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BELBUCA
Narcotic analgesics
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Drug Name:

BELBUCA CIII

Generic Name and Formulations:
Buprenorphine 75mcg, 150mcg, 300mcg, 450mcg, 600mcg, 750mcg, 900mcg; buccal films; peppermint flavor.

Company:
Endo Pharmaceuticals

Therapeutic Use:

Indications for BELBUCA:

Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Limitations Of use:

Reserve for use in patients for whom alternative treatment options are ineffective, not tolerated, or inadequate to provide sufficient management of pain. Not indicated as an as-needed (prn) analgesic.

Adult:

Use lowest effective dose for shortest duration. Apply against inside of cheek; do not chew or swallow. Avoid food or drinks until film dissolves. Individualize. Opioid-naive or opioid non-tolerant: initially 75mcg once daily or every 12hrs (if tolerated) for at least 4 days, then increase to 150mcg every 12hrs. Titrate in increments of 150mcg every 12hrs no sooner than every 4 days. Max 900mcg every 12hrs; consider alternate analgesic if inadequate. Conversion from other opioids: see full labeling. Use 600mcg, 750mcg, and 900mcg doses only following titration from lower doses of Belbuca. Severe hepatic impairment or oral mucositis: reduce initial and titration doses by ½. Concomitant use or discontinuation of CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling).

Children:

Not established.

Contraindications:

Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus.

Warnings/Precautions:

Life-threatening respiratory depression; monitor within first 24–72hrs of initiating therapy and following dose increases. Accidental exposure may cause fatal overdose (esp. in children). COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Abuse potential (monitor). History of long QT syndrome; avoid. Hypokalemia, hypomagnesemia, unstable cardiac disease (eg, unstable atrial fibrillation, symptomatic bradycardia, unstable CHF, active MI); monitor ECG periodically. Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Oral mucositis: use lower dose; monitor for toxicity. Drug abusers. Moderate or severe hepatic impairment. Hepatotoxicity: obtain baseline LFTs in at-risk patients and monitor during treatment. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery, nursing mothers: not recommended.

Interactions:

Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor. Avoid concomitant Class 1A (eg, quinidine, procainamide, disopyramide) or Class III antiarrhythmics (eg, sotalol, amiodarone, dofetilide). During or within 14 days of MAOIs: not recommended. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Avoid concomitant mixed agonist/antagonist and partial agonist opioids (eg, butorphanol, nalbuphine, pentazocine); may reduce effects and precipitate withdrawal symptoms. Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors). Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics. Concomitant NNRTIs (eg, efavirenz, nevirapine, etravirine, delavirdine) or PIs (eg, atazanavir, ritonavir); monitor and adjust buprenorphine dose, if needed.

Pharmacological Class:

Opioid (partial agonist-antagonist).

Adverse Reactions:

Nausea, constipation, headache, vomiting, dizziness, somnolence; respiratory depression, severe hypotension, syncope, hypersensitivity reactions.

REMS:

YES

Generic Availability:

NO

How Supplied:

Films—60

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