Generic Name and Formulations:
Oxymorphone HCl 5mg, 7.5mg, 10mg, 15mg, 20mg, 30mg, 40mg; ext-rel tabs.
Company:
Endo Pharmaceuticals
 
Select therapeutic use: Narcotic analgesics
Indications for OPANA ER:
Management of pain severe enough to require daily, around-the-clock, long-term analgesia for which alternative opioid therapies 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:
Individualize. Take on empty stomach. May give Opana as needed on an every 4–6hrs schedule; Opana ER is given on a continuous basis every 12hrs. ≥18yrs: Opioid-naive: Opana: 5–20mg every 4–6hrs as needed. Opana ER: 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 Opana ER: Give half the total daily Opana dose as Opana ER every 12hrs. Converting from parenteral oxymorphone, or other opioids to Opana or Opana ER: 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: reduce initial dose.

Children:
<18yrs: not established.

Contraindications:
Significant respiratory depression. Acute or severe bronchial asthma. Hypercarbia. Known or suspected paralytic ileus and GI obstruction. Moderate-to-severe hepatic impairment. Hypersensitivity to morphine analogs (eg, codeine).

Warnings/Precautions:
Increased risk of fatal respiratory depression (esp. when initiating therapy and during dose increases); monitor. Abuse potential (monitor routinely). Accidental exposure may result in fatal overdose (esp. children). Risk of neonatal opioid withdrawal syndrome. Pulmonary disease (eg, COPD, cor pulmonale); monitor for respiratory depression (esp. within the first 24–72hrs of initiating therapy and after dose increases); consider alternative non-opioid analgesics. Head injury. Impaired consciousness, coma, shock; avoid. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. Biliary tract disease. Acute pancreatitis. Acute alcoholism. Drug abusers. Avoid abrupt cessation. Re-eva luate periodically. Impaired hepatic or renal function. Elderly. Cachectic. Debilitated. Pregnancy (Cat.C). Labor & delivery, nursing mothers: not recommended.

Interactions:
Co-ingestion of alcohol may cause fatal overdose; avoid. Avoid mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and precipitate withdrawal symptoms. Increased CNS effects with concomitant CNS depressants (eg, sedatives, hypnotics, anxiolytics, neuroleptics, tranquilizers, anesthetics, phenothiazines, other opioids), alcohol; consider reducing dose for one or both drugs. Increased risk of urinary retention and/or severe constipation with anticholinergics; monitor. Potentiates muscle relaxants, cimetidine; monitor. 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, orthostatic hypotension, syncope; CNS and respiratory depression, neonatal opioid withdrawal syndrome.

Metabolism:
Hepatic.

Elimination:
Renal, fecal.

REMS:
YES

Generic Availability:
NO

How Supplied:
Opana ER—60, 100; Opana—100