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SYMMETREL (AMANTADINE HCL) TABLETS AND SYRUP: USE IN SPECIAL POPULATIONS

Pregnancy

Pregnancy Category C

The effect of amantadine on embryofetal and peri-postnatal development has not been adequately tested, that is, in studies conducted under Good Laboratory Practice (GLP) and according to current recommended methodology. However, in two non-GLP studies in rats in which females were dosed from 5 days prior to mating to Day 6 of gestation or on Days 7-14 of gestation, Symmetrel produced increases in embryonic death at an oral dose of 100 mg/kg (or 3 times the maximum recommended human dose on a mg/m2 basis). In the non-GLP rat study in which females were dosed on Days 7-14 of gestation, there was a marked increase in severe visceral and skeletal malformations at oral doses of 50 and 100 mg/kg (or 1.5 and 3 times, respectively, the maximum recommended human dose on a mg/m2 basis). The no-effect dose for teratogenicity was 37 mg/kg (equal to the maximum recommended human dose on a mg/m2 basis). The safety margins reported may not accurately reflect the risk considering the questionable quality of the study on which they are based. There are no adequate and well-controlled studies in pregnant women. Human data regarding teratogenicity after maternal use of amantadine is scarce. Tetralogy of Fallot and tibial hemimelia (normal karyotype) occurred in an infant exposed to amantadine during the first trimester of pregnancy (100 mg P.O. for 7 days during the 6th and 7th week of gestation). Cardiovascular maldevelopment (single ventricle with pulmonary atresia) was associated with maternal exposure to amantadine (100 mg/d) administered during the first 2 weeks of pregnancy. Symmetrel (Amantadine Hydrochloride) should be used during pregnancy only if the potential benefit justifies the potential risk to the embryo or fetus.

Nursing Mothers

Symmetrel is excreted in human milk. Use is not recommended in nursing mothers.

Pediatric Use

The safety and efficacy of Symmetrel (Amantadine Hydrochloride) tablets and syrup in newborn infants and infants below the age of 1 year have not been established.

Usage in the Elderly

Because Symmetrel is primarily excreted in the urine, it accumulates in the plasma and in the body when renal function declines. Thus, the dose of Amantadine (Symmetrel) should be reduced in patients with renal impairment and in individuals who are 65 years of age or older. The dose of Symmetrel may need reduction in patients with congestive heart failure, peripheral edema, or orthostatic hypotension.

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