OPANA(oxymorphone HCI)

Dosage / Administration

Address your patients’ moderate to severe acute pain

Available OPANA^® strengths
5 mg, 10 mg

Initial dose selection¹

In the selection of the initial dose of OPANA , 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.

Additional Dosing Information

OPANA should be administered on an empty stomach, at least 1 hour prior to or 2 hours after eating.
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, prn 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.
When the patient no longer requires therapy with OPANA , doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

Additional Safety Information

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.
Safety and effectiveness of OPANA in pediatric patients below the age of 18 years have not been established.
OPANA 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.

Please see Important Safety Information, including boxed WARNING. Get the full Prescribing Information for OPANA^®.

Dosage and administration

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.

Opioid-naïve patients²

Start with 10-20 mg every 4-6 hours, depending on initial pain intensity.
If necessary, patients may be started with OPANA 5 mg.
The dose should be titrated based upon the individual patient’s response to the initial dose of OPANA . This dose can then be adjusted to an acceptable level of analgesia taking into account the pain intensity and side effects experienced by the patient.
Initiation therapy with doses higher than 20 mg is not recommended because of potential serious side effects.

Conversion from other oral opioids¹

Conversion steps

Step 1: Calculate the total dose of OPANA based on relative potency information from the published literature.
Step 2: Administer the total daily dose from Step 1 as equally divided doses every 4–6 hours.

Sample Calculation

If a healthcare provider has determined the total calculated daily dose of OPANA is 40 mg:

Administer as 10 mg of OPANA every 4–6 hours.

The initial dose of OPANA can be gradually adjusted until adequate pain relief and acceptable side effects have been achieved.

In general, it is safest to start OPANA therapy by administering half of the calculated total daily dose of OPANA in 4 to 6 equally divided doses, every 4–6 hours.

Conversion from OPANA Injection¹

Given the absolute oral bioavailability of approximately 10%, patients receiving OPANA Injection may be converted to OPANA by administering 10 times the patient’s total daily OPANA Injection dose as OPANA in 4 or 6 equally divided doses (e.g., IV dose x 10/4).
For example, approximately 10 mg of OPANA may be required to provide pain relief equivalent to a total daily dose of 4 mg of OPANA Injection.
Due to patient variability with regard to opioid analgesic response, upon conversion patients should be closely monitored to ensure adequate analgesia and to minimize side effects.