Classes
DEA Class; Rx
Common Brand Names; Opana
- Opioid Analgesics;
Description
Semi-synthetic opiate agonist
Used for the relief of moderate to severe acute and chronic pain
Available in multiple formulations
Indications
Indicated for the treatment of severe pain.
Contraindications
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
Adverse Effects
- 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
Warnings
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 and Lactation
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
Maximum Dosage
With appropriate dosage titration, there is no maximum dose of oxymorphone.
With appropriate dosage titration, there is no maximum dose of oxymorphone.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Oxymorphone hydrochloride
tablet, immediate-release: Schedule II
- 5mg
- 10mg
tablet, extended-release: Schedule II
- 5mg
- 7.5mg
- 10mg
- 15mg
- 20mg
- 30mg
- 40mg