DOSAGE AND ADMINISTRATION
OPANA is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine and other opioids.
OPANA, like morphine and other opioids used in analgesia, can be abused and is subject to criminal diversion.
Selection of patients for treatment with OPANA 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 (see DOSAGE AND ADMINISTRATION), 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 Agency for Healthcare Research and Quality, and the American Pain Society.
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, 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.
The following dosing recommendations, 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.
OPANA should be administered on an empty stomach, at least one hour prior to or two hours after eating (see PHARMACOKINETICS: Food Effect).
Initiation of Therapy
Patients who have not been receiving opioid analgesics should be started on OPANA 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, patients may be started with OPANA 5 mg. The dose should be titrated based upon the individual patient’s response to their 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 of therapy with doses higher than 20 mg is not recommended because of potential serious side effects (see Clinical Trials: Orthopedic Surgery ).
Conversion from Parenteral Oxymorphone to OPANA
Given the 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 10/4). For example, approximately 10 mg of OPANA may be required to provide pain relief equivalent to a total daily IM dose of 4 mg oxymorphone. The dose can be titrated to optimal pain relief or combined with acetaminophen/NSAIDs for optimal pain relief. 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
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 the 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.
Individualization of Dose
Once therapy is initiated, pain relief and other opioid effects should be frequently assessed. Patients should be titrated to adequate pain relief (generally mild or no pain). Patients who experience breakthrough pain may require dosage adjustment or non-opioid therapy such as acetaminophen or NSAIDs.
If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. Dose adjustments should be made 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 under control, upward titration should continue 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. Patients and family members should be advised of the potential common side effects to decrease fear of the use of opioids and promote their optimal use.
Patients with Hepatic Impairment
OPANA is contraindicated in patients with moderate and severe hepatic dysfunction. OPANA should be used with caution in patients with mild hepatic impairment. These patients with mild hepatic impairment should be started with the lowest dose and titrated slowly while carefully monitoring side effects (see CLINICAL PHARMACOLOGY , CONTRAINDICATIONS , and PRECAUTIONS).
Patients with Renal Impairment
There are 57% and 65% increases in oxymorphone bioavailability in patients with moderate to severe renal impairment, respectively, treated with OPANA ER (see CLINICAL PHARMACOLOGY and PRECAUTIONS). Accordingly, OPANA should be administered cautiously and in reduced dosages to patients with creatinine clearance rate less than 50 mL/min.
Use with CNS depressants
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 central nervous system depressants including sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers, and alcohol, because respiratory depression, hypotension and profound sedation or coma may result. No specific interaction between oxymorphone and monoamine oxidase inhibitors has been observed, but caution in the use of any opioid in patients taking this class of drugs is appropriate (see PRECAUTIONS: General and PRECAUTIONS: Drug-Drug Interactions).
Caution should be exercised in the selection of the starting dose of OPANA for an elderly patient starting at the low end of the dosing range.
Maintenance of Therapy
OPANA is intended as an opioid analgesic for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. During therapy, continual re-evaluation of the patient receiving OPANA 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 and/or using adjuvant analgesics such as acetaminophen or NSAIDs.
Cessation of Therapy
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.
SAFETY AND HANDLING
OPANA contains oxymorphone, which is a controlled substance. Oxymorphone is controlled under Schedule II of the Controlled Substances Act. Oxymorphone, like all opioids, is liable to diversion and misuse and should be handled accordingly. Patients and their families should be instructed to flush any OPANA tablets that are no longer needed.
OPANA 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.
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).