Buprenorphine

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