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FLUMADINE® TABLETS
(rimantadine hydrochloride tablets)
FLUMADINE® SYRUP
(rimantadine hydrochloride syrup)
DESCRIPTION
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:
CLINICAL PHARMACOLOGY
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.
CONTRAINDICATIONS
Flumadine is contraindicated in patients with known hypersensitivity to drugs of the adamantane class, including rimantadine and amantadine.
PRECAUTIONS
ADVERSE REACTIONS
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.
| 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% |
Less frequent adverse events (0.3 to 1%) at the recommended dose in controlled clinical trials were: Gastrointestinal System: diarrhea, dyspepsia; Nervous System: impairment of concentration, ataxia, somnolence, agitation, depression; Skin and Appendages: rash; Hearing and Vestibular: tinnitus; Respiratory: dyspnea.
Additional adverse events (less than 0.3%) reported at recommended doses in controlled clinical trials were: Nervous System: gait abnormality, euphoria, hyperkinesia, tremor, hallucination, confusion, convulsions; Respiratory: bronchospasm, cough; Cardiovascular: pallor, palpitation, hypertension, cerebrovascular disorder, cardiac failure, pedal edema, heart block, tachycardia, syncope; Reproduction: non-puerperal lactation; Special Senses: taste loss/change, parosmia.
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 | 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% |
OVERDOSAGE
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.
DOSAGE AND ADMINISTRATION
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).
Rx only
REFERENCES:
- Belshe, R.B., Burk, B., Newman, F., Cerruti, R.L. and Sim, I.S. (1989) J. Infect. Dis. 159, 430-435.
- Sim, I.S., Cerruti, R.L. and Connell, E.V., (1989) J. Resp. Dis. (Suppl.), S46-S51.
- Hayden, F.G., Belshe, R.B., Clover, R.D. et al (1989) N.Engl. J. Med. 321 (25), 1696-1702.
- Hall, C.B., Dolin, R., Gala, C.L., et al (1987) Pediatrics 80, 275-282.
- Thompson, J., Fleet, W., Lawrence, E. et al (1987) J. Med. Vir. 21, 249-255.
- Belshe, R.B., Smith, M.H., Hall, C.B., et al (1988) J. Virol. 62, 1508-1512.
- Casey, D.F. N. Engl. J. Med. 1978:298:516.
- Berkowitz, C.D. J. Pediatrics 1979:95:144.
Rev. 9/00
MG #9040 (09)
FOREST PHARMACEUTICALS, INC.
Subsidiary of Forest Laboratories, Inc.
St. Louis, MO 63045