Oxymorphone Tablets are indicated for the management of moderate to severe pain, including chronic cancer pain, arthritis, postoperative pain, and lower back pain.

Oxymorphone Injection is indicated for the relief of moderate to severe pain. It is also used as a preoperative and postoperative medication to support anesthesia, for pain relief during labor (obstetrical analgesia), and for relieving anxiety in patients experiencing shortness of breath due to pulmonary edema caused by acute left ventricular dysfunction.

Oxymorphone is a pure opioid agonist that produces its primary therapeutic effect through analgesia. Like other pure opioid agonists, increasing the dose results in increased pain relief, without a defined maximum analgesic limit, unlike mixed agonist-antagonists or non-opioid analgesics. When administered parenterally, 1 mg of Oxymorphone Hydrochloride is approximately equivalent in analgesic effect 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. As with any opioid product, it is necessary to adjust the dosing regimen for each patient individually taking into account the patient's prior analgesic treatment experience.

Clinical studies have shown that Oxymorphone does not induce CYP450 3A4 or 2C9 enzyme activity. Therefore, dose adjustment is generally not required for drug interactions mediated by these enzymes.

Oxymorphone Hydrochloride tablets and injections are contraindicated in patients with known hypersensitivity to oxymorphone, its components, or other morphine-like drugs such as codeine. It is also contraindicated in patients with respiratory depression, acute or severe bronchial asthma, paralytic ileus, or moderate to severe hepatic impairment.

General: Respiratory depression, fatigue, weakness.
Metabolic: Loss of appetite (anorexia).
Cardiac: Rapid or slow heart rate, palpitations.
Eye: Pupil constriction, double vision, blurred vision.
Gastrointestinal: Vomiting, constipation.
Psychiatric: Mood changes (euphoria/dysphoria), nervousness, restlessness, insomnia, agitation, hallucinations, depression.
Vascular: Low blood pressure, flushing.

Pregnancy Category C. The safety of oxymorphone during pregnancy has not been established. It should only be used if the potential benefits outweigh the risks to the fetus. Use in breastfeeding mothers or women of childbearing age requires careful consideration of risks and benefits.

Opioid analgesics should be administered cautiously, particularly when used in combination with other medications. Oxymorphone requires careful use in elderly or debilitated individuals and in patients who are sensitive to central nervous system (CNS) depressants, including those with cardiovascular, pulmonary, renal, or hepatic disorders. It should also be used cautiously in conditions such as acute alcoholism, coma, and delirium tremens. Extreme caution is necessary when administering Oxymorphone to patients with conditions associated with reduced oxygenation or respiratory capacity, such as hypoxia, hypercapnia, asthma, chronic obstructive pulmonary disease (COPD), severe obesity, sleep apnea syndrome, myxedema, kyphoscoliosis, CNS depression, or coma. As with all opioid analgesics, Oxymorphone should be initiated at one-third to one-half of the usual dose in patients receiving other CNS depressants (e.g., sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, or alcohol), due to the increased risk of respiratory depression, hypotension, profound sedation, coma, or death. In patients with mild hepatic impairment, Oxymorphone should be started at the lowest possible dose (e.g., 5 mg). Plasma concentrations of extended-release Oxymorphone are approximately 40% higher in elderly patients (≥65 years), so a starting dose of 5 mg is recommended. Similarly, bioavailability increases by about 57% and 65% in patients with moderate and severe renal impairment, respectively; therefore, these patients should also begin treatment at 5 mg. Caution is also advised in patients with adrenocortical insufficiency (e.g., Addison’s disease), prostatic hypertrophy, urethral stricture, severe pulmonary or renal dysfunction, and toxic psychosis. Opioid analgesics can impair mental and physical abilities required for activities such as driving or operating machinery.

Dependence: Oxymorphone should not be stopped abruptly. When discontinuing therapy, the dose should be gradually tapered to prevent withdrawal symptoms in physically dependent patients.

Pediatric Use: Safety and effectiveness in patients under 18 years have not been established.
Geriatric Use: Use cautiously in elderly patients due to increased risk of side effects such as dizziness, drowsiness, confusion, and nausea.

Opioid analgesic

Tablet: Store in a cool, dry place and protect from light.
Injection: Store at 25°C and protect from light.