Dangerous Drug: Buprenorphine Hydrochloride(byoo pre nor’ feen)
Buprenex, Butrans Patch
PREGNANCY CATEGORY C
CONTROLLED SUBSTANCE C-III
Drug class
Opioid agonist-antagonist analgesic
Therapeutic Actions
Acts as an agonist at specific mu opioid receptors in the CNS to produce analgesia; also acts as an opioid antagonist; exact mechanism of action not understood.
Indications
Parenteral: Relief of moderate to severe pain
Oral: Treatment of opioid dependence, preferably used as induction treatment
Transdermal system: Management of moderate to severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time
Contraindications and Cautions
Contraindicated with hypersensitivity to buprenorphine.
Use cautiously with physical dependence on opioid analgesics (withdrawal syndrome
may occur); compromised respiratory function; increased intracranial pressure (buprenorphine may elevate CSF pressure; may cause miosis and coma, which could interfere with patient evaluation), myxedema, Addison’s disease, toxic psychosis, prostatic hypertrophy or urethral stricture, acute alcoholism, delirium tremens, kyphoscoliosis, biliary tract dysfunction (may cause spasm of the sphincter of Oddi), hepatic or renal impairment; respiratory depression, paralytic ileus, severe bronchial asthma; lactation, pregnancy.
Available Forms
Injection—0.324 mg/mL (equivalent to 0.3 mg); sublingual tablets—2, 8 mg; transdermal patches—5, 10, 20 mcg/hr
Dosages
Adults
Transdermal system: Initially, 5 mcg/hr, intended to be worn for 7 days; if needed, dosage may be increased after wearing system for 72 hr. Maximum dose, 20 mcg/hr.
Adults and pediatric patients older than 13 yr
Parenteral
Relief of pain: 0.3 mg IM or by slow (over 2 min) IV injection. May repeat once, 30–60 min after first dose; repeat every 6 hr as needed. If necessary, nonrisk patients may be given up to 0.6 mg by deep IM injection.
Adults and pediatric patients 16 yr and older
Oral
Opioid dependence: Initially, 8 mg on day 1, 16 mg on day 2 and subsequent induction days (can be 3–4 days); use buprenorphine/naloxone combination (Suboxone) for maintenance. Maintenance dose, 12–16 mg/day sublingually (Suboxone).
Pediatric patients (2–12 yr)
2–6 mcg/kg of body weight IM or slow IV injection every 4–6 hr.
Geriatric or debilitated patients
Reduce dosage to one-half usual adult dose.
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