphine extended-release capsules or tablets work differently from the regular morphine oral solution or tablets, even at the same dose. Do not switch from one brand or form to the other unless your doctor tells you to.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (extended-release capsules):
- For moderate to severe pain:
  - Patients switching from regular morphine forms:
    - Adults—The capsule is given once a day. The initial dose in milligrams (mg) per day is the same as the total amount of regular morphine that is taken per day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 1600 mg per day.
    - Children—Use and dose must be determined by your doctor.
  - Patients who are not taking narcotic medicines:
    - Adults—At first, 30 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 1600 mg per day.
    - Children—Use and dose must be determined by your doctor.
For oral dosage form (extended-release tablets):
- For moderate to severe pain:
  - Patients switching from regular morphine forms:
    - Adults—The tablet is given every 8 hours or every 12 hours. The total amount of milligrams (mg) per day is the same as the total amount of regular morphine that is taken per day. The total amount per day will be divided and given as 2 or 3 doses during the day. Your doctor may adjust your dose if needed.
    - Children—Use and dose must be determined by your doctor.
For oral dosage form (solution):
- For moderate to severe pain:
  - Adults—10 to 20 milligrams (mg) every 4 hours as needed. Your doctor may adjust your dose if needed.
  - Children—Use and dose must be determined by your doctor.
For oral dosage form (tablets):
- For moderate to severe pain:
  - Adults—15 to 30 milligrams (mg) every 4 hours as needed. Your doctor may adjust your dose if needed.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Morphine can cause serious unwanted effects if taken by adults who are not used to strong narcotic pain medicines, children, or pets. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

Flush the unused capsules, liquid, and tablets down the toilet.

Precautions While Using Roxanol-T

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, confused, or disoriented. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Roxanol-T Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Abdominal or stomach pain
blurred vision
bulging soft spot on the head of an infant
burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
change in the ability to see colors, especially blue or yellow
chest pain or discomfort
chills
confusion
cough
decreased urination
difficulty with breathing
difficulty with swallowing
dizziness
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
fainting
fast, pounding, or irregular heartbeat or pulse
headache
hives
increased sweating
insomnia
itching
loss of appetite
nausea
nervousness
noisy breathing
pounding in the ears
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
severe constipation
severe vomiting
shakiness in the legs, arms, hands, or feet
shortness of breath
skin rash
slow or irregular heartbeat
sweating
swelling
tightness in the chest
trembling or shaking of the hands or feet
trouble with breathing
trouble with urinating
unusual tiredness or weakness
vomiting
wheezing

Incidence not known

Black, tarry stools
bleeding gums
blood in the urine or stools
bluish lips or skin
change in consciousness
chest pain or discomfort
cold, clammy skin
convulsions
decrease in the amount of urine
decrease in the frequency of urination
difficulty in passing urine (dribbling)
extremely shallow or slow breathing
fast, weak pulse
feeling of warmth or heat
flushing or redness of the skin, especially on the face and neck
irregular, fast or slow, or shallow breathing
lightheadedness
loss of consciousness
low blood pressure or pulse
nervousness
painful urination
pale or blue lips, fingernails, or skin
pale skin
pinpoint red spots on the skin
pounding in the ears
shakiness and unsteady walk
troubled breathing with exertion
unconsciousness
unsteadiness, trembling, or other problems with muscle control or coordination
unusual bleeding or bruising
very slow breathing
very slow heartbeat

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Bloody urine
constricted, pinpoint, or small pupils (black part of the eye)
dark-colored urine
decreased awareness or responsiveness
extreme drowsiness
fever
increased blood pressure
increased thirst
lower back or side pain
muscle cramps or spasms
muscle pain or stiffness
no muscle tone or movement
severe sleepiness
swelling of the face, fingers, or lower legs
weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Cramps
diarrhea
difficulty having a bowel movement (stool)
drowsiness
false or unusual sense of well-being
relaxed and calm feeling
sleepiness or unusual drowsiness
weight loss

Less common

Absent, missed, or irregular menstrual periods
acid or sour stomach
agitation
bad, unusual, or unpleasant (after) taste
belching
blurred or loss of vision
change in taste
decreased interest in sexual intercourse
depression
disturbed color perception
double vision
dry mouth
face is warm or hot to touch
fear
floating feeling
halos around lights
heartburn
inability to have or keep an erection
indigestion
loss in sexual ability, desire, drive, or performance
muscle stiffness or tightness
nervousness
night blindness
overbright appearance of lights
problems with muscle control
redness of the skin
seeing double
skin rash
sleeplessness
stomach discomfort, upset, or pain
stopping of menstrual bleeding
trouble sleeping
tunnel vision
unable to sleep
uncontrolled eye movements
upper abdominal or stomach pain
weakness

Incidence not known

Abnormal dreams
belching
burning while urinating
change in vision
change in walking and balance
change or problem with discharge of semen
clumsiness or unsteadiness
confusion as to time, place, or person
delusions
dementia
dry skin
eye pain
feeling of constant movement of self or surroundings
general feeling of discomfort or illness
hiccup
holding false beliefs that cannot be changed by fact
impaired vision
indigestion
loss of memory
problems with memory
seeing, hearing, or feeling things that are not there
sensation of spinning
thirst
unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
unusual excitement, nervousness, or restlessness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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Roxicet

30/06/10

Generic name: Acetaminophen, Oxycodone hydrochloride
Brand names: Tylox, Roxicet, Endocet, Percocet

Why is Roxicet prescribed?

Percocet, a narcotic analgesic, is used to treat moderate to moderately severe pain. It contains two drugs—acetaminophen and oxycodone. Acetaminophen is used to reduce both pain and fever. Oxycodone, a narcotic analgesic, is used for its calming effect and for pain.

Most important fact about Roxicet

Percocet contains a narcotic and, even if taken only in prescribed amounts, can cause physical and psychological dependence when taken for a long time.

How should you take Roxicet?

Percocet may be taken with meals or with milk.

If you miss a dose…
If you take Percocet on a regular schedule, take it as soon as you remember. If it is almost time for the next dose, skip the one you missed and go back to your regular schedule. Never take 2 doses at once.

Storage instructions…
Store at room temperature.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Percocet.

Side effects may include:
Dizziness, light-headedness, nausea, sedation, vomiting

You may be able to alleviate some of these side effects by lying down.

Why should Roxicet not be prescribed?

You should not use Percocet if you are sensitive to either acetaminophen or oxycodone.

Special warnings about Roxicet

You should take Percocet cautiously and according to your doctor’s instructions, as you would take any medication containing a narcotic. If you have ever had a problem with alcohol addiction, make sure your doctor is aware of it.

If you have experienced a head injury, consult your doctor before taking Percocet. The effects of Percocet may be stronger for people with head injuries, and using it may delay recovery.

If you have stomach problems, such as an ulcer, check with your doctor before taking Percocet. Percocet may hide the symptoms of stomach problems, making them difficult to diagnose and treat.

If you have ever had liver, kidney, thyroid gland, or Addison’s disease (a disease of the adrenal glands), difficulty urinating, or an enlarged prostate, consult your doctor before taking Percocet.

Elderly people or those in a weakened condition should take Percocet cautiously.

This drug may impair your ability to drive a car or operate potentially dangerous machinery. Do not participate in any activities that require full alertness if you are unsure about the drug’s effect on you.

Possible food and drug interactions when taking Roxicet

Alcohol may increase the sedative effects of Percocet. You should not take Percocet with alcohol.

If Percocet is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Percocet with the following:

Antispasmodic drugs
Major tranquilizers
Other narcotic painkillers
Sedatives such as phenobarbital
Tranquilizers

Special information if you are pregnant or breastfeeding

It is not known whether Percocet can injure a developing baby or affect a woman’s reproductive capacity. Using any medication that contains a narcotic during pregnancy may cause physical addiction for your newborn baby. If you are pregnant or plan to become pregnant, inform your doctor immediately. As with other narcotic painkillers, taking Percocet shortly before delivery (especially at higher dosages) may cause some degree of impaired breathing in the mother and newborn. It is not known whether Percocet appears in breast milk, possibly harming a nursing infant. If you are breastfeeding use Percocet only under a doctor’s directions.

Recommended dosage for Roxicet

ADULTS

The usual dose is 1 to 2 tablets of the lowest strength (2.5 milligrams oxycodone/325 milligrams acetaminophen) every 6 hours. Doctors sometimes prescribe a higher dose if necessary. The total daily dose of acetaminophen should not exceed 4 grams. The maximum daily dose recommended for each strength of Percocet (oxycodone/acetaminophen) is as follows:

2.5 milligrams/325 milligrams: 12 tablets

5 milligrams/325 milligrams: 12 tablets

7.5 milligrams/500 milligrams: 8 tablets
10 milligrams/650 milligrams: 6 tablets

CHILDREN

The safety and effectiveness of Percocet have not been established in children.

Overdosage

A severe overdose of Percocet can be fatal. If you suspect an overdose, seek medical help immediately.

Symptoms of Percocet overdose may include:
Bluish skin, eyes or skin with yellow tone, cold and clammy skin, decreased or irregular breathing (ceasing in severe overdose), extreme sleepiness progressing to stupor or coma, heart attack, low blood pressure, muscle weakness, nausea, slow heartbeat, sweating, vague bodily discomfort, vomiting

Detailed,R

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Rowasa

30/06/10

Generic Name: mesalamine (rectal) (me SAL a meen)
Brand Names: Canasa, Canasa Pac, Rowasa

What is Rowasa (mesalamine (rectal))?

Mesalamine affects a substance in the body that causes inflammation, tissue damage, and diarrhea.

Mesalamine rectal is used to treat ulcerative colitis, proctitis, and proctosigmoiditis. Mesalamine is also used to prevent the symptoms of ulcerative colitis from recurring.

Mesalamine rectal may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Rowasa (mesalamine (rectal))?

Do not take mesalamine rectal by mouth. It is for use only in your rectum. Tell your doctor if you have any type of kidney or liver disease, or if you are allergic to aspirin. You may not be able to use mesalamine, or you may need a dosage adjustment or special tests during treatment.

This medication comes with patient instructions for using either the rectal suppository or the rectal enema. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Try to empty your bowel and bladder just before using the mesalamine suppository or enema. Try to use the medicine at a time when you can lie down afterward and hold the medicine in. Avoid using the bathroom during this time. It may be best to use this medicine at bedtime.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

Shake the rectal enema liquid well just before each use.

The rectal enema liquid may darken in color after it has been removed from the foil pouch. This should not affect the medicine. However, throw away any enema liquid that has turned dark brown.

Stop using mesalamine and call your doctor at once if you have severe stomach pain, cramping, fever, headache, and bloody diarrhea.

Avoid getting the rectal suppositories or enema liquid on clothing, flooring, painted surfaces, vinyl, marble, granite, and other surfaces. Mesalamine rectal products may stain surfaces.

What should I discuss with my health care provider before taking Rowasa (mesalamine (rectal))?

Tell your doctor if you have any type of kidney or liver disease, or if you are allergic to aspirin. You may not be able to use mesalamine, or you may need a dosage adjustment or special tests during treatment. FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Mesalamine rectal can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Rowasa (mesalamine (rectal))?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger or smaller amounts, or use it for longer than recommended by your doctor.

Mesalamine rectal comes with patient instructions for using either the rectal suppository or the rectal enema. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Do not take mesalamine rectal by mouth. It is for use only in your rectum.

Try to empty your bowel and bladder just before using the mesalamine suppository or enema. It may be best to use this medicine at bedtime.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

For best results from the suppository, lie down after inserting it and hold in the suppository for one to three hours. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in. Avoid using the bathroom during this time.

Shake the rectal enema liquid well just before each use.

For best results from the enema, stay lying down for at least 30 minutes after using the enema to allow the liquid to distribute throughout your intestines. Try to hold in the enema all night if possible. Avoid using the bathroom during this time.

The rectal enema liquid may darken in color after it has been removed from the foil pouch. This should not affect the medicine. However, throw away any enema liquid that has turned dark brown.

Store the rectal enema at room temperature away from moisture and heat. Store the rectal suppositories at cool room temperature away from moisture and heat. Do not refrigerate or freeze them.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Try to use the medicine at a time when you can lie down afterward and hold the medicine in. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of mesalamine rectal is not expected to produce life-threatening symptoms.

What should I avoid while taking Rowasa (mesalamine (rectal))?

Avoid getting the rectal suppositories or enema liquid on clothing, flooring, painted surfaces, vinyl, marble, granite, and other surfaces. Mesalamine rectal products may stain surfaces.

Rowasa (mesalamine (rectal)) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using mesalamine rectal and call your doctor at once if you have severe stomach pain, cramping, fever, headache, and bloody diarrhea.

Less serious side effects may include:

mild nausea, vomiting, stomach cramps, diarrhea, gas;
fever, sore throat, or other flu symptoms;
rectal pain, constipation;
headache or dizziness;
tired feeling; or
skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Rowasa (mesalamine (rectal))?

There may be other drugs that can interact with mesalamine rectal. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about mesalamine rectal.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,R

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Rowasa Enema

30/06/10

Generic Name: Mesalamine (me-SAL-a-meen)
Brand Name: Rowasa

Rowasa Enema is used for:

Treating mild to moderate inflammation of the colon or rectum.

Rowasa Enema is a 5-aminosalicylic acid (5-ASA). It works by preventing the production of substances that cause the inflammation of the colon.

Do NOT use Rowasa Enema if:

you are allergic to any ingredient in Rowasa Enema, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen), or salicylates (eg, aspirin)
you are younger than 18 years of age and you have the flu or chickenpox, or you have received a live vaccine (eg, varicella, influenza) within the past 6 weeks
you are taking probenecid or sulfinpyrazone

Contact your doctor or health care provider right away if any of these apply to you.

Before using Rowasa Enema:

Some medical conditions may interact with Rowasa Enema. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines (including sulfasalazine), foods, or other substances (including sulfites)
if you have had a stroke, bleeding in the brain, or an aneurysm
if you have a history of liver or kidney problems, pancreas problems (eg, pancreatitis), Kawasaki syndrome, or a rheumatic (inflammatory) disease (eg, rheumatoid arthritis)
if you have a history of heart problems (eg, inflammation of the sac around your heart)
if you have the flu or chickenpox, or if you have recently received a live vaccine (eg, varicella, influenza)

Some MEDICINES MAY INTERACT with Rowasa Enema. Tell your health care provider if you are taking any other medicines, especially any of the following:

Gingko biloba extract because side effects, such as increased bleeding, may occur
Corticosteroids (eg, prednisone) because they may decrease Rowasa Enema’s effectiveness
Carbonic anhydrase inhibitors (eg, acetazolamide), insulin, meglitinide antidiabetics (eg, repaglinide), sulfonylureas (eg, glipizide), or valproic acid because the risk of their side effects may be increased by Rowasa Enema
Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), anticoagulants (eg, warfarin), beta-blockers (eg, propranolol), probenecid, spironolactone, or sulfinpyrazone because their effectiveness may be decreased by Rowasa Enema

This may not be a complete list of all interactions that may occur. Ask your health care provider if Rowasa Enema may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Rowasa Enema:

Use Rowasa Enema as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Best results are achieved if the bowel is emptied immediately before using Rowasa Enema.
Use Rowasa Enema at bedtime, unless otherwise directed by your doctor.
Shake the bottle well. Remove the protective sheath from the applicator tip.
Holding the bottle at the neck will not allow the medicine to be discharged. The position most often used is to lay on the left side, with the lower leg extended and the upper right leg flexed forward for balance. An alternative is the knee-chest position.
Gently insert the applicator tip in the rectum, pointing toward the naval. Grasp the bottle firmly, then tilt slightly so that the nozzle is aimed toward the back. Squeeze slowly to instill the medicine. Steady hand pressure will discharge most of the medicine. After using, withdraw the bottle and throw it away.
Remain in this position for at least 30 minutes after using Rowasa Enema to allow complete distribution of the medicine in the body. Retain Rowasa Enema all night if possible.
Rowasa Enema will stain direct contact surfaces, including fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel. Choose a suitable location when using Rowasa Enema.
If you miss a dose of Rowasa Enema and you are using 1 dose daily at bedtime, skip the missed dose. Do not use the dose in the morning. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Rowasa Enema.

Important safety information:

Rowasa Enema may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Rowasa Enema with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Rowasa Enema may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Rowasa Enema. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it.
Some patients may experience an intolerance reaction to Rowasa Enema. Signs of intolerance are very similar to symptoms of inflammatory bowel disease. They may include bloody diarrhea, fever, headache, rash, or severe or persistent stomach pain or cramping. If you experience any of these symptoms, contact your doctor right away.
Salicylates have been linked to a serious illness called Reye syndrome. Do not give Rowasa Enema to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.
Lab tests, including kidney function, liver function, or complete blood cell counts, may be performed while you use Rowasa Enema. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Rowasa Enema with caution in the ELDERLY; they may be more sensitive to its effects, especially blood problems.
Rowasa Enema should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Rowasa Enema while you are pregnant. It is not known if Rowasa Enema is found in breast milk. If you are or will be breast-feeding while you use Rowasa Enema, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Rowasa Enema:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Flu-like symptoms; gas; hemorrhoids; mild headache; mild stomach discomfort or pain; nausea; rectal pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back, leg, or joint pain; bloody or coffee ground-like vomit; chest pain; dark urine; dark, bloody, or tarry stools; fever, chills, or persistent sore throat; hair loss; severe headache; shortness of breath; sudden or severe stomach pain or cramping; unusual bruising or bleeding; yellowing of the skin or eyes.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include confusion; diarrhea; dizziness; drowsiness; fast or difficult breathing; fever; headache; hearing loss; ringing in the ears; seizures; sweating; vomiting of blood; weakness.

Proper storage of Rowasa Enema:

Store Rowasa Enema between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. After the foil-wrapped unit of 7 bottles is opened, use all enemas promptly. The contents of the enemas may darken with time. Slight darkening will not affect the strength of Rowasa Enema. Throw away enemas with dark brown contents. Keep Rowasa Enema out of the reach of children and away from pets.

General information:

If you have any questions about Rowasa Enema, please talk with your doctor, pharmacist, or other health care provider.
Rowasa Enema is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Rowasa Enema. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,R

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Roxal-Estradiol Derm 100

30/06/10

Generic Name: estrogen (Oral route, Parenteral route, Topical application route, Transdermal route)

Commonly used brand name(s):

In the U.S.

Alora
Cenestin
Climara
Divigel
Elestrin
Emcyt
Enjuvia
Esclim
Estinyl
EstroGel
Evamist
Femtrace
Gynodiol
Menest
Menostar
Ogen .625
Ogen 1.25
Ogen 2.5
Premarin
Vivelle
Vivelle-Dot

In Canada

Estraderm
Estradot Transdermal
Estradot Transdermal Therapeutic System
Estradot Transdermal Therapeutic System
Estrogel
Oesclim
Rhoxal-Estradiol Derm 50
Rhoxal-Estradiol Derm 75
Roxal-Estradiol Derm 100
Vivelle 100 Mcg
Vivelle 25 Mcg

Available Dosage Forms:

Tablet
Tablet, Enteric Coated
Capsule
Patch, Extended Release
Gel/Jelly
Spray
Emulsion

Uses For Roxal-Estradiol Derm 100

Estrogens are female hormones. They are produced by the body and are necessary for the normal sexual development of the female and for the regulation of the menstrual cycle during the childbearing years.

The ovaries begin to produce less estrogen after menopause (the change of life). This medicine is prescribed to make up for the lower amount of estrogen. Estrogens help relieve signs of menopause, such as hot flashes and unusual sweating, chills, faintness, or dizziness.

Estrogens are prescribed for several reasons:

To provide additional hormone when the body does not produce enough of its own, such as during menopause or when female puberty (development of female sexual organs) does not occur on time. Other conditions include a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or ovary problems (female hypogonadism or failure or removal of both ovaries).
To help prevent weakening of bones (osteoporosis) in women past menopause.
In the treatment of selected cases of breast cancer in men and women.
In the treatment of cancer of the prostate in men.

Estrogens may also be used for other conditions as determined by your doctor.

There is no medical evidence to support the belief that the use of estrogens will keep the patient feeling young, keep the skin soft, or delay the appearance of wrinkles. Nor has it been proven that the use of estrogens during menopause will relieve emotional and nervous symptoms, unless these symptoms are caused by other menopausal symptoms, such as hot flashes or hot flushes.

Estrogens are available only with your doctor’s prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, estrogen is used in certain patients with the following medical conditions:

Gender identity disorder, male-to-female transsexualism (person who is born as a man but adapts to a woman’s lifestyle, sees himself as a woman, and feels like a woman instead of a man
Osteoporosis caused by lack of estrogen before menopause
Turner’s syndrome (a genetic disorder)

Before Using Roxal-Estradiol Derm 100

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Use of this medicine before puberty is not recommended. Growth of bones can be stopped early. Girls and boys may develop growth of breasts. Girls may have vaginal changes, including vaginal bleeding.

This medicine may be used to start puberty in teenagers with some types of delayed puberty.

Geriatric

Elderly people are especially sensitive to the effects of estrogens. This may increase the chance of side effects during treatment, especially stroke, invasive breast cancer, and memory problems.

Pregnancy

Estrogens are not recommended for use during pregnancy or right after giving birth. Becoming pregnant or maintaining a pregnancy is not likely to occur around the time of menopause.

Certain estrogens have been shown to cause serious birth defects in humans and animals. Some daughters of women who took diethylstilbestrol (DES) during pregnancy have developed reproductive (genital) tract problems and, rarely, cancer of the vagina or cervix (opening to the uterus) when they reached childbearing age. Some sons of women who took DES during pregnancy have developed urinary-genital tract problems.

Breast Feeding

Use of this medicine is not recommended in nursing mothers. Estrogens pass into the breast milk and their possible effect on the baby is not known.

Interactions with Medicines

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

Rotavirus Vaccine, Live

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Bacillus of Calmette and Guerin Vaccine, Live
Felbamate
Influenza Virus Vaccine, Live
Isotretinoin
Measles Virus Vaccine, Live
Mumps Virus Vaccine, Live
Paclitaxel
Paclitaxel Protein-Bound
Poliovirus Vaccine, Live
Rotavirus Vaccine, Live
Rubella Virus Vaccine, Live
Smallpox Vaccine
St John’s Wort
Theophylline
Tizanidine
Typhoid Vaccine
Varicella Virus Vaccine
Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Proper Use of estrogen

This section provides information on the proper use of a number of products that contain estrogen. It may not be specific to Roxal-Estradiol Derm 100. Please read with care.

Estrogens usually come with patient information or directions. Read them carefully before taking this medicine.

Take this medicine only as directed by your doctor. Do not take more of it and do not take or use it for a longer time than your doctor ordered. For patients taking any of the estrogens by mouth, try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

For patients taking any of the estrogens by mouth or by injection:

Nausea may occur during the first few weeks after you start taking estrogens. This effect usually disappears with continued use. If the nausea is bothersome, it can usually be prevented or reduced by taking each dose with food or immediately after food.

For patients using the transdermal (skin patch) form of estradiol:

Wash and dry your hands thoroughly before and after handling the patch.
Apply the patch to a clean, dry, non-oily skin area of your lower abdomen, hips below the waist, or buttocks that has little or no hair and is free of cuts or irritation. The manufacturer of the 0.025-mg patch recommends that its patch be applied to the buttocks only. Furthermore, each new patch should be applied to a new site of application. For instance, if the old patch is taken off the left buttock, then apply the new patch to the right buttock.
Do not apply to the breasts. Also, do not apply to the waistline or anywhere else where tight clothes may rub the patch loose.
Press the patch firmly in place with the palm of your hand for about 10 seconds. Make sure there is good contact, especially around the edges.
If a patch becomes loose or falls off, you may reapply it or discard it and apply a new patch.
Each dose is best applied to a different area of skin on your lower abdomen, hips below the waist, or buttocks so that at least 1 week goes by before the same area is used again. This will help prevent skin irritation.

For patients using the topical emulsion (skin lotion) form of estradiol:

Washing and drying hands thoroughly before each application.
Apply while you are sitting comfortably. Apply one pouch to each leg every morning.
Apply the entire contents of one pouch to clean, dry skin on the left thigh. Rub the emulsion into the entire thigh and calf for 3 minutes until thoroughly absorbed.
Apply entire contents of the second pouch to clean, dry skin on the right thigh. Rub the emulsion into the entire thigh and calf for 3 minutes until thoroughly absorbed.
Rub any remaining emulsion on both hands on the buttocks.
Washing and drying hands thoroughly after application.
To avoid transfer to other individuals, allow the application areas to dry completely before covering with clothing.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

For conjugated estrogens
For oral dosage form (tablets):
- For treating breast cancer in women after menopause and in men:
  - Adults—10 milligrams (mg) three times a day for at least three months.
- For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
  - Adults—0.3 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may change the dose based on how your body responds to the medication.
- To prevent loss of bone (osteoporosis):
  - Adults—0.3 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may change the dose based on how your body responds to the medication.
- For treating ovary problems (female hypogonadism or for starting puberty):
  - Adults and teenagers—0.3 to 0.625 mg a day. Your doctor may want you to take the medicine only on certain days of the month.
- For treating ovary problems (failure or removal of both ovaries):
  - Adults—1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
- For treating prostate cancer:
  - Adults—1.25 to 2.5 mg three times a day.
For injection dosage form:
- For controlling abnormal bleeding of the uterus:
  - Adults—25 mg injected into a muscle or vein. This may be repeated in six to twelve hours if needed.

For esterified estrogens
For oral dosage form (tablets):
- For treating breast cancer in women after menopause and in men:
  - Adults—10 milligrams (mg) three times a day for at least three months.
- For treating a genital skin condition (vulvar atrophy) or inflammation of the vagina (atrophic vaginitis), or to prevent loss of bone (osteoporosis):
  - Adults—0.3 to 1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
- For treating ovary problems (failure or removal of both ovaries):
  - Adults—1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
- For treating ovary problems (female hypogonadism):
  - Adults—2.5 to 7.5 mg a day. This dose may be divided up and taken in smaller doses. Your doctor may want you to take the medicine each day or only on certain days of the month.
- For treating symptoms of menopause:
  - Adults—0.625 to 1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
- For treating prostate cancer:
  - Adults—1.25 to 2.5 mg three times a day.

For estradiol
For oral dosage form:
- For treating breast cancer in women after menopause and in men:
  - Adults—10 milligrams (mg) three times a day for at least three months .
- For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), ovary problems (female hypogonadism or failure or removal of both ovaries), or symptoms of menopause:
  - Adults—At first, 1 to 2 milligrams (mg) one time per day for at least three months. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may also need to change the dose based on how your body responds to the medication .
- For treating prostate cancer:
  - Adults—1 to 2 mg three times a day .
- To prevent loss of bone (osteoporosis):
  - Adults—0.5 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month .
For topical emulsion dosage form (skin lotion):
- For treating symptoms of menopause:
  - Adults—1.74 grams (one pouch) applied to the skin of each leg (thigh and calf) once a day in the morning.
For transdermal dosage form (skin patches):
- For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), symptoms of menopause, ovary problems (female hypogonadism or failure or removal of both ovaries), or to prevent loss of bone (osteoporosis):
  - For the Climara patches
  - Adults—0.025 to 0.1 milligram (mg) (one patch) applied to the skin and worn for one week. Then, remove that patch and apply a new one. A new patch should be applied once a week for three weeks. During the fourth week, you may or may not wear a patch. Your health care professional will tell you what you should do for this fourth week. After the fourth week, you will repeat the cycle.
  - For the Alora, Estraderm, Estradot, Vivelle, or Vivelle-Dot patches
  - Adults—0.025 to 0.1 mg (one patch) applied to the skin and worn for one half of a week. Then, remove that patch and apply and wear a new patch for the rest of the week. A new patch should be applied two times a week for three weeks. During the fourth week, you may or may not apply new patches. Your health care professional will tell you what you should do for this fourth week. After the fourth week, you will repeat the cycle.

For estradiol cypionate
For injection dosage form:
- For treating ovary problems (female hypogonadism):
  - Adults—1.5 to 2 milligrams (mg) injected into a muscle once a month.
- For treating symptoms of menopause:
  - Adults—1 to 5 mg injected into a muscle every three to four weeks.

For estradiol valerate
For injection dosage form:
- For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), symptoms of menopause, or ovary problems (female hypogonadism or failure or removal of both ovaries):
  - Adults—10 to 20 milligrams (mg) injected into a muscle every four weeks as needed.
- For treating prostate cancer:
  - Adults—30 mg injected into a muscle every one or two weeks.

For estrone
For injection dosage form:
- For controlling abnormal bleeding of the uterus:
  - Adults—2 to 5 milligrams (mg) a day, injected into a muscle for several days.
- For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
  - Adults—0.1 to 0.5 mg injected into a muscle two or three times a week. Your doctor may want you to receive the medicine each week or only during certain weeks of the month.
- For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
  - Adults—0.1 to 1 mg a week. This is injected into a muscle as a single dose or divided into more than one dose. Your doctor may want you to receive the medicine each week or only during certain weeks of the month.
- For treating prostate cancer:
  - Adults—2 to 4 mg injected into a muscle two or three times a week.

For estropipate
For oral dosage form (tablets):
- For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
  - Adults—0.75 to 6 milligrams (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
- For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
  - Adults—1.5 to 9 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
- To prevent loss of bone (osteoporosis):
  - Adults—0.75 mg a day. Your doctor may want you to take the medicine each day for twenty-five days of a thirty-one–day cycle.

For ethinyl estradiol
For oral dosage form (tablets):
- For treating breast cancer in women after menopause and in men:
  - Adults—1 milligram (mg) three times a day.
- For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
  - Adults—0.05 mg one to three times a day for three to six months. Your doctor may want you to take the medicine each day or only on certain days of the month.
- For treating prostate cancer:
  - Adults—0.15 to 3 mg a day.
- For treating symptoms of menopause:
  - Adults—0.02 to 0.05 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.

For ethinyl estradiol and norethindrone
For oral dosage form (tablets):
- For treating symptoms of menopause:
  - Adults—1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone) each day.
- To prevent loss of bone (osteoporosis):
  - Adults—1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone) each day

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Roxal-Estradiol Derm 100

It is very important that your doctor check your progress at regular visits to make sure this medicine does not cause unwanted effects. These visits will usually be every year, but some doctors require them more often.

In some patients using estrogens, tenderness, swelling, or bleeding of the gums may occur. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.

Although the incidence is low, the use of estrogens may increase you chance of getting cancer of the breast, ovaries, or uterus (womb).. Therefore, it is very important that you regularly check your breasts for any unusual lumps or discharge. Report any problems to your doctor. You should also have a mammogram (x-ray pictures of the breasts) done if your doctor recommends it. Because breast cancer has occurred in men taking estrogens, regular breast self-exams and exams by your doctor for any unusual lumps or discharge should be done.

If your menstrual periods have stopped, they may start again. This effect will continue for as long as the medicine is taken. However, if taking the continuous treatment (0.625 mg conjugated estrogens and 2.5 mg medroxyprogesterone once a day), monthly bleeding usually stops within 10 months.

Also, vaginal bleeding between your regular menstrual periods may occur during the first 3 months of use. Do not stop taking your medicine. Check with your doctor if bleeding continues for an unusually long time, if your period has not started within 45 days of your last period, or if you think you are pregnant.

Tell the doctor in charge that you are taking this medicine before having any laboratory test because some results may be affected.

Roxal-Estradiol Derm 100 Side Effects

Women rarely have severe side effects from taking estrogens to replace estrogen. Discuss these possible effects with your doctor:

The prolonged use of estrogens has been reported to increase the risk of endometrial cancer (cancer of the lining of the uterus) in women after menopause. This risk seems to increase as the dose and the length of use increase. When estrogens are used in low doses for less than 1 year, there is less risk. The risk is also reduced if a progestin (another female hormone) is added to, or replaces part of, your estrogen dose. If the uterus has been removed by surgery (total hysterectomy), there is no risk of endometrial cancer.

Although the incidence is low, the use of estrogens may increase you chance of getting cancer of the breast. Breast cancer has been reported in men taking estrogens.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

The following side effects may be caused by blood clots, which could lead to stroke, heart attack, or death. These side effects occur rarely, and, when they do occur, they occur in men treated for cancer using high doses of estrogens.

Check with your doctor immediately if any of the following side effects occur:

Rare – for males being treated for breast or prostate cancer only

Headache (sudden or severe)
loss of coordination (sudden)
loss of vision or change of vision (sudden)
pains in chest, groin, or leg, especially in calf of leg
shortness of breath (sudden and unexplained)
slurring of speech (sudden)
weakness or numbness in arm or leg

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Breast pain (in females and males)
fast heartbeat
fever
hives
hoarseness
increased breast size (in females and males)
irritation of skin
itching of skin
joint pain, stiffness or swelling
rash
redness of skin
shortness of breath
swelling of eyelids, face, lips, hands, or feet
swelling of feet and lower legs
tightness in chest
troubled breathing or swallowing
weight gain (rapid)
wheezing

Less common or rare

Changes in vaginal bleeding (spotting, breakthrough bleeding, prolonged or heavier bleeding, or complete stoppage of bleeding)
chest pain
chills
cough
heavy non-menstrual vaginal bleeding
lumps in, or discharge from, breast (in females and males)
pains in stomach, side, or abdomen
yellow eyes or skin

Frequency not determined

Abdominal bloating
abdominal cramps
acid or sour stomach
anxiety
backache
belching
blindness
blistering, peeling, loosening of skin
blue-yellow color blindness
blurred vision
change in vaginal discharge
changes in vision
changes in skin color
chest discomfort
clay-colored stools
clear or bloody discharge from nipple
confusion
constipation
convulsions
dark urine
decrease in amount of urine
decreased vision
depression
diarrhea
difficulty breathing
difficulty in speaking
dimpling of breast skin
dizziness
double vision
dry mouth
eye pain
fainting
fluid-filled skin blisters
full feeling in upper abdomen
full or bloated feeling or pressure in the stomach
headache
heartburn
inability to move arms, legs, or facial muscles
inability to speak
incoherent speech
increased urination
indigestion
inverted nipple
irregular heartbeats
light-colored stools
lightheadedness
loss of appetite
loss of bladder control
lump under the arm
metallic taste
migraine headache
mood or mental changes
muscle cramps in hands, arms, feet, legs, or face
muscle pain
muscle spasm or jerking of all extremities
muscle weakness
nausea
noisy breathing
numbness or tingling of hands, feet, or face
pain in ankles or knees
pains in chest, groin, or legs, especially calves of legs
pain or discomfort in arms, jaw, back or neck
pain or feeling of pressure in pelvis
painful or tender cysts in the breasts
painful, red lumps under the skin, mostly on the legs
pain; tenderness; swelling of foot or leg
partial or complete loss of vision in eye
pelvic pain
persistent crusting or scaling of nipple
pinpoint red or purple spots on skin
prominent superficial veins over affected area
red, irritated eyes
redness or swelling of breast
sensitivity to the sun
severe headaches of sudden onset
skin thinness
skin warmth
slow speech
sore on the skin of the breast that does not heal
sore throat
sores, ulcers, or white spots in mouth or on lips
stomach discomfort, upset or pain
sudden loss of consciousness
sudden loss of coordination
sudden onset of shortness of breath for no apparent reason
sudden onset of slurred speech
sudden vision changes
swelling of abdominal or stomach area
swelling of fingers or hands
thirst
tremor
unpleasant breath odor
unusual tiredness or weakness
vomiting
vomiting of blood
weight loss

More common

Abnormal growth filled with fluid or semisolid material
accidental injury
bladder pain
bloated full feeling
bloody or cloudy urine
body aches or pain
coating or white patches on tongue
congestion
cough producing mucus
decrease in amount of urine
difficult, burning, or painful urination
discouragement
dryness of throat
ear congestion or pain
excess air or gas in stomach or intestines
fear
feeling of warmth
feeling sad or empty
frequent urge to urinate
general feeling of discomfort or illness
headache, severe and throbbing
increased clear or white vaginal discharge
irritability
itching of the vaginal, rectal or genital areas
lack of appetite
lack or loss of strength
loss of interest or pleasure
mild dizziness
neck pain
nervousness
pain
pain during sexual intercourse
painful or difficult urination
pain or tenderness around eyes and cheekbones
passing gas
redness of the face, neck, arms and occasionally, upper chest
runny nose
skin irritation or redness where skin patch was worn
shivering
sleeplessness
sneezing
sore mouth or tongue
stuffy nose
sudden sweating
tender, swollen glands in neck
thick, white vaginal discharge with no odor or with a mild odor
tiredness
trouble concentrating
trouble sleeping
unable to sleep
voice changes

Less common

Blemishes on the skin
burning, crawling, itching, numbness, prickling, “pins and needles” , or tingling feelings
burning or stinging of skin
diarrhea (mild)
difficulty in moving
dizziness (mild)
increased hair growth, especially on the face
lower abdominal pain or pressure
mood or mental changes
muscle stiffness
painful cold sores or blisters on lips, nose, eyes, or genitals
pimples
pounding in the ears
problems in wearing contact lenses
slow heartbeat
tooth or gum pain
unusual decrease in sexual desire (in males)
unusual increase in sexual desire (in females)
white or brownish vaginal discharge

Frequency not determined

Abdominal pain
abnormal turning out of cervix
changes in appetite
dull ache or feeling of pressure or heaviness in legs
fatigue
flushed, dry skin
fruit-like breath odor
increased hunger
irritability
large amount of triglyceride in the blood
leg cramps
patchy brown or dark brown discoloration of skin
poor insight and judgment
problems with memory or speech
trouble recognizing objects
trouble thinking and planning
trouble walking
twitching, uncontrolled movements of tongue, lips, face, arms, or legs
unexpected or excess milk flow from breasts

Also, many women who are taking estrogens with a progestin (another female hormone) will start having monthly vaginal bleeding, similar to menstrual periods, again. This effect will continue for as long as the medicine is taken. However, monthly bleeding will not occur in women who have had the uterus removed by surgery (total hysterectomy).

This medicine may cause loss or thinning of scalp hair in some people.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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rotavirus vaccine, live (Oral route)

30/06/10

ROE-ta-vye-rus VAX-een, lyve

Commonly used brand name(s):

In the U.S.

Rotarix
RotaTeq

Available Dosage Forms:

Powder for Suspension
Suspension

Therapeutic Class: Vaccine

Uses For rotavirus vaccine, live

Rotavirus vaccine live is used to prevent infants and children from getting rotavirus infection. It works by causing your body to produce its own protection (antibodies) against the virus.

Rotavirus is a serious infection that causes diarrhea and vomiting. This infection may also lead to severe dehydration in infants and children.

This vaccine is to be administered only by or under the supervision of your doctor or other health care professional.

Before Using rotavirus vaccine, live

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to rotavirus vaccine, live or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of rotavirus vaccine live in infants younger than 6 weeks or older than 24 weeks of age. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of rotavirus vaccine in geriatric patients.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Receiving this vaccine with any of the following medicines is not recommended. Your doctor may decide not to use this vaccine or change some of the other medicines you take.

Aclarubicin
Aldesleukin
Altretamine
Amonafide
Amsacrine
Asparaginase
Azacitidine
Betamethasone
Bleomycin
Broxuridine
Busulfan
Capecitabine
Carboplatin
Carmustine
Chlorambucil
Cisplatin
Cladribine
Corticotropin
Cortisone
Cosyntropin
Cyclophosphamide
Cytarabine
Cytarabine Liposome
Dacarbazine
Dactinomycin
Daunorubicin
Daunorubicin Citrate Liposome
Decitabine
Deflazacort
Dexamethasone
Docetaxel
Doxifluridine
Doxorubicin Hydrochloride
Doxorubicin Hydrochloride Liposome
Edatrexate
Eflornithine
Epirubicin
Estramustine
Etoposide
Floxuridine
Fludarabine
Fludrocortisone
Fluocortolone
Fluorouracil
Fotemustine
Gallium Nitrate
Gemcitabine
Hydrocortisone
Hydroxyurea
Idarubicin
Ifosfamide
Interferon Alfa
Interferon Alfacon-1
Interferon Beta
Interferon Beta-1a
Interferon Beta-1b
Interferon Gamma
Irinotecan
Lomustine
Mechlorethamine
Melphalan
Mercaptopurine
Methotrexate
Methylprednisolone
Mitolactol
Mitomycin
Mitotane
Mitoxantrone
Oxaliplatin
Paclitaxel
Paclitaxel Protein-Bound
Paramethasone
Pegaspargase
Pentostatin
Pipobroman
Pirarubicin
Plicamycin
Prednisolone
Prednisone
Procarbazine
Raltitrexed
Rituximab
Streptozocin
Teceleukin
Tegafur
Teniposide
Thioguanine
Thiotepa
Topotecan
Treosulfan
Triamcinolone
Trimetrexate
Trofosfamide
Uracil Mustard
Vinblastine
Vincristine
Vincristine Liposome
Vindesine
Vinorelbine

Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Aclarubicin
Adalimumab
Aldesleukin
Alemtuzumab
Altretamine
Amonafide
Amsacrine
Asparaginase
Azacitidine
Azathioprine
Bleomycin
Broxuridine
Busulfan
Capecitabine
Carboplatin
Carmustine
Certolizumab Pegol
Chlorambucil
Cisplatin
Cladribine
Cyclophosphamide
Cytarabine
Cytarabine Liposome
Dacarbazine
Dactinomycin
Daunorubicin
Daunorubicin Citrate Liposome
Decitabine
Docetaxel
Doxifluridine
Doxorubicin Hydrochloride
Doxorubicin Hydrochloride Liposome
Edatrexate
Eflornithine
Epirubicin
Estramustine
Etanercept
Etoposide
Floxuridine
Fludarabine
Fluorouracil
Fotemustine
Gallium Nitrate
Gemcitabine
Golimumab
Hydroxyurea
Idarubicin
Ifosfamide
Irinotecan
Lomustine
Mechlorethamine
Melphalan
Mercaptopurine
Methotrexate
Mitolactol
Mitomycin
Mitotane
Mitoxantrone
Mycophenolic Acid
Oxaliplatin
Paclitaxel
Pegaspargase
Pentostatin
Pipobroman
Pirarubicin
Plicamycin
Procarbazine
Raltitrexed
Rilonacept
Rituximab
Sirolimus
Streptozocin
Tacrolimus
Teceleukin
Tegafur
Temsirolimus
Teniposide
Thioguanine
Thiotepa
Topotecan
Treosulfan
Trimetrexate
Trofosfamide
Uracil Mustard
Vinblastine
Vincristine
Vincristine Liposome
Vindesine
Vinorelbine

Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abatacept
Leflunomide
Vaccinia Immune Globulin, Human

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of rotavirus vaccine, live

A nurse or other trained health professional will give your child this vaccine. It is given by mouth.

rotavirus vaccine, live needs to be given on a fixed schedule. If your child missed the scheduled dose, call your child’s doctor for another appointment.

rotavirus vaccine, live comes with a patient information leaflet. Read the information carefully. Ask your doctor if you have any questions.

Dosing

The dose of rotavirus vaccine, live will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of rotavirus vaccine, live. If your dose is different, do not change it unless your doctor tells you to do so.

For oral dosage form (suspension):
- To prevent rotavirus infection:
  - Infants and children older than 24 weeks of age—Use and dose must be determined by your doctor.
  - Infants 6 to 24 weeks of age—The first dose should be given at around 6 weeks of age. Then, the second dose should be given at least 4 weeks after the first dose. Both doses must be completed before the baby is 6 months of age (or 24 weeks old).
  - Infants younger than 6 weeks of age—Use and dose must be determined by your doctor.

Precautions While Using rotavirus vaccine, live

It is very important that your child’s doctor check your child’s progress at regular visits to make sure that this vaccine is working properly and to check for unwanted effects.

Make sure your child’s doctor knows if your child is receiving a treatment that may weaken the immune system, such as steroid medicine, radiation treatment, or medicine to treat cancer. Also, tell your child’s doctor if your child spends time with a person who has immune system problems or is getting cancer treatment.

The oral applicator of this vaccine contains dry natural latex rubber. Make sure your child’s doctor knows if your child has had an allergic reaction to latex rubber.

Call your child’s doctor right away if your child has diarrhea, blood in their stool, high fever, severe stomach pain, or vomiting. These could be symptoms of a serious bowel problem called intussusception.

rotavirus vaccine, live Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Diarrhea
fever
nausea and vomiting
pain or cramping in the abdomen or stomach

Rare

Confusion
decreased urination
dizziness
dry mouth
fainting
increase in heart rate
lightheadedness
loss of appetite
rapid breathing
sunken eyes
thirst
unusual tiredness or weakness
wrinkled skin

Incidence not known

Black, tarry stools
blood in the urine
bloody nose
heavier menstrual periods
pinpoint red spots on the skin
red eyes
red mouth
skin rash
swollen glands
swollen hands and feet
unusual bleeding or bruising

More common

Cough
crying, fussiness, or irritability
runny nose

Less common

Bloated
excess air or gas in the stomach or intestines
full feeling
passing gas

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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Drugs & Medications:A-Z

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30/06/10

Roxicet Oral Solution Description

Inactive Ingredients

Roxicet Oral Solution – Clinical Pharmacology

Central Nervous System

Gastrointestinal Tract and Other Smooth Muscle

Cardiovascular System

Pharmacokinetics

Metabolism and Elimination

Indications and Usage for Roxicet Oral Solution

ï»¿CONTRAINDICATIONS

Warnings

Misuse, Abuse and Diversion of Opioids

Respiratory Depression

Head Injury and Increased Intracranial Pressure

Hypotensive Effect

Hepatotoxicity

Precautions

General

Acute Abdominal Conditions

Interactions with Other CNS Depressants

Interactions with Mixed Agonist/Antagonist Opioid Analgesics

Ambulatory Surgery and Postoperative Use

Use in Pancreatic/Biliary Tract Disease

Tolerance and Physical Dependence

Information for Patients/Caregivers

Laboratory Tests

Drug/Drug Interactions with Oxycodone

Drug/Drug Interactions with Acetaminophen

Drug/Laboratory Test Interactions

Carcinogenesis, Mutagenesis, Impairment of Fertility

Pregnancy

Pregnancy Category C

Labor and Delivery

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Pediatric Use

Geriatric Use

Hepatic Impairment

Renal Impairment

Adverse Reactions

Body as a Whole

Cardiovascular

Central and Peripheral Nervous System

Fluid and Electrolyte

Gastrointestinal

Hepatic

Hearing and Vestibular

Hematologic

Hypersensitivity

Metabolic and Nutritional

Musculoskeletal

Ocular

Psychiatric

Respiratory System

Skin and Appendages

Urogenital

Drug Abuse and Dependence

Interactions with Alcohol and Drugs of Abuse

Overdosage

ï»¿Signs and Symptoms

Treatment

Roxicet Oral Solution Dosage and Administration

ROXICET Tablets:

Roxicet Oral Solution:

Cessation of Therapy

How is Roxicet Oral Solution Supplied

Storage

Storage

Package Label – ROXICET™ Tablets, Oxycodone and Acetaminophen Tablets, USP (Oxycodone Hydrochloride 5 mg and Acetaminophen 325 mg)

Package Label – ROXICET™ Oral Solution, Oxycodone and Acetaminophen Oral Solution (Oxycodone Hydrochloride 5 mg and Acetaminophen 325 mg Oral Solution per 5 mL)

30/06/10

What is Roxicodone (oxycodone)?

What is the most important information I should know about Roxicodone (oxycodone)?

What should I discuss with my healthcare provider before using Roxicodone (oxycodone)?

How should I use Roxicodone (oxycodone)?

What happens if I miss a dose?

What happens if I overdose?