Flumadine

Rimantadine is a synthetic (man-made) anti-viral drug that can prevent viruses in cells from multiplying. Rimantadine is chemically related to amantadine (Symmetrel), but rimantadine has fewer side effects on the nervous system than amantadine. It is useful in treating and preventing influenza A virus in adults and in preventing influenza A virus in children. However, the Center for Disease Control and Prevention recommends that rimantadine should not to be used to replace the annual influenza vaccination. Prolonged and frequent use of rimantadine can cause it to be less effective in its activity against the influenza A virus. Rimantadine is most effective when given within 48 hours of the start of symptoms associated with the influenza A. The FDA approved rimantadine in September 1993.

Yes

Tablets: 100 mg. Syrup: 50 mg per teaspoonful.

Tablets and syrup should be stored at room temperature, between 15 C and 30 C (59 F and 86 F).

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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 rimantadine and call your doctor at once if you have a seizure (black-out or convulsions).

Less serious side effects may include:

• nausea, vomiting, diarrhea, loss of appetite, stomach pain;
• dry mouth;
• sleep problems (insomnia);
• dizziness;
• headache; or
• anxiety, trouble concentrating.

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.

Flumadine is a prescription medication used to prevent and treat influenza A (flu) virus in adults. It is also used to prevent influenza A virus in children.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Common side effects include:

• insomnia
• dizziness
• headache
• nervousness
• fatigue
• nausea
• vomiting

Tell your doctor about any side effect that bothers you or that does not go away.

These are not all of the possible side effects with Flumadine. For more information, ask your doctor or pharmacist.

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

Do not use this medicine if you are allergic to rimantadine or a similar medicine called amantadine (Symmetrel).

Before taking rimantadine, tell your doctor if you are allergic to any drugs, or if you have a seizure disorder, kidney disease, or liver disease.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated.

Do not use FluMist nasal influenza "live vaccine" while you are being treated with rimantadine and for at least 48 hours after you stop taking rimantadine. The nasal vaccine may not be as effective if you receive it while you are taking rimantadine. Before taking rimantadine, tell your doctor if you have received a nasal flu vaccine within the past 14 days.

Avoid coming into close contact with someone who has a weak immune system, such as a person who is taking steroids, being treated for cancer, or has a bone marrow disorder or an illness such as HIV or AIDS. If you have a type of influenza that is resistant to rimantadine, your body may actually shed that virus and a person with a weak immune system could easily become ill from being near you.

Do not use this medicine if you are allergic to rimantadine or a similar medicine called amantadine (Symmetrel).

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

• epilepsy or other seizure disorder;
• kidney disease; or
• liver disease.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

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 rimantadine 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.

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

• Flu (Influenza)

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

If you are taking rimantadine to treat influenza A, take it within 48 hours of when you notice your first flu symptoms.

Take this medication with a full glass of water.

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

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated.

Store rimantadine at room temperature away from moisture and heat.

• If you have an allergy to rimantadine or any other part of Flumadine (rimantadine).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are breast-feeding. Do not breast-feed while you take this medicine.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Flumadine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Flumadine is indicated for the prophylaxis and treatment of illness caused by various strains of influenza A virus in adults (17 years and older).

Flumadine is indicated for prophylaxis against influenza A virus in children (1 year to 16 years of age).

PROPHYLAXIS: In controlled studies of children (1 year to 16 years of age), healthy adults (17 years and older), and elderly patients (65 yeas of age and older), Flumadine has been shown to be safe and effective in preventing signs and symptoms of infection caused by various strains of influenza A virus. Since Flumadine does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically-related viruses. Following vaccination during an influenza outbreak, Flumadine prophylaxis should be considered for the 2 to 4 week time period required to develop an antibody response. However, the safety and effectiveness of Flumadine prophylaxis have not been demonstrated for longer than 6 weeks.

TREATMENT: Flumadine therapy should be considered for adults (17 years and older) who develop an influenza-like illness during known or suspected influenza A infection in the community. When administered within 48 hours after onset of signs and symptoms of infection caused by influenza A virus strains, Flumadine has been shown to reduce the duration of fever and systemic symptoms.

The following points should be considered before initiating treatment or prophylaxis with
Flumadine:

• Flumadine is not a substitute for early vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.
• Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use Flumadine.

As with any overdose, supportive therapy should be administered as indicated. Overdoses of a related drug, amantadine, have been reported with adverse reactions consisting of agitation, hallucinations, cardiac arrhythmia and death. The administration of intravenous physostigmine (a cholinergic agent) at doses of 1 to 2 mg in adults (Ref. 7) and 0.5 mg in children (Ref. 8) repeated as needed as long as the dose did not exceed 2 mg/hour has been reported anecdotally to be beneficial in patients with central nervous system effects from overdoses of amantadine.

1. Belshe RB, Burk, B, Newman F,et al. J Infect Dis. 1989;159(3), 430-435.
2. Sim IS, Cerruti RL, Connell, EV. J Resp. Dis. 1989 (Suppl.), S46-S51.
3. Hayden FG, Belshe, RB, Clover RD, et al N Engl J Med. 1989;321(25): 1696-1702.
4. Hall, CB, Dolin R, Gala CL, et al. Pediatrics. 1987;80(2): 275-282.
5. Thompson J, Fleet W, Lawrence E. et al. J Med Virol. 1987;21(3):249-255.
6. Belshe RB, Smith MH, Hall CB, et al. J Virol. 1988;62(5):1508-1512.
7. Casey DE. N Engl J Med. 1978:298(9):516.
8. Berkowitz CD. J Pediatr 1979:95(1):144-145.
9. Hayden FG, Sperber SJ, Belshe RB, et al. Antimicrob Agents Chemother. 1991;35(9):1741-1747
10. Deyde VM, Xu X, Bright RA, et al. J Infect Dis. 2007;196(2):249-257.
11. CDC. MMWR Morb Mortal Wkly Rep. 2009;58(16):433-435.

C.S. No. 7105T02

Rev. 02/10

MG#9040(11)

Manufactured by:
Forest Pharmaceuticals, Inc.
Subsidiary of Forest Laboratories, Inc.
St. Louis, MO 63045

Distributed By:
Caraco Pharmaceutical Laboratories, Ltd.
1150 Elijah McCoy Drive
Detroit, MI 48202

NDC 49708-521-88

Flumadine® Tablets (rimantadine hydrochloride tablets)

Each tablet contains 100 mg rimantadine hydrochloride

Rx only

100 Tablets

Distributed by:

Caraco Pharmaceutical Laboratories, Ltd.

Detroit, MI 48202

Applies to rimantadine: oral syrup, oral tablet

General

Gastrointestinal and nervous system side effects are most frequently reported. In a prophylaxis trial, 6.9% of subjects discontinued treatment due to adverse reactions. In geriatric patients, gastrointestinal and nervous system adverse effects occurred twice as often with rimantadine (the active ingredient contained in Flumadine) than with placebo.[Ref]

Nervous system

Seizures were reported in a few patients during clinical trials with rimantadine (the active ingredient contained in Flumadine) In two patients, seizure activity had been absent for greater than 10 years. However, their anticonvulsant medications had been withdrawn in the previous few months.[Ref]

Nervous system side effects have included insomnia (up to 3.4%), dizziness (up to 1.9%), headache (1.4%), and jitteriness. Ataxia, somnolence, agitation, and tinnitus have been reported in 0.3% to 1% of patients. Gait abnormality, hyperkinesia, tremor, hallucination, confusion, syncope, taste loss/change, parosmia, and convulsions have been reported in less than 0.3% of patients. Agitation and hypesthesia have occurred with higher than recommended doses of rimantadine. Dizziness and headache were reported up to two times more often in geriatric patients receiving rimantadine than in those receiving placebo.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea (2.8%), vomiting (1.7%), anorexia (1.6%), dry mouth (1.5%), and abdominal pain (1.4%). Diarrhea and dyspepsia have been reported in 0.3% to 1% of patients. Constipation, dysphagia, and stomatitis have occurred with higher than recommended doses of rimantadine (the active ingredient contained in Flumadine) Gastrointestinal symptoms (particularly nausea, vomiting, and abdominal pain) were reported at least twice as often in geriatric patients receiving rimantadine than in those receiving placebo. Tolerance may be improved by giving the drug in two divided daily doses.[Ref]

Psychiatric

Psychiatric side effects have included impaired concentration (up to 2.1%), nervousness (up to 2.1%), depression (up to 1%), and euphoria (less than 0.3%). Anxiety was reported up to two times more often in geriatric patients receiving rimantadine (the active ingredient contained in Flumadine) than in those receiving placebo.

Cardiovascular

Cardiovascular side effects have included cardiac failure, cerebrovascular disorder, heart block, hypertension, palpitation, pedal edema, and tachycardia in less than 0.3% of patients.[Ref]

Respiratory

Respiratory side effects have included dyspnea (0.3% to 0.1%), bronchospasm (less than 0.3%), and cough (less than 0.3%).[Ref]

Other

Other side effects have included asthenia (1.4%), fatigue (1%), and pallor (less than 0.3%). Fever and rigors have occurred with higher than recommended doses of rimantadine (the active ingredient contained in Flumadine) Asthenia and fatigue were reported up to two times more often in geriatric patients receiving rimantadine than in those receiving placebo.[Ref]

Dermatologic

Dermatologic side effects have included rash (0.3% to less than 1%). Diaphoresis has occurred with higher than recommended doses of rimantadine (the active ingredient contained in Flumadine) [Ref]

Genitourinary

Genitourinary side effects have included nonpuerperal lactation in less than 0.3% of patients. Increased micturition frequency has occurred with higher than recommended doses of rimantadine (the active ingredient contained in Flumadine)

Ocular

Ocular side effects have included increased lacrimation and eye pain with higher than recommended doses of rimantadine (the active ingredient contained in Flumadine)

Some side effects of Flumadine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.