Cialis and pregnancy
Cialis: Pregnancy Category B — Cialis (tadalafil) is not indicated for use in women. There are no adequate and well controlled studies of Cialis use in pregnant women. Animal reproduction studies in rats and mice revealed no evidence of fetal harm.
Cialis Non-teratogenic effects — Animal reproduction studies showed no evidence of teratogenicity, embryotoxicity, or fetotoxicity when Cialis was given to pregnant rats or mice at exposures up to 11 times the maximum recommended human dose (MRHD) of 20 mg/day during organogenesis. In one of two perinatal/postnatal developmental studies in rats, postnatal pup survival decreased following maternal exposure to Cialis doses greater than 10 times the MRHD based on AUC. Signs of maternal toxicity occurred at doses greater than 16 times the MRHD based on AUC. Surviving offspring had normal development and reproductive performance.
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