There was no evidence of teratogenicity, embryotoxicity, or fetotoxicity in
rat or mouse fetuses that received up to 1000 mg/ kg/ day during the major organ
development. Plasma exposure at this dose is approximately 11-fold greater than
the AUC values for unbound tadalafil in humans given the MRHD of 20 mg. In a
rat prenatal and postnatal development study at doses of 60, 200, and 1000 mg/
kg, there was a reduction in postnatal survival of pups. The no-observed-effect-level
(NOEL) for maternal toxicity was 200 mg/ kg/ day and for developmental toxicity
was 30 mg/ kg/ day, which gives approximately 16-and 10-fold exposure multiples,
respectively, of the human AUC for the MRHD dose of 20 mg. There are no adequate
and well-controlled studies of tadalafil in pregnant women.
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