Flumadine label

Flumadine

Flumadine Recall

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Uses

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.

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History

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Other Information

Flumadine® (rimantadine hydrochloride) is a synthetic antiviral drug available as a 100 mg film-coated tablet and as a syrup for oral administration. Each film-coated tablet contains 100 mg of rimantadine hydrochloride plus hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, FD&C Yellow No. 6 Lake and FD&C Yellow No. 6. The film coat contains hydroxypropyl methylcellulose and polyethylene glycol. Each teaspoonful (5 mL) of the syrup contains 50 mg of rimantadine hydrochloride in an aqueous solution containing citric acid, parabens (methyl and propyl), saccharin sodium, sorbitol, D&C Red No. 33 and flavors.

Rimantadine hydrochloride is a white to off-white crystalline powder which is freely soluble in water (50 mg/mL at 20°C). Chemically, rimantadine hydrochloride is alpha-methyltricyclo-[3.3.1.1/3.7]decane-1-methanamine hydrochloride, with an empirical formula of C12H21N•HCI, a molecular weight of 215.77 and the following structural formula:Image from Drug Label Content

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Flumadine Manufacturers

  • Forest Pharmaceuticals, Inc.
    Flumadine | Forest Pharmaceuticals, Inc.
    No Recall

    Flumadine | Forest Pharmaceuticals, Inc.

    Flumadine | Forest Pharmaceuticals, Inc.

    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.

  • Caraco Pharma, Inc.
    Flumadine | Caraco Pharma, Inc.
    No Recall

    Flumadine | Caraco Pharma, Inc.

    Flumadine | Caraco Pharma, Inc.

    FOR PROPHYLAXIS IN ADULTS AND CHILDREN:
    Adults( 17 years and older):
    The recommended adult dose of Flumadine is 100 mg twice a day. Study durations ranged from 11 days to 6 weeks in adult and elderly patients. In patients with severe hepatic dysfunction, severe renal impairment (CrCl 5 to 29 mL/min) or renal failure (CrCI ≤ 10 mL/min) and elderly nursing home patients, a dose reduction to 100 mg daily is recommended. Because of the potential for accumulation of rimantadine metabolites during multiple dosing, patients with hepatic or renal impairment should be monitored for adverse effects.

    Children (1 year to 16 years of age):

    Study durations ranged from 5 weeks to 6 weeks in pediatric patients. In children 1 year to 9 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 to 16 years of age, use the adult dose.

    (see Directions for Compounding of an Oral Suspension from Flumadine Tablets to prepare an oral suspension for administration to children and patients with difficulty swallowing tablets).

    Children(Birth to 11 months):
    The safety and efficacy of Flumadine for prophylaxis of influenza in pediatric patients younger than 1 year of age have not been established.

    FOR TREATMENT IN ADULTS
    Adults(17 years and older):
    The recommended adult dose of Flumadine is 100 mg twice a day for 7 days. In patients with severe hepatic dysfunction, severe renal impairment (CrCl 5 to 29 mL/min) or renal failure (CrCI ≤ 10 mL/ min) and elderly nursing home patients, a dose reduction to 100 mg daily is recommended. Because of the potential for accumulation of rimantadine metabolites during multiple dosing, patients with hepatic or renal impairment should be monitored for adverse effects. 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.

    Children (16 years of age and younger):
    Flumadine is not indicated for treatment of influenza in pediatric patients 16 years or younger.

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