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Author: Admin | 2025-04-28
Those with a family history of SIDS, and those who are less prone than usual to spontaneous arousal from sleep. Overdosage and toxicity (including death) have been reported in children younger than 2 years of age receiving nonprescription (over-the-counter, OTC) preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection. Clinicians should ask caregivers about use of nonprescription cough and cold preparations to avoid overdosage. Geriatric PrecautionsClinical studies of promethazine did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger patients. While clinical experience generally has not revealed age-related differences in response to the drug, care should be taken in dosage selection of promethazine. Because of increased risk of sedative effects and confusion (associated with promethazine) and the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy in geriatric patients, the manufacturers suggest that patients in this age group receive initial dosages of the drug in the lower end of the usual range.Mutagenicity and CarcinogenicityLong-term animal studies to determine the carcinogenic potential of promethazine have not been performed to date. There was no evidence of promethazine-induced mutagenesis in the Ames microbial mutagen test. There are no human or other animal data concerning the carcinogenic or mutagenic potentials of the drug. .Pregnancy, Fertility, and LactationPregnancySafe use of promethazine during pregnancy (except during labor) with respect to possible adverse effects on fetal development has not been established. Although there are no adequate and controlled studies to date in humans, promethazine has not been shown to be teratogenic in rats receiving oral dosages of 6.25–12.5 mg/kg daily (about 2.1–4.2 times the maximum recommended human dosage, depending on the use of the drug). The drug has been shown to produce fetal mortality in rats receiving intraperitoneal dosages of 25 mg/kg daily. Antihistamines, including promethazine, have been fetocidal in rodents, but the pharmacologic effects of histamine in rodents differ from those in humans. Promethazine has been reported to possibly ameliorate the effects of hemolytic
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