Description

Tablet is indicated for treatment of moderate to severe pain like chronic cancer, arthritis, postoperative & low back pain. Injection is indicated for the relief of moderate to severe pain. It is also indicated for pre-operative & post-operative 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.

Significant respiratory depression Acute or severe bronchial asthma or hypercarbia Known or suspected paralytic ileus Moderate and severe hepatic impairment Hypersensitivity (e.g. anaphylaxis) to oxymorphone

General Disorders: Respiratory depression, Fatigue, Asthenia. Metabolism and Nutrition Disorders: Anorexia. Cardiac Disorders: Tachycardia, Bradycardia, Palpitations. Eye Disorders: Miosis, Diplopia, Blurred vision. Gastrointestinal Disorders: Vomiting, Constipation. Psychiatric Disorders: Dysphoria, Euphoric mood, Nervousness, Restlessness, Insomnia, Agitation, Hallucination, Depression. Vascular Disorders: Hypotension & Flushing.

Pregnancy Category C. The safety of using Oxymorphone in pregnancy has not been established with regard to possible adverse effects on fetal development. The use of Oxymorphone in pregnancy, in nursing mothers, or in women of child-bearing potential requires that the possible benefits of the drug be weighed against the possible hazards to the mother and the child.

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, cor pulmonale, chronic pulmonary disease, emphysema, kyphoscoliosis, severe obesity, renal or hepatic impairment, elderly or debilitated patients. 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, life-threatening, or fatal respiratory depression may occur Monitor for respiratory depression, especially during initiation or following a dose increase

Pediatric use: Safety and effectiveness of Oxymorphone Hydrochloride tablet and injection in pediatric patients below the age of 18 years have not been established. Geriatric use: Oxymorphone Hydrochloride tablet and injection should be used with caution in elderly patients. These adverse events included dizziness, somnolence, confusion and nausea.

Signs and Symptoms: Acute overdosage with Oxymorphone 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 Oxymorphone overdosage, primary attention should be given to the re-establishment of a patient airway and institution of assisted or controlled ventilation. Supportive measures (including oxygen and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. The opioid antagonist naloxone hydrochloride is a specific antidote against respiratory depression that may result from overdosage or unusual sensitivity to opioids including Oxymorphone