Oxymorphone HCl Extended-Release Tablets CII

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Oxymorphone HCl Extended-Release Tablets

Narcotic analgesics
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Generic Name and Formulations:

Oxymorphone HCl 5mg, 7.5mg, 10mg, 15mg, 20mg, 30mg, 40mg; ext-rel tabs.

Select therapeutic use:

Indications for Oxymorphone HCl Extended-Release Tablets:

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:

Not for use as an as-needed (prn) analgesic. Use only if alternative treatment options (eg, non-opioid analgesics, immediate-release opioids) are ineffective, not tolerated, or otherwise inadequate to provide sufficient management of pain.

Adult:

Use lowest effective dose for shortest duration. Individualize. Take on empty stomach. May give Opana as needed on an every 4–6hrs schedule; oxymorphone ext-rel tab is given on a continuous basis every 12hrs. ≥18yrs: Opioid-naive: Opana: 10–20mg every 4–6hrs as needed. Ext-rel tab: Swallow whole; 5mg every 12hrs, titrate by 5–10mg every 12hrs every 3–7 days; if breakthrough pain occurs: adjust dose or use a small-dose rescue medication (eg, immediate-release oxymorphone). Converting from Opana to ext-rel tab: Give half the total daily Opana dose as oxymorphone ext-rel every 12hrs. Conversion from other opioids: see full labeling. Mild hepatic impairment, renal impairment (CrCl <50mL/min), or elderly (≥65yrs): opioid-naive: initiate with 5mg dose; opioid-experience: initiate at 50% lower than normal starting dose and titrate slowly. Concomitant other CNS depressants: initiate at ⅓–½ of usual starting dose and monitor. Withdraw gradually by 25–50% every 2–4 days.

Children:

<18yrs: 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. Moderate-to-severe hepatic impairment.

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. Biliary tract disease. Acute pancreatitis. Drug and alcohol abusers. Renal or hepatic impairment. ER tabs: difficulty in swallowing or at risk for underlying GI disorders (eg, esophageal or colon cancer); consider other analgesics. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery, nursing mothers: not recommended.

Interactions:

Avoid alcohol or alcohol-containing products. 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. May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics. May be potentiated by cimetidine. May increase serum amylase.

See Also:

OPANA

Pharmacological Class:

Opioid agonist.

Adverse Reactions:

Nausea, constipation, dizziness, somnolence, vomiting, pruritus, headache, sweating increased, dry mouth, sedation, diarrhea, insomnia, fatigue, appetite decreased, abdominal pain; respiratory depression, severe hypotension, syncope, hypersensitivity, angioedema.

Note:

Formerly known under the brand name Opana ER.

Metabolism:

Hepatic.

Elimination:

Renal, fecal.

REMS:

YES

Generic Availability:

YES

How Supplied:

Ext-rel tabs—contact supplier; Opana—100