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Flumadine (Rimantadine Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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

Flumadine is indicated for prophylaxis against influenza A virus in children.

PROPHYLAXIS: In controlled studies of children over the age of 1 year, healthy adults and elderly patients, Flumadine has been shown to be safe and effective in preventing signs and symptoms of infection caused by various strains of influenza A virus. Early vaccination on an annual basis as recommended by the Centers for Disease Control's Immunization Practices Advisory Committee is the method of choice in the prophylaxis of influenza unless vaccination is contraindicated, not available or not feasible. 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 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.

DOSAGE AND ADMINISTRATION

FOR PROPHYLAXIS IN ADULTS AND CHILDREN: Adults: The recommended adult dose of Flumadine is 100 mg twice a day. In patients with severe hepatic dysfunction, renal failure (CrCI ≤10 mL/min.) and elderly nursing home patients, a dose reduction to 100 mg daily is recommended. There are currently no data available regarding the safety of rimantadine during multiple dosing in subjects with renal or hepatic impairment. Because of the potential for accumulation of rimantadine metabolites during multiple dosing, patients with any degree of renal insufficiency should be monitored for adverse effects, with dosage adjustments being made as necessary.

Children: In children less than 10 years of age, Flumadine should be administered once a day, at a dose of 5 mg/kg but not exceeding 150 mg. For children 10 years of age or older, use the adult dose.

FOR TREATMENT IN ADULTS: The recommended adult dose of Flumadine is 100 mg twice a day. In patients with severe hepatic dysfunction, renal failure (CrCI ≤10 mL/min) and elderly nursing home patients, a dose reduction to 100 mg daily is recommended. There are currently no data available regarding the safety of rimantadine during multiple dosing in subjects with renal or hepatic impairment. Because of the potential for accumulation of rimantadine metabolites during multiple dosing, patients with any degree of renal insufficiency should be monitored for adverse effects, with dosage adjustments being made as necessary. Flumadine therapy should be initiated as soon as possible, preferably within 48 hours after onset of signs and symptoms of influenza A infection. Therapy should be continued for approximately seven days from the initial onset of symptoms.

HOW SUPPLIED

Flumadine® tablets (rimantadine hydrochloride tablets) are supplied as 100 mg tablets (orange, oval-shaped, film-coated) in bottles of 100 (NDC 0456-0521-01). Imprint on tablets: (Front) FLUMADINE 100; (Back) FOREST.

Flumadine® syrup (rimantadine hydrochloride syrup) containing 50 mg of rimantadine hydrochloride per teaspoonful (5 mL) (purplish-red, raspberry-flavored) is supplied in bottles of 8 oz (NDC 0456-0527-08).

Tablets and syrup should be stored at 15° - 30°C (59° - 86°F).

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