Oxymorphone

DEA Class; Rx

Common Brand Names; Opana

  • Opioid Analgesics; 

Semi-synthetic opiate agonist
Used for the relief of moderate to severe acute and chronic pain
Available in multiple formulations

Indicated for the treatment of severe pain.

For the 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 in an unmonitored setting or in the absence of resuscitative equipment

Known or suspected GI obstruction, including paralytic ileus

Hypersensitivity

Moderate-to-severe hepatic impairment

  • Nausea (19%)
  • Pyrexia (14%)
  • Somnolence (9%)
  • Vomiting (9%)
  • Pruritus (8%)
  • Headache (7%)
  • Dizziness (7%)
  • Constipation (4%)
  • Confusion (3%)
  • Cardiac disorders: tachycardia
  • Gastrointestinal disorders: dry mouth, abdominal distention, and flatulence
  • General disorders and administration site conditions: sweating increased
  • Nervous system disorders: anxiety and sedation
  • Respiratory, thoracic and mediastinal disorders: hypoxia
  • Vascular disorders: hypotension
  • Abdominal pain
  • Ileus
  • Diarrhea
  • Agitation
  • Disorientation
  • Restlessness
  • Feeling jittery
  • Hypersensitivity
  • Allergic reactions
  • Bradycardia
  • CNS depression
  • Depressed level of consciousness
  • Lethargy
  • Mental impairment
  • Mental status changes
  • Fatigue
  • Depression
  • Clamminess
  • Flushing
  • Hot flashes
  • Dehydration

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 (GI) disorder, pseudomembranous colitis, GI 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

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

Therapy may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients; there is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (eg, phenothiazines or general anesthetics); monitor patients for signs of hypotension after initiating or titrating dosage; in patients with circulatory shock, therapy may cause vasodilation that can further reduce cardiac output and blood pressure; avoid therapy in patients with circulatory shock

In patients who may be susceptible to intracranial effects of CO2 retention (eg, those with evidence of increased intracranial pressure or brain tumors), therapy may reduce respiratory drive, and resultant CO2 retention can further increase intracranial pressure; monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy; opioids may obscure clinical course in a patient with a head injury; avoid the use in patients with impaired consciousness or coma

Contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus; may cause spasm of sphincter of Oddi; opioids may cause increases in serum amylase; monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms

Pregnancy

Prolonged use during pregnancy may cause neonatal opioid withdrawal syndrome (see Black Box Warnings)

Lactation

Oxycodone is present in breast milk; because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, breastfeeding is not recommended during treatment with oxycodone/naltrexone

Adults

With appropriate dosage titration, there is no maximum dose of oxymorphone.

Geriatric

With appropriate dosage titration, there is no maximum dose of oxymorphone.

Adolescents

Safety and efficacy have not been established.

Children

Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Oxymorphone hydrochloride

tablet, immediate-release: Schedule II

  • 5mg
  • 10mg

tablet, extended-release: Schedule II

  • 5mg
  • 7.5mg
  • 10mg
  • 15mg
  • 20mg
  • 30mg
  • 40mg

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