Impaired Respiration: As with other potent opioids, clinically significant respiratory depression may occur within the recommended dose range in patients receiving therapeutic doses of buprenorphine.
Buprenorphine hydrochloride should be used with caution in patients with compromised respiratory function (e.g., chronic obstructive pulmonary disease, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression).
Particular caution is advised if buprenorphine is administered to patients taking or recently receiving drugs with CNS/respiratory depressant effects.
In patients with the physical and/or pharmacological risk factors above, the dose should be reduced by approximately one-half.NALOXONE MAY NOT BE EFFECTIVE IN REVERSING THE RESPIRATORY DEPRESSION PRODUCED BY BUPRENORPHINE. THEREFORE, AS WITH OTHER POTENT OPIOIDS, THE PRIMARY MANAGEMENT OF OVERDOSE SHOULD BE THE RE-ESTABLISHMENT OF ADEQUATE VENTILATION WITH MECHANICAL ASSISTANCE OF RESPIRATION, IF REQUIRED.Interaction with Other Central Nervous System Depressants: Patients receiving buprenorphine hydrochloride in the presence of other narcotic analgesics, general anesthetics, antihistamines, benzodiazepines, phenothiazines, other tranquilizers, sedative/hypnotics or other CNS depressants (including alcohol) may exhibit increased CNS depression.
When such combined therapy is contemplated, it is particularly important that the dose of one or both agents be reduced.Head Injury and Increased Intracranial Pressure: Buprenorphine hydrochloride, like other potent analgesics, may itself elevate cerebrospinal fluid pressure and should be used with caution in head injury, intracranial lesions and other circumstances where cerebrospinal pressure may be increased. Buprenorphine can produce miosis and changes in the level of consciousness which may interfere with patient evaluation.Use In Ambulatory Patients: Buprenorphine may impair the mental or physical abilities required for the performance of potentially dangerous tasks such as driving a car or operating machinery.Therefore, buprenorphine hydrochloride should be administered with caution to ambulatory patients who should be warned to avoid such hazards.Use in Narcotic-Dependent Patients: Because of the narcotic antagonist activity of buprenorphine, use in the physically dependent individual may result in withdrawal effects.