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Butisol

30/06/10

Generic Name: butabarbital sodium
Dosage Form: tablet and solution

Butisol SODIUM®
CIII
(BUTABARBITAL SODIUM TABLETS, USP
AND BUTABARBITAL SODIUM ORAL SOLUTION, USP)
TABLETS & ORAL SOLUTION
IN-0110-12 REV 1/09

Description

Butisol SODIUM® (butabarbital sodium tablets, USP and butabarbital sodium oral solution, USP) is a non-selective central nervous system depressant which is used as a sedative or hypnotic. It is available for oral administration as Tablets containing 30 mg or 50 mg butabarbital sodium; and as Oral Solution containing 30 mg/5 mL, with alcohol (by volume) 7%. Other ingredients in the Tablets are: calcium stearate, corn starch, dibasic calcium phosphate, FD&C Blue No. 1 (30 mg only), FD&C Yellow No. 5 (30 mg and 50 mg — see Precautions), FD&C Yellow No. 6 (50 mg only). Other ingredients in the Oral Solution are: D&C Green No. 5, edetate disodium, FD&C Yellow No. 5 (see Precautions), flavors (natural and artificial), propylene glycol, purified water, saccharin sodium, sodium benzoate. Butabarbital sodium occurs as a white, bitter powder which is freely soluble in water and alcohol, but practically insoluble in benzene and ether. The structural formula for butabarbital sodium is:

Clinical Pharmacology

Butisol SODIUM® (butabarbital sodium tablets, USP and butabarbital sodium oral solution, USP), like other barbiturates, is capable of producing all levels of CNS mood alteration from excitation to mild sedation, to hypnosis, and deep coma. Overdosage can produce death. Barbiturates depress the sensory cortex, decrease motor activity, alter cerebellar function, and produce drowsiness, sedation, and hypnosis.

Barbiturate-induced sleep differs from physiological sleep. Sleep laboratory studies have demonstrated that barbiturates reduce the amount of time spent in the rapid eye movement (REM) phase of sleep or dreaming stage. Also, Stages III and IV sleep are decreased. Following abrupt cessation of barbiturates used regularly, patients may experience markedly increased dreaming, nightmares, and/or insomnia. Therefore, withdrawal of a single therapeutic dose over 5 or 6 days has been recommended to lessen the REM rebound and disturbed sleep which contribute to drug withdrawal syndrome (for example, decrease the dose from 3 to 2 doses a day for 1 week).

In studies, secobarbital sodium and pentobarbital sodium have been found to lose most of their effectiveness for both inducing and maintaining sleep by the end of 2 weeks of continued drug administration even with the use of multiple doses. As with secobarbital sodium and pentobarbital sodium, other barbiturates might be expected to lose their effectiveness for inducing and maintaining sleep after about 2 weeks. The short-, intermediate-, and, to a lesser degree, long-acting barbiturates have been widely prescribed for treating insomnia. Although the clinical literature abounds with claims that the short-acting barbiturates are superior for producing sleep while the intermediate-acting compounds are more effective in maintaining sleep, controlled studies have failed to demonstrate these differential effects. Therefore, as sleep medications, the barbiturates are of limited value beyond short-term use.

Barbiturates are respiratory depressants. The degree of respiratory depression is dependent upon dose. With hypnotic doses, respiratory depression produced by barbiturates is similar to that which occurs during physiologic sleep with slight decrease in blood pressure and heart rate.

Barbiturates do not impair normal hepatic function, but have been shown to induce liver microsomal enzymes, thus increasing and/or altering the metabolism of barbiturates and other drugs (see Precautions-Drug interactions).

Pharmacokinetics: Butisol SODIUM® (butabarbital sodium tablets, USP and butabarbital sodium oral solution, USP) is the sodium salt of a weak acid. Barbiturates are weak acids that are absorbed and rapidly distributed to all tissues and fluids with high concentrations in the brain, liver, and kidneys. Barbiturates are bound to plasma and tissue proteins. The rate of absorption is increased if it is ingested as a dilute solution or taken on an empty stomach.

Barbiturates are metabolized primarily by the hepatic microsomal enzyme system, and most metabolic products are excreted in the urine. The excretion of unchanged butabarbital in the urine is negligible. Butisol SODIUM® (butabarbital sodium tablets, USP and butabarbital sodium oral solution, USP) is classified as an intermediate-acting barbiturate. The average plasma half-life for butabarbital is 100 hours in the adult.

Although variable from patient to patient, butabarbital has an onset of action of about 3/4 to 1 hour, and a duration of action of about 6 to 8 hours.

Indications and Usage

Butisol SODIUM® (butabarbital sodium tablets, USP and butabarbital sodium oral solution, USP) is indicated for use as a sedative or hypnotic.

Since barbiturates appear to lose their effectiveness for sleep induction and sleep maintenance after 2 weeks, use of Butisol SODIUM® in treating insomnia should be limited to this time (see Clinical Pharmacology above).

Contraindications

Barbiturates are contraindicated in patients with known barbiturate sensitivity. Barbiturates are also contraindicated in patients with a history of manifest or latent porphyria.

Warnings

Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated.

Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequences of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative-hypnotic drugs. Because some of the important adverse effects of sedative-hypnotics appear to be dose related (see Precautions and Dosage and Administration), it is important to use the smallest possible effective dose, especially in the elderly.

Complex behaviors such as “sleep driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported. These events can occur in sedative-hypnotic-naive as well as in sedative-hypnotic-experienced persons. Although behaviors such as sleep-driving may occur with sedative-hypnotics alone at therapeutic doses, the use of alcohol and other CNS depressants with sedative-hypnotics appears to increase the risk of such behaviors, as does the use of sedative-hypnotics at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of sedative-hypnotics should be strongly considered for patients who report a “sleep driving” episode”.

Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with sleep-driving, patients usually do not remember these events.

Severe anaphylactic and anaphylactoid reactions: Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with sedative-hypnotics should not be rechallenged with the drug.

Habit forming: Barbiturates may be habit forming. Tolerance, psychological and physical dependence may occur with continued use (see Drug Abuse and Dependence below). Patients who have psychological dependence on barbiturates may increase the dosage or decrease the dosage interval without consulting a physician and may subsequently develop a physical dependence on barbiturates. To minimize the possibility of overdosage or the development of dependence, the prescribing and dispensing of sedative-hypnotic barbiturates should be limited to the amount required for the interval until the next appointment. Abrupt cessation after prolonged use in the dependent person may result in withdrawal symptoms, including delirium, convulsions, and possibly death. Barbiturates should be withdrawn gradually from any patient known to be taking excessive dosage over long periods of time. (See Drug Abuse and Dependence below.)

Acute or chronic pain: Caution should be exercised when barbiturates are administered to patients with acute or chronic pain, because paradoxical excitement could be induced, or important symptoms could be masked. However, the use of barbiturates as sedatives in the postoperative surgical period, and as adjuncts to cancer chemotherapy, is well established.

Use in pregnancy: Barbiturates can cause fetal damage when administered to a pregnant woman. Retrospective, case-controlled studies have suggested a connection between the maternal consumption of barbiturates and a higher than expected incidence of fetal abnormalities. Following oral administration, barbiturates readily cross the placental barrier and are distributed throughout fetal tissues with highest concentrations found in the placenta, fetal liver, and brain.

Withdrawal symptoms occur in infants born to mothers who receive barbiturates throughout the last trimester of pregnancy (See Drug Abuse and Dependence). If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Precautions

General: Barbiturates should be administered with caution, if at all, to patients who are mentally depressed, have suicidal tendencies, or a history of drug abuse.

Elderly or debilitated patients may react to barbiturates with marked excitement, depression, and confusion. In some persons, barbiturates repeatedly produce excitement rather than depression.

In patients with hepatic damage, barbiturates should be administered with caution and initially in reduced doses. Barbiturates should not be administered to patients showing the premonitory signs of hepatic coma.

Butisol SODIUM® (butabarbital sodium tablets, USP and butabarbital sodium oral solution, USP) Tablets and Oral Solution contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Information for patients: Practitioners should give the following information and instructions to patients receiving barbiturates.

“Sleep Driving” and other complex behaviors: There have been reports of people getting out of bed after taking a sedative-hypnotic and driving their cars while not fully awake, often with no memory of the event. If a patient experiences such an episode, it should be reported to his or her doctor immediately, since “sleep driving” can be dangerous. This behavior is more likely to occur when sedative-hypnotics are taken with alcohol or other central nervous depressants (see Warnings). Other complex behaviors (e.g. preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with sleep-driving, patients usually do not remember these events.

The use of barbiturates carries with it an associated risk of psychological and/or physical dependence. The patient should be warned against increasing the dose of the drug without consulting a physician.

Barbiturates may impair mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving or operating machinery.

Alcohol should not be consumed while taking barbiturates. Concurrent use of the barbiturates with other CNS depressants, including other sedatives or hypnotics, alcohol, narcotics, tranquilizers, and antihistamines, may result in additional CNS depressant effects.

Laboratory tests: Prolonged therapy with barbiturates should be accompanied by periodic laboratory evaluation of organ systems, including hematopoietic, renal, and hepatic systems (See Precautions-General and Adverse Reactions).

Drug interactions: Most reports of clinically significant drug interactions occurring with the barbiturates have involved phenobarbital. However, the application of these data to other barbiturates appears valid and warrants serial blood level determinations of the relevant drugs when there are multiple therapies.

Anticoagulants. Phenobarbital lowers the plasma levels of dicumarol and causes a decrease in anticoagulant activity as measured by the prothrombin time. Barbiturates can induce hepatic microsomal enzymes resulting in increased metabolism and decreased anticoagulant response of oral anticoagulants (e.g., warfarin, acenocoumarol, dicumarol, and phenprocoumon). Patients stabilized on anticoagulant therapy may require dosage adjustments if barbiturates are added to or withdrawn from their dosage regimen.
Corticosteroids. Barbiturates appear to enhance the metabolism of exogenous corticosteroids probably through the induction of hepatic microsomal enzymes. Patients stabilized on corticosteroid therapy may require dosage adjustments if barbiturates are added to or withdrawn from their dosage regimen.
Griseofulvin. Phenobarbital appears to interfere with the absorption of orally administered griseofulvin, thus decreasing its blood level. The effect of the resultant decreased blood levels of griseofulvin on therapeutic response has not been established. However, it would be preferable to avoid concomitant administration of these drugs.
Doxycycline. Phenobarbital has been shown to shorten the half-life of doxycycline for as long as 2 weeks after barbiturate therapy is discontinued. This mechanism is probably through the induction of hepatic microsomal enzymes that metabolize the antibiotic. If phenobarbital and doxycycline are administered concurrently, the clinical response to doxycycline should be monitored closely.
Phenytoin, sodium valproate, valproic acid. The effect of barbiturates on the metabolism of phenytoin appears to be variable. Some investigators report an accelerating effect, while others report no effect. Because the effect of barbiturates on the metabolism of phenytoin is not predictable, phenytoin and barbiturate blood levels should be monitored more frequently if these drugs are given concurrently. Sodium valproate and valproic acid appear to decrease barbiturate metabolism; therefore, barbiturate blood levels should be monitored and appropriate dosage adjustments made as indicated.
Central nervous system. The concomitant use of other central nervous system depressants, including other sedatives or hypnotics, antihistamines, tranquilizers, or alcohol, may produce additive depressant effects.
Monoamine oxidase inhibitors (MAOI). MAOI prolong the effects of barbiturates probably because metabolism of the barbiturate is inhibited.
Estradiol, estrone, progesterone, and other steroid hormones. Pretreatment with or concurrent administration of phenobarbital may decrease the effect of estradiol by increasing its metabolism. There have been reports of patients treated with antiepileptic drugs (e.g., phenobarbital) who become pregnant while taking oral contraceptives. An alternate contraceptive method might be suggested to women taking phenobarbital.

Carcinogenesis, mutagenesis, impairment of fertility: No long-term studies in animals have been performed with butabarbital sodium to determine carcinogenic and mutagenic potential, or effects on fertility.

Pregnancy: Teratogenic effects – - Pregnancy Category D (see Warnings - Use in pregnancy above).

Nonteratogenic effects – Infants suffering from long-term barbiturate exposure in utero may have an acute withdrawal syndrome of seizures and hyperirritability from birth to a delayed onset of up to 14 days (see Drug Abuse and Dependence).

Labor and delivery: Hypnotic doses of barbiturates do not appear to significantly impair uterine activity during labor. Administration of sedative-hypnotic barbiturates to the mother during labor may result in respiratory depression in the newborn. Premature infants are particularly susceptible to the depressant effects of barbiturates. If barbiturates are used during labor and delivery, resuscitation equipment should be available.

Nursing mothers: Caution should be exercised when a barbiturate is administered to a nursing woman since small amounts of some barbiturates are excreted in the milk.

Geriatric use: Clinical studies of Butisol Sodium Tablets/Oral Solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Adverse Reactions

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The following adverse reactions have been observed with the use of barbiturates in hospitalized patients. Because such patients may be less aware of certain of the milder adverse effects of barbiturates, the incidence of these reactions may be somewhat higher in fully ambulatory patients.

More than 1 in 100 patients. The most common adverse reaction, somnolence, is estimated to occur at a rate of 1 to 3 patients per 100.

Less than 1 in 100 patients. The most common adverse reactions estimated to occur at a rate of less than 1 in 100 patients listed below, grouped by organ system, and by decreasing order of occurrence are:

Central nervous system/psychiatric: Agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, dizziness, thinking abnormality.

Respiratory: Hypoventilation, apnea.

Cardiovascular: Bradycardia, hypotension, syncope.

Gastrointestinal: Nausea, vomiting, constipation.

Other reported reactions: Headache, hypersensitivity (angioedema, skin rashes, exfoliative dermatitis), fever, liver damage.

Drug Abuse and Dependence

Controlled substance: Schedule III.

Abuse and dependence: Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. Physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug and/or administration of an antagonist. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug’s effects over time. Tolerance may occur to both the desired and undesired effects of drugs and may develop at different rates for different effects.

Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.

Barbiturates may be habit-forming. Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. Daily administration in excess of 400 milligrams (mg) of pentobarbital or secobarbital for approximately 90 days is likely to produce some degree of physical dependence. A dosage of from 600 to 800 mg taken for at least 35 days is sufficient to produce withdrawal seizures. The average daily dose for the barbiturate addict is usually about 1.5 grams. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between an intoxicating dosage and a fatal dosage becomes smaller.

Symptoms of acute intoxication with barbiturates include unsteady gait, slurred speech, and sustained nystagmus. Mental signs of chronic intoxication include confusion, poor judgment, irritability, insomnia, and somatic complaints. Symptoms of barbiturate dependence are similar to those of chronic alcoholism.

If an individual appears to be intoxicated with alcohol to a degree that is radically disproportionate to the amount of alcohol in his or her blood, the use of barbiturates should be suspected. The lethal dose of a barbiturate is far less if alcohol is also ingested.

The symptoms of barbiturate withdrawal can be severe and may cause death. Minor withdrawal symptoms may appear 8 to 12 hours after the last dose of a barbiturate. These symptoms usually appear in the following order: anxiety, muscle twitching, tremor of hands and fingers, progressive weakness, dizziness, distortion in visual perception, nausea, vomiting, insomnia, and orthostatic hypotension. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days.

Drug dependence to barbiturates arises from repeated administration of a barbiturate or agent with barbiturate-like effect on a continuous basis, generally in amounts exceeding therapeutic dose levels. The characteristics of drug dependence to barbiturates include: (a) a strong desire or need to continue taking the drug; (b) a tendency to increase the dose; (c) a psychic dependence on the effects of the drug related to subjective and individual appreciation for those effects; and (d) a physical dependence on the effects of the drug requiring its presence for maintenance of homeostasis and resulting in a definite, characteristic, and self-limited abstinence syndrome when the drug is withdrawn.

Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. In all cases, withdrawal takes an extended period of time. One method involves initiating treatment at the patient’s regular dosage level, in 3 to 4 divided doses, and decreasing the daily dose by 10 percent if tolerated by the patient.

Infants physically dependent on barbiturates may be given phenobarbital 3 to 10 mg/kg/day. After withdrawal symptoms (hyperactivity, disturbed sleep, tremors, hyperreflexia) are relieved, the dosage of phenobarbital should be gradually decreased and completely withdrawn over a 2- week period.

Overdosage

Signs and symptoms: The toxic dose of barbiturates varies considerably. In general, an oral dose of 1 gram of most barbiturates produces serious poisoning in an adult. Death commonly occurs after 2 to 10 grams of ingested barbiturates. Symptoms of acute intoxication with barbiturates include unsteady gait, slurred speech, and sustained nystagmus. Mental signs of chronic intoxication include confusion, poor judgment, irritability, insomnia, and somatic complaints. Barbiturate intoxication may be confused with alcoholism, bromide intoxication, and with various neurological disorders.

Acute overdosage with barbiturates is manifested by CNS and respiratory depression which may progress to Cheyne-Stokes respiration, areflexia, constriction of the pupils to a slight degree (though in severe poisoning they may show paralytic dilation), oliguria, tachycardia, hypotension, lowered body temperature, and coma. Typical shock syndrome (apnea, circulatory collapse, respiratory arrest, and death) may occur.

In extreme overdose, all electrical activity in the brain may cease, in which case a “flat” EEG normally equated with clinical death cannot be accepted. This effect is fully reversible unless hypoxic damage occurs. Consideration should be given to the possibility of barbiturate intoxication even in situations that appear to involve trauma.

Complications: Pneumonia, pulmonary edema, cardiac arrhythmias, congestive heart failure, and renal failure may occur. Uremia may increase CNS sensitivity to barbiturates if renal function is impaired. Differential diagnosis should include hypoglycemia, head trauma, cerebrovascular accidents, convulsive states, and diabetic coma.

Treatment: Treatment of overdosage is mainly supportive and consists of the following:

Maintenance of an adequate airway, with assisted respiration and oxygen administration as necessary.
Monitoring of vital signs and fluid balance.
If the patient is conscious and has not lost the gag reflex, emesis may be induced with ipecac. Care should be taken to prevent pulmonary aspiration of vomitus. After completion of vomiting, 30 grams activated charcoal in a glass of water may be administered.
If emesis is contraindicated, gastric lavage may be performed with a cuffed endotracheal tube in place with the patient in the face down position. Activated charcoal may be left in the emptied stomach and a saline cathartic administered.
Fluid therapy and other standard treatment for shock, if needed.
If renal function is normal, forced diuresis may aid in the elimination of the barbiturate.
Although not recommended as a routine procedure, hemodialysis may be used in severe barbiturate intoxications or if the patient is anuric or in shock.
Appropriate nursing care, including rolling patients from side-to-side every 30 minutes, to prevent hypostatic pneumonia, decubiti, aspiration, and other complications of patients with altered states of consciousness.
Antibiotics should be given if pneumonia is suspected.

Dosage and Administration

Usual adult dosage:

Daytime sedative – 15 to 30 mg, 3 or 4 times daily.

Bedtime hypnotic – 50 to 100 mg.

Preoperative sedative – 50 to 100 mg, 60 to 90 minutes before surgery.

Usual pediatric dosage:

Preoperative sedative – 2 to 6 mg/kg maximum 100 mg.

Special patient population:

Dosage should be reduced in the elderly or debilitated because these patients may be more sensitive to barbiturates. Dosage should be reduced for patients with impaired renal function or hepatic disease (see Precautions).

How Supplied

Butisol SODIUM® (butabarbital sodium tablets, USP):

30 mg – colored green, scored, imprinted “Butisol SODIUM” and 37/113 in bottles of 100 (NDC 0037-0113-60).

50 mg – colored orange, scored, imprinted “Butisol SODIUM” and 37/114 in bottles of 100 (NDC 0037-0114-60).

Butisol SODIUM® (butabarbital sodium oral solution, USP): 30 mg/ 5 mL, alcohol (by volume) 7% – colored green, in bottles of one pint (NDC 0037-0110-16).

Contains FD&C Yellow No. 5 (See Precautions).

Storage: Store at controlled room temperature 20°-25°C (68°-77°F).
Dispense in a tight container.

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Meda Pharmaceuticals®

Meda Pharmaceuticals Inc.
Somerset, NJ 08873-4120
Printed in U.S.A.
Rev. 1/09

Package Label – Principal Display Panel – 100-count Bottle, 30 mg Tablets

NDC 0037-0113-60
100 Tablets
CIII
Butisol Sodium ®
(butabarbital sodium
tablets, USP)
30 mg
Rx Only
MEDA PHARMACEUTICALS

LB-011360-07 Rev. 8/07

Usual Dosage:Adults: One tablet
three or four times daily.
For complete information for use,
see accompanying product literature.
Contains FD&C Yellow No. 5
(tartrazine) as a color additive.
Store at controlled room temperature
20°-25°C (68°-77°F).
Dispense in a tight container.

MEDA PHARMACEUTICALS
Meda Pharmaceuticals Inc.
Somerset, New Jersey 08873-4120

Package Label – Principal Display Panel – 100-count Bottle, 50 mg Tablets

NDC 0037-0114-60
100 Tablets
CIII
Butisol Sodium ®
(butabarbital sodium
tablets, USP)
50 mg
Rx Only
MEDA PHARMACEUTICALS

LB-011460-07 Rev. 8/07

Usual Dosage:Adults: One to two tablets
as a hypnotic or for preoperative sedation.
For complete information for use,
see accompanying product literature.
Contains FD&C Yellow No. 5
(tartrazine) as a color additive.
Store at controlled room temperature
20°-25°C (68°-77°F).
Dispense in a tight container.

MEDA PHARMACEUTICALS
Meda Pharmaceuticals Inc.
Somerset, New Jersey 08873-4120

Package Label – Principal Display Panel – Pint Bottle, Butisol Sodium Oral Solution

NDC 0037-0110-16
One Pint (473 mL)
CIII
Butisol Sodium ®
(butabarbital sodium
oral solution, USP)
Oral Solution
Each 5 mL (one teaspoonful)
contains:
Butabarbital Sodium 30 mg
Alcohol (by volume) 7%
Rx Only

LB-011016-08 Rev. 6/05

Usual Dosage: Adults: As a daytime sedative, one-half to one teaspoon (2.5 to
5 mL) with water, three to four times daily. As a hypnotic or as a preoperative
sedative, two to three teaspoonfuls (10 to 15 mL).
For complete information for use, see accompanying product literature.
Contains FD&C Yellow No. 5 (tartrazine) as a color additive.
Store at controlled room temperature 20°-25°C (68°-77°F).
Dispense in a tight container.

MedPointe Pharmaceuticals®

MedPointe Healthcare Inc.

Somerset, New Jersey 08873

Butisol SODIUM TABLETS
butabarbital sodium tablets, usp tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0037-0113
Route of Administration	ORAL	DEA Schedule	CIII

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BUTABARBITAL SODIUM (BUTABARBITAL)	BUTABARBITAL SODIUM	30 mg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	GREEN	Score	2 pieces
Shape	ROUND	Size	7mm
Flavor		Imprint Code	Butisol;SODIUM;37;113
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0037-0113-60	100 TABLET In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA000793	08/01/1939

Butisol SODIUM TABLETS
butabarbital sodium tablets, usp tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0037-0114
Route of Administration	ORAL	DEA Schedule	CIII

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BUTABARBITAL SODIUM (BUTABARBITAL)	BUTABARBITAL SODIUM	50 mg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	ORANGE	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor		Imprint Code	Butisol;SODIUM;37;114
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0037-0114-60	100 TABLET In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA000793	08/01/1939

Butisol SODIUM ORAL SOLUTION
butabarbital sodium oral solution, usp solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0037-0110
Route of Administration	ORAL	DEA Schedule	CIII

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BUTABARBITAL SODIUM (BUTABARBITAL)	BUTABARBITAL SODIUM	30 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor	PEPPERMINT, VANILLA	Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0037-0110-16	473 mL In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA085380	06/01/1978

Labeler - Meda Pharmaceuticals Inc. (051229602)

Revised: 07/2009Meda Pharmaceuticals Inc.

B,Professional

Comments (0)

Butisol Sodium

30/06/10

Generic Name: butabarbital (byoo ta BAR bi tal)
Brand Names: Butisol Sodium

What is Butisol Sodium (butabarbital)?

Butabarbital is in a group of drugs called barbiturates (bar-BIT-chur-ates). Butabarbital slows the activity of your brain and nervous system.

Butabarbital is used short-term to treat insomnia, or as a sedative before surgery.

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

What is the most important information I should know about Butisol Sodium (butabarbital)?

Butabarbital may cause a severe allergic reaction. Stop taking butabarbital and 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. Take butabarbital only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking butabarbital and talk with your doctor about another treatment for your sleep disorder.

Do not use butabarbital without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Butabarbital can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking butabarbital. Butabarbital may be habit-forming and should be used only by the person it was prescribed for. Butabarbital 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.

What should I discuss with my healthcare provider before taking Butisol Sodium (butabarbital)?

Do not take this medication if you are allergic to butabarbital, aspirin, or any kind of yellow dye (coloring in food or medicines).

Before taking butabarbital, tell your doctor if you are allergic to any drugs, or if you have:

severe asthma, chronic obstructive pulmonary disorder (COPD), or other breathing disorder;
liver disease;
anemia (lack of red blood cells);
a history of depression, mental illness, or suicide attempt; or
a history of drug or alcohol addiction.

If you have any of these conditions, you may not be able to use butabarbital, or you may need a dosage adjustment or special tests during treatment.

Butabarbital may be habit-forming and should be used only by the person it was prescribed for. Butabarbital 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. FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use butabarbital without your doctor’s consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. Butabarbital can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking butabarbital. Butabarbital 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 take Butisol Sodium (butabarbital)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take butabarbital only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine. Take this medicine with a full glass of water. Do not mix butabarbital oral liquid with any type of fruit juice.

Measure the liquid form of butabarbital 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 for one.

If you are taking this medicine to treat insomnia, take it only at bedtime. Call your doctor if your insomnia symptoms do not improve within 7 to 10 days of taking butabarbital.

Do not change your dose of butabarbital without your doctor’s advice. Do not use butabarbital for longer than 2 weeks to treat insomnia, unless your doctor has told you to. You may have withdrawal symptoms (such as anxiety, insomnia, or feeling irritable) when you stop using butabarbital after using it over a long period of time. Do not stop using butabarbital suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely. Store butabarbital at room temperature away from moisture and heat.

Keep track of how many pills have been used from each new bottle of this medicine. Butabarbital 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.

What happens if I miss a dose?

Skip the missed dose and wait until your next regularly scheduled time to take the medicine. Do not take 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 butabarbital can be fatal.

Symptoms of a butabarbital overdose may include slow or shallow breathing, blurred vision, extreme drowsiness, feeling light-headed, or fainting.

What should I avoid while taking Butisol Sodium (butabarbital)?

Butabarbital 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. Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by butabarbital. Tell your doctor if you need to use any of these other medicines while you are taking butabarbital. Avoid drinking alcohol. It can increase some of the side effects of butabarbital.

Butisol Sodium (butabarbital) side effects

Butabarbital may cause a severe allergic reaction. Stop taking butabarbital and 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:

feeling like you might pass out;
a fever or a sore throat;
sores in your mouth;
easy bruising or bleeding; or
trouble breathing or swallowing.

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

drowsiness or dizziness;
problems with memory or concentration;
excitement (especially in children or older adults);
joint or muscle pain;
nausea, vomiting, upset stomach, constipation; or
nightmares or increased dreaming.

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 Butisol Sodium (butabarbital)?

The following drugs can interact with butabarbital. Tell your doctor if you are using any of these:

a blood thinner such as warfarin (Coumadin);
seizure medication;
metronidazole (Flagyl);
theophylline (Theo-Dur, Theochron, Theolair, Slo-Bid, others);
rifampin (Rifadin, Rifamate, Rimactane);
a beta-blocker such as metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), and others;
an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);
a calcium channel blocker such as felodipine (Plendil) or verapamil (Calan, Covera); or
steroids such as prednisone (Orasone, Deltasone), prednisolone (Prelone, Delta Cortef), methylprednisolone (Medrol), and others.

This list is not complete and there may be other drugs that can interact with butabarbital. 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 butabarbital.

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.

B,Concise

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Butisol Sodium Elixir

30/06/10

Generic Name: Butabarbital (BUE-ta-BAR-bi-tal)
Brand Name: Butisol Sodium

Butisol Sodium Elixir is used for:

Treating sleep disorders. It may also be used for other conditions as determined by your doctor.

Butisol Sodium Elixir is a barbiturate. It works by depressing the central nervous system, causing mild sedation or sleep, depending on the dose.

Do NOT use Butisol Sodium Elixir if:

you are allergic to any ingredient in Butisol Sodium Elixir
you have the blood disease porphyria
you are taking sodium oxybate (GHB)

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

Before using Butisol Sodium Elixir:

Some medical conditions may interact with Butisol Sodium Elixir. 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 liver problems, lung or respiratory tract disease, or a painful condition
if you are in shock
if you have a history of substance abuse or dependence, mental or mood problems (eg, depression), or suicidal thoughts or behavior

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

Monoamine oxidase inhibitors (MAOIs) (eg, phenelzine) or sodium oxybate (GHB) because the risk of severe drowsiness may be increased
Beta-blockers (eg, atenolol), clozapine, corticosteroids (eg, prednisone), doxycycline, estrogens (eg, micronized estradiol), griseofulvin, metronidazole, oral contraceptives (birth control pills), phenytoin, quinidine, theophylline, or valproic acid because their effectiveness may be decreased by Butisol Sodium Elixir

This may not be a complete list of all interactions that may occur. Ask your health care provider if Butisol Sodium Elixir 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 Butisol Sodium Elixir:

Use Butisol Sodium Elixir as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Butisol Sodium Elixir may be taken with or without food.
Use a measuring device marked for medicine dosing. Ask your pharmacist if you are unsure of how to measure your dose.
If you miss a dose of Butisol Sodium Elixir, 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 Butisol Sodium Elixir.

Important safety information:

Butisol Sodium Elixir may cause drowsiness. This effect may be worse if you take it with alcohol or certain medicines. Use Butisol Sodium Elixir 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 Butisol Sodium Elixir; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Exceeding the recommended dose or taking Butisol Sodium Elixir for longer than prescribed may be habit-forming.
If your symptoms do not get better within 7 to 10 days or if they get worse, check with your doctor.
Tell your doctor or dentist that you take Butisol Sodium Elixir before you receive any medical or dental care, emergency care, or surgery.
Hormonal birth control (eg, birth control pills) may not work as well while you are using Butisol Sodium Elixir. To prevent pregnancy, use an extra form of birth control (eg, condoms).
This product may contain tartrazine dye (FD&C Yellow No. 5). This may cause an allergic reaction in some patients. If you have ever had an allergic reaction to tartrazine, ask your pharmacist if your product has tartrazine in it.
Some patients taking sleep medicines have performed certain activities while they were not fully awake. These have included sleep-driving, making and eating food, making phone calls, and having sex. Patients often do not remember these events after they happen. Such an event may be more likely to occur if you use a high dose of Butisol Sodium Elixir. It may also be more likely if you drink alcohol or take other medicines that may cause drowsiness while you use Butisol Sodium Elixir. Tell your doctor right away if such an event happens to you.
Lab tests, including complete blood cell counts and kidney and liver function tests, may be performed while you use Butisol Sodium Elixir. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Butisol Sodium Elixir with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness, depression, excitement, or confusion.
PREGNANCY and BREAST-FEEDING: Butisol Sodium Elixir has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Butisol Sodium Elixir while you are pregnant. Butisol Sodium Elixir is found in breast milk. If you are or will be breast-feeding while you use Butisol Sodium Elixir, check with your doctor. Discuss any possible risks to your baby.

When sleep medicines are used every night for more than a few weeks, they may lose their effectiveness to help you sleep. This is known as TOLERANCE. Sleep medicines should usually be used only for short periods of time, such as a few days and generally no longer than 1 or 2 weeks. If your sleep problems continue, contact your doctor.

When used for longer than a few weeks or at high doses, some people develop a need to continue taking Butisol Sodium Elixir. This is known as DEPENDENCE or addiction. If you suddenly stop taking Butisol Sodium Elixir, you may experience WITHDRAWAL symptoms. These may include anxiety, dizziness, hallucinations, lightheadedness, nausea, muscle twitching, seizures, sleeplessness, trembling hands and fingers, weakness, or vomiting.

Possible side effects of Butisol Sodium Elixir:

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:

Clumsiness; dizziness; excessive daytime drowsiness; lightheadedness.

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; unusual hoarseness); abnormal thoughts or behavior; confusion; fainting; fever; hallucinations; mental or mood changes; nausea or vomiting; new or worsening trouble sleeping; severe dizziness; shortness of breath; swelling or tightness of the throat; very slow breathing.

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 change in size of pupil; cold, clammy skin; deep sleep; incoordination; loss of consciousness; slowed or fast breathing; slurred speech; trouble walking; unusual eye movements.

Proper storage of Butisol Sodium Elixir:

Store Butisol Sodium Elixir between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Keep Butisol Sodium Elixir out of the reach of children and away from pets.

General information:

If you have any questions about Butisol Sodium Elixir, please talk with your doctor, pharmacist, or other health care provider.
Butisol Sodium Elixir 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 Butisol Sodium Elixir. 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

B,Med-facts

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Butoconazole Cream

30/06/10

Generic Name: Butoconazole (byoo-toe-KOE-na-zole)
Brand Name: Gynazole-1

Butoconazole Cream is used for:

Treating vaginal yeast infections.

Butoconazole Cream is an antifungal agent. It works by weakening the cell wall of sensitive fungi, causing the cell contents to leak. This kills the fungi.

Do NOT use Butoconazole Cream if:

you are allergic to any ingredient in Butoconazole Cream

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

Before using Butoconazole Cream:

Some medical conditions may interact with Butoconazole Cream. 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

Some MEDICINES MAY INTERACT with Butoconazole Cream. However, no specific interactions with Butoconazole Cream are known at this time.

Ask your health care provider if Butoconazole Cream 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 Butoconazole Cream:

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

Butoconazole Cream is for vaginal use only. Do not use in the eyes or take by mouth.
Wash your hands before and after using Butoconazole Cream. Insert 1 applicator-full of cream into the vagina. Throw the applicator away after using it.
Only one dose of Butoconazole Cream is required. If you forget to use Butoconazole Cream, use it as soon as you remember.

Ask your health care provider any questions you may have about how to use Butoconazole Cream.

Important safety information:

If your symptoms do not get better within a few days or if they get worse, check with your doctor.
If your infection clears up and occurs again in a few weeks, see your doctor. Recurrent vaginal infections, especially those that are difficult to cure, may be an early sign of HIV infection in women who are considered at risk for HIV infection.
Butoconazole Cream may be used during your period. Use a sanitary pad rather than a tampon to prevent staining of clothing.
Butoconazole Cream contains mineral oil, which may weaken latex or rubber products such as condoms and diaphragms. Do not use condoms or diaphragms within 72 hours of using Butoconazole Cream.
Butoconazole Cream 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 Butoconazole Cream while you are pregnant. It is not known if Butoconazole Cream is found in breast milk. If you are or will be breast-feeding while you use Butoconazole Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Butoconazole Cream:

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:

Burning, itching, soreness, or swelling in or around the vagina not present before using Butoconazole Cream.

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); pain or cramping in the stomach or pelvic area.

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. Butoconazole Cream may be harmful if swallowed.

Proper storage of Butoconazole Cream:

Store Butoconazole Cream at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Butoconazole Cream out of the reach of children and away from pets.

General information:

If you have any questions about Butoconazole Cream, please talk with your doctor, pharmacist, or other health care provider.
Butoconazole Cream 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 Butoconazole Cream. 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

B,Med-facts

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Butoconazole nitrate

30/06/10

Brand names: Mycelex-3

Why is Butoconazole nitrate prescribed?

Mycelex-3 Vaginal Cream cures yeast-like fungal infections of the vulva and vagina.

Most important fact about Butoconazole nitrate

To obtain maximum benefit, it is important that you continue to use Mycelex-3 for 3 consecutive days, even if your symptoms have disappeared.

How should you use Butoconazole nitrate?

To keep Mycelex-3 from getting on your clothing, wear a sanitary napkin. Do not use a tampon; it will absorb the drug. Do not douche unless your doctor tells you to do so.
1. Following the instructions, fill the applicator that comes with the vaginal cream to the level indicated; the cream also comes in a prefilled applicator.
2. Lie on your back with your knees drawn up.
3. Gently insert the applicator high into the vagina and push the plunger.
4. Withdraw the applicator and discard it.

–If you miss a dose…

Insert it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule.

–Storage instructions…

Store at room temperature, away from heat. Do not freeze.

Butoconazole nitrate side effects

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 using Mycelex-3.

Side effects may include:
Itching of the fingers, soreness, swelling, vaginal discharge, vulvar itching, vulvar or vaginal burning

Why should Butoconazole nitrate not be prescribed?

If you are sensitive to or have ever had an allergic reaction to butoconazole nitrate or any other ingredients in this product, you should not use Mycelex-3. Make sure your doctor is aware of any drug reactions you have experienced.

Special warnings about Butoconazole nitrate

If your symptoms persist, or if you become irritated or have an allergic reaction while using Mycelex-3, notify your doctor.

If this is the first time you have had vaginal itching and discomfort, see your doctor before using Mycelex-3 to be sure it is the right medication to use.

Do not use Mycelex-3 if you have abdominal pain, a fever, or a vaginal discharge with a foul odor; instead, see your doctor.

If your infection doesn’t clear up in 3 days, call your doctor. The problem may not be a yeast infection.

If your symptoms come back within 2 months, call your doctor. It could be a sign of pregnancy or a condition such as AIDS or diabetes.

Do not use this product if you have diabetes, have tested positive for HIV, or have AIDS.

Mycelex-3 may damage condoms and diaphragms. Employ another method of birth control while you are using this product.

This product is for vaginal use only. Avoid getting it in your eyes or mouth.

Possible food and drug interactions when taking Butoconazole nitrate

No interactions with other drugs have been reported.

Special information if you are pregnant or breastfeeding

You should not use Mycelex-3 if you are pregnant or think you may be pregnant. It is not known whether Mycelex-3 appears in breast milk. If Mycelex-3 is essential to your health, your doctor may advise you to discontinue breastfeeding until your treatment is finished.

Recommended dosage for Butoconazole nitrate

ADULTS

The recommended dose is 1 applicatorful of cream inserted in the vagina at bedtime for 3 days.

CHILDREN

Not for use by girls under 12 years of age.

Overdosage

No overdosage has been reported.

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butoconazole vaginal

30/06/10

Generic Name: butoconazole vaginal (byoo toe CON a zole)
Brand names: Gynazole 1, Femstat Prefill, Femstat 3, Femstat, Mycelex-3

What is butoconazole vaginal?

Butoconazole is an antifungal medication. It prevents fungus from growing.

Butoconazole vaginal is used to treat vaginal candida (yeast) infections.

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

What is the most important information I should know about butoconazole vaginal?

Use this medication for the entire length of time prescribed by your doctor, even during your menstrual period. Your symptoms may get better before the infection is completely treated.

Butoconazole contains mineral oil, which can weaken the latex rubber that condoms and diaphragms are made of. If you use either of these forms of birth control, they may not be as effective during your treatment with butoconazole. Use another form of birth control while you are using butoconazole and for at least 3 full days after your treatment has ended.

Avoid wearing tight-fitting, synthetic clothing such as nylon underwear or panty hose that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until your infection is healed.

Avoid using other vaginal creams or douches at the same time as butoconazole vaginal unless your doctor approves.

If the infection does not clear up after you have finished one course of therapy, or if your symptoms get worse, see your doctor. You may have another type of infection that butoconazole will not treat.

What should I discuss with my doctor before using butoconazole vaginal?

Do not use butoconazole vaginal if you have ever had an allergic reaction to it.

You should not use butoconazole vaginal if you have a fever, abdominal pain, foul-smelling vaginal discharge, diabetes, HIV, or AIDS.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether butoconazole passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use butoconazole vaginal?

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

Wash your hands before and after using this medication. Insert the cream into your vagina using the applicator as directed. Avoid getting this medication in your eyes, nose, or mouth.

Use this medication for the entire length of time prescribed by your doctor, even during your menstrual period. Your symptoms may get better before the infection is completely treated.

You may use a sanitary napkin to prevent the medication from staining your clothing but do not use a tampon.

Store butoconazole vaginal at room temperature away from moisture and heat.

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 use the medicine at the next regularly scheduled time. 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, or if anyone has accidentally swallowed it.

An overdose of butoconazole applied in the vagina is not expected to produce life-threatening symptoms.

What should I avoid while using butoconazole vaginal?

Avoid using other vaginal creams or douches at the same time as butoconazole vaginal unless your doctor approves.

Butoconazole vaginal 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.

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

burning;
itching;
pelvic pain or cramps;
itching;
soreness and swelling; or
increased urination.

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.

Butoconazole vaginal Dosing Information

Usual Adult Dose for Vaginal Candidiasis:

1 applicatorful intravaginally once a day, preferably at bedtime for 3 consecutive days.
Alternatively, some brands offer a single dosage formulation.

What other drugs will affect butoconazole vaginal?

There may be other drugs that can affect butoconazole vaginal. 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 butoconazole vaginal.

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.

B,Concise

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butorphanol

30/06/10

Generic Name: butorphanol (nasal) (byoo TOR fa nole)
Brand names: Stadol NS, Stadol

What is butorphanol nasal?

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

Butorphanol is used to treat moderate to severe pain.

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

What is the most important information I should know about butorphanol nasal?

You should not use butorphanol if you have recently used narcotic medications and have become dependent on them. Butorphanol may be habit-forming and should be used only by the person it was prescribed for. Butorphanol should never be given to another person, especially someone with 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 butorphanol. 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. Butorphanol 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. Never use more than your prescribed dose of butorphanol. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Do not stop using butorphanol 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 butorphanol nasal?

Do not use this medication if you have ever had an allergic reaction to a narcotic medicine.

You should not use butorphanol if you have recently used narcotic medications and have become dependent on them.

Butorphanol may be habit-forming and should be used only by the person it was prescribed for. Butorphanol should never be shared with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Before using this medication, tell your doctor if you have

asthma, COPD, sleep apnea, or other breathing disorders;
liver or kidney disease;
a history of head injury or brain tumor;
heart disease, high blood pressure, recent heart attack;
mental illness; or
a history of drug or alcohol addiction.

If you have any of these conditions, you may not be able to use butorphanol or you may require a dose adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Butorphanol passes into breast milk and may harm a nursing baby. Do not use butorphanol without telling your doctor if you are breast-feeding a baby.

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

How should I use butorphanol nasal?

Use this medication exactly as it was prescribed for you. Never use butorphanol 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.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

The usual dose of butorphanol nasal for pain is 1 spray into one nostril every 3 to 4 hours. Your dose may be different. Follow your doctor’s instructions carefully.

For best results, blow your nose before using the nasal spray.

Before using the spray for the first time, you must prime the spray pump. Remove the protective clip and pump 7 or 8 times into the air until a fine mist appears. Prime the spray pump any time you have not used your nasal spray for longer than 48 hours.

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

Store butorphanol at room temperature away from moisture and heat.

After you are finished using this medication, remove the cap and rinse out the bottle under running water. Throw away the bottle and cap where children or pets cannot get to them.

What happens if I miss a dose?

Since butorphanol is used as needed, you are not likely to be on a dosing schedule. If you are using the medication regularly, use 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.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of butorphanol 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 butorphanol nasal?

Do not drink alcohol while you are using this medication. Dangerous side effects or death can occur when alcohol is combined with butorphanol. Check your food and medicine labels to be sure these products do not contain alcohol. This medication 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.

If your prescribed dose is more than 1 spray at a time, you may have severe dizziness. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Butorphanol nasal 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. Tell your caregivers at once if you have any of these serious side effects:

pounding, or uneven heartbeats;
increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
shallow breathing, slow heartbeat;
cold, clammy skin;
problems with urination;
tremors, numbness or tingling;
confusion, feeling like you are floating; or
feeling light-headed, fainting.

Less serious side effects include:

drowsiness, dizziness;
nosebleed, stuffy nose, cough;
sleep problems (insomnia);
constipation;
nausea, vomiting, loss of appetite;
warmth or redness under the skin;
dry mouth, unpleasant taste; or
ringing in your ear.

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.

Butorphanol Dosing Information

Usual Adult Dose for Anesthesia:

The preoperative dosage of butorphanol should be individualized. However, the following guidelines may be helpful.

Preoperative Medication:
Initial dose: 2 mg intramuscularly 60 to 90 minutes before surgery

Balanced Anesthesia:
Initial dose: 2 mg intravenously shortly before induction and/or 0.5 mg to 1 mg in increments during anesthesia. The increments may be higher, up to 0.06 mg/kg (4 mg/70 kg) depending on the previous sedative, analgesic, and hypnotic drugs administered.

The total dose needed will vary. However, patients have generally been reported to have needed between a total dosage of 4 mg to 12.5 mg (approximately 0.06 to 0.18 mg/kg).

Because butorphanol nasal spray has not been studied for use in induction or maintenance anesthesia, use of the nasal spray for anesthesia is not recommended.

Usual Adult Dose for Labor Pain:

For use In the treatment of patients at full term early in labor:
Initial dose: 1 or 2 mg intravenously or intramuscularly once.

This dose may be repeated in 4 hours if necessary.

Alternative analgesia should be used for pain associated with delivery or if delivery is expected to occur within 4 hours.

Because butorphanol nasal spray has not been studied for use in labor, use of the nasal spray for labor is not recommended.

Usual Adult Dose for Pain:

Initial dose: 1 mg intravenously once. Depending on the severity of the pain, effective intravenous doses range from 0.5 to 2 mg.

An initial dose of 2 mg of butorphanol intramuscularly once may be appropriate for patients who will be able to remain recumbent if drowsiness or dizziness occurs. Depending on the severity of the pain, effective intramuscular doses range from 1 to 4 mg.

Alternatively, an initial dose of 1 mg of butorphanol by nasal administration (1 spray in one nostril) once. Adherence to this dose has been reported to have led to a reduced incidence of drowsiness and dizziness. If adequate pain relief is not achieved within 60 to 90 minutes, an additional 1 mg dose may be administered. Depending on the severity of the pain, an initial dose of 2 mg (1 spray in each nostril) may be appropriate in patients who will be able to remain recumbent if drowsiness or dizziness occurs.

Initial doses may be repeated after 3 to 4 hours if necessary. (This includes the initial dosage sequence of 1 mg by nasal administration followed by a second 1 mg dose in 60 to 90 minutes if necessary. This sequence may be repeated 3 to 4 hours after the second dose if necessary.)

Subsequent doses may be determined by patient response, rather than being scheduled at fixed dosing intervals.

What other drugs will affect butorphanol nasal?

You should not use butorphanol 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. Tell your doctor if you need to use any of these other medicines while you are using butorphanol.

There may be other drugs that can interact with butorphanol. 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 has additional information about butorphanol written for health professionals that you may read.

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.

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butorphanol (Nasal route)

30/06/10

bue-TOR-fa-nol

Commonly used brand name(s):

In the U.S.

Stadol NS

Available Dosage Forms:

Spray

Therapeutic Class: Analgesic

Pharmacologic Class: Opioid Agonist/Antagonist

Chemical Class: Opioid

Uses For butorphanol

Butorphanol nasal spray is used to relieve pain. It belongs to the group of medicines called narcotic analgesics (pain medicines). Butorphanol acts on the central nervous system (CNS) to relieve pain.

When butorphanol 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.

butorphanol is available only with your doctor’s prescription.

Before Using butorphanol

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 butorphanol, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to butorphanol 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 butorphanol nasal spray 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 butorphanol nasal spray in the elderly. However, elderly patients may be more sensitive to the effects of butorphanol than younger adults, and are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving butorphanol nasal spray.

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

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using butorphanol 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.

Alfentanil
Alphaprodine
Codeine
Dihydrocodeine
Fentanyl
Fospropofol
Hydrocodone
Hydromorphone
Levorphanol
Meperidine
Methadone
Morphine
Morphine Sulfate Liposome
Oxycodone
Oxymorphone
Propoxyphene
Sufentanil
Tapentadol

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 butorphanol

butorphanol should come with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

butorphanol is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off right away.

If you are using the nasal spray for the first time, you will need to prime the spray. To do this, you should release eight test sprays into the air away from the face, or pump the bottle until some of the medicine sprays out. Now it is ready to use. Prime the spray if it has not been used for more than 48 hours or longer. Shake the medicine well before each use.

Before using butorphanol, gently blow your nose to clear the nostrils.

After using the nasal spray, wipe the tip of the bottle with a clean tissue and put the cap back on.

Dosing

The dose of butorphanol 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 butorphanol. 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 nasal dosage form (spray):
- For pain:
  - Adults—1 milligram (mg) or 1 spray in one nostril. A second spray may be taken 60 to 90 minutes after the first dose if needed. This may be repeated every 3 to 4 hours as needed.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of butorphanol, 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.

Precautions While Using butorphanol

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

butorphanol 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 the other medicines listed above while you are using butorphanol.

butorphanol 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. These symptoms are more likely to occur when you begin taking butorphanol, or when the dose is increased. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

butorphanol may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to butorphanol 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.

Do not change your dose or suddenly stop using butorphanol without first 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.

For pregnant women: Do not use butorphanol during labor and delivery of your child.

Using butorphanol while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your child has the following symptoms: abnormal sleep pattern, diarrhea, high-pitched cry, irritability, shakiness or tremor, weight loss, vomiting, or failure to gain weight.

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.

butorphanol 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

Bloody nose
body aches or pain
burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
chills
cough
cough producing mucus
difficult or labored breathing
difficulty with breathing
ear congestion
fast, irregular, pounding, or racing heartbeat or pulse
feeling faint, dizzy, or lightheaded
feeling of warmth or heat
fever
flushing or redness of the skin, especially on the face and neck
headache
loss of voice
runny nose
shakiness in the legs, arms, hands, or feet
shortness of breath
sneezing
sore throat
stuffy nose
sweating
tightness in the chest
trembling or shaking of the hands or feet
unusual tiredness or weakness
wheezing

Rare

Blurred vision
chest pain
confusion
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
fainting
shallow breathing

Incidence not known

Bluish lips or skin
convulsion
not breathing

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

Symptoms of overdose

Change in consciousness
extremely shallow or slow breathing
loss of consciousness

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

Nausea
sleepiness or unusual drowsiness
sleeplessness
trouble sleeping
unable to sleep
vomiting

Less common

Bad or unusual or unpleasant (after) taste
continuing ringing or buzzing or other unexplained noise in the ears
difficulty having a bowel movement (stool)
dry mouth
ear pain
false or unusual sense of well-being
fear or nervousness
floating feeling
hearing loss
lack or loss of strength
loss of appetite
pain or tenderness around the eyes and cheekbones
sneezing
stomach pain
tender, swollen glands in the neck
trouble with swallowing
unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
voice changes
weight loss

Incidence not known

Dizziness or lightheadedness
false beliefs that cannot be changed by facts
feeling of constant movement of self or surroundings
sensation of spinning

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.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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butorphanol (Injection route)

30/06/10

bue-TOR-fa-nol

Commonly used brand name(s):

In the U.S.

Stadol

Available Dosage Forms:

Solution

Therapeutic Class: Analgesic

Pharmacologic Class: Opioid Agonist/Antagonist

Chemical Class: Opioid

Uses For butorphanol

Butorphanol injection is used to relieve pain. It may also be given before a surgery, when giving birth, or with general anesthesia before an operation.

Butorphanol injection belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

When butorphanol injection 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.

butorphanol is available only with your doctor’s prescription.

Before Using butorphanol

Allergies

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of butorphanol injection 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 butorphanol injection in the elderly. However, elderly patients may be more sensitive to the effects of butorphanol than younger adults, and are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving butorphanol injection.

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

Interactions with Medicines

Alfentanil
Alphaprodine
Codeine
Dihydrocodeine
Fentanyl
Fospropofol
Hydrocodone
Hydromorphone
Levorphanol
Meperidine
Methadone
Morphine
Morphine Sulfate Liposome
Oxycodone
Oxymorphone
Propoxyphene
Sufentanil
Tapentadol

Interactions with Food/Tobacco/Alcohol

Proper Use of butorphanol

A nurse or other trained health professional will give you butorphanol. butorphanol is given as a shot into a muscle or through a needle placed in one of your veins.

Precautions While Using butorphanol

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

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.

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.

butorphanol 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 or nurse immediately if any of the following side effects occur:

Less common

Cough producing mucus
difficulty breathing
shortness of breath
tightness in chest
wheezing

Rare

Blurred vision
chest pain
confusion
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
fast, pounding, or irregular heartbeat or pulse
nervousness
pounding in the ears
slow or fast heartbeat

Incidence not known

Bluish lips or skin
false beliefs that cannot be changed by facts
not breathing
seizures

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

Symptoms of overdose

Change in consciousness
extremely shallow or slow breathing
irregular heartbeats
loss of consciousness
shortness of breath
swelling in hands and feet

More common

Dizziness
nausea
sleepiness or unusual drowsiness
vomiting

Less common

Bad unusual or unpleasant (after) taste
bloody nose
body aches or pain
burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
change in taste
clammy skin
congestion
continuing ringing or buzzing or other unexplained noise in ears
cough
dry mouth
dryness or soreness of throat
ear pain
false or unusual sense of well-being
fear or nervousness
feeling of warmth or heat
fever
floating feeling
flushing or redness of skin, especially on face and neck
headache
hearing loss
heat sensation on body
hoarseness
loss of appetite
nasal irritation
runny nose
shakiness
skin itching
sleeplessness
sneezing
stomach pain
stuffy nose
tender, swollen glands in neck
trouble in swallowing
trouble sleeping
unable to sleep
voice changes
weight loss

Rare

Sweating
unusual tiredness or weakness

Incidence not known

Dizziness or lightheadedness
feeling of constant movement of self or surroundings
lack or loss of strength
problems in speaking
sensation of spinning

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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Butorphanol Solution

30/06/10

Generic Name: Butorphanol (byoo-TOR-fan-ahl)
Brand Name: Generic only. No brands available.

Butorphanol Solution is used for:

Relieving headache or pain due to surgery, labor, or other causes. It may also be used for other conditions as determined by your doctor.

Butorphanol Solution is a narcotic analgesic. It works by blocking certain nerve stimulation that causes pain.

Do NOT use Butorphanol Solution if:

you are allergic to any ingredient in Butorphanol Solution
you are taking sodium oxybate (GHB) or you drink alcohol
you have diarrhea due to poisoning, difficulty breathing, or pseudomembranous colitis
you are dependent on narcotic pain relievers

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

Before using Butorphanol Solution:

Some medical conditions may interact with Butorphanol Solution. 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 stomach problems; prostate problems; asthma or other breathing problems; heart problems; liver disease; high blood pressure; an underactive thyroid; increased pressure on the brain or a brain lesion; thoughts of suicide; seizures; bowel problems; urinary problems, or you have had a recent heart attack, surgery, or trauma
if you have a history of substance abuse or dependence

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

Naltrexone or rifampin because they may decrease Butorphanol Solution’s effectiveness
Cimetidine or ketorolac because side effects, such as difficulty breathing or seizures, may occur
Barbiturate anesthetics (eg, thiopental) or sodium oxybate (GHB) because the risk of their side effects may be increased by Butorphanol Solution
Methadone or mexiletine because their effectiveness may be decreased by Butorphanol Solution

This may not be a complete list of all interactions that may occur. Ask your health care provider if Butorphanol Solution 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 Butorphanol Solution:

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

An extra patient leaflet is available with Butorphanol Solution. Talk to your pharmacist if you have questions about this information.
Butorphanol Solution is supplied as a nasal pump. Your pharmacist may have assembled the pump for you.
The usual dose of Butorphanol Solution is one spray into one nostril. Do not spray into both nostrils unless directed by your doctor.
If you miss a dose of Butorphanol Solution and are using it regularly, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Butorphanol Solution.

Important safety information:

Butorphanol Solution may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Butorphanol Solution 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 Butorphanol Solution; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
Tell your doctor or dentist that you take Butorphanol Solution before you receive any medical or dental care, emergency care, or surgery.
Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
Use Butorphanol Solution with caution in the ELDERLY; they may be more sensitive to its effects.
Butorphanol Solution 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 Butorphanol Solution while you are pregnant. It is not known if Butorphanol Solution is found in breast milk. If you are or will be breast-feeding while you use Butorphanol Solution, check with your doctor. Discuss any possible risks to your baby.

Some people who use Butorphanol Solution 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 Butorphanol Solution suddenly, you may have WITHDRAWAL symptoms. This may include unpleasant feelings. In more severe cases, you may have stomach and muscle cramps, vomiting, sweating, and shakiness. Seizures may rarely occur. If you take Butorphanol Solution for more than 1 to 2 weeks, do not stop taking it without talking to your doctor.

Possible side effects of Butorphanol Solution:

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:

Blurred vision; dizziness; drowsiness; dry mouth; lightheadedness; nasal irritation; nasal stuffiness; nausea; runny nose; sleeplessness; sore throat; stuffy nose; unpleasant taste.

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); anxiety; blurred vision; chest pain; confusion; cough; ear pain; excessive confusion; excessive drowsiness; fainting; flushing; rash or hives; restlessness; ringing in the ears; seizures; slow or difficult breathing; slow or irregular heartbeat; tremors; vomiting.

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; deep sleep; dizziness; drowsiness; lightheadedness; loss of consciousness; slowed breathing; and slowed heartbeat.

Proper storage of Butorphanol Solution:

Store Butorphanol Solution at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Butorphanol Solution out of the reach of children and away from pets.

General information:

If you have any questions about Butorphanol Solution, please talk with your doctor, pharmacist, or other health care provider.
Butorphanol Solution 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 summary only. It does not contain all information about Butorphanol Solution. 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

B,Med-facts

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