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HYSINGLA ER
Narcotic analgesics
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Drug Name:

HYSINGLA ER CII

Generic Name and Formulations:
Hydrocodone bitartrate 20mg, 30mg, 40mg, 60mg, 80mg, 100mg, 120mg; ext-rel tabs.

Company:
Purdue Pharma L.P.

Therapeutic Use:

Indications for HYSINGLA ER:

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 treatments (eg, non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or inadequate to manage pain. Not indicated as an as-needed (prn) analgesic.

Adult:

Use lowest effective dose for shortest duration. Swallow whole. Individualize. Opioid-naïve or opioid non-tolerant: initially 20mg every 24hrs. May increase dose in increments of 10–20mg every 3–5 days as needed. ≥80mg: for use in opioid-tolerant patients only. Conversion from other opioids: see full labeling. Severe hepatic impairment, moderate-to-severe renal impairment, or ESRD: initiate with ½ the initial dose. Concomitant use or discontinuation of CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling). Withdraw gradually by 25–50% every 2–4 days.

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). Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Risk of QT prolongation; consider dose reduction or use alternatives if develops; avoid in congenital long QT syndrome. Difficulty swallowing or at risk for underlying GI disorders (eg, esophageal or colon cancer): consider other analgesics. Biliary tract disease. Acute pancreatitis. Drug abusers. Renal or hepatic impairment. 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. 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 opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); 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 strong laxatives (eg, lactulose); monitor.

Pharmacological Class:

Opioid agonist.

Adverse Reactions:

Constipation, nausea, vomiting, fatigue, upper respiratory tract infection, dizziness, headache, somnolence; respiratory depression, severe hypotension, syncope.

REMS:

YES

How Supplied:

ER tabs—60

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