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Because of the difficulty in assessing opioid tolerance in patients who have recently received repeated doses of narcotic analgesic medication, caution should be used in the administration of butorphanol to such patients.
Head Injury and Increased Intracranial Pressure: As with other opioids, the use of butorphanol in patients with head injury may be associated with carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure, drug-induced miosis, and alterations in mental state that would obscure the interpretation of the clinical course of patients with head injuries. In such patients, butorphanol should be used only if the benefits of use outweigh the potential risks.
Disorders of Respiratory Function or Control: Butorphanol may produce respiratory depression, especially in patients receiving other CNS active agents, or patients suffering from CNS diseases or respiratory impairment.
Cardiovascular effects: Because butorphanol may increase the work of the heart, especially the pulmonary circuit, the use of butorphanol in patients with acute myocardial infarction, ventricular dysfunction, or coronary insufficiency should be limited to those situations where the benefits clearly outweigh the risk.
Severe hypertension has been reported rarely during butorphanol therapy. In such cases, butorphanol should be discontinued and the hypertension treated with antihypertensive drugs. In patients who are not opioid dependent, naloxone has also been reported to be effective.
Carcinogenesis, Mutagenesis, Impairment of Fertility: There was no evidence of carcinogenicity in studies. Butorphanol was not genotoxic in S. typhimurium or 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.
General Caution: Opioid analgesics, including butorphanol, 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.
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 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.
