# Buprenorphine ```text DRUG INFORMATION ADULT - The dosing on the initial day of treatment may be given in 2 mg to 4 mg increments if preferred. Source: US FDA label for buprenorphine (Buprenorphine), section 'dosage and administration', retrieved 2026-08-29 - In a one-month study, patients received 8 mg of buprenorphine sublingual tablets on Day 1 and 16 mg buprenorphine sublingual tablets on Day 2. Source: US FDA label for buprenorphine (Buprenorphine), section 'dosage and administration', retrieved 2026-08-29 - Withdrawal appears more likely in patients maintained on higher doses of methadone (>30 mg) and when the first buprenorphine dose is administered shortly after the last methadone dose. 2.4 Maintenance Buprenorphine and naloxone is preferred for maintenance treatment. Source: US FDA label for buprenorphine (Buprenorphine), section 'dosage and administration', retrieved 2026-08-29 CHILD - The safety and effectiveness of buprenorphine sublingual tablets has not been established in pediatric patients. Source: US FDA label for buprenorphine (Buprenorphine), section 'pediatric use', retrieved 2026-08-29 - Administer buprenorphine sublingual tablets sublingually as a single daily dose. ( 2.1 ) Strongly consider recommending or prescribing an opioid overdose reversal agent (e.g., naloxone, nalmefene) at the time buprenorphine sublingual tablets are initiated or renewed because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose. Source: US FDA label for buprenorphine (Buprenorphine), section 'dosage and administration', retrieved 2026-08-29 RENAL IMPAIRMENT - For patients with severe hepatic impairment, a dose adjustment is recommended, and patients with moderate or severe hepatic impairment should be monitored for signs and symptoms of toxicity or overdose caused by increased levels of buprenorphine [see Dosage and Administration ( 2.7 ), Warnings and Precautions ( 5.12 ) , Clinical Pharmacology ( 12.3 )]. Source: US FDA label for buprenorphine (Buprenorphine), section 'use in specific populations', retrieved 2026-08-29 - ( 5.5 ) A d renal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. Source: US FDA label for buprenorphine (Buprenorphine), section 'warnings and cautions', retrieved 2026-08-29 HEPATIC IMPAIRMENT - If treatment goals are not being achieved, the healthcare provider should re- evaluate the appropriateness of continuing the current treatment. 2.7 Patients with Severe Hepatic Impairment Consider reducing the starting and titration incremental dose by half and monitor for signs and symptoms of toxicity or overdose caused by increased levels of buprenorphine. Source: US FDA label for buprenorphine (Buprenorphine), section 'dosage and administration', retrieved 2026-08-29 - ( 8.5 ) Severe Hepatic Impairment: Consider reducing the starting and titration incremental dose by half and monitor for signs and symptoms of toxicity or overdose. Source: US FDA label for buprenorphine (Buprenorphine), section 'use in specific populations', retrieved 2026-08-29 - Due to possible decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy in geriatric patients, the decision to prescribe buprenorphine sublingual tablets should be made cautiously in individuals 65 years of age or older and these patients should be monitored for signs and symptoms of toxicity or overdose. Source: US FDA label for buprenorphine (Buprenorphine), section 'use in specific populations', retrieved 2026-08-29 PREGNANCY - Risk Summary The data on use of buprenorphine, the active ingredient in buprenorphine sublingual tablets, in pregnancy, are limited; however, these data do not indicate an increased risk of major malformations specifically due to buprenorphine exposure. Source: US FDA label for buprenorphine (Buprenorphine), section 'pregnancy', retrieved 2026-08-29 - There are limited data from randomized clinical trials in women maintained on buprenorphine that were not designed appropriately to assess the risk of major malformations [see Data] . Source: US FDA label for buprenorphine (Buprenorphine), section 'pregnancy', retrieved 2026-08-29 - Observational studies have reported on congenital malformations among buprenorphine-exposed pregnancies, but were also not designed appropriately to assess the risk of congenital malformations specifically due to buprenorphine exposure [see Data] . Source: US FDA label for buprenorphine (Buprenorphine), section 'pregnancy', retrieved 2026-08-29 BREASTFEEDING - Risk Summary Based on two studies in 13 lactating women maintained on buprenorphine treatment, buprenorphine and its metabolite norbuprenorphine were present in low levels in human milk and available data have not shown adverse reactions in breastfed infants. Source: US FDA label for buprenorphine (Buprenorphine), section 'nursing mothers', retrieved 2026-08-29 - The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for buprenorphine sublingual tablets and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. Source: US FDA label for buprenorphine (Buprenorphine), section 'nursing mothers', retrieved 2026-08-29 - Clinical Considerations Advise breastfeeding women taking buprenorphine products to monitor the infant for increased drowsiness and breathing difficulties. Source: US FDA label for buprenorphine (Buprenorphine), section 'nursing mothers', retrieved 2026-08-29 ``` --- Dawaa Reference is a reference for prescribers, not a medical device, and does not replace clinical judgement. [Privacy policy](/privacy)