This dosage information may not include all the information needed to use Oxymorphone safely and effectively. See additional information for Oxymorphone.
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Pain
Subcutaneous or intramuscular: 1 mg to 1.5 mg repeated every 4 to 6 hours as needed.
Intravenous: 0.5 mg as an initial dose. In non-debilitated patients the dose can be cautiously increased until satisfactory pain relief is obtained.
Rectal: one suppository (5 mg) every 4 to 6 hours. In non-debilitated patients the dose can be cautiously increased until satisfactory pain relief is obtained.
Oral Immediate Release Tablets (Opana [R]):
Initiation of Therapy for Patients Who Are Not Opioid-Experienced:
Patients who have not been receiving opioid analgesics should be started on Opana (R) 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 (R) 5 mg. The dose should be titrated based upon the individual patient response to their initial dose of Opana (R). 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.
Conversion from Parenteral Oxymorphone to Opana (R):
Given the absolute oral bioavailability of approximately 10%, patients receiving parenteral oxymorphone may be converted to Opana (R) by administering 10 times the patient's total daily parenteral oxymorphone dose as Opana, in four or six equally divided doses. 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.
Oral Extended Release Tablets (Opana ER [R]) :
Initiation of Therapy for Patients Who Are Not Opioid-Experienced:
Chronic around-the-clock opioid therapy may be started with Opana ER (R) 5 mg every 12 hours. Thereafter, it is recommended that the dose be individually titrated, preferably at increments of 5 to 10 mg every 12 hours every 3 to 7 days, to a level that provides adequate analgesia and minimizes side effects under the close supervision of the prescribing physician.
Initiation of Therapy for Opioid-Experienced Patients:
(Conversion from Opana [R] to Opana ER [R])
Patients receiving Opana (R) may be converted to Opana ER (R) by administering half the patient's total daily oral Opana (R) dose as Opana ER (R), every 12 hours.
Conversion from Parenteral Oxymorphone to Opana ER (R):
Given the absolute oral bioavailability of approximately 10%, patients receiving parenteral oxymorphone may be converted to Opana ER (R) by administering 10 times the patient's total daily parenteral oxymorphone dose as Opana ER (R) in two equally divided doses. For example, approximately 20 mg of Opana ER (R), every 12 hours, may be required to provide pain relief equivalent to a total daily dose of 4 mg of parenteral oxymorphone. Due to patient variability with regards to opioid analgesic response, upon conversion patients should be closely monitored to ensure adequate analgesia and to minimize side effects.
Opana ER (R) should be administered on an empty stomach, at least one hour prior to or two hours after eating.
Usual Adult Dose for Labor Pain
During labor: 0.5 mg to 1.0 mg intramuscularly
Renal Dose Adjustments
CrCl less than 50 mL/min: Both Opana (R) and Opana ER (R) should be started with the lowest dose and titrated slowly while carefully monitoring side effects.
Liver Dose Adjustments
Both Opana (R) and Opana ER (R) are contraindicated in patients with moderate and severe hepatic dysfunction. Patients with mild hepatic impairment should be started with the lowest dose and titrated slowly while carefully monitoring side effects.
Factors such as age, disease state, concomitant drug therapy, and tolerance to narcotics can have variable but important effects on dose and response.
Opana ER (R) Tablets: Symmetric (same dose AM and PM), around-the-clock, every 12 hours dosing is appropriate for the majority of patients. However, some patients may benefit from asymmetric (different dose given in AM than in PM) dosing, tailored to their pain pattern.
When a physically dependent patient no longer requires therapy for pain relief, doses should be tapered gradually to prevent signs and symptoms of withdrawal.
Oxymorphone, particularly in large doses or when administered by parenteral routes, may cause life-threatening respiratory depression. Treatment includes maintenance of the airway, artificial ventilation if necessary, and the opiate antagonist, naloxone (the usual adult dose of naloxone is 1 to 2 mg every 5 minutes as necessary). This dose can be administered intravenously, intramuscularly, subcutaneously and sublingually.)
Oxymorphone, like other narcotic analgesics, should be administered with caution to patients with head injuries, increased intracranial pressure, acute undiagnosed abdominal pain, hypothyroidism, severe renal disease, severe liver disease, Addison's disease, prostatic hyperplasia, urethral stricture, and general debilitation. Even small doses of oxymorphone may jeopardize cerebral circulation in the postoperative period following craniotomy.
Opana ER (R) tablets are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed. Taking broken, chewed, dissolved, or crushed Opana ER (R) tablets leads to rapid release and absorption of a potentially fatal dose of oxymorphone.
Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).
Data not available
The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting opioid analgesics. The REMS consists of a medication guide and elements to assure safe use. Additional information is available at www.fda.gov/Drugs/DrugSafety/postmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm.
Opana ER (R) Tablets: It is usually appropriate to treat a patient with only one extended-release opioid for around-the-clock therapy.
Selection of patients for treatment with Opana ER (R) tablets should be governed by the same principles that apply to the use of other extended-release opioid analgesics. 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, as needed 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.
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