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Trifluridine Drops

30/06/10

Generic Name: Trifluridine (trye-FLURE-i-deen)
Brand Name: Viroptic

Trifluridine Drops are used for:

Treating herpes eye infection.

Trifluridine Drops are an antiviral. It works by killing sensitive viruses.

Do NOT use Trifluridine Drops if:

you are allergic to any ingredient in Trifluridine Drops

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

Before using Trifluridine Drops:

Some medical conditions may interact with Trifluridine Drops. 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 Trifluridine Drops. Because little, if any, of Trifluridine Drops are absorbed into the blood, the risk of it interacting with another medicine is low.

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

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

To use Trifluridine Drops, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them. To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including your eye. Keep the container tightly closed.
Contact your doctor for instructions on using your contact lenses while using Trifluridine Drops.
To clear up your infection completely, continue using Trifluridine Drops for the full course of treatment even if you feel better in a few days.
If you miss a dose of Trifluridine Drops, 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 Trifluridine Drops.

Important safety information:

Do not exceed the recommended dose or use Trifluridine Drops for longer than prescribed without checking with your doctor.
If your condition does not improve within 7 days or if it becomes worse, check with your doctor.
Do not use Trifluridine Drops for other eye problems without first checking with your doctor.
It is important to use Trifluridine Drops for the full course of treatment. Failure to do so may decrease the effectiveness of Trifluridine Drops and increase the risk that the virus will no longer be sensitive to Trifluridine Drops and will not be able to be treated by this or certain other antivirals in the future.
Use Trifluridine Drops with extreme caution in CHILDREN younger than 6 years of age. Safety and effectiveness in this age group have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Trifluridine Drops during pregnancy. It is unknown if Trifluridine Drops are excreted in breast milk. If you are or will be breast-feeding while you are using Trifluridine Drops, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Trifluridine Drops:

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:

Temporary burning or stinging.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); new or worsening eye irritation or pain; red or bloodshot eyes; swelling of the eye or eyelid; vision changes.

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.

Proper storage of Trifluridine Drops:

Store Trifluridine Drops in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Keep Trifluridine Drops out of the reach of children and away from pets.

General information:

If you have any questions about Trifluridine Drops, please talk with your doctor, pharmacist, or other health care provider.
Trifluridine Drops are 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 Trifluridine Drops. 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

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trifluridine ophthalmic

30/06/10

Generic Name: trifluridine ophthalmic (trye FLURE i deen off THAL mik)
Brand Names: Trifluridine, Viroptic

What is trifluridine ophthalmic?

Trifluridine ophthalmic is an antiviral medication. It fights eye infections that are caused by certain viruses.

Trifluridine ophthalmic is used to treat eye infections caused by the herpes simplex virus, which can lead to swelling or ulcers in the eyelids or cornea (surface of the eyeball).

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

What is the most important information I should know about trifluridine ophthalmic?

Do not use this medication if you are allergic to trifluridine. This medication will not treat an infection that is caused by bacteria or fungus.

The usual dose of trifluridine ophthalmic is one drop into the affected eye every 2 hours while you are awake. Do not use more than 9 drops in the course of one full day.

Once your condition improves, you may need to keep using the medication 4 times daily (up to 5 drops per day) for another 7 days. Your doctor should check your eyes to determine how long you need to use the medicine.

If you wear contact lenses, remove them before applying trifluridine ophthalmic. Ask your doctor if contact lenses can be reinserted after putting in the eye drops.

Avoid using other eye medications while using trifluridine ophthalmic, unless your doctor has told you to.

Trifluridine ophthalmic may cause blurred vision. Be careful if you drive, operate machinery, or do anything else that requires you to be able to see clearly.

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the eye drops if the liquid has changed colors or has particles in it.

Contact your doctor if your symptoms do not improve, or if they get worse after using this medication for 7 days.

What should I discuss with my healthcare provider before using trifluridine ophthalmic?

Do not use this medication if you are allergic to trifluridine. This medication will not treat an infection that is caused by bacteria or fungus. 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 trifluridine ophthalmic 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. Do not use this medication in a child younger than 6 years old.

How should I use trifluridine ophthalmic?

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. Follow the instructions on your prescription label.

The usual dose of trifluridine ophthalmic is one drop into the affected eye every 2 hours while you are awake. Do not use more than 9 drops in the course of one full day.

Wash your hands before using the eye drops.

If you wear contact lenses, remove them before applying trifluridine ophthalmic. Ask your doctor if contact lenses can be reinserted after putting in the eye drops.

To apply the eye drops:

Tilt your head back slightly and pull down your lower eyelid. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye. Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct.
Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the eye drops if the liquid has changed colors or has particles in it.

Contact your doctor if your symptoms do not improve, or if they get worse after using this medication for 7 days.

Store the eye drops at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Rinse the eye with water and seek emergency medical attention if you think you have used too much of this medicine.

An overdose of trifluridine ophthalmic is not expected to produce life-threatening symptoms.

What should I avoid while taking trifluridine ophthalmic?

This medication may cause blurred vision. Be careful if you drive, operate machinery, or do anything else that requires you to be able to see clearly.

Avoid using other eye medications while using trifluridine ophthalmic, unless your doctor has told you to.

Trifluridine ophthalmic side effects

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

severe swelling around your eyes;
tunnel vision; or
severe pain, burning, or other irritation of your eyes.

Keep using the medication and talk to your doctor if you have any of these less serious side effects:

mild eye pain, burning, stinging, itching, or redness;
blurred vision; or
feeling of pressure inside the eye.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect trifluridine ophthalmic?

There may be other drugs that can affect trifluridine ophthalmic. 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 information about trifluridine ophthalmic 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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Trifluoperazine Tablets

30/06/10

Generic Name: trifluoperazine hydrochloride
Dosage Form: tablet, film coated

Insert

Trifluoperazine Tablets Description

Each tablet for oral administration contains trifluoperazine hydrochloride equivalent to 1 mg, 2 mg, 5 mg, or 10 mg trifluoperazine.

The structural formula is:

Inactive ingredients: D and C Red #30 Aluminum Lake, FD and C Blue #2 Aluminum Lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose (monohydrate), magnesium stearate, polyethylene glycol, povidone, starch (corn), and titanium dioxide.

Indications and Usage for Trifluoperazine Tablets

For the management of schizophrenia.

Trifluoperazine HCl is effective for the short-term treatment of generalized non-psychotic anxiety. However, trifluoperazine HCl is not the first drug to be used in therapy for most patients with non-psychotic anxiety because certain risks associated with its use are not shared by common alternative treatments (i.e., benzodiazepines).

When used in the treatment of non-psychotic anxiety, trifluoperazine HCl should not be administered at doses of more than 6 mg per day or for longer than 12 weeks because the use of trifluoperazine HCl at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see

Warnings

The effectiveness of trifluoperazine HCl as a treatment for non-psychotic anxiety was established in a four-week clinical multicenter study of outpatients with generalized anxiety disorder (DSM-III). This evidence does not predict that trifluoperazine HCl will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (i.e., physical illness, organic mental conditions, agitated depression, character pathologies, etc.).

Trifluoperazine HCl has not been shown effective in the management of behavioral complications in patients with mental retardation.

Contraindications

A known hypersensitivity to phenothiazines, comatose or greatly depressed states due to central nervous system depressants and, in cases of existing blood dyscrasias, bone marrow depression and pre-existing liver damage.

Warnings

Tardive Dyskinesia

Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with neuroleptic (antipsychotic) drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of neuroleptic treatment, which patients are likely to develop the syndrome. Whether neuroleptic drug products differ in their potential to cause tardive dyskinesia is unknown.

Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of neuroleptic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses.

There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if neuroleptic treatment is withdrawn. Neuroleptic treatment itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying disease process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown.

Given these considerations, neuroleptics should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic neuroleptic treatment should generally be reserved for patients who suffer from a chronic illness that 1) is known to respond to neuroleptic drugs, and 2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically.

If signs and symptoms of tardive dyskinesia appear in a patient on neuroleptics, drug discontinuation should be considered. However, some patients may require treatment despite the presence of the syndrome.

For further information about the description of tardive dyskinesia and its clinical detection, please refer to the sections on

Precautions

and

Adverse Reactions

.Neuroleptic Malignant Syndrome (NMS)

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmias).

The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.

The management of NMS should include 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.

If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The patient should be carefully monitored, since recurrences of NMS have been reported.

An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis, elevated serum enzymes, BUN and FBS) has occurred in a few patients treated with lithium plus a neuroleptic. In some instances, the syndrome was followed by irreversible brain damage. Because of a possible causal relationship between these events and the concomitant administration of lithium and neuroleptics, patients receiving such combined therapy should be monitored closely for early evidence of neurologic toxicity and treatment discontinued promptly if such signs appear. This encephalopathic syndrome may be similar to or the same as neuroleptic malignant syndrome (NMS).

Patients who have demonstrated a hypersensitivity reaction (e.g., blood dyscrasias, jaundice) with a phenothiazine should not be re-exposed to any phenothiazine, including trifluoperazine HCl, unless in the judgment of the physician, the potential benefits of treatment outweigh the possible hazard.

Trifluoperazine HCl may impair mental and/or physical abilities, especially during the first few days of therapy. Therefore, caution patients about activities requiring alertness (e.g., operating vehicles or machinery).

If agents such as sedatives, narcotics, anesthetics, tranquilizers, or alcohol are used either simultaneously or successively with the drug, the possibility of an undesirable additive depressant effect should be considered.

Usage In Pregnancy

Safety for the use of trifluoperazine HCl during pregnancy has not been established. Therefore, it is not recommended that the drug be given to pregnant patients except when, in the judgment of the physician, it is essential. The potential benefits should clearly outweigh possible hazards. There are reported instances of prolonged jaundice, extrapyramidal signs, hyperreflexia or hyporeflexia in newborn infants whose mothers received phenothiazines.

Reproductive studies in rats given over 600 times the human dose showed an increased incidence of malformations above controls and reduced litter size and weight linked to maternal toxicity. These effects were not observed at half this dosage. No adverse effect on fetal development was observed in rabbits given 700 times the human dose nor in monkeys given 25 times the human dose.

Nursing Mothers

There is evidence that phenothiazines are excreted in the breast milk of nursing mothers. Because of the potential for serious adverse reactions in nursing infants from trifluoperazine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother

Precautions

General

Given the likelihood that some patients exposed chronically to neuroleptics will develop tardive dyskinesia, it is advised that all patients in whom chronic use is contemplated be given, if possible, full information about this risk. The decision to inform patients and/or their guardians must obviously take into account the clinical circumstances and the competency of the patient to understand the information provided.

Thrombocytopenia and anemia have been reported in patients receiving the drug. Agranulocytosis and pancytopenia have also been reported – warn patients to report the sudden appearance of sore throat or other signs of infection. If white blood cell and differential counts indicate cellular depression, stop treatment and start antibiotic and other suitable therapy.

Jaundice of the cholestatic type of hepatitis or liver damage has been reported. If fever with grippe-like symptoms occurs, appropriate liver studies should be conducted. If tests indicate an abnormality, stop treatment.

One result of therapy may be an increase in mental and physical activity. For example, a few patients with angina pectoris have complained of increased pain while taking the drug. Therefore, angina patients should be observed carefully and, if an unfavorable response is noted, the drug should be withdrawn.

Because hypotension has occurred, large doses and parenteral administration should be avoided in patients with impaired cardiovascular systems. To minimize the occurrence of hypotension after injection, keep patient lying down and observe for at least 1/2 hour. If hypotension occurs from parenteral or oral dosing, place patient in head-low position with legs raised. If a vasoconstrictor is required, norepinephrine bitartrate and phenylephrine HCl are suitable. Other pressor agents, including epinephrine, should not be used as they may cause a paradoxical further lowering of blood pressure.

Since certain phenothiazines have been reported to produce retinopathy, the drug should be discontinued if ophthalmoscopic examination or visual field studies should demonstrate retinal changes.

An antiemetic action of trifluoperazine HCl may mask the signs and symptoms of toxicity or overdosage of other drugs and may obscure the diagnosis and treatment of other conditions such as intestinal obstruction, brain tumor and Reye’s Syndrome.

With prolonged administration at high dosages, the possibility of cumulative effects, with sudden onset of severe central nervous system or vasomotor symptoms, should be kept in mind.

Neuroleptic drugs elevate prolactin levels; the elevation persists during chronic administration. Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin-dependent in vitro, a factor of potential importance if the prescribing of these drugs is contemplated in a patient with a previously detected breast cancer. Although disturbances such as galactorrhea, amenorrhea, gynecomastia and impotence have been reported, the clinical significance of elevated serum prolactin levels is unknown for most patients. An increase in mammary neoplasms has been found in rodents after chronic administration of neuroleptic drugs. Neither clinical nor epidemiologic studies conducted to date, however, have shown an association between chronic administration of these drugs and mammary tumorigenesis; the available evidence is considered too limited to be conclusive at this time.

Chromosomal aberrations in spermatocytes and abnormal sperm have been demonstrated in rodents treated with certain neuroleptics.

Because phenothiazines may interfere with thermoregulatory mechanisms, use with caution in persons who will be exposed to extreme heat.

As with all drugs which exert an anticholinergic effect, and/or cause mydriasis, trifluoperazine should be used with caution in patients with glaucoma.

Phenothiazines may diminish the effect of oral anticoagulants.

Phenothiazines can produce alpha-adrenergic blockade.

Concomitant administration of propranolol with phenothiazines results in increased plasma levels of both drugs.

Antihypertensive effects of guanethidine and related compounds may be counteracted when phenothiazines are used concurrently.

Thiazide diuretics may accentuate the orthostatic hypotension that may occur with phenothiazines.

Phenothiazines may lower the convulsive threshold; dosage adjustments of anticonvulsants may be necessary. Potentiation of anticonvulsant effects does not occur. However, it has been reported that phenothiazines may interfere with the metabolism of phenytoin and thus precipitate phenytoin toxicity.

Drugs which lower the seizure threshold, including phenothiazine derivatives, should not be used with metrizamide. As with other phenothiazine derivatives, trifluoperazine HCl should be discontinued at least 48 hours before myelography, should not be resumed for at least 24 hours postprocedure, and should not be used for the control of nausea and vomiting occurring either prior to myelography or postprocedure with metrizamide.

The presence of phenothiazines may produce false positive phenylketonuria (PKU) test results.

Long-Term Therapy

To lessen the likelihood of adverse reactions related to cumulative drug effect, patients with a history of long-term therapy with trifluoperazine HCl and/or other neuroleptics should be evaluated periodically to decide whether the maintenance dosage could be lowered or drug therapy discontinued.

Adverse Reactions

Drowsiness, dizziness, skin reactions, rash, dry mouth, insomnia, amenorrhea, fatigue, muscular weakness, anorexia, lactation, blurred vision and neuromuscular (extrapyramidal) reactions.

Extrapyramidal Symptoms

These symptoms are seen in a significant number of hospitalized mental patients. They may be characterized by motor restlessness, be of the dystonic type, or they may resemble parkinsonism.

Depending on the severity of symptoms, dosage should be reduced or discontinued. If therapy is reinstituted, it should be at a lower dosage. Should these symptoms occur in children or pregnant patients, the drug should be stopped and not reinstituted. In most cases, barbiturates by suitable route of administration will suffice. (Or, injectable diphenhydramine hydrochloride may be useful.) In more severe cases, the administration of an anti-parkinsonism agent, except levodopa, usually produces rapid reversal of symptoms. Suitable supportive measures such as maintaining a clear airway and adequate hydration should be employed.

Dystonia

Class Effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

Motor Restlessness

Symptoms may include agitation or jitteriness and sometimes insomnia. These symptoms often disappear spontaneously. At times these symptoms may be similar to the original neurotic or psychotic symptoms. Dosage should not be increased until these side effects have subsided.

If this phase becomes too troublesome, the symptoms can usually be controlled by a reduction of dosage or change of drug. Treatment with anti-parkinsonian agents, benzodiazepines or propranolol may be helpful.

Pseudo-parkinsonism

Symptoms may include: mask-like facies; drooling, tremors; pill-rolling motion; cogwheel rigidity; and shuffling gait. Reassurance and sedation are important. In most cases, these symptoms are readily controlled when an anti-parkinsonism agent is administered concomitantly. Anti-parkinsonism agents should be used only when required. Generally, therapy of a few weeks to two to three months will suffice. After this time patients should be evaluated to determine their need for continued treatment. (Note: Levodopa has not been found effective in pseudo-parkinsonism.) Occasionally it is necessary to lower the dosage of trifluoperazine HCl or to discontinue the drug.

Tardive Dyskinesia

As with all antipsychotic agents, tardive dyskinesia may appear in some patients on long-term therapy or may appear after drug therapy has been discontinued. The syndrome can also develop, although much less frequently, after relatively brief treatment periods at low doses. This syndrome appears in all age groups. Although its prevalence appears to be highest among elderly patients, especially elderly women, it is impossible to rely upon prevalence estimates to predict at the inception of neuroleptic treatment which patients are likely to develop the syndrome. The symptoms are persistent and in some patients appear to be irreversible. The syndrome is characterized by rhythmical involuntary movements of the tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). Sometimes these may be accompanied by involuntary movements of extremities. In rare instances, these involuntary movements of the extremities are the only manifestations of tardive dyskinesia. A variant of tardive dyskinesia, tardive dystonia, has also been described.

There is no known effective treatment for tardive dyskinesia; anti-parkinsonism agents do not alleviate the symptoms of this syndrome. If clinically feasible, it is suggested that all antipsychotic agents be discontinued if these symptoms appear. Should it be necessary to reinstitute treatment, or increase the dosage of the agent, or switch to a different antipsychotic agent, the syndrome may be masked.

It has been reported that fine vermicular movements of the tongue may be an early sign of the syndrome and if the medication is stopped at that time the syndrome may not develop.

Adverse Reactions Reported with Trifluoperazine HCl or Other Phenothiazine Derivatives

Adverse effects with different phenothiazines vary in type, frequency, and mechanism of occurrence, i.e., some are dose-related, while others involve individual patient sensitivity. Some adverse effects may be more likely to occur, or occur with greater intensity, in patients with special medical problems, e.g., patients with mitral insufficiency or pheochromocytoma have experienced severe hypotension following recommended doses of certain phenothiazines.

Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs. (See

Warnings

Not all of the following adverse reactions have been observed with every phenothiazine derivative, but they have been reported with one or more and should be borne in mind when drugs of this class are administered: extrapyramidal symptoms (opisthotonos, oculogyric crisis, hyperreflexia, dystonia, akathisia, dyskinesia, parkinsonism) some of which have lasted months and even years – particularly in elderly patients with previous brain damage; grand mal and petit mal convulsions, particularly in patients with EEG abnormalities or history of such disorders; altered cerebrospinal fluid proteins; cerebral edema; intensification and prolongation of the action of central nervous system depressants (opiates, analgesics, antihistamines, barbiturates, alcohol), atropine, heat, organophosphorus insecticides; autonomic reactions (dryness of mouth, nasal congestion, headache, nausea, constipation, obstipation, adynamic ileus, ejaculatory disorders/impotence, priapism, atonic colon, urinary retention, miosis and mydriasis); reactivation of psychotic processes, catatonic-like states; hypotension (sometimes fatal); cardiac arrest; blood dyscrasias (pancytopenia, thrombocytopenic purpura, leukopenia, agranulocytosis, eosinophilia, hemolytic anemia, aplastic anemia); liver damage (jaundice, biliary stasis); endocrine disturbances (hyperglycemia, hypoglycemia, glycosuria, lactation, galactorrhea, gynecomastia, menstrual irregularities, false positive pregnancy tests); skin disorders (photosensitivity, itching, erythema, urticaria, eczema up to exfoliative dermatitis); other allergic reactions (asthma, laryngeal edema, angioneurotic edema, anaphylactoid reactions); peripheral edema; reversed epinephrine effect; hyperpyrexia; mild fever after large I.M. doses; increased appetite; increased weight; a systemic lupus erythematosus-like syndrome; pigmentary retinopathy; with prolonged administration of substantial doses, skin pigmentation, epithelial keratopathy, and lenticular and corneal deposits.

EKG changes – particularly nonspecific, usually reversible Q and T wave distortions – have been observed in some patients receiving phenothiazine tranquilizers. Although phenothiazines cause neither psychic nor physical dependence, sudden discontinuance in long-term psychiatric patients may cause temporary symptoms, e.g., nausea and vomiting, dizziness, tremulousness.

Note: There have been occasional reports of sudden death in patients receiving phenothiazines. In some cases, the cause appeared to be cardiac arrest or asphyxia due to failure of the cough reflex.

Overdosage

(See also under ADVERSE REACTIONS)

DOSAGE AND ADMINISTRATIONAdults

Dosage should be adjusted to the needs of the individual. The lowest effective dosage should always be used. Dosage should be increased more gradually in debilitated or emaciated patients. When maximum response is achieved, dosage may be reduced gradually to a maintenance level. Because of the inherent long action of the drug, patients may be controlled on convenient b.i.d. administration; some patients may be maintained on once-a-day administration.

When trifluoperazine HCl is administered by intramuscular injection, equivalent oral dosage may be substituted once symptoms have been controlled.

Note: Although there is little likelihood of contact dermatitis due to the drug, persons with known sensitivity to phenothiazine drugs should avoid direct contact.

Elderly Patients

In general, dosages in the lower range are sufficient for most elderly patients. Since they appear to be more susceptible to hypotension and neuromuscular reactions, such patients should be observed closely. Dosage should be tailored to the individual, response carefully monitored, and dosage adjusted accordingly. Dosage should be increased more gradually in elderly patients.

Non-psychotic Anxiety

Usual dosage is 1 or 2 mg twice daily. Do not administer at doses of more than 6 mg per day or for longer than 12 weeks.

Psychotic Disorders

ORAL: Usual starting dosage is 2 mg to 5 mg b.i.d. (Small or emaciated patients should always be started on the lower dosage).

Most patients will show optimum response on 15 mg or 20 mg daily, although a few may require 40 mg a day or more. Optimum therapeutic dosage levels should be reached within two or three weeks.

Psychotic Children

Dosage should be adjusted to the weight of the child and the severity of the symptoms. These dosages are for children ages 6 to 12, who are hospitalized or under close supervision.

ORAL: The starting dosage is 1 mg administered once a day or b.i.d. Dosage may be increased gradually until symptoms are controlled or until side effects become troublesome.

While it is usually not necessary to exceed dosages of 15 mg daily, some older children with severe symptoms may require higher dosages.

How is Trifluoperazine Tablets Supplied

Trifluoperazine hydrochloride tablets, USP are available as:

1 mg: Round, film-coated, lavender colored tablets, debossed GG 51 on one side and 1 on the reverse side, and supplied as:

NDC 0781-1030-01 bottles of 100

NDC 0781-1030-05 bottles of 500

NDC 0781-1030-10 bottles of 1000

NDC 0781-1030-13 unit dose packages of 100

2 mg: Round, film-coated, lavender colored tablets, debossed GG 53 on one side and 2 on the reverse side, and supplied as:

NDC 0781-1032-01 bottles of 100

NDC 0781-1032-05 bottles of 500

NDC 0781-1032-10 bottles of 1000

NDC 0781-1032-13 unit dose packages of 100

5 mg: Round, film-coated, lavender colored tablets, debossed GG 55 on one side and 5 on the reverse side, and supplied as:

NDC 0781-1034-01 bottles of 100

NDC 0781-1034-05 bottles of 500

NDC 0781-1034-10 bottles of 1000

NDC 0781-1034-13 unit dose packages of 100

This strength tablet for use only in severe neuropsychiatric conditions.

10 mg: Round, film-coated, lavender colored tablets, debossed GG 58 on one side and 10 on the reverse side, and supplied as:

NDC 0781-1036-01 bottles of 100

NDC 0781-1036-05 bottles of 500

NDC 0781-1036-10 bottles of 1000

NDC 0781-1036-13 unit dose packages of 100

This strength tablet for use only in severe neuropsychiatric conditions.

Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from moisture.

Dispense in a tight, light-resistant container.

02-2008M

7193

Sandoz Inc.

Princeton, NJ 08540

trifluoperazine2mg

TRIFLUOPERAZINE
trifluoperazine tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	16590-305 (0781-1035)
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Trifluoperazine Hydrochloride (Trifluoperazine)	Trifluoperazine Hydrochloride	2 mg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	purple	Score	2 pieces
Shape	ROUND	Size	7mm
Flavor		Imprint Code	GG;53;2
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	16590-305-30	30 TABLET In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA085786	11/20/1981

Labeler - Stat Rx USA (786036330)

Revised: 10/2009Stat Rx USA

Professional,T

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Trifluridine

30/06/10

Generic Name: trifluridine ophthalmic (trye FLURE i deen off THAL mik)
Brand Names: Trifluridine, Viroptic

What is Trifluridine (trifluridine ophthalmic)?

Trifluridine ophthalmic is an antiviral medication. It fights eye infections that are caused by certain viruses.

Trifluridine ophthalmic is used to treat eye infections caused by the herpes simplex virus, which can lead to swelling or ulcers in the eyelids or cornea (surface of the eyeball).

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

What is the most important information I should know about Trifluridine (trifluridine ophthalmic)?

Do not use this medication if you are allergic to trifluridine. This medication will not treat an infection that is caused by bacteria or fungus.

The usual dose of trifluridine ophthalmic is one drop into the affected eye every 2 hours while you are awake. Do not use more than 9 drops in the course of one full day.

If you wear contact lenses, remove them before applying trifluridine ophthalmic. Ask your doctor if contact lenses can be reinserted after putting in the eye drops.

Avoid using other eye medications while using trifluridine ophthalmic, unless your doctor has told you to.

Trifluridine ophthalmic may cause blurred vision. Be careful if you drive, operate machinery, or do anything else that requires you to be able to see clearly.

Do not use the eye drops if the liquid has changed colors or has particles in it.

Contact your doctor if your symptoms do not improve, or if they get worse after using this medication for 7 days.

What should I discuss with my healthcare provider before using Trifluridine (trifluridine ophthalmic)?

How should I use Trifluridine (trifluridine ophthalmic)?

The usual dose of trifluridine ophthalmic is one drop into the affected eye every 2 hours while you are awake. Do not use more than 9 drops in the course of one full day.

Wash your hands before using the eye drops.

If you wear contact lenses, remove them before applying trifluridine ophthalmic. Ask your doctor if contact lenses can be reinserted after putting in the eye drops.

To apply the eye drops:

Tilt your head back slightly and pull down your lower eyelid. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye. Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct.
Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the eye drops if the liquid has changed colors or has particles in it.

Contact your doctor if your symptoms do not improve, or if they get worse after using this medication for 7 days.

Store the eye drops at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

What happens if I overdose?

Rinse the eye with water and seek emergency medical attention if you think you have used too much of this medicine.

An overdose of trifluridine ophthalmic is not expected to produce life-threatening symptoms.

What should I avoid while taking Trifluridine (trifluridine ophthalmic)?

This medication may cause blurred vision. Be careful if you drive, operate machinery, or do anything else that requires you to be able to see clearly.

Avoid using other eye medications while using trifluridine ophthalmic, unless your doctor has told you to.

Trifluridine (trifluridine ophthalmic) side effects

severe swelling around your eyes;
tunnel vision; or
severe pain, burning, or other irritation of your eyes.

Keep using the medication and talk to your doctor if you have any of these less serious side effects:

mild eye pain, burning, stinging, itching, or redness;
blurred vision; or
feeling of pressure inside the eye.

What other drugs will affect Trifluridine (trifluridine ophthalmic)?

Where can I get more information?

Your pharmacist has information about trifluridine ophthalmic 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.

Concise,T

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trifluridine (Ophthalmic route)

30/06/10

trye-FLURE-i-deen

Commonly used brand name(s):

In the U.S.

Viroptic

Available Dosage Forms:

Solution

Therapeutic Class: Antiviral

Pharmacologic Class: Viral DNA Thymidylate Synthetase Inhibitor

Chemical Class: Pyrimidine Nucleoside Analog

Uses For trifluridine

Trifluridine ophthalmic preparations are used to treat virus infections of the eye.

Trifluridine is available only with your doctor’s prescription.

Before Using trifluridine

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 trifluridine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to trifluridine 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

Although there is no specific information comparing the use of trifluridine in children with use in other age groups, it is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of trifluridine in the elderly with use in other age groups.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 trifluridine

The bottle is only partially full to provide proper drop control.

To use:

First, wash your hands. Then tilt the head back and pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes to allow the medicine to come into contact with the infection.
If you think you did not get the drop of medicine into your eye properly, use another drop.
To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

Do not use trifluridine more often or for a longer time than your doctor ordered. To do so may cause problems in the eyes. If you have any questions about this, check with your doctor.

To help clear up your infection completely, keep using trifluridine for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses.

Dosing

The dose of trifluridine 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 trifluridine. 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 ophthalmic solution dosage forms:
- For viral eye infection:
  - Adults and children 6 years of age and older—One drop every two hours while you are awake. After healing has occurred, the dose may be reduced for seven more days to one drop every four hours (at least 5 doses a day) while you are awake.
  - Children up to 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

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

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using trifluridine

It is very important that you keep your appointment with your doctor. If your symptoms become worse, check with your doctor sooner.

trifluridine 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 as soon as possible if any of the following side effects occur:

Rare

Blurred vision or other change in vision
dryness of eye
irritation of eye
itching, redness, swelling, or other sign of irritation not present before use of trifluridine

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

Burning or stinging

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.

Advanced,T

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Trifluoperazine hydrochloride

30/06/10

Why is Trifluoperazine hydrochloride prescribed?

Trifluoperazine is used for the treatment of schizophrenia (severe disruptions in thought and perception). It is also prescribed for anxiety that does not respond to ordinary tranquilizers.

Most important fact about Trifluoperazine hydrochloride

Trifluoperazine may cause tardive dyskinesia–a condition marked by involuntary muscle spasms and twitches in the face and body. This condition may be permanent and appears to be most common among the elderly, especially women. Ask your doctor for information about this possible risk.

How should you take Trifluoperazine hydrochloride?

If taking trifluoperazine in a liquid concentrate form, you will need to dilute it with a liquid such as a carbonated beverage, coffee, fruit juice, milk, tea, tomato juice, or water. You can also use puddings, soups, and other semisolid foods. Trifluoperazine should be diluted just before you take it.

You should not take trifluoperazine with alcohol.

–If you miss a dose…

If you take 1 dose a day, take the dose you missed as soon as you remember. Then go back to your regular schedule. If you do not remember until the next day, skip the missed dose and go back to your regular schedule.

If you take more than 1 dose a day, take the dose you missed if it is within an hour or so of the scheduled time. If you do not remember until later, skip the missed dose and go back to your regular schedule. Do not take 2 doses at once.

–Storage instructions…

Store at room temperature. Protect the concentrate from light.

Trifluoperazine hydrochloride 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 taking trifluoperazine.

Side effects may include:
Blood disorders, convulsions, dry mouth, headache, muscle stiffness or rigidity, nausea, restlessness, Parkinson’s–like movements, tardive dyskinesia (see “Most important fact about Trifluoperazine hydrochloride”)

Why should Trifluoperazine hydrochloride not be prescribed?

You should not be using trifluoperazine if you have liver damage, or if you are taking central nervous system depressants such as alcohol, barbiturates, or narcotic pain relievers. Trifluoperazine should not be used if you have an abnormal bone marrow or blood condition.

Special warnings about Trifluoperazine hydrochloride

You should use trifluoperazine cautiously if you have ever had a brain tumor, breast cancer, intestinal blockage, the eye condition called glaucoma, heart or liver disease, or seizures. Be cautious, too, if you are exposed to certain pesticides or extreme heat. Be aware that trifluoperazine may hide the signs of overdose of other drugs and may make it more difficult for your doctor to diagnose intestinal obstruction, brain tumor, and the dangerous neurological condition called Reye’s syndrome.

Tell your doctor if you have ever had an allergic reaction to any major tranquilizer similar to trifluoperazine.

Dizziness, nausea, vomiting, and tremors can result if you suddenly stop taking trifluoperazine. Follow your doctor’s instructions when discontinuing Trifluoperazine hydrochloride.

Tell your doctor immediately if you experience symptoms such as a fever or sore throat, mouth, or gums. These signs of infection may signal the need to stop trifluoperazine treatment. Notify your doctor, too, if you develop flu-like symptoms with fever.

Trifluoperazine can cause Neuroleptic Malignant Syndrome (NMS), a dangerous–and possibly life-threatening–condition marked by high body temperature, rigid muscles, irregular pulse or blood pressure, rapid or abnormal heartbeat, excessive sweating, and high fever. Seek medical attention immediately if you develop any of these symptoms.

This drug may impair your ability to drive a car or operate potentially dangerous machinery, especially during the first few days of treatment. Do not participate in any activities that require full alertness if you are unsure about your ability.

If you have any trouble with your vision, tell your doctor. Trifluoperazine has been known to cause vision problems.

Trifluoperazine concentrate contains a sulfite that may cause allergic reactions in some people, especially in those with asthma.

Possible food and drug interactions when taking Trifluoperazine hydrochloride

Extreme drowsiness and other potentially serious effects can result if trifluoperazine is combined with alcohol, tranquilizers such as Valium, narcotic painkillers such as Percocet, antihistamines such as Benadryl, and barbiturates such as phenobarbital.

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

Antiseizure drugs such as Dilantin
Atropine (Donnatal)
Blood thinners such as Coumadin
Guanethidine
Lithium (Lithobid, Eskalith)
Propranolol (Inderal)
Thiazide diuretics such as Dyazide

Special information if you are pregnant or breastfeeding

Pregnant women should use trifluoperazine only if clearly needed. The effects of trifluoperazine during pregnancy have not been adequately studied. If you are pregnant or plan to become pregnant, inform your doctor immediately. Trifluoperazine appears in breast milk and may affect a nursing infant. If Trifluoperazine hydrochloride is essential to your health, your doctor may have you discontinue breastfeeding while you are taking it.

Recommended dosage for Trifluoperazine hydrochloride

ADULTS

Nonpsychotic Anxiety

Doses usually range from 2 to 4 milligrams daily. This amount should be divided into 2 equal doses and taken twice a day. Do not take more than 6 milligrams a day or take Trifluoperazine hydrochloride for more than 12 weeks.

Schizophrenia

The usual starting dose is 4 to 10 milligrams a day, divided into 2 equal doses; doses range from 15 to 40 milligrams daily.

CHILDREN

Doses are based on the child’s weight and the severity of his or her symptoms.

Schizophrenia in Children 6 to 12 Years Old Who Are Closely Monitored or Hospitalized

The starting dose is 1 milligram a day, taken all at once or divided into 2 doses. Your doctor will increase the dosage gradually, up to 15 milligrams a day.

OLDER ADULTS

Older people usually take trifluoperazine at lower doses. Because you may develop low blood pressure while taking Trifluoperazine hydrochloride, your doctor will watch you closely. Older people (especially older women) may be more susceptible to tardive dyskinesia–a possibly permanent condition characterized by involuntary muscle spasms and twitches in the face and body. Consult your doctor for information about these potential risks.

Overdosage

Any medication taken in excess can have serious consequences. If you suspect an overdose of trifluoperazine, seek medical help immediately.

Symptoms of trifluoperazine overdose may include:
Agitation, coma, convulsions, difficulty breathing, difficulty swallowing, dry mouth, extreme sleepiness, fever, intestinal blockage, irregular heart rate, low blood pressure, restlessness

Detailed,T

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Triesence Suspension

30/06/10

Generic Name: Triamcinolone (TRYE-am-SIN-oh-lone)
Brand Name: Triesence

Triesence Suspension is used for:

Treating certain inflammatory conditions of the eye. It is also used to aid a certain eye procedure (vitrectomy).

Triesence Suspension is a corticosteroid. It works by decreasing inflammation.

Do NOT use Triesence Suspension if:

you are allergic to any ingredient in Triesence Suspension
you have a systemic fungal infection, malaria infection in the brain, or active herpes infection of the eye

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

Before using Triesence Suspension:

Some medical conditions may interact with Triesence Suspension. 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 a bacterial or fungal infection; a viral infection (eg, chickenpox, shingles); measles; tuberculosis (TB); a parasitic, ameba, or worm infection; or a history of herpes infection of the eye
if you have unexplained diarrhea, inflammation of the esophagus, ulcers, colitis, stomach or bowel problems (eg, blockage, inflammation, perforation), or recent stomach or bowel surgery
if you have a history of heart problems (eg, congestive heart failure), recent heart attack, high blood pressure, blood clotting problems, diabetes, cataracts, glaucoma, increased eye pressure, kidney problems, liver problems (eg, cirrhosis), mood or mental problems, a seizure disorder (eg, epilepsy), thyroid problems, or weak or brittle bones (osteoporosis)
if you have had joint surgery or a positive TB skin test, or if you have recently had a vaccination
if you have myasthenia gravis and take anticholinesterases (eg, pyridostigmine)

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

Amphotericin B, digoxin, or diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood potassium and heart problems (eg, enlarged heart, irregular heartbeat, heart failure) may be increased
Cyclosporine because the risk of seizures may be increased
Anticoagulants (eg, warfarin) because an increase or decrease of their effects may occur
Azole antifungals (eg, itraconazole, ketoconazole), estrogens, hormonal contraceptives (eg, birth control pills), or macrolide antibiotics (eg, clarithromycin) because they may increase the risk of Triesence Suspension’s side effects
Barbiturates (eg, phenobarbital), carbamazepine, cholestyramine, hydantoins (eg, phenytoin), or rifampin because they may decrease Triesence Suspension’s effectiveness
Aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), or ritodrine because the risk of their side effects may be increased by Triesence Suspension
Anticholinesterases (eg, pyridostigmine) or isoniazid because their effectiveness may be decreased by Triesence Suspension

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

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

Triesence Suspension is given as an injection at your doctor’s office, hospital, or clinic.
Triesence Suspension is only for injection into the eye. Do not inject Triesence Suspension into a vein or into other areas.
Do not use Triesence Suspension if it is discolored, has been frozen, or if the vial is cracked or damaged.
Shake well before each use.
If you miss a dose of Triesence Suspension, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Triesence Suspension.

Important safety information:

Triesence Suspension may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does. Tell your doctor right away if you are exposed to anyone who has these infections or to anyone who has TB.
If you are on long-term therapy, you may have withdrawal symptoms if you suddenly stop using Triesence Suspension. Contact your doctor right away if you have muscle and joint pain, exhaustion, or depression.
If you are on long-term therapy, contact your doctor right away in the event of situations of physical stress (eg, infection, injury, loss of blood electrolytes, surgery). You may need additional fast-acting steroids to help the body handle these situations.
Tell your doctor or dentist that you take Triesence Suspension before you receive any medical or dental care, emergency care, or surgery.
Triesence Suspension may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Triesence Suspension for a few days before the tests.
Do not receive a live vaccine (eg, measles, mumps) while you are using Triesence Suspension. Talk with your doctor before you receive any vaccine.
Lab tests, including blood pressure checks, bone density, and eye exams, may be performed while you use Triesence Suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Diabetes patients – Triesence Suspension may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Triesence Suspension.
Caution is advised when using Triesence Suspension in CHILDREN; they may be more sensitive to its effects.
PREGNANCY and BREAST-FEEDING: Triesence Suspension may 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 Triesence Suspension while you are pregnant. Triesence Suspension is found in breast milk. If you are or will be breast-feeding while you use Triesence Suspension, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Triesence Suspension:

All medicines may cause side effects, but many people have no, or minor side effects. No COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty swallowing or breathing; hoarseness; tightness in the chest; swelling of the mouth, face, hands, legs, eyes, throat, lips, or tongue); decreased vision or other vision changes; depression; eye “floaters”; eye pain; fainting; fast, slow, or irregular heartbeat; joint stiffness; mood or mental changes; muscle pain or weakness; numbness or tingling in the hands or feet; personality changes; seizures; severe redness or irritation of the eye; shortness of breath; signs of infection (eg, chills, fever, or sore throat); slow wound healing; swelling of the ankles, hands, legs, or feet.

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.

Proper storage of Triesence Suspension:

Triesence Suspension is usually handled and stored by a health care provider. If you are using Triesence Suspension at home, store Triesence Suspension as directed by your pharmacist or health care provider. Keep Triesence Suspension out of the reach of children and away from pets.

General information:

If you have any questions about Triesence Suspension, please talk with your doctor, pharmacist, or other health care provider.
Triesence Suspension 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 Triesence Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,T

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trifluoperazine

30/06/10

Generic Name: trifluoperazine (trye floo oh PER a zeen)
Brand Names: Stelazine

What is trifluoperazine?

Trifluoperazine is an anti-psychotic medication in a group of drugs called phenothiazines (FEEN-oh-THYE-a-zeens). It works by changing the actions of chemicals in your brain.

Trifluoperazine is used to treat anxiety or psychotic disorders such as schizophrenia.

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

What is the most important information I should know about trifluoperazine?

Stop using this medication and call your doctor at once if you have twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs. These could be early signs of dangerous side effects. Trifluoperazine is not for use in psychotic conditions related to dementia. Trifluoperazine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. Do not use trifluoperazine if you have liver disease, brain damage, bone marrow depression, a blood cell disorder (such as low platelets or low red or white blood cell counts), or if you are also using large amounts of alcohol or medicines that make you sleepy. Do not use if you are allergic to trifluoperazine or other phenothiazines.

Before you take trifluoperazine, tell your doctor if you have heart disease, high blood pressure, angina (chest pain), severe asthma or breathing problems, glaucoma, a history of seizures, adrenal gland tumor, Parkinson’s disease, enlarged prostate or urination problems, low levels of calcium in your blood, past or present breast cancer, or if you have ever had a serious side effect while using trifluoperazine or similar medicines.

Before taking trifluoperazine, tell your doctor about all other medications you use.

What should I discuss with my healthcare provider before taking oral trifluoperazine?

Trifluoperazine is not for use in psychotic conditions related to dementia. Trifluoperazine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. Do not use trifluoperazine if you have liver disease, brain damage, bone marrow depression, a blood cell disorder (such as low platelets or low red or white blood cell counts), or if you are also using large amounts of alcohol or medicines that make you sleepy. Do not use if you are allergic to trifluoperazine or other phenothiazines such as chlorpromazine (Thorazine), fluphenazine (Permitil), perphenazine (Trilafon), prochlorperazine (Compazine, Compro), promethazine (Adgan, Pentazine, Phenergan), or thioridazine (Mellaril).

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take trifluoperazine, tell your doctor if you have:

heart disease high blood pressure, or angina (chest pain);
severe asthma, emphysema, or other breathing problem;
glaucoma;
a history of seizures;
adrenal gland tumor (pheochromocytoma);
Parkinson’s disease;
enlarged prostate or urination problems;
low levels of calcium in your blood (hypocalcemia);
past or present breast cancer; or
if you have ever had a serious side effect while using trifluoperazine or another phenothiazine.

Tell your doctor if you will be exposed to extreme heat or cold, or to insecticide poisons while you are taking trifluoperazine.

It is not known whether trifluoperazine will harm an unborn baby. Trifluoperazine may cause side effects in a newborn if the mother takes the medication during pregnancy. Do not take this medication without first talking to your doctor if you are pregnant. Tell your doctor if you become pregnant while taking trifluoperazine. Trifluoperazine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medication.

Talk with your doctor before giving this medication to a child who has been ill with a fever or flu symptoms.

How should I take trifluoperazine?

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

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Call your doctor if your symptoms do not improve, or if they get worse while taking trifluoperazine.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using trifluoperazine.

If you need to have an x-ray or CT scan of your spinal column using a dye that is injected into a vein, you may need to temporarily stop taking trifluoperazine. Be sure the doctor knows ahead of time that you are using this medication.

Do not stop using trifluoperazine suddenly after long-term use, or you could have unpleasant withdrawal symptoms such as nausea, vomiting, dizziness, or feeling shaky. Talk to your doctor about how to avoid withdrawal symptoms when you stop using trifluoperazine.

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

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. 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. Overdose symptoms may include dry mouth, constipation, bloating or stomach cramps, extreme drowsiness or feeling restless and agitated, changes in heart rate, fever, fainting, and seizure (convulsions).

What should I avoid while taking trifluoperazine?

Trifluoperazine 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. 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. Avoid drinking alcohol. It can increase some of the side effects of trifluoperazine. Avoid exposure to sunlight or tanning beds. Trifluoperazine can make your skin more sensitive to sunlight, and a sunburn may result. Wear sunscreen (SPF 15 or higher) and protective clothing if you must be outdoors.

Trifluoperazine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using trifluoperazine and call your doctor at once if you have a serious side effect such as:

twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
tremor (uncontrolled shaking), drooling, trouble swallowing, problems with balance or walking;
feeling restless, jittery, or agitated;
high fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing;
feeling like you might pass out;
decreased night vision, tunnel vision, watery eyes, increased sensitivity to light;
seizure (black-out or convulsions);
nausea and stomach pain, skin rash, and jaundice (yellowing of the skin or eyes);
urinating less than usual or not at all;
pale skin, easy bruising or bleeding, fever, sore throat, flu symptoms;
joint pain or swelling with fever, swollen glands, muscle aches, chest pain, vomiting, unusual thoughts or behavior, and patchy skin color; or
slow heart rate, weak pulse, fainting, slow breathing (breathing may stop).

Less serious side effects may include:

dizziness, drowsiness, anxiety;
sleep problems (insomnia);
blurred vision, headache;
dry mouth, stuffy nose;
constipation;
breast swelling or discharge;
a missed menstrual period;
weight gain, swelling in your hands or feet;
mild itching or skin rash; or
impotence, trouble having an orgasm.

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.

Trifluoperazine Dosing Information

Usual Adult Dose for Schizophrenia:

Oral:
Initial dose: 2 to 5 mg twice a day (small or emaciated patients should be started on the lower dosage).
Maintenance dose: 15 to 20 mg/day, occasionally up to 40 mg/day or more in some cases. Optimum therapeutic dosage levels should be reached within 2 or 3 weeks.

IM:
For patients requiring prompt control of severe symptoms:
1 to 2 mg (1/2 to 1 mL) by deep IM injection every 4 to 6 hours as needed. Dosages exceeding 6 mg/24 hours are rarely necessary, and only in very exceptional cases should the dosage exceed 10 mg/24 hours.

Injections should not be given at intervals of less than 4 hours because of a possible cumulative effect.

Usual Adult Dose for Anxiety:

For treatment of nonpsychotic anxiety:
1 or 2 mg orally twice daily, not to exceed 6 mg/day or for longer than 12 weeks.

Usual Geriatric Dose for Schizophrenia:

Oral:
Initial dose: 2 mg twice a day.
Maintenance dose: 15 mg/day.
Optimum therapeutic dosage levels should be reached within 2 or 3 weeks.

IM:
For patients requiring prompt control of severe symptoms:
1 mg (1/2 mL) by deep IM injection every 4 to 6 hours as needed. Injections should not be given at intervals of less than 4 hours because of a possible cumulative effect.

Usual Geriatric Dose for Anxiety:

For treatment of nonpsychotic anxiety:
1 mg orally twice daily for no more than 12 weeks.

Usual Pediatric Dose for Schizophrenia:

6 to 12 years (patients who are hospitalized or under close supervision):

Oral:
Initial dose: 1 mg once or twice a day.
Dosage may be increased gradually until symptoms are controlled or until side effects become troublesome. While dosages exceeding 15 mg/day are generally not necessary, some older children with severe symptoms may require higher dosages.

IM:
There has been little experience with the use of trifluoperazine injection in children. However, if it is necessary to achieve rapid control of severe symptoms, 1 mg (1/2 mL) of the drug may be administered IM once or twice a day.

Dosage should be adjusted to the weight of the child and severity of the symptoms.

What other drugs will affect trifluoperazine?

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can interact with trifluoperazine and cause medical problems or increase side effects. Tell your doctor if you regularly use any of these medicines, or any other anti-psychotic medications.

Also tell your doctor if you are taking any of the following medicines:

atropine (Atreza, Sal-Tropine);
lithium (Eskalith, Lithobid);
phenytoin (Dilantin);
an antibiotic;
birth control pills or hormone replacement estrogens;
a blood thinner such as warfarin (Coumadin);
certain asthma medications or bronchodilators;
a diuretic (water pill);
drugs to treat high blood pressure or a prostate disorder, such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin), tamsulosin (Flomax);
incontinence medications;
insulin or diabetes medications you take by mouth;
medication for nausea, vomiting, or motion sickness;
medications to treat or prevent malaria;
medications used for general anesthesia;
medicines used to prevent organ transplant rejection;
numbing medicine such as lidocaine or Novocain;
a stimulant or ADHD medication;
ulcer or irritable bowel medications; or
medicines to treat Parkinson’s disease, restless leg syndrome, or pituitary gland tumor (prolactinoma).

This list is not complete and there are many other medicines that can interact with trifluoperazine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about trifluoperazine.

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

Concise,T

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Trientine Hydrochloride

30/06/10

Pronunciation: (TRY-eh-TEEN HIGH-droe-KLOR-ide)
Class: Chelating agent

Trade Names:
Syprine
- Capsules 250 mg

Pharmacology

Forms chelate with copper, facilitating removal from the body.

Indications and Usage

Treatment of Wilson disease in patients intolerant of penicillamine.

Contraindications

Standard considerations.

Dosage and Administration

Adults

PO Initially, 750 to 1,250 mg/day in divided doses 2, 3, or 4 times daily (max, 2,000 mg/day).

Children 12 yr of age and younger

PO Initially, 500 to 750 mg/day in divided doses 2, 3, or 4 times daily (max, 1500 mg/day).

Storage/Stability

Store capsules in refrigerator (36° to 46°F). Keep container tightly closed.

Drug Interactions

Mineral supplements

In general, do not give mineral supplements because they may block the absorption of trientine. Because iron deficiency may develop, iron may be given in short courses if necessary, separating the administration times of iron and trientine by 2 h.

Food, other drugs

To permit max absorption, administer trientine on an empty stomach at least 1 h before or 2 h after meals and at least 1 h apart from any other drug, food, or milk.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Malaise; weakness.

Dermatologic

Thickening, fissuring, and flaking of the skin.

GI

Heartburn; epigastric pain and tenderness; acute gastritis; abdominal pain; anorexia; cramps.

Hematologic

Hypochromic microcytic anemia.

Metabolic

Iron deficiency.

Respiratory

Asthma; bronchitis.

Miscellaneous

System lupus erythematosus; dystonia; muscular spasm; myasthenia gravis; aphthoid ulcers; melena; muscle pain; rhabdomyolysis.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established; however, trientine has been used clinically in children as young as 6 yr of age without reported adverse reactions.

Elderly

Use with caution because of the greater frequency of decreased hepatic, renal, or cardiac function and concomitant diseases or other drug therapy.

Hypersensitivity

Although not reported, observe patients for signs of possible hypersensitivity.

Patient Information

Remind patient or caregiver that following a low-copper diet is an important part of therapy and that medication therapy will be continued for months to years.
Advise patient or caregiver that each dose should be taken with a full glass of water on an empty stomach, 1 h before or 2 h after meals and at least 1 h apart from any other drug, food, or milk. Advise patient who is also taking iron supplements to separate trientine and iron administration by at least 2 h.
Advise patient or caregiver that capsules should be swallowed whole. Do not crush, chew, cut, or open capsules.
Advise patient or caregiver that if accidental skin contact occurs with contents of capsule to immediately flush exposed skin with water to remove medication.
Instruct patient or caregiver to take and record temperature each night for the first month of therapy and to report any fever or elevated temperature to health care provider.
Instruct patient or caregiver to immediately report skin rash or eruption to health care provider.
Instruct patient not to take any prescription or OTC medications or dietary supplements, including mineral supplements, unless advised by health care provider.

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Triesence

30/06/10

Generic Name: triamcinolone (ophthalmic) (trye am SIN oh lone off THAL mik)
Brand Names: Triesence, Trivaris Intravitreal

What is triamcinolone ophthalmic?

Triamcinolone ophthalmic is a steroid. It prevents the release of substances in the body that cause inflammation.

Triamcinolone ophthalmic (for the eyes) is injected into the eye to treat inflammation caused by disease or injury. Triamcinolone ophthalmic is usually given after steroid eye drops have been used without successful treatment of symptoms.

Triamcinolone ophthalmic is also used during a certain type of eye surgery.

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

What is the most important information I should know about triamcinolone ophthalmic?

You should not receive this medication if you are allergic to triamcinolone, or if you have a fungal infection anywhere in your body. Do not use triamcinolone ophthalmic without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before receiving triamcinolone ophthalmic, tell your doctor if you have any type of bacterial, fungal, or viral infection (including tuberculosis). Also tell your doctor if you have cataracts or glaucoma, herpes infection of your eye, diabetes, high blood pressure, congestive heart failure, a thyroid disorder, myasthenia gravis, a stomach or intestinal disorder, or a history of recent heart attack.

Before you receive any vaccine, talk with the doctor who is treating you with triamcinolone ophthalmic. Some vaccines may not work as well or could cause harmful side effects during treatment with steroid medicine.

Steroids can lower the blood cells that help your body fight infections Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles.

There are many other medicines that can interact with triamcinolone ophthalmic. Tell your doctor about all the prescription and over-the-counter medications you use. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

What should I discuss with my health care provider before receiving triamcinolone ophthalmic?

You should not receive this medication if you are allergic to triamcinolone, or if you have a fungal infection anywhere in your body.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely receive triamcinolone ophthalmic:

herpes infection of your eye;
eye conditions such as cataract or glaucoma;
diabetes;
high blood pressure, congestive heart failure;
any type of bacterial, fungal, or viral infection (including tuberculosis);
a thyroid disorder;
a muscle disorder such as myasthenia gravis;
diverticulitis, stomach or intestinal ulcer, or recent stomach surgery; or
if you have recently had a heart attack.

FDA pregnancy category D. Triamcinolone ophthalmic can cause harm to an unborn baby or cause birth defects. Before you receive triamcinolone ophthalmic, tell your doctor if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Triamcinolone can pass into breast milk and may harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

This medication can decrease bone formation, which could lead to osteoporosis, especially with long-term use. Talk with your doctor about your specific risk of bone loss while receiving triamcinolone ophthalmic.

Steroids can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

How is triamcinolone ophthalmic given?

Triamcinolone ophthalmic is given as an injection into your eye. Your doctor will use a medicine to numb your eye before giving you the injection. You will receive this injection in your doctor’s office or other clinic setting.

For at least 30 minutes after your injection, your eyes will be checked periodically to make sure the injection has not caused any side effects.

Long-term use of steroids can cause harmful effects on the eyes, such as glaucoma or cataracts. If you receive triamcinolone ophthalmic for longer than 6 weeks, your doctor may want you to have regular eye exams.

Steroids can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill, or from bacteria in a skin wound. Steroids can also slow the healing of skin wounds. Use caution to prevent illness, infection, or injury.

Your doctor may instruct you to limit your salt intake while you are receiving triamcinolone ophthalmic. You may also need to take potassium supplements. Follow your doctor’s instructions.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are being treated with triamcinolone ophthalmic.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your injection.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine.

Since this medication is given by a healthcare professional, an overdose is unlikely to occur.

What should I avoid while receiving triamcinolone ophthalmic?

Do not receive a smallpox vaccine or any other “live” vaccine if you are being treated long-term with triamcinolone ophthalmic. Some vaccines may not work as well during treatment with steroid medicine at certain doses. Some vaccines may even cause dangerous side effects when used during steroid treatment. Before you receive any vaccine, talk with the doctor who is treating you with triamcinolone ophthalmic.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroids.

Triamcinolone ophthalmic side effects

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

problems with your vision, blurred vision, or seeing halos around lights;
eye swelling, redness, severe discomfort, crusting or drainage (may be signs of infection);
large red or purple spots on your skin;
fast, slow, or uneven heart rate;
feeling short of breath, swelling in your hands or feet;
increased blood pressure (severe headache, blurred vision, chest pain, shortness of breath, uneven heartbeats);
ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes;
severe depression, changes in mood or behavior, seizures (convulsions); or
severe pain in your upper stomach.

Less serious side effects may include:

mild eye discomfort;
headaches, back aches, weakness, confusion;
bloating, appetite changes, weight gain;
changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist), roundness in your face, ;
increased acne or facial hair;
menstrual problems (in women), impotence or loss of interest in sex (in men);
dry skin, thinning skin, changes in skin color;
bruising, sweating more than usual; or
a wound that is slow to heal.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect triamcinolone ophthalmic?

Many drugs can interact with triamcinolone. Below is just a partial list. Tell your doctor if you are using:

amphotericin B (Fungizone, AmBisome, Abelcet);
birth control pills or hormone replacement therapy;
a blood thinner such as warfarin (Coumadin);
cholestyramine (Prevalite, Questran);
cyclosporine (Neoral, Gengraf, Sandimmune);
digoxin (digitalis, Lanoxin);
a diuretic (water pill);
insulin or diabetes medications you take by mouth;
isoniazid (for treating tuberculosis);
rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), or rifapentine (Priftin);
an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);
an antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);
aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), etodolac (Lodine), indomethacin (Indocin), piroxicam (Feldene), and others;
heart or blood pressure medication such as diltiazem (Cardizem, Dilacor, Tiazac), quinidine (Quinaglute, Quinidex, Quin-Release), or verapamil (Calan, Covera, Isoptin, Verelan);
HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), fosamprenavir (Lexiva), indinavir (Crixivan), nevirapine (Viramune), saquinavir (Invirase, Fortovase), ritonavir (Norvir), and others;
medications to treat dementia, such as donepezil (Aricept), rivastigmine (Exelon), galantamine (Razadyne), tacrine (Cognex); or
seizure medication such as carbamazepine (Carbatrol, Tegretol), phenobarbital (Solfoton), phenytoin (Dilantin), and others.

This list is not complete and there are many other medicines that can interact with triamcinolone ophthalmic. 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. Keep a list of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?

Your doctor can provide more information about triamcinolone ophthalmic.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,T

Comments (0)

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Drugs & Medications:A-Z

Recent Posts

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30/06/10

Trifluridine Drops are used for:

Do NOT use Trifluridine Drops if:

Before using Trifluridine Drops:

How to use Trifluridine Drops:

Important safety information:

Possible side effects of Trifluridine Drops:

If OVERDOSE is suspected:

General information:

30/06/10

What is trifluridine ophthalmic?

What is the most important information I should know about trifluridine ophthalmic?

What should I discuss with my healthcare provider before using trifluridine ophthalmic?

How should I use trifluridine ophthalmic?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking trifluridine ophthalmic?

Trifluridine ophthalmic side effects

What other drugs will affect trifluridine ophthalmic?

Where can I get more information?

30/06/10

Trifluoperazine Tablets Description

Indications and Usage for Trifluoperazine Tablets

Contraindications

Warnings

Precautions

Adverse Reactions

Overdosage

How is Trifluoperazine Tablets Supplied

30/06/10

What is Trifluridine (trifluridine ophthalmic)?

What is the most important information I should know about Trifluridine (trifluridine ophthalmic)?

What should I discuss with my healthcare provider before using Trifluridine (trifluridine ophthalmic)?

How should I use Trifluridine (trifluridine ophthalmic)?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking Trifluridine (trifluridine ophthalmic)?

Trifluridine (trifluridine ophthalmic) side effects

What other drugs will affect Trifluridine (trifluridine ophthalmic)?

Where can I get more information?

30/06/10

Uses For trifluridine

Before Using trifluridine

Allergies

Pediatric

Geriatric

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of trifluridine

Dosing

Missed Dose

Storage

Precautions While Using trifluridine

trifluridine Side Effects

30/06/10

Why is Trifluoperazine hydrochloride prescribed?

Most important fact about Trifluoperazine hydrochloride

How should you take Trifluoperazine hydrochloride?

Trifluoperazine hydrochloride side effects

Why should Trifluoperazine hydrochloride not be prescribed?

Special warnings about Trifluoperazine hydrochloride

Possible food and drug interactions when taking Trifluoperazine hydrochloride

Special information if you are pregnant or breastfeeding

Recommended dosage for Trifluoperazine hydrochloride

Overdosage

30/06/10

Triesence Suspension is used for:

Do NOT use Triesence Suspension if:

Before using Triesence Suspension:

How to use Triesence Suspension:

Important safety information:

Possible side effects of Triesence Suspension:

If OVERDOSE is suspected:

General information:

30/06/10

What is trifluoperazine?

What is the most important information I should know about trifluoperazine?