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Partial Opioid Agonist (Opioid Substitution Therapy) Pregnancy: Compatible in pregnancy (Subutex/Suboxone) — continued OST essential to prevent relapse; monitor for neonatal abstinence syndrome

Buprenorphine (Opioid Dependence)

Brand names: Subutex (SL tablet), Suboxone (buprenorphine + naloxone SL film)

Adult dose

Dose: Induction: 0.8–4 mg SL on day 1 (start when in mild withdrawal — COWS score ≥8). Titrate by 2–4 mg daily. Maintenance: 8–24 mg/day SL. Maximum licensed: 32 mg/day.
Route: Sublingual (SL) — must dissolve under tongue, not swallowed
Frequency: OD (or BD in some patients)
Max: 32 mg/day
Suboxone contains naloxone to discourage IV diversion (naloxone is poorly absorbed SL; systemically active if injected). Never swallow — bioavailability minimal orally. Must be in mild withdrawal at induction (not in precipitated withdrawal).

Paediatric dose

Route: N/A
Frequency: N/A
Max: Not licensed in children/adolescents
Not established for opioid dependence in patients <18 years

Dose adjustments

Renal

No dose adjustment required

Hepatic

Caution in hepatic impairment — buprenorphine extensively metabolised; elevated LFTs common in opioid users, especially with hepatitis C

Clinical pearls

  • Induction timing: start when COWS score ≥8 (Clinical Opiate Withdrawal Scale) — mild withdrawal ensures no precipitation of acute withdrawal from receptor displacement
  • Ceiling effect: buprenorphine has ceiling effect on respiratory depression (safer than full agonists at high doses)
  • Suboxone vs Subutex: Suboxone preferred (contains naloxone) to reduce IV diversion; Subutex reserved for those allergic to naloxone or in pregnancy
  • Pregnancy: buprenorphine (without naloxone — Subutex) maintained through pregnancy; neonatal abstinence syndrome (NAS) managed with morphine; benefits of treatment outweigh NAS risk

Contraindications

  • Not in full opioid withdrawal state without mild symptoms (precipitated severe withdrawal)
  • Severe hepatic impairment
  • Respiratory failure

Side effects

  • Constipation
  • Nausea
  • Headache
  • Insomnia
  • Sweating
  • Precipitated withdrawal (if too early induction)
  • Hepatitis (especially in hepatitis C co-infection — monitor LFTs)
  • Dental caries (Subutex — from acidic SL dissolution)

Interactions

  • CNS depressants, particularly benzodiazepines — respiratory depression (significant — buprenorphine + benzodiazepine deaths reported)
  • Naltrexone — precipitates withdrawal (reverse order)

Monitoring

  • Urine drug screens
  • LFTs
  • COWS score at induction
  • Adherence and supervised consumption compliance
  • Dental hygiene (SL film erosion)

Reference: BNFc; BNF; NICE NG58; Drug Misuse and Dependence: UK Clinical Guidelines (Orange Guidelines). Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.