"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
OPANA (oxymorphone hydrochloride) is indicated for the relief of moderate to severe acute pain where the use of an opioid is appropriate.
DOSAGE AND ADMINISTRATION
Selection of patients for treatment with OPANA (oxymorphone hydrochloride) should be governed by the same principles that apply to the use of similar opioid analgesics [see INDICATIONS AND USAGE]. Physicians should individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis, combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.
Individualization of Dosage
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. In the selection of the initial dose of OPANA (oxymorphone hydrochloride) , 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 analgesics and other medications;
- The type and severity of the patient's pain;
- The balance between pain control and adverse experiences;
- Risk factors for abuse or addiction, including a prior history of abuse or addiction.
Once therapy is initiated, frequently assess pain relief and other opioid effects. Titrate dose to adequate pain relief (generally mild or no pain). Patients who experience breakthrough pain may require dosage adjustment.
If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. Adjust dosing to obtain an appropriate balance between pain relief and opioid-related adverse experiences. If significant adverse events occur before the therapeutic goal of mild or no pain is achieved, the events should be treated aggressively. Once adverse events are adequately managed, continue upward titration to an acceptable level of pain control.
During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient, and the caregiver/family. Advise patients and family members of the potential common adverse reactions associated with changing opioid doses.
The dosing recommendations below, therefore, can 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.
Initiation of Therapy
Titrate dose to adequate pain relief (generally mild or no pain).
Patients who have not been receiving opioid analgesics should be started on OPANA (oxymorphone hydrochloride) in a dosing range of 10 to 20 mg every four to six hours depending on the initial pain intensity. If deemed necessary to initiate therapy at a lower dose (e.g., for renal or hepatic impairment or for geriatric patients), patients may be started with OPANA (oxymorphone hydrochloride) 5 mg. The dose should be titrated based upon the individual patient's response to their initial dose of OPANA (oxymorphone hydrochloride) . This dose can then be adjusted to an acceptable level of analgesia taking into account the pain intensity and adverse reactions experienced by the patient.
Initiation of therapy with doses higher than 20 mg is not recommended because of potential serious adverse reactions [see Clinical Studies].
Conversion from Parenteral Oxymorphone to OPANA (oxymorphone hydrochloride)
Given OPANA (oxymorphone hydrochloride) 's absolute oral bioavailability of approximately 10%, patients receiving parenteral oxymorphone may be converted to OPANA (oxymorphone hydrochloride) by administering 10 times the patient's total daily parenteral oxymorphone dose as OPANA (oxymorphone hydrochloride) , 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 (oxymorphone hydrochloride) 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 Other Oral Opioids to OPANA (oxymorphone hydrochloride)
For conversion from other opioids to OPANA (oxymorphone hydrochloride) , 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 (oxymorphone hydrochloride) therapy by administering half of the calculated total daily dose of OPANA (oxymorphone hydrochloride) in 4 to 6 equally divided doses, every 4-6 hours. The initial dose of OPANA (oxymorphone hydrochloride) can be gradually adjusted until adequate pain relief and acceptable side effects have been achieved.
Maintenance of Therapy
During therapy, continual re-evaluation of the patient receiving OPANA (oxymorphone hydrochloride) is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose.
Cessation of Therapy
When the patient no longer requires therapy with OPANA (oxymorphone hydrochloride) , doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient [see Drug Abuse and Dependence].
Patients with Hepatic Impairment
OPANA (oxymorphone hydrochloride) is contraindicated in patients with moderate or severe hepatic impairment. Use OPANA (oxymorphone hydrochloride) with caution in patients with mild hepatic impairment, starting with the lowest dose (e.g., 5 mg) and titrating slowly while carefully monitoring side effects [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].
Patients with Renal Impairment
There are 57% and 65% increases in oxymorphone bioavailability in patients with moderate and severe renal impairment, respectively; treated with extended-release oxymorphone tablets [see CLINICAL PHARMACOLOGY]. Accordingly, OPANA (oxymorphone hydrochloride) should be administered cautiously and in reduced dosages to patients with creatinine clearance rates less than 50 mL/min.
Use with Central Nervous System Depressants
OPANA (oxymorphone hydrochloride) , like all opioid analgesics, should be started at 1/3 to ½ 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.
Although no specific interaction between oxymorphone and monoamine oxidase inhibitors has been observed, OPANA (oxymorphone hydrochloride) is not recommended for use in patients who have received MAO inhibitors within 14 days [see DRUG INTERACTIONS].
Exercise caution in the selection of the starting dose of OPANA (oxymorphone hydrochloride) for an elderly patient by starting at the low end of the dosing range (e.g., 5 mg) [see Use in Specific Populations].
Dosage Forms And Strengths
The 5 mg dosage form is a blue, round, convex tablet debossed with E612 over 5 on one side and plain on the other.
The 10 mg dosage form is a 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 63481-612-70
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 63481-613-70
Unit-Dose package of 100 tablets (5 blister cards of 20 tablets, not child-resistant, for hospital use only) NDC 63481-613-75
OPANA (oxymorphone hydrochloride) may be targeted for theft and diversion. Healthcare professionals should contact their State Medical Board, State Board of Pharmacy, or State Control Board for information on how to detect or prevent diversion of this product, and security requirements for storing and handling of OPANA (oxymorphone hydrochloride) .
Healthcare professionals should advise patients to store OPANA (oxymorphone hydrochloride) in a secure place, preferably locked and out of the reach of children and other non-caregivers.
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).
Advise patients to dispose of any unused tablets from a prescription by flushing them down the toilet as soon as they are no longer needed [see PATIENT INFORMATION].
Manufactured for: Endo Pharmaceuticals Inc., Chadds Ford, PA 19317. Manufactured by: Novartis Consumer Health Inc., Lincoln, NE 68517. 2006854. Rev: January 2011This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/28/2011
Additional Opana Information
Opana - User Reviews
Opana User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.