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Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse.

Administer on an empty stomach, at least 1 hour prior to or 2 hours after eating.

OPANA ER tablets should be taken one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth.

For opioid-naïve and opioid non-tolerant patients, initiate treatment with 5 mg tablets orally every 12 hours.

To convert to OPANA ER from another opioid, use available conversion factors to obtain estimated dose.

Dose can be increased every 3 to 7 days, using increments of 5 to 10 mg every 12 hours (i.e., 10 to 20 mg per day).

Do not abruptly discontinue OPANA ER in a physically dependent patient.

Mild Hepatic Impairment: For opioid-naïve patients, initiate treatment with 5 mg and titrate slowly. For patients on prior opioid therapy, reduce starting dose by 50% and titrate slowly. Monitor for signs of respiratory and central nervous system depression.

Renal Impairment: For opioid-naïve patients, initiate treatment with 5 mg and titrate slowly. For patients on prior opioid therapy, reduce starting dose by 50% and titrate slowly. Monitor for signs of respiratory and central nervous system depression.

Geriatric Patients: Initiate dosing with 5 mg, titrate slowly, and monitor for signs of respiratory and central nervous system depression.

Dosage form and strength:5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg

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Some contraindications are as follows below ;

• Known hypersensitivity to oxymorphone, any other ingredients in OPANA ER, ormorphine analogs.
• Respiratory depression
• Acute or severe bronchial asthma or hypercarbia
• Paralytic ileus
• Moderate or severe hepatic impairment

Warnings

• Respiratory depression: Increased risk in elderly, debilitated patients, and those suffering from conditions accompanied by hypoxia, hypercapnia, or decreased respiratory reserve.
• Misuse, abuse, and diversion: OPANA ER is an opioid agonist and a Schedule
• II controlled substance with an abuse liability similar to morphine.
• CNS effects: Additive CNS-depressive effects when used in conjunction with alcohol, other opioids, or illicit drugs.
• Head Injury: Effects may be markedly exaggerated. Administer with extreme caution.
• Hypotensive effect: Increased risk with compromised ability to maintain blood pressure. Administer with caution to patients in circulatory shock.
• Mild hepatic impairment: Use with caution and at lower doses due to higher plasma concentrations than in patients with normal hepatic function.
• Prolonged gastric obstruction: May occur in patients with gastrointestinal obstruction.
• Sphincter of Oddi: Administer with caution in patients with biliary tract disease.

Impaired mental/physical abilities: Caution must be used with potentially hazardous activities. More info : WIKI

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