Composition
Inj Per 1 ml amp: Buprenorphine HCI 0.324 mg equiv to 0.3 mg buprenorphine base. Tab: Buprenorphine HCI 0.216 mg equiv to 0.2 mg buprenorphine base.
Indications & Dosage
Moderate to severe pain: BY SUBLINGUAL ADMINISTRATION: Adult: 200-400 mcg every 6-8 hours. Children 6 yrs & above: (body-weight 16-25 kg): 100 mcg every 6-8 hours; (body-weight 25-37.5 kg): 100-200 mcg every 6-8 hours; (body-weight 37.5-50 kg): 200-300 mcg every 6-8 hours; (body-weight 50 kg and above): 200-400 mcg every 6-8 hours BY IM INJ, OR BY SLOW IV INJ: Adult & Children above 12 yrs: 300-600 mcg every 6-8 hours. Children 6 months-11 yrs: 3-6 mcg/kg every 6-8 hours (max. per dose 9 mcg/kg). Premedication: BY SUBLINGUAL ADMINISTRATION: Adult: 400 mcg. BY IM INJ: Adult: 300 mcg. Intra-operative analgesia: BY SLOW IV INJ: Adult: 300-450 mcg. Adjunct in the treatment of opioid dependence: BY SUBLINGUAL ADMINISTRATION: Adult: Initially 0.8-4 mg for 1 dose on the first day, adjusted in steps of 2-4 mg daily if required; usual dose12-24 mg daily; max. 32 mg per day.
Administration
Administer deep IM or by IV slowly, over a period of at least 2 min. Administer via-deep IM injection. IV administer slowly over at least 2 min. Administer over 20-30 min preferred when managing opioid withdrawal in heroin-dependent hospitalized patients.
Compatibility
Compatible with D5NS, D5W, NS and LR.
Stability
Protect from excessive heat > 40C. Protect from light.
Contraindications
Acute respiratory depression, comatose patients, head injury and raised intracranial pressure (opioid analgesics interfere with pupillary responses vital for neurological assessment), risk of paralytic ileus, severe renal impairment; avoid use or reduce dose; opioid effects increased, prolonged and increased cerebral sensitivity occurs.
Precautions
Impaired consciousness, adrenocortical insufficiency (reduced dose), asthma (avoid during an acute attack), convulsive disorders, debilitated patients and elderly (reduced dose) diseases of the biliary tract, hypotension, hypothyroidism (reduced dose is recommended), impaired respiratory function (avoid in chronic obstructive pulmonary disease), inflammatory bowel disorders, myasthenia gravis, obstructive bowel disorders, prostatic hypertrophy, shock, urethral stenosis, hepatic insufficiency and pre-existing liver enzyme abnormalities. Documentation of viral hepatitis status is recommended before commencing therapy for opioid dependence. Monitor liver function; before commencing therapy and throughout treatment
Interactions
MAOis or CNS depressants.
Pregnancy
Risk of respiratory depression and withdrawal symptoms in the neonate, risk of gastric stasis and inhalation pneumonia in the mother if opioid analgesics are used during labour and delivery
Side Effects
: Abdominal pain, biliary spasm, bradycardia, confusion, constipation, drug dependence, difficulty with micturition, dizziness, drowsiness, dry mouth, dysphoria, euphoria, flushing, hallucinations, headache, miosis, nausea, oedema, palpitation, postural hypotension, pruritus, rash, respiratory depression, sexual dysfunction, sleep disturbances, sweating, tachycardia, ureteric spasm, urinary retention, urticaria, vertigo, visual disturbances, vomiting, agitation, anorexia, anxiety, asthenia, diarrhoea, dyspepsia, dyspnea, fatigue, mild withdrawal symptoms in patients dependent on opioids, paraesthesia, vasodilatation. Rare: Angina, diverticulitis, dysphagia, impaired concentration, paralytic ileus, psychosis