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OPANA^® ER: Flexible titration and dosing

OPANA ER has seven tablet strengths

Tablets shown are not actual size

The following dosing recommendations should only be considered as suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient. Before prescribing OPANA ER, please see full Prescribing Information, including the Dosage and Administration section.

Initiating OPANA ER in opioid-naïve patients

• Start with 5 mg OPANA ER every 12 hours for 2 days
• Titrate dose individually every 3-7 days by 5-10 mg every 12 hours to a level that provides adequate analgesia and minimizes side effects

Get detailed information on conversion to OPANA ER.

Initial dose selection

In the selection of the initial dose of OPANA ER, attention should be given to the following:

• The total daily dose, potency, and specific characteristics of the opioid the patient has been taking previously
• The relative potency estimate used to calculate the equivalent oxymorphone dose needed
• The patient’s degree of opioid tolerance
• The age, general condition, and medical status of the patient
• Concurrent non-opioid analgesic and other medications
• The type and severity of the patient’s pain
• The balance between pain control and adverse experiences
• Risk factors for abuse, addiction, or diversion, including a prior history of abuse, addiction, or diversion

Individualization of therapy

• As with any opioid drug product, it is necessary to adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience
• Physicians should individualize treatment in every case, using non-opioid analgesics, as needed opioids and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the American Pain Society, and the Federation of State Medical Boards Model Guidelines
• Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring

Cessation

• OPANA ER should not be abruptly discontinued. When the patient no longer requires therapy with OPANA ER tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient
• Patients and their families should be instructed to flush any OPANA ER tablets that are no longer needed

Additional Safety Information

• OPANA ER TABLETS are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed. Taking broken, chewed, dissolved, or crushed OPANA ER TABLETS leads to rapid release and absorption of a potentially fatal dose of oxymorphone
• Patients must not consume alcoholic beverages, or prescription or nonprescription medications containing alcohol, while on OPANA ER therapy. The co-ingestion of alcohol with OPANA ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone
• OPANA ER should be administered on an empty stomach, at least 1 hour prior to or 2 hours after eating
• Elderly patients, patients with mild hepatic impairment and patients with moderate or severe renal impairment should be started at the lowest dose and titrated slowly while carefully monitoring for side effects
• OPANA ER, like all opioid analgesics, should be started at 1/3 to 1/2 of the usual dose in patients who are concurrently receiving other CNS depressants
• Safety and effectiveness of OPANA ER in pediatric patients below the age of 18 years have not been established