Adult Dosing

Moderate to severe pain

• 300 mcg IM/IV q6-8 hrs, may repeat 300 mcg once, after 30-60 mins of initial dose
• High risk patients (elderly, debilitated, respiratory disease): Reduce dose by 50%
• Severe pain: 600 mcg IM (not in high risk patients)
• Max: 300 mcg/dose IV; 600 mcg/dose IM

Note:

• To be administered deep intramuscular or slow IV over 2 mins

Pediatric Dosing

Moderate to severe pain

2-12 yrs

• 2-6 mcg/kg IM/IV q4-6 hrs
• Max: 6 mcg/kg/dose

13 yrs

• 300 mcg IM/IV q6-8 hrs, may repeat 300 mcg once, after 30-60 mins of initial dose
• High risk patients (debilitated, respiratory disease): Reduce dose by 50%

Note:

• To be administered deep intramuscular or slow IV over 2 mins

• Relief of moderate to severe pain

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Severe renal impairment: Caution advised, dose adjustments not defined

Hepatic Dose Adjustment

• Moderate-severe hepatic impairment: Caution advised, dose adjustments not defined

• Buprenorphine causes significant respiratory depression. Use cautiously in patients with compromised respiratory function (e.g., chronic obstructive pulmonary disease, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia,or preexisting respiratory depression) and in patients taking or recently receiving CNS/respiratory depressant
• In case of overdosage of buprenorphine, re-establish adequate ventilation with mechanical assistance of respiration as naloxone may not be effective in reversing the respiratory depression
• Buprenorphine causes CNS depression when administered concomitantly with other narcotic analgesics, general anesthetics, benzodiazepines, phenothiazines, other tranquilizers, sedative/hypnotics or other CNS depressants. In such case reduce the dose of one or both agents
• Buprenorphine elevates cerebrospinal fluid pressure and can produce miosis and changes in the level of consciousness. Use cautiously in patients with head injury, intracranial lesions and other circumstances where cerebrospinal pressure may be increased
• Buprenorphine produce orthostatic hypotension and can impair the mental or physical abilities, especially during drug induction and dose adjustment. Caution patients against operating hazardous machinery, including automobiles
• Use of buprenorphine hydrochloride injection in the physically dependent individual may result in withdrawal effects, because of its narcotic antagonist activity
• Use cautiously in patients with dysfunction of the biliary tract as it increases intracholedochal pressure

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• Myxedema or hypothyroidism
• Adrenal cortical insufficiency
• Compromised respiratory function
• CNS depression
• Coma
• Increased intracranial pressure
• Head injury
• Intracranial lesion
• Concomitant CNS depressant
• Toxic psychoses
• Prostatic hypertrophy
• Urethral stricture
• Acute alcoholism
• Delirium tremens
• Kyphoscoliosis
• Biliary tract dysfunction
• Elderly or debilitated patients

Pregnancy Category:C

Breastfeeding: Buprenorphine use is acceptable in nursing mother, as low level is excreted in breastmilk, have poor oral bioavailability in infants and low drug concentration is found in serum and urine of breastfed infants. Monitor the infant for drowsiness, adequate weight gain, and developmental milestones in exclusively breastfed infants, if any sign of increased sleepiness, difficulty breastfeeding, breathing difficulties, or limpness is seen, immediately contact physician. Mothers taking buprenorphine for opiate addiction have lower rate of breastfeeding than in other mother. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 26 February 2011).As per manufacturer's data breastfeeding is not advised in mother receiving buprenorphine injectable.

• CV: Hypotension, bradycardia
• CNS: Headache, dizziness, sedation, depression
• GI: Nausea, vomiting, hepatoxicity, constipation
• RESP: Respiratory depression, hypoventilation, bronchospasm
• EENT: Miosis, vertigo
• DERM: Sweating, angioneurotic edema
• MISC: Anaphylaxis, injection site reaction, chills

• Opioid analgesic; binds to opioid receptors in CNS, and alters the perception of and response to painful stimuli
• Metabolized by liver; CYP450: 3A4 substrate
• Renally excreted 27%, feces 70%
• Half-life: 1.2-7.2 hrs (mean 2.2 hrs) [IV]

US Trade Name(s)

• Buprenex

US Availability

buprenorphine (generic)

• INJ: 0.3 mg/mL (1 mL vial)

Buprenex

• INJ: 0.3 mg/mL (1 mL amp)

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• Temgesic

UK Availability

Temgesic

• INJ: 0.3 mg/mL (1 mL amp)

Australian Trade Name(s)

• Temgesic

Australian Availability

Temgesic

• INJ: 0.3 mg/mL (1 mL amp)

Analgesics

Opioid Analgesics

opioid Agonists Antagonist

Pricing data from www.DrugStore.com in U.S.A.

• Buprenex 0.3 MG/ML SOLN [Vial] (RECKITT BENCKISER)
  5 ml = $55.99
  10 ml = $99.97

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.