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DOSAGE AND ADMINISTRATION
Extended-Release Tablets, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30mg, and 40 mg.
- Administered on an empty stomach, at least 1 hour prior to or 2 hours after eating.
- Symmetrical, every 12h dosing is appropriate for the majority of patients.
- Opioid-Naïve Patients: Initiate treatment with 5 mg every 12 hours.
- Opioid-Experienced Patients: Ratios as a guide to convert only from other opioids to OPANA ER.
- Individualize treatment; titrate to effective and tolerable dose.
- Don’t stop abruptly; taper gradually to stop treatment
CONTRAINDICATIONS
OPANA ER is contraindicated in patients with:
- Significant respiratory depression
- Acute or severe bronchial asthma or hypercarbia
- Known or suspected paralytic ileus
- Moderate and severe hepatic impairment
- Hypersensitivity (e.g. anaphylaxis) to oxymorphone, any other ingredients in OPANA ER, or to morphine analogs such as codeine.
Side Effects
nausea,
vomiting,
headache,
constipation,
dry mouth,
mild rash or
itching,
lightheadedness,
dizziness,
drowsiness, or
fever.
See your doctor if you have serious side effects of Opana ER including:
slow or fast heartbeat,
difficulty urinating,
severe stomach or abdominal pain,
changes in the amount of urine,
shortness of breath,
mental/mood changes, or
vision changes
Warnings
Assess each patient’s risk for opioid abuse or addiction prior to prescribing OPANA ER. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients at increased risk may still be appropriately treated with modified-release opioid formulations; however, these patients will require intensive monitoring for signs of misuse, abuse, or addiction. Routinely monitor all patients receiving opioids for signs of misuse, abuse, and addiction because these drugs carry a risk for addiction even under appropriate medical use.
Serious, life-threatening, or fatal respiratory depression may occur with the use of OPANA ER. Monitor for respiratory depression, especially during initiation of OPANA ER or following a dose increase. Instruct patients to swallow OPANA ER tablets whole; crushing, chewing, or dissolving OPANA ER tablets can cause rapid release and absorption of a potentially fatal dose of oxymorphone
Accidental ingestion of even one dose of OPANA ER, especially by children, can result in a fatal overdose of oxymorphone
In patients who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), OPANA ER may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with OPANA ER.