High Alert
Contraindicated in:
Use Cautiously in:
prolonged use of buccal, transdermal, or SL buprenorphine during pregnancy can result in neonatal opioid withdrawal syndrome
;CV: hypertension, hypotension, palpitations, QT interval prolongation
Derm: sweating, clammy feeling, erythema, pruritus, rash
EENT: blurred vision, diplopia, miosis (high doses)
Endo: adrenal insufficiency
GI: nausea, constipation, dry mouth, HEPATOTOXICITY, ileus, vomiting
Local: injection site reactions
Neuro: confusion, dysphoria, hallucinations, sedation, dizziness, euphoria, floating feeling, headache, unusual dreams
Resp: RESPIRATORY DEPRESSION (INCLUDING CENTRAL SLEEP APNEA AND SLEEP-RELATED HYPOXEMIA)
Misc: allodynia, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS, ANGIOEDEMA, AND BRONCHOSPASM), opioid-induced hyperalgesia,
physical dependence
,psychological dependence
, toleranceDrug-drug:
Use with benzodiazepines or other CNS depressants, including other opioids, nonbenzodiazepine sedative/hypnotics, anxiolytics, general anesthetics, muscle relaxants, antipsychotics, and alcohol, may cause profound sedation, respiratory depression, coma, and death; reserve concurrent use for when alternative treatment options are inadequate.
Drug-Natural Products:
Analgesia
Hepatic Impairment
Hepatic Impairment
Treatment of Opioid Use Disorder
Hepatic Impairment
Therapeutic Classification: opioid analgesics
Pharmacologic Classification: opioid agonists antagonists
Absorption: Well absorbed after IM and SL use; 4665% absorbed with buccal use; 15% of transdermal dose absorbed through skin; IV administration results in complete bioavailability.
Distribution: Extensively distributed to tissues; CNS concentration is 1525% of plasma.
Protein Binding: 96%.
Half-Life: IV: 23 hr; Buccal: 27 hr; Transdermal: 26 hr; SL: 37 hr; Subdermal: 2448 hr; SUBQ: 4360 days.
(analgesia)
ROUTE | ONSET | PEAK | DURATION |
---|---|---|---|
IM | 15 min | 60 min | 6 hr‡ |
IV | rapid | less than 60 min | 6 hr‡ |
SL | unknown | unknown | unknown |
Transdermal | unknown | unknown | 7 days |
Buccal | unknown | unknown | unknown |
SUBQ | unknown | unknown | unknown |
‡45 hr in children.
Inform patient of potential for neonatal opioid withdrawal syndrome with prolonged use during pregnancy. Monitor infant for signs and symptoms of neonatal opioid withdrawal syndrome (irritability, hyperactivity and abnormal sleep pattern, high-pitched cry, tremor, vomiting, diarrhea, and/or failure to gain weight); usually occur in the first days after birth.
Chronic use may impair fertility.Instruct patient in correct method for application, removal, storage, and disposal of transdermal system. Wear patches for 7 days. May be worn while bathing, showering, or swimming. Do not discontinue or change dose without consulting health care provider. Instruct patient to read the Medication Guide prior to starting and with each Rx refill.
Advise patients and caregivers/family members of the potential side effects. Instruct patient to notify health care provider if pain is not controlled or if bothersome side effects occur. Contact immediately if difficulty or changes in breathing; unusual deep "sighing" breathing; slow or shallow breathing; new or unusual snoring; slow heartbeat; severe sleepiness; cold, clammy skin; feeling faint, dizzy, or confused; having difficulty thinking, walking, or talking normally; or swelling or blistering around patch occur.
NDC Code