Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals ( 2.1).To be prescribed only by health care providers knowledgeable in use of potent opioids for management of chronic pain.Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation. Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Prolonged use of BELBUCA during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated.
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