Agencia Lei Va Hong
Concise Prescribing Info
Buprenorphine HCl
Relief of moderate to severe pain.
Dosage/Direction for Use
Tab Adult 0.2-0.4 mg 6-8 hrly or as required sublingually. Childn 2-12 yr, 16-25 kg ½ tab; 25-37.5 kg ½-1 tab; 37.5-50 kg 1-1½ tab 6-8 hrly sublingually. Inj Adult 1-2 mL (300-600 mcg) IM or slow IV 6-8 hrly as required. Childn <12 yr 3-6 mcg/kg 6-8 hrly. In refractory cases, up to 9 mcg/kg may be administered. No clinical experience in infants <6 mth for inj.
May be taken with or without food: Place under the tongue & allow to dissolve completely, do not chew/swallow.
Hypersensitivity to buprenorphine, other opiates or to other centrally-acting analgesics. Tab severe resp & hepatic insufficiency.
Special Precautions
History of drug abuse, emotional instability; patients w/ impaired resp function; patients w/ biliary tract dysfunction, myxedema or hypothyroidism, adrenal insufficiency (eg, Addison's disease), CNS depression or coma, toxic psychoses, prostatic hypertrophy or urethral stricture, acute alcoholism, delirium tremens or kyphoscoliosis; patients w/ head injuries; ambulatory patients; patients previously treated w/ narcotic analgesics. Hepatic & renal impairment. Can impair cognitive function & can affect a patient's ability to drive safely. Pregnancy & lactation. Elderly or debilitated patients. Inj Diversion. Positive results for anti-doping tests in athletes.
Adverse Reactions
Tab Sedation. Bronchospasm, angioneurotic edema & anaphylactic shock. Nausea, dizziness/vertigo. Sweating, hypotension, vomiting, miosis, headache, hypoventilation. Inj Nausea, vomiting, dizziness, sweating, drowsiness; hypotension; rashes, headache, urinary retention, blurring of vision; significant resp depression.
Drug Interactions
May precipitate abstinence effects in individuals on high doses of opioids. Increased sedative effect w/ alcohol. Potentiated resp depression w/ benzodiazepines, w/ risk of death. Increased CNS depression w/ other CNS depressants, other opioid derivatives (eg, analgesics & antitussives); certain antidepressants, sedative H1-receptor antagonist, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines, neuroleptics, clonidine & related substances. Possible exaggeration of the effects of opioids w/ MAOIs. Concomitant use w/ diazepam may lead to resp & CV collapses. Increased plasma conc w/ CYP3A4 inhibitors (eg, ketoconazole, gestodene, TAO, HIV PIs ritonavir, indinavir & saquinavir). May decrease plasma conc w/ CYP3A4 inducers (eg, phenobarb, carbamazepine, phenytoin, rifampicin). Tab Concomitant use w/ phenoprocoumon may lead to purpura.
MIMS Class
Analgesics (Opioid) / Supportive Care Therapy
ATC Classification
N02AE01 - buprenorphine ; Belongs to the class of oripavine derivative opioids. Used to relieve pain.
Temgesic inj 0.3 mg/mL
1 mL x 5 × 1's
Temgesic sublingual tab 0.2 mg
10 × 5's
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