OPANA ER (oxymorphone HCI)

New Tablet Strengths

Dosage / Administration

Address your patients’ moderate to severe pain with proven every
12-hour OPANA® ER

Multiple strengths of OPANA® ER for flexible titration and dosing1
5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg

Initial dose selection1

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.

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

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. Conversion ratios are only approximate. Before prescribing OPANA ER, please see full Prescribing Information, including the Dosage and Administration section.

Opioid-naïve patients1

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.

Conversion from other oral opioids1

Refer to published relative potency information or the conversion chart provided, keeping in mind that conversion ratios are only approximate. In general, it is safest to start the OPANA ER therapy by administering half of the calculated total daily dose of OPANA ER in 2 divided doses, every 12 hours.

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

Conversion ratios to OPANA ER1

The conversion ratios and approximate equivalent doses in this conversion table are only to be used for the conversion from current opioid therapy to OPANA ER.
Opioid Approximate
Equivalent
Oral Dose		 Oral
Conversion
Ratioa
aRatio for conversion of oral opioid dose to approximate OPANA ER equivalent dose. Select opioid and multiply the dose by the conversion ratio to calculate the approximate oral oxymorphone equivalent.
  • Sum the total daily dose for the opioid and multiply by the conversion ratio to calculate the oxymorphone total daily dose.
  • For patients on a regimen of mixed opioids, calculate the approximate oral oxymorphone dose for each opioid and sum the totals to estimate the total daily oxymorphone dose.
bIt is extremely important to monitor all patients closely when converting from methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and tends to accumulate in the plasma.
Oxymorphone 10mg 1
Hydrocodone 20mg 0.5
Oxycodone 20mg 0.5
Methadoneb 20mg 0.5
Morphine 30mg 0.333

Conversion Steps

Sample Calculation

A healthcare provider with a patient on a total daily dose of 80 mg of oxycodone could do the following calculation:

The dose of OPANA ER can be gradually adjusted, at increments of 10 mg every 12 hours every 3–7 days, until adequate pain relief and acceptable side effects have been achieved.

Patients should be titrated to generally mild or no pain with the regular use of no more than 2 doses of supplemental analgesia, i.e., “rescue,” per 24 hours.

Get additional information on conversion to OPANA ER.

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

Additional Safety Information

References
  1. OPANA ER Full Prescribing Information. Chadds Ford, PA: Endo Pharmaceuticals; 2008.

Important Safety Information

OPANA® ER has a boxed warning as follows:

WARNING: OPANA ER contains oxymorphone, which is a morphine-like opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics.

Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OPANA ER in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

OPANA ER is an extended-release oral formulation of oxymorphone indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

OPANA ER is NOT intended for use as an as needed analgesic.

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, like OPANA ER, contains oxymorphone, an opioid agonist and Schedule II controlled substance with an abuse liability similar to morphine and can be abused in a manner similar to other opioid agonists, legal or illicit.

OPANA and OPANA ER are contraindicated in patients with a known hypersensitivity to oxymorphone hydrochloride, morphine analogs such as codeine, or any of the other ingredients of OPANA and OPANA ER; in patients with moderate or severe hepatic impairment or in any situation where opioids are contraindicated such as: patients with respiratory depression (in the absence of resuscitative equipment or in unmonitored settings), acute or severe bronchial asthma, hypercarbia, and in any patient who has or is suspected of having paralytic ileus.

OPANA ER is not indicated for pain in the immediate post-operative period (the first 12–24 hours following surgery), or if the pain is mild, or not expected to persist for an extended period of time. OPANA ER is only indicated for post-operative use if the patient is already receiving the drug prior to surgery or if the post-operative pain is expected to be moderate or severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate (see American Pain Society guidelines).

Respiratory depression is the chief hazard of OPANA and OPANA ER, particularly in elderly or debilitated patients. OPANA and OPANA ER should be administered with extreme caution to patients with conditions accompanied by hypoxia, hypercapnia, or decreased respiratory reserve such as: asthma, chronic obstructive pulmonary disease or cor pulmonale, severe obesity, sleep apnea syndrome, myxedema, kyphoscoliosis, central nervous system (CNS) depression, or coma.

Patients receiving other opioid analgesics, general anesthetics, phenothiazines or other tranquilizers, sedatives, hypnotics, or other CNS depressants (including alcohol) may experience additive effects resulting in respiratory depression, hypotension, profound sedation, or coma.

OPANA and OPANA ER should be used with caution in elderly and debilitated patients and in patients who are known to be sensitive to CNS depressants, such as those with cardiovascular, pulmonary, renal, or hepatic disease. OPANA and OPANA ER should be used with caution in patients with mild hepatic impairment and in patients with moderate to severe renal impairment. These patients should be started cautiously with lower doses of OPANA or OPANA ER while carefully monitoring for side effects.

OPANA ER is not indicated for preemptive analgesia (administration preoperatively for the management of postoperative pain).

The most common adverse drug reactions (≥10%) reported at least once by patients treated with OPANA in the clinical trials were nausea and pyrexia. The most common adverse drug reactions (≥10%) in clinical trials for OPANA ER were nausea, constipation, dizziness (excluding vertigo), vomiting, pruritus, somnolence, headache, increased sweating, and sedation.

Patients and their families should be instructed to flush any OPANA and OPANA ER tablets that are no longer needed.

Please see full Prescribing Information for OPANA and full Prescribing Information, including boxed WARNING for OPANA ER.

Vermont prescribers, please see additional information for OPANA and OPANA ER.

Oxymorphone is also available in injectable form. For more information, please see the full prescribing information for OPANA Injection.