(oks i MOR fone)
- Oxymorphone HCl
- Oxymorphone Hydrochloride
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Injection, as hydrochloride:
Opana: 1 mg/mL (1 mL)
Tablet, Oral, as hydrochloride:
Opana: 5 mg [contains fd&c blue #2 aluminum lake]
Opana: 10 mg [contains d&c red #30 aluminum lake]
Generic: 5 mg, 10 mg
Tablet ER 12 Hour Abuse-Deterrent, Oral, as hydrochloride:
Opana ER: 5 mg, 7.5 mg
Opana ER: 10 mg [contains fd&c yellow #6 (sunset yellow)]
Opana ER: 15 mg
Opana ER: 20 mg [contains brilliant blue fcf (fd&c blue #1), fd&c yellow #10 (quinoline yellow), fd&c yellow #6 (sunset yellow)]
Opana ER: 30 mg
Opana ER: 40 mg [contains fd&c yellow #10 (quinoline yellow), fd&c yellow #6 (sunset yellow)]
Tablet Extended Release 12 Hour, Oral, as hydrochloride:
Generic: 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg
Brand Names: U.S.
- Opana ER
- Analgesic, Opioid
Oxymorphone hydrochloride is a potent opioid analgesic with uses similar to those of morphine. The drug is a semisynthetic derivative of morphine (phenanthrene derivative) and is closely related to hydromorphone chemically (Dilaudid®).
Vd: IV: 1.94-4.22 L/kg
Hepatic via glucuronidation to active and inactive metabolites
Urine (<1% as unchanged drug); feces
Onset of Action
Parenteral: 5-10 minutes
Duration of Action
Analgesic: Parenteral: 3-6 hours
Oral: Immediate release: 7-9 hours; Extended release: 9-11 hours
10% to 12%
Special Populations: Renal Function Impairment
There is an increase of 26%, 57%, and 65% in bioavailability in patients with mild, moderate, and severe renal function impairment, respectively.
Special Populations: Hepatic Function Impairment
Bioavailability of orally administered oxymorphone may be markedly increased in patients with moderate to severe hepatic function impairment.
Special Populations: Elderly
On average, patients older than 65 years of age experience 1.4- and 1.5-fold increases in oxymorphone AUC and Cmax, respectively.
Special Populations: Gender
No differences in pharmacokinetics are observed between men and women when AUC and Cmax are adjusted for body weight.
Use: Labeled Indications
Parenteral: Management of moderate-to-severe acute pain; analgesia during labor; preoperative medication; anesthesia support; relief of anxiety in patients with dyspnea associated with pulmonary edema secondary to acute left ventricular failure
Oral, regular release: Management of moderate-to-severe acute pain
Oral, extended release: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate
Limitations of use: 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 ER opioid formulations, reserve oxymorphone ER for use in patients for whom alternative treatment options (eg, nonopioid analgesics, immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient pain management. Not indicated as an as-needed analgesic.
Hypersensitivity to oxymorphone, other morphine analogs (phenanthrene derivatives), or any component of the formulation; paralytic ileus (known or suspected); moderate-to-severe hepatic impairment; severe respiratory depression (unless using immediate release or parenteral formulation in monitored setting with resuscitative equipment); acute/severe bronchial asthma; hypercarbia
Note: Parenteral formulation is also contraindicated in the treatment of upper airway obstruction and pulmonary edema due to a chemical respiratory irritant.
Analgesia: Note: Dosage must be individualized.
IM, SubQ: Initial: 1 to 1.5 mg; may repeat every 4 to 6 hours as needed
Labor analgesia: IM: 0.5 to 1 mg
IV: Initial: 0.5 mg
Immediate release: Acute pain:
Opioid-naive: Initial: 5 to 10 mg every 4 to 6 hours as needed (American Pain Society [Miaskowski, 2008]). Dosage adjustment should be based on level of analgesia, side effects, pain intensity, and patient comorbidities.
Currently on stable dose of parenteral oxymorphone: Approximately 10 times the total daily parenteral requirement. The calculated total oral daily amount should be given in 4 to 6 equally divided doses.
Currently on other opioids: Use standard conversion chart to convert total daily dose of current opioid to oxymorphone equivalent. Generally start with one-half (1/2) the calculated total daily oxymorphone dosage and administer in divided doses every 4 to 6 hours.
Extended release: Chronic pain:
Opioid-naive (use as the first opioid analgesic or in patients who are not opioid tolerant): Initial: 5 mg every 12 hours.
Note: Opioid tolerance is defined as: Patients already taking at least 60 mg of oral morphine daily, 25 mcg of transdermal fentanyl per hour, 30 mg of oral oxycodone daily, 8 mg oral hydromorphone daily, 25 mg oral oxymorphone daily, or an equivalent dose of another opioid for at least 1 week.
Conversion from stable dose of parenteral oxymorphone to extended-release oxymorphone: Approximately 10 times the total daily parenteral requirement should be given in 2 divided doses as oxymorphone extended-release tablets (eg, [IV dose x 10] divided by 2). Due to patient variability, closely monitor patient for analgesia and adverse reactions upon conversion.
Conversion of stable dose of immediate-release oxymorphone to extended-release oxymorphone: Use same total daily dose. Administer one-half (1/2) of the daily dose of immediate-release oxymorphone as the extended-release formulation every 12 hours
Conversion from other oral opioids to extended-release oxymorphone: Discontinue all other around-the-clock opioids when extended release oxymorphone is initiated. Substantial interpatient variability exists in relative potency of opioids. Therefore, it is safer to underestimate a patient’s daily oral oxymorphone requirement and provide breakthrough pain relief with rescue medication (eg, immediate release opioid) than to overestimate requirements. The conversion factors, per the manufacturer, in the chart (see table) provide an estimate to convert the daily dose of current opioid to an oxymorphone equivalent. Select the prior oral opioid, sum the current total daily dose, multiply by the conversion factor on the table to calculate the approximate oral oxymorphone daily dose, then divide daily dose by 2 to administer every 12 hours as oxymorphone extended release. Round down, if necessary, to the nearest strength available. For patients on a regimen of more than one opioid, calculate the approximate oral oxymorphone dose for each opioid and sum the totals to obtain the approximate total oxymorphone daily dose. For patients on a regimen of fixed-ratio opioid/nonopioid analgesic medications, only the opioid component of these medications should be used in the conversion. Note: The conversion factors in this conversion table are only to be used for the conversion from current opioid therapy to oxymorphone ER. Conversion factors in this table cannot be used to convert from oxymorphone ER to another opioid (doing so may lead to fatal overdose due to overestimation of the new opioid). This is not a table of equianalgesic doses. When converting from methadone to extended release oxymorphone, close monitoring is required. Ratio between methadone and other opioid agonists varies widely according to previous dose exposure. Methadone has a long half-life and can accumulate in the plasma.
Prior Oral Opioid
Approximate Oral Conversion Factor
Conversion Factors to Oxymorphone ER
Prior oral opioid: Oxymorphone
Approximate oral conversion factor: 1
Prior oral opioid: Hydrocodone
Approximate oral conversion factor: 0.5
Prior oral opioid: Oxycodone
Approximate oral conversion factor: 0.5
Prior oral opioid: Methadone
Approximate oral conversion factor: 0.5
Prior oral opioid: Morphine
Approximate oral conversion factor: 0.333
Titration and maintenance: Adjust therapy incrementally by 5 to 10 mg every 12 hours at intervals of every 3 to 7 days. Breakthrough pain may require a dose increase or rescue medication with an immediate-release analgesic.
Discontinuation of therapy: Gradually titrate dose downward every 2 to 4 days to prevent withdrawal signs/symptoms. Do not abruptly discontinue.
Refer to adult dosing. Note: Initiate dosing at the lower end of the dosage range.
Dosing: Renal Impairment
CrCl <50 mL/minute: Reduce initial dosage of oral and parenteral formulations (bioavailability increased 57% to 65%). Begin therapy at lowest dose and titrate slowly with careful monitoring.
Dosing: Hepatic Impairment
Mild impairment: Initiate with lowest possible dose and titrate slowly with careful monitoring.
Moderate to severe impairment: Use is contraindicated.
Oral: Administer immediate release and extended release tablets 1 hour before or 2 hours after eating. ER tablet should be swallowed whole; do not break, crush, dissolve, or chew.
Immediate release and extended release tablets should be taken 1 hour before or 2 hours after eating.
Injection solution, tablet: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect injection from light.
Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Monitor therapy
Alvimopan: Analgesics (Opioid) may enhance the adverse/toxic effect of Alvimopan. This is most notable for patients receiving long-term (i.e., more than 7 days) opiates prior to alvimopan initiation. Management: Alvimopan is contraindicated in patients receiving therapeutic doses of opioids for more than 7 consecutive days immediately prior to alvimopan initiation. Consider therapy modification
Amphetamines: May enhance the analgesic effect of Analgesics (Opioid). Monitor therapy
Anticholinergic Agents: May enhance the adverse/toxic effect of Analgesics (Opioid). Specifically, the risk for constipation and urinary retention may be increased with this combination. Monitor therapy
Antipsychotic Agents (Phenothiazines): May enhance the hypotensive effect of Analgesics (Opioid). Monitor therapy
Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). Avoid combination
Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Consider therapy modification
Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Cannabis: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Monitor therapy
Desmopressin: Analgesics (Opioid) may enhance the adverse/toxic effect of Desmopressin. Monitor therapy
Dimethindene: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Diuretics: Analgesics (Opioid) may enhance the adverse/toxic effect of Diuretics. Analgesics (Opioid) may diminish the therapeutic effect of Diuretics. Monitor therapy
Doxylamine: May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended. Monitor therapy
Dronabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (e.g., opioids, barbiturates) with concomitant use. Consider therapy modification
Eluxadoline: Analgesics (Opioid) may enhance the constipating effect of Eluxadoline. Avoid combination
Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Consider therapy modification
HYDROcodone: CNS Depressants may enhance the CNS depressant effect of HYDROcodone. Management: Consider starting with a 20% to 30% lower hydrocodone dose when using together with any other CNS depressant. Dose reductions in the other CNS depressant may also be warranted. Consider therapy modification
HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Kava Kava: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy
Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
MAO Inhibitors: OxyMORphone may enhance the adverse/toxic effect of MAO Inhibitors. Avoid combination
Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Consider therapy modification
MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Monitor therapy
Minocycline: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Mirtazapine: CNS Depressants may enhance the CNS depressant effect of Mirtazapine. Monitor therapy
Mixed Agonist / Antagonist Opioids: May diminish the analgesic effect of Analgesics (Opioid). Management: Seek alternatives to mixed agonist/antagonist opioids in patients receiving pure opioid agonists, and monitor for symptoms of therapeutic failure/high dose requirements (or withdrawal in opioid-dependent patients) if patients receive these combinations. Avoid combination
Nabilone: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Nalmefene: May diminish the therapeutic effect of Analgesics (Opioid). Management: Avoid the concomitant use of nalmefene and opioid analgesics. Discontinue nalmefene 1 week prior to any anticipated use of opioid analgesics. If combined, larger doses of opioid analgesics will likely be required. Consider therapy modification
Naltrexone: May diminish the therapeutic effect of Analgesics (Opioid). Management: Seek therapeutic alternatives to opioids. See full drug interaction monograph for detailed recommendations. Consider therapy modification
Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Avoid combination
OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: When oxycodone is combined with another CNS depressant, a dose reduction of one or both agents should be considered. The extended release oxycodone starting dose should be reduced 50% to 67% when initiated in patients already receiving CNS depressants. Consider therapy modification
Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Avoid combination
Pegvisomant: Analgesics (Opioid) may diminish the therapeutic effect of Pegvisomant. Monitor therapy
Perampanel: May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. Consider therapy modification
Piribedil [INT]: CNS Depressants may enhance the CNS depressant effect of Piribedil [INT]. Monitor therapy
Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Monitor therapy
Ramosetron: Analgesics (Opioid) may enhance the constipating effect of Ramosetron. Monitor therapy
ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Monitor therapy
Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Monitor therapy
Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Monitor therapy
Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Monitor therapy
Serotonin Modulators: Analgesics (Opioid) may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Exceptions: Nicergoline. Monitor therapy
Sodium Oxybate: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to combined use. When combined use is needed, consider minimizing doses of one or more drugs. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated. Consider therapy modification
Succinylcholine: May enhance the bradycardic effect of Analgesics (Opioid). Monitor therapy
Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Consider therapy modification
Tapentadol: May enhance the CNS depressant effect of CNS Depressants. Management: Start tapentadol at a dose of one-third to one-half of the normal dose if being initiated in a patient who is taking another drug with CNS depressant effects. Monitor closely for evidence of excessive CNS depression. Consider therapy modification
Tetrahydrocannabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Avoid combination
Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Consider therapy modification
Some quinolones may produce a false-positive urine screening result for opioids using commercially-available immunoassay kits. This has been demonstrated most consistently for levofloxacin and ofloxacin, but other quinolones have shown cross-reactivity in certain assay kits. Confirmation of positive opioid screens by more specific methods should be considered. May cause elevation in amylase (due to constriction of the sphincter of Oddi).
Incidence usually on higher end with extended release (ER) tablet.
Central nervous system: Drowsiness (9% to 19%), dizziness (7% to 18%), headache (7% to 12%)
Dermatologic: Pruritus (8% to 15%)
Gastrointestinal: Nausea (19% to 33%), constipation (4% to 28%), vomiting (9% to 16%)
Miscellaneous: Fever (1% to 14%)
1% to 10%:
Cardiovascular: Edema (<10%), flushing (<10%), hypertension (<10%), hypotension (<10%), tachycardia (<10%)
Central nervous system: Depression (<10%), disorientation (<10%), lethargy (<10%), nervousness (<10%), restlessness (<10%), anxiety (1% to <10%), sedation (1% to <10%), fatigue (≤4%), insomnia (≤4%), confusion (3%)
Dermatologic: Diaphoresis (1% to <10%)
Endocrine & metabolic: Dehydration (<10%), weight loss (<10%)
Gastrointestinal: Abdominal distention (<10%), dyspepsia (<10%), flatulence (1% to <10%), xerostomia (1% to <10%), diarrhea (≤4%), abdominal pain (≤3%), decreased appetite (≤3%)
Neuromuscular & skeletal: Weakness (<10%)
Ophthalmic: Blurred vision (<10%)
Respiratory: Dyspnea (<10%), hypoxia (<10%)
<1% (Limited to important or life-threatening): Agitation, apnea (injection), atelectasis (injection), biliary colic, bradycardia, bronchospasm (injection), cold and clammy skin, dermatitis, difficulty in micturition, diplopia (injection), drug dependence, dysphoria, euphoria, hallucination, hot flash, hypersensitivity, hypersensitivity reaction, hypogonadism (Brennan, 2013; Debono, 2011), injection site reaction, intestinal obstruction, miosis, oliguria (injection), orthostatic hypotension, palpitations, respiratory depression, syncope, thrombotic thrombocytopenic purpura (inappropriate injection of ER tablet), ureteral spasm (injection), urinary retention, urticaria
Concerns related to adverse effects:
• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
• Constipation: May cause constipation which may be problematic in patients with unstable angina and patients post-myocardial infarction. Consider preventive measures (eg, stool softener, increased fiber) to reduce the potential for constipation.
• Hypotension: May cause hypotension; use with caution in patients with hypovolemia, cardiovascular disease (including acute MI), or with drugs which may exaggerate hypotensive effects (including phenothiazines or general anesthetics).
• Phenanthrene hypersensitivity: Due to structural similarities, hypersensitivity to other phenanthrene-derivative opioid agonists (codeine, hydrocodone, hydromorphone, levorphanol, morphine) may result in similar hypersensitivity reaction if oxymorphone is used; therefore, the use of oxymorphone is contraindicated in patients with previous hypersensitivity to other phenanthrene derivatives.
• Respiratory depression: Extended-release tablets: [U.S. Boxed Warning]: May cause serious, life-threatening, or fatal respiratory depression. Monitor closely for respiratory depression, especially during initiation or dose escalation. Patients should swallow tablets whole; crushing, chewing, or dissolving can cause rapid release and a potentially fatal dose. Carbon dioxide retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.
• Thrombotic thrombocytopenic purpura (TTP): Cases of TTP resulting in kidney failure (requiring dialysis) and death have been reported as a result of misuse by drug abusers injecting the extended-release tablets intravenously. Tablets are intended for oral administration only.
• Abdominal conditions: May obscure diagnosis or clinical course of patients with acute abdominal conditions.
• Adrenal insufficiency: Use with caution in patients with adrenal insufficiency, including Addison disease. Long-term opioid use may cause secondary hypogonadism, which may lead to sexual dysfunction, infertility, mood disorders, and osteoporosis (Brennan, 2013).
• Biliary tract impairment: Use with caution in patients with biliary tract dysfunction including acute pancreatitis; may cause constriction of sphincter of Oddi.
• CNS depression/coma: Avoid use in patients with CNS depression or coma as these patients are susceptible to intracranial effects of CO2 retention.
• Drug abuse: Use with caution in patients with a history of drug abuse or acute alcoholism; potential for drug dependency exists. Tolerance, psychological and physical dependence may occur with prolonged use.
• Head trauma: Use with extreme caution in patients with head injury, intracranial lesions, or elevated intracranial pressure (ICP); exaggerated elevation of ICP may occur.
• Hepatic impairment: Use with caution in patients with mild hepatic dysfunction; use is contraindicated in moderate-to-severe impairment.
• Obesity: Use with caution in patients who are morbidly obese.
• Prostatic hyperplasia/urinary stricture: Use with caution in patients with prostatic hyperplasia and/or urinary stricture.
• Psychosis: Use with caution in patients with toxic psychosis.
• Renal impairment: Use with caution in patients with renal impairment.
• Respiratory disease: Use with caution and monitor for respiratory depression in patients with significant chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercarbia, or preexisting respiratory depression, particularly when initiating therapy and titrating with oxymorphone; even therapeutic doses may decrease respiratory drive to the point of apnea. Consider the use of alternative nonopioid analgesics in these patients.
• Seizure disorders: Use with caution in patients with seizure disorders.
• Thyroid dysfunction: Use with caution in patients with thyroid dysfunction.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
• Ethanol use: Extended release tablets: [U.S. Boxed Warning]: Patients should not consume alcoholic beverages or medication containing ethanol while taking oxymorphone ER; ethanol may increase oxymorphone plasma levels resulting in a potentially fatal overdose.
• MAO inhibitors: Use not recommended within 14 days of MAO inhibitors; severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics.
• Sedatives: Effects may be potentiated when used with other CNS depressants (eg, sedatives, anxiolytics, hypnotics, neuroleptics, other opioids).
• Cachectic or debilitated patients: Use with caution in debilitated or cachectic patients; there is a greater potential for critical respiratory depression, even at therapeutic dosages.
• Elderly: Use with caution in the elderly; may be more sensitive to adverse effects, such as life-threatening respiratory depression. Decrease initial dose.
• Neonates: Neonatal withdrawal syndrome: Extended release: [U.S. Boxed Warning]: Prolonged maternal use of opioids during pregnancy can cause neonatal withdrawal syndrome in the newborn which may be life-threatening if not recognized and treated according to protocols developed by neonatology experts. If prolonged opioid therapy is required in a pregnant woman, ensure treatment is available and warn patient of risk to the neonate. Signs and symptoms include irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. Onset, duration and severity depend on the drug used, duration of use, maternal dose, and rate of drug elimination by the newborn.
Dosage form specific issues:
• Extended-release tablets: Therapy should only be prescribed by healthcare professionals familiar with the use of potent opioids for chronic pain.
• Abuse/misuse/diversion: Extended-release tablets: [U.S. Boxed Warning]: Users are exposed to the risks of addiction, abuse, and misuse, potentially leading to overdose and death. Assess each patient’s risk prior to prescribing; monitor all patients regularly for development of these behaviors or conditions. Risk of opioid abuse is increased in patients with a history or family history of alcohol or drug abuse or mental illness.
• Accidental exposure: Extended-release tablets: [U.S. Boxed Warning]: Accidental ingestion of even one dose, especially in children, can result in a fatal overdose of oxymorphone.
• Optimal regimen: An opioid-containing analgesic regimen should be tailored to each patient's needs and based upon the type of pain being treated (acute versus chronic), the route of administration, degree of tolerance for opioids (naive versus chronic user), age, weight, and patient comorbidities. The optimal analgesic dose varies widely among patients; doses should be titrated to pain relief/prevention.
• Withdrawal: Concurrent use of mixed agonist/antagonist analgesics (eg, pentazocine, nalbuphine, butorphanol) or partial agonist (eg, buprenorphine) analgesics may precipitate withdrawal symptoms and/or reduced analgesic efficacy in patients following prolonged therapy with mu opioid agonists. Taper dose gradually when discontinuing.
Respiratory rate, heart rate, blood pressure, CNS activity; signs or symptoms of hypogonadism or hypoadrenalism (Brennan 2013)
Alternate recommendations: Chronic pain (long-term therapy outside of end-of-life or palliative care, active cancer treatment, sickle cell disease, or medication-assisted treatment for opioid use disorder): Evaluate benefits/risks of opioid therapy within 1 to 4 weeks of treatment initiation and with dose increases. Re-evaluate benefits/risks every 3 months during therapy or more frequently in patients at increased risk of overdose or opioid use disorder. Urine drug testing is recommended prior to initiation and re-checking should be considered at least yearly (includes controlled prescription medications and illicit drugs of abuse). State prescription drug monitoring program (PDMP) data should be reviewed by clinicians prior to initiation and periodically during therapy (frequency ranging from every prescription to every 3 months) (Dowell [CDC 2016]).
Pregnancy Risk Factor
Adverse events were observed in some animal reproduction studies. Opioids cross the placenta. When used for pain relief during labor, opioids may temporarily affect the heart rate of the fetus (ACOG, 2002). Oxymorphone injection is indicated for analgesia during labor. Neonates should be monitored for respiratory depression.
[U.S. Boxed Warning]: Prolonged maternal use of opioids during pregnancy can cause neonatal withdrawal syndrome in the newborn which may be life-threatening if not recognized and treated according to protocols developed by neonatology experts. If prolonged opioid therapy is required in a pregnant woman, ensure treatment is available and warn patient of risk to the neonate. If chronic opioid exposure occurs in pregnancy, adverse events in the newborn (including withdrawal) may occur; monitoring of the neonate is recommended. The minimum effective dose should be used if opioids are needed (Chou, 2009). Neonatal abstinence syndrome following opioid exposure may present with autonomic (eg, fever, temperature instability), gastrointestinal (eg, diarrhea, vomiting, poor feeding/weight gain), or neurologic (eg, high-pitched crying, increased muscle tone, irritability, seizure, tremor) symptoms (Dow, 2012; Hudak, 2012).
Long-term opioid use may cause secondary hypogonadism, which may lead to sexual dysfunction or infertility (Brennan, 2013).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience dry mouth, flatulence, sweating a lot, itching, loss of strength and energy, or tablet shell in stool. Have patient report immediately to prescriber severe dizziness, passing out, difficulty breathing, slow breathing, shallow breathing, illogical thinking, severe nausea, vomiting, severe constipation, angina, tachycardia, bradycardia, arrhythmia, hallucinations, mood changes, seizures, severe abdominal pain, severe headache, difficult urination, edema, vision changes, memory impairment, or severe fatigue (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.