Norvasc

[Amlodipine]

Drug/ Laboratory Test Interactions: None known.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Rats and mice treated with amlodipine in the diet for two years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 mg/ kg/ day showed no evidence of carcinogenicity. The highest dose (for mice, similar to, and for rats twice* the maximum recommended clinical dose of 10 mg on a mg/ m 2 basis) was close to the maximum tolerated dose for mice but not for rats.

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Mutagenicity studies revealed no drug related effects at either the gene or chromosome levels.

There was no effect on the fertility of rats treated with amlodipine (males for 64 days and females 14 days prior to mating) at doses up to 10 mg/ kg/ day (8 times* the maximum recommended human dose of 10 mg on a mg/ m 2 basis).

Pregnancy Category C

No evidence of teratogenicity or other embryo/ fetal toxicity was found when pregnant rats or rabbits were treated orally with up to 10 mg/ kg amlodipine (respectively 8 times* and 23 times* the maximum recommended human dose of 10 mg on a mg/ m 2 basis) during their respective periods of major organogenesis. However, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold) in rats administered 10 mg/ kg amlodipine for 14 days before mating and throughout mating and gestation. Amlodipine has been shown to prolong both the gestation period and the duration of labor in rats at this dose. There are no adequate and well-controlled studies in pregnant women. Amlodipine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

*Based on patient weight of 50 kg.
Nursing Mothers

It is not known whether amlodipine is excreted in human milk. In the absence of this information, it is recommended that nursing be discontinued while NORVASC is administered.

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