Caution should be given to potential anticholinergic (drying) effects in patients with lower airway diseases.
Caution should be used in patients with cirrhosis or other liver diseases (See CLINICAL PHARMACOLOGY.)
Astemizole does not appear to be dialyzable. Caution should also be used when treating patients with renal impairment.
Information for the Patient
See PATIENT INFORMATION section.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Carcinogenic potential has not been revealed in rats given 260x the recommended human dose of astemizole for 24 months, or in mice given 400x the recommended human dose for 18 months. Micronucleus, dominant lethal, sister chromatid exchange and Ames tests of astemizole have not revealed mutagenic activity.
Impairment of fertility was not observed in male or female rats given 200x the recommended human dose.
Pregnancy Category C Teratogenic effects were not observed in rats administered 200x the recommended human dose or in rabbits given 200x the recommended human dose. Maternal toxicity was seen in rabbits administered 200x the recommended human dose. Embryocidal effects accompanied by maternal toxicity were observed at 100x the recommended human dose in rats. Embryotoxicity or maternal toxicity was not observed in rats or rabbits administered 50x the recommended human dose. There are no adequate and well controlled studies in pregnant women. Hismanal (astemizole (withdrawn from us market)) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Metabolites may remain in the body for as long as 4 months after the end of dosing, calculated on the basis of 6 times the terminal half-life. (See CLINICAL PHARMACOLOGY.)
It is not known whether this drug is excreted in human milk.
Because certain drugs are known to be excreted in human milk, caution should be exercised when Hismanal is administered to a nursing woman. Astemizole is excreted in the milk of dogs.
Safety and efficacy in children under 12 years of age has not been demonstrated.