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Flumadine
Overview
What is Flumadine?
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 CHN•HCI, a molecular weight of 215.77 and the following structural formula:
What does Flumadine look like?
What are the available doses of Flumadine?
Sorry No records found.
What should I talk to my health care provider before I take Flumadine?
Sorry No records found
How should I use Flumadine?
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.
FOR PROPHYLAXIS IN ADULTS AND CHILDREN:
What interacts with Flumadine?
Flumadine is contraindicated in patients with known hypersensitivity to drugs of the adamantane class, including rimantadine and amantadine.
What are the warnings of Flumadine?
Sorry No Records found
What are the precautions of Flumadine?
GENERAL:
The safety and pharmacokinetics of rimantadine in renal and hepatic insufficiency have only been evaluated after single dose administration. In a single dose study of patients with anuric renal failure, the apparent clearance of rimantadine was approximately 40% lower and the elimination half-life was 1.6-fold greater than that in healthy age-matched controls. In a study of 14 persons with chronic liver disease (mostly stabilized cirrhotics), no alterations in the pharmacokinetics were observed after the administration of a single dose of rimantadine. However, the apparent clearance of rimantadine following a single dose to 10 patients with severe liver dysfunction was 50% lower than reported for healthy subjects. Because of the potential for accumulation of rimantadine and its metabolites in plasma, caution should be exercised when patients with renal or hepatic insufficiency are treated with rimantadine.
Transmission of rimantadine resistant virus should be considered when treating patients whose contacts are at high risk for influenza A illness. Influenza A virus strains resistant to rimantadine can emerge during treatment and such resistant strains have been shown to be transmissible and to cause typical influenza illness (Ref. 3). Although the frequency, rapidity, and clinical significance of the emergence of drug-resistant virus are not yet established, several small studies have demonstrated that 10% to 30% of patients with initially sensitive virus, upon treatment with rimantadine, shed rimantadine resistant virus. (Ref. 3, 4, 5, 6)
Clinical response to rimantadine, although slower in those patients who subsequently shed resistant virus, was not significantly different from those who did not shed resistant virus. (Ref. 3) No data are available in humans that address the activity or effectiveness of rimantadine therapy in subjects infected with resistant virus.
DRUG INTERACTIONS:
Acetaminophen: Flumadine, 100 mg, was given twice daily for 13 days to 12 healthy volunteers. On day 11, acetaminophen (650 mg four times daily) was started and continued for 8 days. The pharmacokinetics of rimantadine were assessed on days 11 and 13. Coadministration with acetaminophen reduced the peak concentration and AUC values for rimantadine by approximately 11%.
Aspirin: Flumadine, 100 mg, was given twice daily for 13 days to 12 healthy volunteers. On day 11, aspirin (650 mg, four times daily) was started and continued for 8 days. The pharmacokinetics of rimantadine were assessed on days 11 and 13. Peak plasma concentrations and AUC of rimantadine were reduced approximately 10% in the presence of aspirin.
Live Attenuated Influenza Vaccine (LAIV): The concurrent use of Flumadine with live attenuated influenza vaccine has not been evaluated. However, because of potential interference between these products, the live attenuated intranasal influenza vaccine should not be administered until 48 hours after cessation of Flumadine and Flumadine should not be administered until two weeks after the administration of live attenuated intranasal influenza vaccine unless medically indicated. The concern about potential interference arises principally from the potential for antiviral drugs to inhibit replication of live vaccine virus.
CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY:
Carcinogenesis:
Mutagenesis:
Impairment of Fertility:
PREGNANCY: Teratogenic Effects:
Nonteratogenic Effects:
For these reasons, Flumadine should be used during pregnancy only if the potential benefit justifies the risk to the fetus.
NURSING MOTHERS:
PEDIATRIC USE:
What are the side effects of Flumadine?
In 1,027 patients treated with Flumadine in controlled clinical trials at the recommended dose of 200 mg daily, the most frequently reported adverse events involved the gastrointestinal and nervous systems.
Incidence >1%: Adverse events reported most frequently (1-3%) at the recommended dose in controlled clinical trials are shown in the table below.
Less frequent adverse events (0.3 to 1%) at the recommended dose in controlled clinical trials were: diarrhea, dyspepsia; impairment of concentration, ataxia, somnolence, agitation, depression; rash; tinnitus; dyspnea.
Additional adverse events (less than 0.3%) reported at recommended doses in controlled clinical trials were:
Respiratory:
Cardiovascular:
Reproduction:
Special Senses:
Rates of adverse events, particularly those involving the gastrointestinal and nervous systems, increased significantly in controlled studies using higher than recommended doses of Flumadine. In most cases, symptoms resolved rapidly with discontinuation of treatment. In addition to the adverse events reported above, the following were also reported at higher than recommended doses: increased lacrimation, increased micturition frequency, fever, rigors, agitation, constipation, diaphoresis, dysphagia, stomatitis, hypesthesia and eye pain.
Adverse Reactions in Trials of Rimantadine and Amantadine: In a six-week prophylaxis study of 436 healthy adults comparing rimantadine with amantadine and placebo, the following adverse reactions were reported with an incidence >1 %.
| Rimantadine | Control | ||
| (n=1027) | (n=986) | ||
| Nervous System | |||
| Insomnia | 2.1% | 0 9% | |
| Dizziness | 1.9% | 1.1% | |
| Headache | 1.4% | 1.3% | |
| Nervousness | 1.3% | 0.6% | |
| Fatigue | 1.0% | 0.9% | |
| Gastrointestinal System | |||
| Nausea | 2.8% | 1.6% | |
| Vomiting | 1.7% | 0.6% | |
| Anorexia | 1.6% | 0.8% | |
| Dry mouth | 1.5% | 0.6% | |
| Abdominal Pain | 1.4% | 0.8% | |
| Body as a Whole | |||
| Asthenia | 1.4% | 0.5% | |
| Rimantadine | Placebo | Amantadine | |
| 200 mg/day | 200 mg/day | ||
| (n=145) | (n=143) | (n=148) | |
| Nervous System | |||
| Insomnia | 3.4% | 0.7% | 7.0% |
| Nervousness | 2.1% | 0.7% | 2.8% |
| Impaired Concentration | 2.1% | 1.4% | 2.1% |
| Dizziness | 0.7% | 0.0% | 2.1% |
| Depression | 0.7% | 0.7% | 3.5% |
| Total % of subjects with adverse reactions | 6.9% | 4.1% | 14.7% |
| Total % of subjects withdrawn due to adverse reactions | 6.9% | 3.4% | 14.0% |
GERIATRIC USE:
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What should I look out for while using Flumadine?
Flumadine is contraindicated in patients with known hypersensitivity to drugs of the adamantane class, including rimantadine and amantadine.
What might happen if I take too much 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.
How should I store and handle Flumadine?
Refrigerate the product upon receipt at 2°C to 8°C.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).Rx onlyFlumadine 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).Rx onlyFlumadine 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).Rx onlyFlumadine 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).Rx only
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
MECHANISM OF ACTION:
2
Non-Clinical Toxicology
Flumadine is contraindicated in patients with known hypersensitivity to drugs of the adamantane class, including rimantadine and amantadine.DRUG INTERACTIONS:
Acetaminophen: Flumadine, 100 mg, was given twice daily for 13 days to 12 healthy volunteers. On day 11, acetaminophen (650 mg four times daily) was started and continued for 8 days. The pharmacokinetics of rimantadine were assessed on days 11 and 13. Coadministration with acetaminophen reduced the peak concentration and AUC values for rimantadine by approximately 11%.
Aspirin: Flumadine, 100 mg, was given twice daily for 13 days to 12 healthy volunteers. On day 11, aspirin (650 mg, four times daily) was started and continued for 8 days. The pharmacokinetics of rimantadine were assessed on days 11 and 13. Peak plasma concentrations and AUC of rimantadine were reduced approximately 10% in the presence of aspirin.
Live Attenuated Influenza Vaccine (LAIV): The concurrent use of Flumadine with live attenuated influenza vaccine has not been evaluated. However, because of potential interference between these products, the live attenuated intranasal influenza vaccine should not be administered until 48 hours after cessation of Flumadine and Flumadine should not be administered until two weeks after the administration of live attenuated intranasal influenza vaccine unless medically indicated. The concern about potential interference arises principally from the potential for antiviral drugs to inhibit replication of live vaccine virus.
GENERAL:
The safety and pharmacokinetics of rimantadine in renal and hepatic insufficiency have only been evaluated after single dose administration. In a single dose study of patients with anuric renal failure, the apparent clearance of rimantadine was approximately 40% lower and the elimination half-life was 1.6-fold greater than that in healthy age-matched controls. In a study of 14 persons with chronic liver disease (mostly stabilized cirrhotics), no alterations in the pharmacokinetics were observed after the administration of a single dose of rimantadine. However, the apparent clearance of rimantadine following a single dose to 10 patients with severe liver dysfunction was 50% lower than reported for healthy subjects. Because of the potential for accumulation of rimantadine and its metabolites in plasma, caution should be exercised when patients with renal or hepatic insufficiency are treated with rimantadine.
Transmission of rimantadine resistant virus should be considered when treating patients whose contacts are at high risk for influenza A illness. Influenza A virus strains resistant to rimantadine can emerge during treatment and such resistant strains have been shown to be transmissible and to cause typical influenza illness (Ref. 3). Although the frequency, rapidity, and clinical significance of the emergence of drug-resistant virus are not yet established, several small studies have demonstrated that 10% to 30% of patients with initially sensitive virus, upon treatment with rimantadine, shed rimantadine resistant virus. (Ref. 3, 4, 5, 6)
Clinical response to rimantadine, although slower in those patients who subsequently shed resistant virus, was not significantly different from those who did not shed resistant virus. (Ref. 3) No data are available in humans that address the activity or effectiveness of rimantadine therapy in subjects infected with resistant virus.
In 1,027 patients treated with Flumadine in controlled clinical trials at the recommended dose of 200 mg daily, the most frequently reported adverse events involved the gastrointestinal and nervous systems.
Incidence >1%: Adverse events reported most frequently (1-3%) at the recommended dose in controlled clinical trials are shown in the table below.
Less frequent adverse events (0.3 to 1%) at the recommended dose in controlled clinical trials were: diarrhea, dyspepsia; impairment of concentration, ataxia, somnolence, agitation, depression; rash; tinnitus; dyspnea.
Additional adverse events (less than 0.3%) reported at recommended doses in controlled clinical trials were:
Respiratory:
Cardiovascular:
Reproduction:
Special Senses:
Rates of adverse events, particularly those involving the gastrointestinal and nervous systems, increased significantly in controlled studies using higher than recommended doses of Flumadine. In most cases, symptoms resolved rapidly with discontinuation of treatment. In addition to the adverse events reported above, the following were also reported at higher than recommended doses: increased lacrimation, increased micturition frequency, fever, rigors, agitation, constipation, diaphoresis, dysphagia, stomatitis, hypesthesia and eye pain.
Adverse Reactions in Trials of Rimantadine and Amantadine: In a six-week prophylaxis study of 436 healthy adults comparing rimantadine with amantadine and placebo, the following adverse reactions were reported with an incidence >1 %.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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