It is indicated for the relief of moderate to severe pain. It is also indicated for preoperative medication, for support of anesthesia, for obstetrical analgesia, and for relief of anxiety in patients with dyspnea associated with pulmonary edema secondary to acute left ventricular dysfunction.
Oxymorphone is an opioid agonist whose principal therapeutic action is analgesia. Like all pure opioid agonist
analgesics, with increasing doses there is increasing analgesia, unlike with mixed agonist/antagonists or non opioid analgesics, where there is a limit to the analgesic effect with increasing doses. With pure opioid agonist analgesics, there is no defined maximum dose. Administered parenterally, 1 mg of Oxymorphone Hydrochloride injection is approximately equivalent in analgesic activity to 10 mg of Morphine sulfate.
Oxymorphone Tablet: This may be used as needed in the treatment of acute post-surgical pain with a dose of 5-10 mg every 4 hours. Administer Oxymorphone Tablet on an empty stomach at least one hour prior to or two hours after eating. Oxymorphone Injection: Subcutaneous or Intramuscular Administration: Initially 1 mg to 1.5 mg, repeated every 4 to 6 hours as needed. Intravenous: 0.5 mg initially. For analgesia during labor 0.5 mg to 1 mg intramuscularly is recommended. Conversion from Oral Oxymorphone to Oxymorphone Injection: Given the absolute oral bioavailability of approximately 10%, patients receiving oral Oxymorphone may be converted to Oxymorphone Hydrochloride injection by administering one-tenth the patient's total daily oral Oxymorphone dose as Oxymorphone Hydrochloride injectable in four or six equally divided doses (e.g., total daily oral dose/ [10X4]). For example, approximately 1 mg of Oxymorphone Hydrochloride injectable IM every 6 hours (4 mg total IM dose) may be required to provide pain relief equivalent to a total daily dose of 40 mg oral Oxymorphone.
Clinical drug interaction studies with Oxymorphone showed no induction of CYP450 3A4 or 2C9 enzyme activity indicating that no dose adjustment for CYP 3A4 or 2C9 mediated drug-drug interactions is required.
Significant respiratory depression Acute or severe bronchial asthma or hypercarbia Known or suspected paralytic ileus Moderate and severe hepatic impairment
Nausea, constipation, dizziness, somnolence, vomiting, pruritus, headache, sweating increased, dry mouth, sedation, diarrhea, insomnia, fatigue, appetite decreased, and abdominal pain
? Pregnancy: Based on animal data, may cause fetal harm. ? Nursing mothers: Closely monitor infants of nursing women receiving it
Acute overdosage with oxymorphone is manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal
muscle flaccidity, cold and clammy skin, constricted pupils, and, sometimes, pulmonary edema, bradycardia, hypotension, and death.
Marked mydriasis rather than miosis may be seen due to severe hypoxia in overdose situations.
Tablet: Store in a cool and dry place, protect from light.
Injection: Store at 25°C, protect from light.