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General Caution: Effects such as drowsiness or dizziness impair the mental and physical abilities required for the performance of potentially dangerous tasks such as driving a car or operating machinery.
Alcohol should not be consumed while using butorphanol.
Drugs having antagonistic action and effect of opioid less frequent than morphine but can be abused. Due to prolonged use of this drug, light withdrawal symptoms, excessive use and addition have been reported. Special care should be exercised in administering butorphanol to patients with a history of drug abuse or to patients receiving the drug on a continuous basis for an extended period.
Use for outpatients: Drowsiness and dizziness may occur. Caution should be taken until individual characteristic response to this drug is obtained.
Carcinogenesis, Mutagenesis, Impairment of Fertility: There was no evidence of carcinogenicity for this drug.
Butorphanol was not genotoxic in S. typhimurium of E. coli assays or in unscheduled DNA synthesis and repair assays conducted in cultured human fibroblast cells.
Rats treated orally with 160 mg/kg/day (944 mg/m2) had a reduced pregnancy rate. However, a similar effect was not observed with a 2.5 mg/kg/day (14.75 mg/m2) subcutaneous dose.
Use in Children: Butorphanol is not recommended for use in patients below 18 years of age because safety and efficacy have not been established in this population.
Use in the Elderly: Due to changes in clearance, the mean half-life of butorphanol is increased by 25% (to over 6 hours) in patients over the age of 65 years. Elderly patients may be more sensitive to the side effects of butorphanol.
