Flumig Special Precautions

Carcinogenicity/Mutagenicity: A 24-month study in 4 groups of 50 male and 50 female Wistar rats at doses of 0, 5, 20, or 40 mg/kg per day (the 40 mg/kg group received 80 mg/kg for the first 2 months) did not produce an effect on tumor rate or type; however, the validity of the study is questionable because of an extremely high mortality rate (more than 90% in the males and 80% in the females), Mutagenicity studies (Ames test, sister chromatid exchange test in human lymphocytes, sex-linked recessive lethal test in Drosophila melanogaster, micronucleus test in male rats, dominant lethal test in male and female mice) were negative.
Pediatrics: Although appropriate studies on the relationship of age to the effects of calcium channel blocking agents have not been performed in the pediatric population, pediatrics-specific problems that would limit the usefulness of calcium channel blocking agents in children are not expected.
Geriatrics: Elderly patients are more likely to have age-related renal function impairment, which may require caution in patients receiving calcium channel blocking agents.