Cialis - NPS MedicineWise

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There were no effects on fertility, reproductive performance or reproductive organ morphology in male or female rats given oral doses of tadalafil up to 400 mg/kg/day (systemic exposure ca 13 (males) or 25 (females) times that expected at the maximum recommended dose of 20 mg taken once daily, based on AUC for unbound drug at steady state). However, regression of the seminiferous tubular epithelium of the testes resulting in oligospermia or aspermia in the epididymides was observed in dogs treated for 6 or 12 months with oral tadalafil doses ≥ 25 mg/kg/day. The no observed effect level for these effects in the 6 month dog study was 10 mg/kg/day. At this dose, systemic exposure to tadalafil, based on unbound drug concentrations, was similar to that expected in humans taking the maximum recommended dose of 20 mg Cialis daily. Similar findings were not observed in rats and mice (see Section 5.1 Pharmacodynamic Properties). (Category B1) Cialis is not intended for use by women. Studies in rats have shown that tadalafil and/or its metabolites cross the placenta and distribute to the foetus. No evidence of embryofoetal toxicity or teratogenicity was observed in pregnant rats or mice given oral doses of tadalafil up to 1000 mg/kg/day. These doses were associated with systemic exposure to tadalafil ca 12-14-fold that expected at the maximum recommended dose of 20 mg taken once daily, based on AUC for unbound drug at steady state. Increased postnatal pup mortality was observed in rats after oral treatment with tadalafil doses ≥ 60 mg/kg/day during gestation and lactation. The no effect dose of 30 mg/kg/day was associated with systemic exposure ca 10-fold that expected in humans at the maximum recommended dose of 20 mg tadalafil taken once daily, based on AUC for unbound drug at steady state. There are no studies of tadalafil in pregnant women. Cialis is not intended for use by women. Tadalafil and/or its metabolites are excreted in the milk of lactating rats at concentrations up to 2.4-fold higher than the maximal maternal plasma concentration. Increased postnatal pup mortality was observed in rats after treatment with oral tadalafil doses ≥ 60 mg/kg/day during gestation and lactation (see Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy). There are no human data on the excretion of tadalafil into breast milk or on the safety of tadalafil exposure in infants.