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Limitations Of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see WARNINGS AND PRECAUTIONS], reserve OPANA for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
- Have not been tolerated, or are not expected to be tolerated,
- Have not provided adequate analgesia, or are not expected to provide adequate analgesia
DOSAGE AND ADMINISTRATION
Important Dosage And Administration Instructions
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS].
Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see WARNINGS AND PRECAUTIONS].
Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with OPANA and adjust the dosage accordingly [see WARNINGS AND PRECAUTIONS].
OPANA should be administered on an empty stomach, at least one hour prior to or two hours after eating [see CLINICAL PHARMACOLOGY].
To avoid medication errors, prescribers and pharmacists must be aware that oxymorphone is available as both immediate-release 5 mg and 10 mg tablets and extended-release 5 mg and 10 mg tablets [see Dosage Forms and Strengths].
Use Of OPANA As The First Opioid Analgesic
Initiate treatment with OPANA in a dosing range of 10 to 20 mg every 4 to 6 hours as needed for pain.
Do not initiate treatment with doses higher than 20 mg because of the potential serious adverse reactions [see Clinical Studies].
Conversion From Other Opioids To OPANA
There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of OPANA. It is safer to underestimate a patient's 24-hour OPANA dosage than to overestimate the 24-hour OPANA dosage and manage an adverse reaction due to overdose.
For conversion from other opioids to OPANA, physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate. 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. The initial dose of OPANA can be gradually adjusted until adequate pain relief and acceptable side effects have been achieved.
Conversion From Parenteral Oxymorphone To OPANA
Given OPANA's absolute oral bioavailability of approximately 10%, patients receiving parenteral oxymorphone may be converted to OPANA by administering 10 times the patient's total daily parenteral oxymorphone dose as OPANA, in four or six equally divided doses (e.g., [IV dose x 10] divided by 4 or 6). For example, approximately 10 mg of OPANA four times daily may be required to provide pain relief equivalent to a total daily IM dose of 4 mg oxymorphone. 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.
Conversion From OPANA To Extended-Release Oxymorphone
The relative bioavailability of OPANA compared to extended-release oxymorphone is unknown, so conversion to extended-release tablets must be accompanied by close observation for signs of excessive sedation and respiratory depression.
Dosage Modifications In Patients With Mild Hepatic Impairment
OPANA is contraindicated in patients with moderate or severe hepatic impairment. Use OPANA with caution in patients with mild hepatic impairment, starting with the lowest dose (e.g., 5 mg) and titrating slowly while carefully monitoring for signs of respiratory and central nervous system depression [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].
Dosage Modifications In Patients With Renal Impairment
Use OPANA with caution in patients with creatinine clearance rates less than 50 mL/min., starting with the lowest dose (e.g., 5 mg) and titrating slowly while carefully monitoring for signs of respiratory and central nervous system depression [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].
Dosage Modifications In Geriatric Patients
Exercise caution in the selection of the starting dose of OPANA for an elderly patient by starting with the lowest dose (e.g., 5 mg) and titrate slowly while carefully monitoring for signs of respiratory and central nervous system depression [see Use in Specific Populations].
Dosage Modifications With Concomitant Use With Central Nervous System Depressants
OPANA, like all opioid analgesics, should be started at one-third to one-half of the usual dose in patients who are concurrently receiving other central nervous system (CNS) depressants including sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers, and alcohol, because respiratory depression, hypotension and profound sedation, coma or death may result [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS]. When combined therapy with any of the above medications is considered, the dose of one or both agents should be reduced.
Titration And Maintenance Of Therapy
Individually titrate OPANA to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving OPANA to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see WARNINGS AND PRECAUTIONS]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.
If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the OPANA dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
Discontinuation Of OPANA
When a patient who has been taking OPANA regularly and may be physically dependent no longer requires therapy with OPANA, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue OPANA in a physically-dependent patient [see WARNINGS AND PRECAUTIONS, Drug Abuse and Dependence].
Dosage Forms And Strengths
Tablets 5 mg: blue, round, convex tablet debossed with E612 over 5 on one side and plain on the other.
Tablets 10 mg: red, round, convex tablet debossed with E613 over 10 on one side and plain on the other.
Storage And Handling
OPANA (oxymorphone hydrochloride) tablets are supplied as follows:
5 mg Tablet
Blue, round, convex tablets debossed with E612 over 5 on one side and plain on the other.
Bottles of 100 tablets with child-resistant closure NDC
Unit-Dose package of 100 tablets (5 blister cards of 20 tablets, not child-resistant, for hospital use only) NDC 63481-612-75
10 mg Tablet
Red, round, convex tablets debossed with E613 over 10 on one side and plain on the other.
Bottles of 100 tablets with child-resistant closure NDC
Unit-Dose package of 100 tablets (5 blister cards of 20tablets, not child-resistant, for hospital use only) NDC 63481-613-75
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].
Dispense in tight container as defined in the USP, with a child-resistant closure (as required).
Distributed by: Endo Pharmaceuticals Inc., Malvern, PA 19355. Revised: Dec 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/3/2017
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