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oxymorphone (Rx)Brand and Other Names:Opana, Opana ER

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution: Schedule II

  • 1mg/mL

tablet: Schedule II

  • 5mg
  • 10mg

tablet, extended release: Schedule II

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

tablet, extended release: abuse deterrent Schedule II

  • 5mg
  • 7.5mg
  • 10mg
  • 15mg
  • 20mg
  • 30mg
  • 40mg
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Preoperative Anesthesia/Analgesia

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

Moderate-to-Severe Pain

Acute pain

  • 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

Opioid-tolerant definition

  • 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

Dosing limitations

  • 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

Dosing Modifications

Renal impairment

  • CrCl <50 mL/min: Initiate therapy at lowest dose; titrate to effect slowly; monitor

Hepatic impairment

  • Mild: Initiate therapy at lowest dose; titrate to effect slowly; monitor
  • Moderate to severe: Do not administer

Administration

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

Not recommended

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Interactions

Interaction Checker

oxymorphone and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Dizziness (7-18%)

            Headache (7-12%)

            Fever (1-14%)

            Somnolence (9-19%)

            Pruritus (8-15%)

            Nausea (19-33%)

            Vomiting (9-16%)

            Constipation (4-28%)

            Agitation 

            Angina pectoris

            Anticholinergic effects (dry mouth, palpitation, tachycardia) 

            Bradycardia 

            Cardiac arrest 

            Coma 

            Constipation 

            1-10%

            Hypotension (<10%)

            Flushing (<10%)

            Hypertension (<10%)

            Edema (<10%)

            Sedation (1-10%)

            Nervousness (<10%)

            Insomnia (<4%)

            Confusion (3%)

            Depression (<10%)

            Disorientation (<10%)

            Lethargy (<10%)

            Dehydration (<10%)

            Flatulence (1-10%)

            Dyspepsia (<10%)

            Diarrhea (<4%)

            Decreased appetite (<3%)

            Hypoxia (<10%)

            Dyspnea (<10%)

            Diaphoresis (1-10%)

            <1%

            Agitation

            Dermatitis

            Bronchospasm

            Miosis

            Oliguria

            Bradycardia

            Apnea

            M:icturition difficulty

            Palpitation

            Euphoric mood

            Urethral spasm

            Urinary retention

            Physical and psychological dependence

            Hot flashes

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            Warnings

            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 exposure

            • 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

            Contraindications

            Hypersensitivity

            Non-opioid-tolerant patient

            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)

            Cautions

            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

            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

            Long-acting opioids

            • 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
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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Unknown whether drug is excreted in breast milk; use caution

            Pregnancy Categories

            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.

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            Pharmacology

            Mechanism of Action

            Opioid agonist; inhibits ascending pain pathways, thus altering response to pain; produces analgesia, respiratory depression, and sedation  

            Absorption

            Bioavailability: 10% (PO)

            Onset: 5-10 min

            Duration: 3-6 hr

            Distribution

            Protein bound: 10-12%

            Vd: IV, 1.94-4.22 L/kg

            Metabolism

            Metabolized in liver via conjugation

            Elimination

            Half-life: Immediate release, 7-9 hr; extended release, 9-11 hr

            Excretion: Urine, feces

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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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