Brand and Other Names:Opana, Opana ER
- Classes: Opioid Analgesics
Dosing & Uses
Dosage Forms & Strengths
injectable solution: Schedule II
tablet: Schedule II
tablet, extended release: Schedule II
tablet, extended release: abuse deterrent Schedule II
Also effective for relief of anxiety in patients with dyspnea associated with pulmonary edema secondary to acute left ventricular dysfunction
1-1.5 mg IM/SC q4-6hr PRN
Analgesia during labor: 0.5-1 mg IM
IV: 0.5 mg, increased PRN
- Immediate-release tablets indicated for acute moderate-to-severe pain where opioid use is appropriate
- Opioid-naive patients (immediate-release): 10-20 mg PO q4-6 hr PRN initially, then titrated as warranted (may start with 5-mg increments)
- Conversion from IV oxymorphone to PO: The absolute bioavailability of PO is ~10%, therefore conversion from 1 mg IV q4-6hr is equipotent to 10 mg PO q4-6hr
- Elderly patients or those with renal or hepatic impairment: 5 mg PO q4-6hr initially
Chronic Severe Pain
Extended-release is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate
Opioid-naive patients (extended-release): 5 mg PO q12hr initially, then titrated in increments of 5-10 mg q12hr every 3-7 days to level that provides adequate analgesia and minimizes side effects
Conversion from IV oxymorphone to extended-release PO: The absolute oral bioavailability of Opana ER is ~10%, therefore convertion from 1 mg IV q6hr (4 mg/day) is equipotent to 20 mg PO q12hr (40 mg/day)
Conversion from PO opioids to Opana ER: See prescribing information
- Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression
- Patients who are opioid tolerant are those receiving, for 1 week or longer, at least 60 mg/day PO morphine, 25 mcg/hr transdermal fentanyl, 30 mg/day PO oxycodone, 8 mg/day PO hydromorphone, 25 mg/day PO oxymorphone, or an equianalgesic dose of another opioid
- Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve for patients whom alternative treatment options (eg, nonopioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain
- Not indicated as a PRN analgesic
- CrCl <50 mL/min: Initiate therapy at lowest dose; titrate to effect slowly; monitor
- Mild: Initiate therapy at lowest dose; titrate to effect slowly; monitor
- Moderate to severe: Do not administer
Do not stop abruptly; taper gradually to stop treatment
Extended-release tablets must be taken on empty stomach (ie, at least 1 hour before or 2 hours after eating)
Opana ER tablets are designed to be crush-resistant; must not be broken, chewed, dissolved, or crushed; too-rapid release and absorption may potentially cause fatal overdose
Serious - Use Alternative
Significant - Monitor Closely
Anticholinergic effects (dry mouth, palpitation, tachycardia)
Decreased appetite (<3%)
Physical and psychological dependence
Black Box Warnings
Addiction, abuse, and misuse *
- 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
- Serious, life-threatening, or fatal respiratory depression may occur
- Monitor for respiratory depression, especially during initiation or following a dose increase
- Instruct patients to swallow tablet/capsule whole; crushing, chewing, or dissolving can cause rapid release and absorption of a potentially fatal dose
- Accidental of even 1 dose, especially by children, can result in a fatal overdose
Neonatal opioid withdrawal syndrome
- Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts
- Syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight
- Onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn
- If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available
Interaction with alcohol
- Instruct patients not to consume alcoholic beverages or use prescription or nonprescription products that contain alcohol
- Coingestion of alcohol may cause rapid release of opioid content from long-acting tablet/capsule and result in increased plasma levels and a potentially fatal overdose
Paralytic ileus, toxin-mediated diarrhea
Respiratory depression, acute or severe bronchial asthma, hypercapnia, upper airway obstruction
Treatment of pulmonary edema secondary to chemical respiratory irritant
Moderate-to-severe hepatic impairment (PO)
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
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
- Schedule II opioid analgesics expose users to the risks of addiction, abuse, and misuse; there is a greater risk for overdose and death with extended-release opioids due to the larger amount of active opioid present (see Black Box Warnings)
- Addiction, abuse, and misuse risks are increased in patients with a personal or family history of substance abuse or mental illness (eg, major depression); the potential for these risks should not, however, prevent the prescribing of proper pain management in any given patient; intensive monitoring is necessary (see Black Box Warnings)
- Serious, life-threatening, or fatal respiratory depression reported (see Black Box Warnings)
- Accidental exposure reported, including fatalities (see Black Box Warnings)
- Neonatal opioid withdrawal syndrome reported with long-term use during pregnancy (see Black Box Warnings)
- Interactions with CNS depressants (eg, alcohol, sedatives, anxiolytics, hypnotics, neuroleptics, other opioids) can cause additive effects and increase risk for respiratory depression, profound sedation, and hypotension
- Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients
Pregnancy & Lactation
Pregnancy category: C
Lactation: Unknown whether drug is excreted in breast milk; use caution
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Opioid agonist; inhibits ascending pain pathways, thus altering response to pain; produces analgesia, respiratory depression, and sedation
Bioavailability: 10% (PO)
Onset: 5-10 min
Duration: 3-6 hr
Protein bound: 10-12%
Vd: IV, 1.94-4.22 L/kg
Metabolized in liver via conjugation
Half-life: Immediate release, 7-9 hr; extended release, 9-11 hr
Excretion: Urine, feces
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