This drug should not be used in newborn or premature infants. Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. Of antihistamines, particularly in infants and children, may produce hallucinations, central nervous system depression, convulsions, and death. CNS Depressants Antihistamines may have additive effects with alcohol and other CNS depressants, e.g., hypnotics, sedatives, tranquilizers, antianxiety agents. Activities Requiring Mental Alertness Patients should be warned about engaging in activities requiring mental alertness and motor coordination, such as driving a car or operating machinery.
Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.
Patients should be warned about engaging in activities requiring mental alertness and motor coordination, such as driving a car or operating machinery. Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term carcinogenic studies have not been done with cyproheptadine. Cyproheptadine had no effect on fertility in a two-litter study in rats or a two generation study in mice at about 10 times the human dose. Pregnancy Category B Reproduction studies have been performed in rabbits, mice, and rats at oral or subcutaneous doses up to 32 times the maximum recommended human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to cyproheptadine. Cyproheptadine has been shown to be fetotoxic in rats when given by intraperitoneal injection in doses four times the maximum recommended human oral dose.