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    There was no effect on the fertility of rats treated orally with amlodipine maleate males for 64 days and females for 14 amlodipine effective time prior to mating at doses up to 10 mg amlodipine/kg/day 8 times the amlodipine effective time recommended human dose3of 10 mg/day on a mg/m2 basis The antihypertensive efficacy of amlodipine besylate has been demonstrated in a total of 15 double-blind, placebo-controlled, randomized studies involving 800 patients on amlodipine besylate and 538 on placebo.

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