Rabbits treated subcutaneously at a dose of 0.8 mg/ kg/ day achieved an AUC of 100 µg° h/ L, which is about 3-fold higher than that resulting from the human dose. This dose did not result in any embryotoxicity or teratogenicity. There are no studies of tolterodine in pregnant women. Therefore, DETROL LA should be used during pregnancy only if the potential benefit for the mother justifies the potential risk to the fetus. Nursing Mothers Tolterodine immediate release is excreted into the milk in mice. Offspring of female mice treated with tolterodine 20 mg/ kg/ day during the lactation period had slightly reduced bodyweight gain. The offspring regained the weight during the maturation phase. It is not known whether tolterodine is excreted in human milk; therefore, DETROL LA should not be administered during nursing. A decision should be made whether to discontinue nursing or to discontinue DETROL LA in nursing mothers. Pediatric Use The safety and effectiveness of tolterodine in pediatric patients has not been established. Geriatric Use No overall differences in safety were observed between the older and younger patients treated with tolterodine (see CLINICAL PHARMACOLOGY, Pharmacokinetics in Special Populations). | ||||
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