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Oxymorphone, sold under the brand names Numorphan and Opana among others, is an opioid pain medication. Oxymorphone is used to relieve moderate to severe pain in people whose pain is not controlled with other medications.

Indications

Tablet is indicated for treatment of moderate to severe pain like chronic cancer, arthritis, postoperative & low back pain.

Therapeutic Class: Opioid analgesics

Pharmacology

Oxymorphone is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of oxymorphone is analgesia.

Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression.

The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.

Dosage & Administration

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.

Interaction

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.

Contraindications: Significant respiratory depression, Acute or severe bronchial asthma or hypercarbia, Known or suspected paralytic ileus, Moderate and severe hepatic impairment

Side Effects

General Disorders: Respiratory depression, Fatigue, Asthenia.
Metabolism and Nutrition Disorders: Anorexia.
Cardiac Disorders: Tachycardia, Bradycardia, Palpitations.

Gastrointestinal Disorders: Vomiting, Constipation.
Psychiatric Disorders: Dysphoria, Euphoric mood, Nervousness, Restlessness, Insomnia, Agitation, Hallucination, Depression

Pregnancy & Lactation

Pregnancy Category C. The safety of using Oxymorphone / Opana in pregnancy has not been established with regard to possible adverse effects on fetal development.

Precautions & Warnings

Do not stop abruptly; taper gradually to stop treatment. Use caution in patients with acute pancreatitis, Addison disease, benign prostatic hyperplasia, cardiac arrhythmias, central nervous system (CNS) depression, drug abuse or dependence, emotional lability, gallbladder disease,

gastrointestinal (Gl) disorder, pseudomembranous colitis, Gl surgery, head injury, hypothyroidism or untreated myxedema, intracranial hypertension, brain tumor, toxic psychosis, urethral stricture, urinary tract surgery, seizures, acute alcoholism, delirium tremens, shock

Avoid alcohol. Reduce dosage if drug is coadministered with other CNS depressants. Thrombocytopenia purpura resulting in kidney failure or death has been reported when extended-release tablets are dissolved and injected IV. May obscure diagnosis of abdominal conditions.

Risk of opioid addiction, abuse, and misuse, which can lead to overdose and death Assess each patient’s risk prior to prescribing and monitor all patients regularly for the development of these behaviors or conditions Life-threatening respiratory depression may occur.

Monitor for respiratory depression, especially during initiation or following a dose increase

Use in Special Populations

Pediatric use: Safety and effectiveness of opana tablet and injection in pediatric patients below the age of 18 years have not been established.

Geriatric use: opana tablet and injection should be used with caution in elderly patients. These adverse events included dizziness, somnolence, confusion and nausea.

Overdose Effects

Signs and Symptoms: Acute overdosage with Opana is characterized by respiratory depression, extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils and sometimes bradycardia and hypotension.

Treatment: In the treatment of Opana overdosage, primary attention should be given to the re-establishment of a patient airway and institution of assisted or controlled ventilation.

Storage Conditions

Store in a cool and dry place, protect from light.