oxymorphone (Rx)

Brand and Other Names:Opana
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet, immediate-release: Schedule II

  • 5mg
  • 10mg

tablet, extended-release: Schedule II

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

reformulated extended-release tablet (Opana ER)

  • Opana ER was discontinued from market at the request of FDA owing to a significant shift in route of abuse from nasal to injection following the product’s reformulation Injection abuse of reformulated
  • Opana ER has been associated with a serious outbreak of HIV, hepatitis C, and thrombotic microangiopathy

Moderate-to-Severe Pain

Acute pain

  • Immediate-release tablets are indicated for acute moderate-to-severe pain where pain is severe enough to require an opioid analgesic and for which alternative therapies are inadequate
  • Opioid-naive patients (immediate-release): 10-20 mg PO q4-6 hr PRN initially, then titrated as warranted (may start with 5-mg increments)

Chronic Severe Pain

Extended-release oxymorphone 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

Extended-release tablet initial dosing

  • Patients who are opioid-naive or not opioid-tolerant
    • 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
  • Patients who are opioid-tolerant
    • Opioid-tolerant definition: Patients who are 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
    • Conversion from immediate-release to extended-release oxymorphone: Administer one-half of total immediate-release daily dose as extended-release q12hr
    • Conversion from other opioids: Refer to equianalgesic recommendations within the prescribing information

Dosage Modifications

Renal impairment

  • Immediate-release tablet; CrCl <50 mL/min: Initiate therapy at lowest dose (eg, 5 mg); titrate to effect slowly; monitor
  • Extended-release tablet
    • CrCl <50 mL/min (opioid-naïve): Initiate with 5 mg PO q12hr
    • CrCl <50 mL/min (prior opioid therapy): Initiate at 50% lower than the starting dose for a patient with normal hepatic function and titrate slowly

Hepatic impairment

  • Mild; immediate-release or injection: Initiate therapy at lowest dose; titrate to effect slowly; monitor
  • Moderate to severe: Contraindicated
  • Extended-release
    • Mild (opioid-naïve): Initiate with 5 mg PO q12hr
    • Mild (prior opioid therapy): Initiate at 50% lower than the starting dose for a patient with normal hepatic function and titrate slowly
    • Moderate or severe: Contraindicated

Dosing Considerations

Immediate-release tablets

  • Limitations of use
    • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve use when alternative treatment options (eg, nonopioid analgesics, opioid/opioid antagonist combination products) have not been tolerated, or are not expected to be tolerated, or have not provided adequate analgesia, or are not expected to provide adequate analgesia

Extended-release tablets

  • Limitations of use
    • Because of risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because the greater risks of overdose and death with extended-release formulations, reserve for use in patients for whom alternative treatment options (eg, nonopioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient pain management
    • Extended-release formulations are not indicated as an as-needed (prn) analgesic

Access to naloxone for opioid overdose

  • Assess need for naloxone upon initiating and renewing treatment
  • Consider prescribing naloxone
    • Based on patient’s risk factors for overdose (eg, concomitant use of CNS depressants, a history of opioid use disorder, prior opioid overdose); presence of risk factors should not prevent proper pain management
    • Household members (including children) or other close contacts at risk for accidental ingestion or overdose
  • Consult patients and caregivers on the following:
    • Availability of naloxone for emergency treatment of opioid overdose
    • Ways differ on how to obtain naloxone as permitted by individual state dispensing and prescribing requirements or guidelines (eg, by prescription, directly from a pharmacist, as part of a community-based program)

Safety and efficacy not established

Steady-state plasma concentrations are ~40% higher in elderly individuals

Initiate with lowest dose; consider less frequent dosing

Carefully monitor for respiratory or CNS depression

Next:

Interactions

Interaction Checker

and oxymorphone

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            Contraindicated (1)

            • alvimopan

              alvimopan, oxymorphone. receptor binding competition. Contraindicated. Alvimopan is contraindicated in opioid tolerant patients (ie, those who have taken therapeutic doses of opioids for >7 consecutive days immediately prior to taking alvimopan). Patients recently exposed to opioids are expected to be more sensitive to the effects of alvimopan and therefore may experience abdominal pain, nausea and vomiting, and diarrhea. No significant interaction is expected with concurrent use of opioid analgesics and alvimopan in patients who received opioid analgesics for 7 or fewer consecutive days prior to alvimopan.

            Serious - Use Alternative (38)

            • artemether/lumefantrine

              artemether/lumefantrine will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug.

            • benzhydrocodone/acetaminophen

              benzhydrocodone/acetaminophen, oxymorphone. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

            • bremelanotide

              bremelanotide will decrease the level or effect of oxymorphone by Other (see comment). Avoid or Use Alternate Drug. Bremelanotide may slow gastric emptying and potentially reduces the rate and extent of absorption of concomitantly administered oral medications. Avoid use when taking any oral drug that is dependent on threshold concentrations for efficacy. Interactions listed are representative examples and do not include all possible clinical examples.

            • buprenorphine

              buprenorphine, oxymorphone. Other (see comment). Avoid or Use Alternate Drug. Comment: Mixed opiate agonist/antagonists usually produce additive sedation with narcotics; however, in narcotic addicted pts., the antagonist activity may provoke withdrawal Sx.

            • buprenorphine buccal

              buprenorphine buccal, oxymorphone. Other (see comment). Avoid or Use Alternate Drug. Comment: Mixed opiate agonist/antagonists usually produce additive sedation with narcotics; however, in narcotic addicted pts., the antagonist activity may provoke withdrawal Sx.

            • butorphanol

              butorphanol, oxymorphone. Other (see comment). Avoid or Use Alternate Drug. Comment: Mixed opiate agonist/antagonists usually produce additive sedation with narcotics; however, in narcotic addicted pts., the antagonist activity may provoke withdrawal Sx.

            • calcium/magnesium/potassium/sodium oxybates

              oxymorphone, calcium/magnesium/potassium/sodium oxybates. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

            • cimetidine

              cimetidine increases effects of oxymorphone by decreasing metabolism. Avoid or Use Alternate Drug.

            • clonidine

              clonidine, oxymorphone. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration enhances CNS depressant effects.

            • diazepam intranasal

              diazepam intranasal, oxymorphone. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

            • eluxadoline

              oxymorphone, eluxadoline. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid coadministration with other drugs that cause constipation. Increases risk for constipation related serious adverse reactions. .

            • fentanyl

              fentanyl, oxymorphone. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration with other CNS depressants, such as skeletal muscle relaxants, may cause respiratory depression, hypotension, profound sedation, coma, and/or death. Consider dose reduction of either or both agents to avoid serious adverse effects. Monitor for hypotension, respiratory depression, and profound sedation.

            • fentanyl intranasal

              fentanyl intranasal, oxymorphone. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration with other CNS depressants, such as skeletal muscle relaxants, may cause respiratory depression, hypotension, profound sedation, coma, and/or death. Consider dose reduction of either or both agents to avoid serious adverse effects. Monitor for hypotension, respiratory depression, and profound sedation.

            • fentanyl transdermal

              fentanyl transdermal, oxymorphone. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration with other CNS depressants, such as skeletal muscle relaxants, may cause respiratory depression, hypotension, profound sedation, coma, and/or death. Consider dose reduction of either or both agents to avoid serious adverse effects. Monitor for hypotension, respiratory depression, and profound sedation.

            • fentanyl transmucosal

              fentanyl transmucosal, oxymorphone. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration with other CNS depressants, such as skeletal muscle relaxants, may cause respiratory depression, hypotension, profound sedation, coma, and/or death. Consider dose reduction of either or both agents to avoid serious adverse effects. Monitor for hypotension, respiratory depression, and profound sedation.

            • fluoxetine

              fluoxetine will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug.

            • hydrocodone

              hydrocodone, oxymorphone. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

            • isocarboxazid

              isocarboxazid increases toxicity of oxymorphone by unknown mechanism. Avoid or Use Alternate Drug. Risk of hypotension, hyperpyrexia, somnolence, or death; separate by 14 d.

            • linezolid

              linezolid increases toxicity of oxymorphone by unknown mechanism. Avoid or Use Alternate Drug. Risk of hypotension, hyperpyrexia, somnolence, or death; separate by 14 d.

            • lumefantrine

              lumefantrine will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug.

            • metoclopramide intranasal

              oxymorphone, metoclopramide intranasal. Either increases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid use of metoclopramide intranasal or interacting drug, depending on importance of drug to patient.

            • nalbuphine

              nalbuphine, oxymorphone. Other (see comment). Avoid or Use Alternate Drug. Comment: Mixed opiate agonist/antagonists usually produce additive sedation with narcotics; however, in narcotic addicted pts., the antagonist activity may provoke withdrawal Sx.

            • ozanimod

              ozanimod and oxymorphone both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Avoid or Use Alternate Drug. Because the active metabolite of ozanimod inhibits MAO-B in vitro, there is a potential for serious adverse reactions, including hypertensive crisis. Therefore, coadministration of ozanimod with drugs that can increase norepinephrine or serotonin is not recommended. Monitor for hypertension with concomitant use.

            • paroxetine

              paroxetine will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug.

            • pentazocine

              pentazocine, oxymorphone. Other (see comment). Avoid or Use Alternate Drug. Comment: Mixed opiate agonist/antagonists usually produce additive sedation with narcotics; however, in narcotic addicted pts., the antagonist activity may provoke withdrawal Sx.

            • phenelzine

              phenelzine increases toxicity of oxymorphone by unknown mechanism. Avoid or Use Alternate Drug. Risk of hypotension, hyperpyrexia, somnolence, or death; separate by 14 d.

            • prasugrel

              oxymorphone will decrease the level or effect of prasugrel by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Co-administration of opioid agonists delay and reduce absorption of prasugrel and its active metabolite presumably by slowing gastric emptying; consider the use of a parenteral anti-platelet agent in acute coronary syndrome patients requiring co-administration of opioid agonists

            • procarbazine

              procarbazine increases toxicity of oxymorphone by unknown mechanism. Avoid or Use Alternate Drug. MAOIs may potentiate CNS depression and hypotension. Do not use within 14 days of MAOI use. .

            • quinidine

              quinidine will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug.

            • rasagiline

              rasagiline increases toxicity of oxymorphone by unknown mechanism. Avoid or Use Alternate Drug. May cause additive CNS depression, drowsiness, dizziness or hypotension, so use with MAOIs should be cautious; lower initial dosages of the analgesic are recommended followed by careful titration. Avoid combination within 14 days of MAOI use.

            • selegiline transdermal

              selegiline transdermal increases toxicity of oxymorphone by unknown mechanism. Avoid or Use Alternate Drug. Risk of hypotension, hyperpyrexia, somnolence, or death.

            • selinexor

              selinexor, oxymorphone. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.

            • sodium oxybate

              oxymorphone, sodium oxybate. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

            • sufentanil SL

              sufentanil SL, oxymorphone. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration may result in hypotension, profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

            • ticagrelor

              oxymorphone will decrease the level or effect of ticagrelor by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Co-administration of opioid agonists delay and reduce absorption of ticagrelor and its active metabolite presumably by slowing gastric emptying; consider the use of a parenteral anti-platelet agent in acute coronary syndrome patients requiring co-administration of opioid agonists

            • tramadol

              tramadol, oxymorphone. Other (see comment). Avoid or Use Alternate Drug. Comment: Tramadol may reinitiate opiate dependence in pts. previously addicted to other opiates; it may also provoke withdrawal Sx. in pts. who are currently opiate dependent.

            • tranylcypromine

              tranylcypromine increases toxicity of oxymorphone by unknown mechanism. Avoid or Use Alternate Drug. Risk of hypotension, hyperpyrexia, somnolence, or death; separate by 14 d.

            • valerian

              valerian and oxymorphone both increase sedation. Avoid or Use Alternate Drug.

            Monitor Closely (206)

            • albuterol

              oxymorphone increases and albuterol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • alfentanil

              alfentanil and oxymorphone both increase sedation. Use Caution/Monitor.

            • alprazolam

              alprazolam and oxymorphone both increase sedation. Use Caution/Monitor.

            • amiodarone

              amiodarone will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • amitriptyline

              oxymorphone and amitriptyline both increase sedation. Use Caution/Monitor.

            • amobarbital

              amobarbital and oxymorphone both increase sedation. Use Caution/Monitor.

            • amoxapine

              oxymorphone and amoxapine both increase sedation. Use Caution/Monitor.

            • apomorphine

              oxymorphone and apomorphine both increase sedation. Use Caution/Monitor.

            • arformoterol

              oxymorphone increases and arformoterol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • aripiprazole

              oxymorphone and aripiprazole both increase sedation. Use Caution/Monitor.

            • armodafinil

              oxymorphone increases and armodafinil decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • asenapine

              asenapine will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • azelastine

              azelastine and oxymorphone both increase sedation. Use Caution/Monitor.

            • baclofen

              baclofen and oxymorphone both increase sedation. Use Caution/Monitor.

            • belladonna and opium

              belladonna and opium and oxymorphone both increase sedation. Use Caution/Monitor.

            • benperidol

              oxymorphone and benperidol both increase sedation. Use Caution/Monitor.

            • benzphetamine

              oxymorphone increases and benzphetamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • brexanolone

              brexanolone, oxymorphone. Either increases toxicity of the other by sedation. Use Caution/Monitor.

            • brompheniramine

              brompheniramine and oxymorphone both increase sedation. Use Caution/Monitor.

            • buprenorphine

              buprenorphine and oxymorphone both increase sedation. Use Caution/Monitor.

            • buprenorphine buccal

              buprenorphine buccal and oxymorphone both increase sedation. Use Caution/Monitor.

            • buprenorphine, long-acting injection

              oxymorphone increases toxicity of buprenorphine, long-acting injection by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of buprenorphine and benzodiazepines or other CNS depressants increases risk of adverse reactions including overdose, respiratory depression, and death. Cessation of benzodiazepines or other CNS depressants is preferred in most cases. In some cases, monitoring at a higher level of care for tapering CNS depressants may be appropriate. In others, gradually tapering a patient off of a prescribed benzodiazepine or other CNS depressant or decreasing to the lowest effective dose may be appropriate.

            • butabarbital

              butabarbital and oxymorphone both increase sedation. Use Caution/Monitor.

            • butalbital

              butalbital and oxymorphone both increase sedation. Use Caution/Monitor.

            • butorphanol

              butorphanol and oxymorphone both increase sedation. Use Caution/Monitor.

            • caffeine

              oxymorphone increases and caffeine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • carbinoxamine

              carbinoxamine and oxymorphone both increase sedation. Use Caution/Monitor.

            • carisoprodol

              carisoprodol and oxymorphone both increase sedation. Use Caution/Monitor.

            • celecoxib

              celecoxib will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • cenobamate

              cenobamate, oxymorphone. Either increases effects of the other by sedation. Use Caution/Monitor.

            • chloral hydrate

              chloral hydrate and oxymorphone both increase sedation. Use Caution/Monitor.

            • chlordiazepoxide

              chlordiazepoxide and oxymorphone both increase sedation. Use Caution/Monitor.

            • chloroquine

              chloroquine will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • chlorpheniramine

              chlorpheniramine and oxymorphone both increase sedation. Use Caution/Monitor.

            • chlorpromazine

              oxymorphone and chlorpromazine both increase sedation. Use Caution/Monitor.

            • chlorzoxazone

              chlorzoxazone and oxymorphone both increase sedation. Use Caution/Monitor.

            • cimetidine

              cimetidine will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • cinnarizine

              cinnarizine and oxymorphone both increase sedation. Use Caution/Monitor.

            • clemastine

              clemastine and oxymorphone both increase sedation. Use Caution/Monitor.

            • clomipramine

              oxymorphone and clomipramine both increase sedation. Use Caution/Monitor.

            • clonazepam

              clonazepam and oxymorphone both increase sedation. Use Caution/Monitor.

            • clorazepate

              clorazepate and oxymorphone both increase sedation. Use Caution/Monitor.

            • clozapine

              oxymorphone and clozapine both increase sedation. Use Caution/Monitor.

            • codeine

              codeine and oxymorphone both increase sedation. Use Caution/Monitor.

            • cyclizine

              cyclizine and oxymorphone both increase sedation. Use Caution/Monitor.

            • cyclobenzaprine

              cyclobenzaprine and oxymorphone both increase sedation. Use Caution/Monitor.

            • cyproheptadine

              cyproheptadine and oxymorphone both increase sedation. Use Caution/Monitor.

            • dantrolene

              dantrolene and oxymorphone both increase sedation. Use Caution/Monitor.

            • darifenacin

              darifenacin will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • desflurane

              desflurane and oxymorphone both increase sedation. Use Caution/Monitor. Opioids may decrease MAC requirements, less inhalation anesthetic may be required.

            • desipramine

              oxymorphone and desipramine both increase sedation. Use Caution/Monitor.

            • desvenlafaxine

              desvenlafaxine will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. Desvenlafaxine inhibits CYP2D6; with higher desvenlafaxine doses (ie, 400 mg) decrease the CYP2D6 substrate dose by up to 50%; no dosage adjustment needed with desvenlafaxine doses <100 mg

            • deutetrabenazine

              oxymorphone and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • dexchlorpheniramine

              dexchlorpheniramine and oxymorphone both increase sedation. Use Caution/Monitor.

            • dexfenfluramine

              oxymorphone increases and dexfenfluramine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • dexmedetomidine

              dexmedetomidine and oxymorphone both increase sedation. Use Caution/Monitor.

            • dexmethylphenidate

              oxymorphone increases and dexmethylphenidate decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • dextroamphetamine

              oxymorphone increases and dextroamphetamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • dextromoramide

              dextromoramide and oxymorphone both increase sedation. Use Caution/Monitor.

            • diamorphine

              diamorphine and oxymorphone both increase sedation. Use Caution/Monitor.

            • diazepam

              diazepam and oxymorphone both increase sedation. Use Caution/Monitor.

            • diethylpropion

              oxymorphone increases and diethylpropion decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • difenoxin hcl

              difenoxin hcl and oxymorphone both increase sedation. Use Caution/Monitor.

            • dimenhydrinate

              dimenhydrinate and oxymorphone both increase sedation. Use Caution/Monitor.

            • diphenhydramine

              diphenhydramine will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

              diphenhydramine and oxymorphone both increase sedation. Use Caution/Monitor.

            • diphenoxylate hcl

              diphenoxylate hcl and oxymorphone both increase sedation. Use Caution/Monitor.

            • dipipanone

              dipipanone and oxymorphone both increase sedation. Use Caution/Monitor.

            • dobutamine

              oxymorphone increases and dobutamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • dopamine

              oxymorphone increases and dopamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • dopexamine

              oxymorphone increases and dopexamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • dosulepin

              oxymorphone and dosulepin both increase sedation. Use Caution/Monitor.

            • doxepin

              oxymorphone and doxepin both increase sedation. Use Caution/Monitor.

            • doxylamine

              doxylamine and oxymorphone both increase sedation. Use Caution/Monitor.

            • dronedarone

              dronedarone will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • droperidol

              oxymorphone and droperidol both increase sedation. Use Caution/Monitor.

            • duloxetine

              duloxetine will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • eltrombopag

              eltrombopag increases levels of oxymorphone by decreasing metabolism. Use Caution/Monitor. UGT inhibition; significance of interaction unclear.

            • ephedrine

              oxymorphone increases and ephedrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • epinephrine

              oxymorphone increases and epinephrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • epinephrine racemic

              oxymorphone increases and epinephrine racemic decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • esketamine intranasal

              esketamine intranasal, oxymorphone. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

            • estazolam

              estazolam and oxymorphone both increase sedation. Use Caution/Monitor.

            • ethanol

              oxymorphone and ethanol both increase sedation. Use Caution/Monitor.

            • etomidate

              etomidate and oxymorphone both increase sedation. Use Caution/Monitor.

            • fenfluramine

              oxymorphone increases and fenfluramine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • flibanserin

              oxymorphone and flibanserin both increase sedation. Modify Therapy/Monitor Closely. Risk for sedation increased if flibanserin is coadministration with other CNS depressants.

            • fluphenazine

              oxymorphone and fluphenazine both increase sedation. Use Caution/Monitor.

            • flurazepam

              flurazepam and oxymorphone both increase sedation. Use Caution/Monitor.

            • formoterol

              oxymorphone increases and formoterol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • gabapentin

              gabapentin, oxymorphone. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of CNS depressants can result in serious, life-threatening, and fatal respiratory depression. Use lowest dose possible and monitor for respiratory depression and sedation.

            • gabapentin enacarbil

              gabapentin enacarbil, oxymorphone. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of CNS depressants can result in serious, life-threatening, and fatal respiratory depression. Use lowest dose possible and monitor for respiratory depression and sedation.

            • haloperidol

              haloperidol will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

              oxymorphone and haloperidol both increase sedation. Use Caution/Monitor.

            • hydromorphone

              hydromorphone and oxymorphone both increase sedation. Use Caution/Monitor.

            • hydroxyzine

              hydroxyzine and oxymorphone both increase sedation. Use Caution/Monitor.

            • iloperidone

              oxymorphone and iloperidone both increase sedation. Use Caution/Monitor.

            • imatinib

              imatinib will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • imipramine

              oxymorphone and imipramine both increase sedation. Use Caution/Monitor.

            • isoproterenol

              oxymorphone increases and isoproterenol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • ketamine

              ketamine and oxymorphone both increase sedation. Use Caution/Monitor.

            • ketotifen, ophthalmic

              oxymorphone and ketotifen, ophthalmic both increase sedation. Use Caution/Monitor.

            • lasmiditan

              lasmiditan, oxymorphone. Either increases effects of the other by sedation. Use Caution/Monitor. Coadministration of lasmiditan and other CNS depressant drugs, including alcohol have not been evaluated in clinical studies. Lasmiditan may cause sedation, as well as other cognitive and/or neuropsychiatric adverse reactions.

            • lemborexant

              lemborexant, oxymorphone. Either increases effects of the other by sedation. Modify Therapy/Monitor Closely. Dosage adjustment may be necessary if lemborexant is coadministered with other CNS depressants because of potentially additive effects.

            • levalbuterol

              oxymorphone increases and levalbuterol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • levorphanol

              levorphanol and oxymorphone both increase sedation. Use Caution/Monitor.

            • lisdexamfetamine

              oxymorphone increases and lisdexamfetamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • lofepramine

              oxymorphone and lofepramine both increase sedation. Use Caution/Monitor.

            • lofexidine

              oxymorphone and lofexidine both increase sedation. Use Caution/Monitor.

            • loprazolam

              loprazolam and oxymorphone both increase sedation. Use Caution/Monitor.

            • lorazepam

              lorazepam and oxymorphone both increase sedation. Use Caution/Monitor.

            • lormetazepam

              lormetazepam and oxymorphone both increase sedation. Use Caution/Monitor.

            • loxapine

              oxymorphone and loxapine both increase sedation. Use Caution/Monitor.

            • loxapine inhaled

              oxymorphone and loxapine inhaled both increase sedation. Use Caution/Monitor.

            • lurasidone

              lurasidone, oxymorphone. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Potential for increased CNS depressant effects when used concurrently; monitor for increased adverse effects and toxicity.

            • maprotiline

              oxymorphone and maprotiline both increase sedation. Use Caution/Monitor.

            • maraviroc

              maraviroc will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • marijuana

              marijuana will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

              oxymorphone and marijuana both increase sedation. Use Caution/Monitor.

            • melatonin

              oxymorphone and melatonin both increase sedation. Use Caution/Monitor.

            • meperidine

              meperidine and oxymorphone both increase sedation. Use Caution/Monitor.

            • meprobamate

              oxymorphone and meprobamate both increase sedation. Use Caution/Monitor.

            • metaproterenol

              oxymorphone increases and metaproterenol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • metaxalone

              metaxalone and oxymorphone both increase sedation. Use Caution/Monitor.

            • methadone

              methadone and oxymorphone both increase sedation. Use Caution/Monitor.

            • methamphetamine

              oxymorphone increases and methamphetamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • methocarbamol

              methocarbamol and oxymorphone both increase sedation. Use Caution/Monitor.

            • methylenedioxymethamphetamine

              oxymorphone increases and methylenedioxymethamphetamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • midazolam

              midazolam and oxymorphone both increase sedation. Use Caution/Monitor.

            • midazolam intranasal

              midazolam intranasal, oxymorphone. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Concomitant use of barbiturates, alcohol, or other CNS depressants may increase the risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect.

            • midodrine

              oxymorphone increases and midodrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • mirtazapine

              oxymorphone and mirtazapine both increase sedation. Use Caution/Monitor.

            • modafinil

              oxymorphone increases and modafinil decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • morphine

              morphine and oxymorphone both increase sedation. Use Caution/Monitor.

            • motherwort

              oxymorphone and motherwort both increase sedation. Use Caution/Monitor.

            • moxonidine

              oxymorphone and moxonidine both increase sedation. Use Caution/Monitor.

            • nabilone

              oxymorphone and nabilone both increase sedation. Use Caution/Monitor.

            • nalbuphine

              nalbuphine and oxymorphone both increase sedation. Use Caution/Monitor.

            • norepinephrine

              oxymorphone increases and norepinephrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • nortriptyline

              oxymorphone and nortriptyline both increase sedation. Use Caution/Monitor.

            • olanzapine

              oxymorphone and olanzapine both increase sedation. Use Caution/Monitor.

            • oliceridine

              oliceridine, oxymorphone. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

            • opium tincture

              opium tincture and oxymorphone both increase sedation. Use Caution/Monitor.

            • orphenadrine

              orphenadrine and oxymorphone both increase sedation. Use Caution/Monitor.

            • oxazepam

              oxazepam and oxymorphone both increase sedation. Use Caution/Monitor.

            • oxycodone

              oxycodone and oxymorphone both increase sedation. Use Caution/Monitor.

            • paliperidone

              oxymorphone and paliperidone both increase sedation. Use Caution/Monitor.

            • papaveretum

              oxymorphone and papaveretum both increase sedation. Use Caution/Monitor.

            • papaverine

              oxymorphone and papaverine both increase sedation. Use Caution/Monitor.

            • parecoxib

              parecoxib will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • pegvisomant

              oxymorphone decreases effects of pegvisomant by unknown mechanism. Use Caution/Monitor.

            • pentazocine

              oxymorphone and pentazocine both increase sedation. Use Caution/Monitor.

            • pentobarbital

              pentobarbital and oxymorphone both increase sedation. Use Caution/Monitor.

            • perampanel

              perampanel and oxymorphone both increase sedation. Use Caution/Monitor.

            • perphenazine

              perphenazine will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

              oxymorphone and perphenazine both increase sedation. Use Caution/Monitor.

            • phendimetrazine

              oxymorphone increases and phendimetrazine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • phenobarbital

              phenobarbital and oxymorphone both increase sedation. Use Caution/Monitor.

            • phentermine

              oxymorphone increases and phentermine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • phenylephrine

              oxymorphone increases and phenylephrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • phenylephrine PO

              oxymorphone increases and phenylephrine PO decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor. .

            • pholcodine

              oxymorphone and pholcodine both increase sedation. Use Caution/Monitor.

            • pimozide

              oxymorphone and pimozide both increase sedation. Use Caution/Monitor.

            • pirbuterol

              oxymorphone increases and pirbuterol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • pregabalin

              pregabalin, oxymorphone. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of CNS depressants can result in serious, life-threatening, and fatal respiratory depression. Use lowest dose possible and monitor for respiratory depression and sedation.

            • primidone

              primidone and oxymorphone both increase sedation. Use Caution/Monitor.

            • prochlorperazine

              oxymorphone and prochlorperazine both increase sedation. Use Caution/Monitor.

            • promethazine

              promethazine and oxymorphone both increase sedation. Use Caution/Monitor.

            • propafenone

              propafenone will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • propofol

              propofol and oxymorphone both increase sedation. Use Caution/Monitor.

            • propylhexedrine

              oxymorphone increases and propylhexedrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • protriptyline

              oxymorphone and protriptyline both increase sedation. Use Caution/Monitor.

            • quazepam

              quazepam and oxymorphone both increase sedation. Use Caution/Monitor.

            • quetiapine

              oxymorphone and quetiapine both increase sedation. Use Caution/Monitor.

            • quinacrine

              quinacrine will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • ramelteon

              oxymorphone and ramelteon both increase sedation. Use Caution/Monitor.

            • ranolazine

              ranolazine will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • remimazolam

              remimazolam, oxymorphone. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely. Coadministration may result in profound sedation, respiratory depression, coma, and/or death. Continuously monitor vital signs during sedation and recovery period if coadministered. Carefully titrate remimazolam dose if administered with opioid analgesics and/or sedative/hypnotics.

            • risperidone

              oxymorphone and risperidone both increase sedation. Use Caution/Monitor.

            • ritonavir

              ritonavir will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • salmeterol

              oxymorphone increases and salmeterol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • scullcap

              oxymorphone and scullcap both increase sedation. Use Caution/Monitor.

            • secobarbital

              secobarbital and oxymorphone both increase sedation. Use Caution/Monitor.

            • selegiline

              selegiline increases toxicity of oxymorphone by unknown mechanism. Modify Therapy/Monitor Closely. Potential for increased CNS depression, drowsiness, dizziness or hypotension, so use with any MAOI should be cautious.

            • sertraline

              sertraline will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • sevoflurane

              sevoflurane and oxymorphone both increase sedation. Use Caution/Monitor.

            • shepherd's purse

              oxymorphone and shepherd's purse both increase sedation. Use Caution/Monitor.

            • stiripentol

              stiripentol, oxymorphone. Either increases effects of the other by sedation. Use Caution/Monitor. Concomitant use stiripentol with other CNS depressants, including alcohol, may increase the risk of sedation and somnolence.

            • sufentanil

              oxymorphone and sufentanil both increase sedation. Use Caution/Monitor.

            • suvorexant

              suvorexant and oxymorphone both increase sedation. Modify Therapy/Monitor Closely. Dosage adjustments of suvorexant and concomitant CNS depressants may be necessary

            • tapentadol

              oxymorphone and tapentadol both increase sedation. Use Caution/Monitor.

            • temazepam

              temazepam and oxymorphone both increase sedation. Use Caution/Monitor.

            • terbutaline

              oxymorphone increases and terbutaline decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • thioridazine

              thioridazine will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

              oxymorphone and thioridazine both increase sedation. Use Caution/Monitor.

            • thiothixene

              oxymorphone and thiothixene both increase sedation. Use Caution/Monitor.

            • tipranavir

              tipranavir will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • topiramate

              oxymorphone and topiramate both increase sedation. Modify Therapy/Monitor Closely.

            • tramadol

              oxymorphone and tramadol both increase sedation. Use Caution/Monitor.

            • trazodone

              oxymorphone and trazodone both increase sedation. Use Caution/Monitor.

            • triazolam

              triazolam and oxymorphone both increase sedation. Use Caution/Monitor.

            • triclofos

              triclofos and oxymorphone both increase sedation. Use Caution/Monitor.

            • trifluoperazine

              oxymorphone and trifluoperazine both increase sedation. Use Caution/Monitor.

            • trimipramine

              oxymorphone and trimipramine both increase sedation. Use Caution/Monitor.

            • triprolidine

              triprolidine and oxymorphone both increase sedation. Use Caution/Monitor.

            • venlafaxine

              venlafaxine will increase the level or effect of oxymorphone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • xylometazoline

              oxymorphone increases and xylometazoline decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • yohimbine

              oxymorphone increases and yohimbine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • ziconotide

              oxymorphone and ziconotide both increase sedation. Use Caution/Monitor.

            • ziprasidone

              oxymorphone and ziprasidone both increase sedation. Use Caution/Monitor.

            • zotepine

              oxymorphone and zotepine both increase sedation. Use Caution/Monitor.

            Minor (6)

            • brimonidine

              brimonidine increases effects of oxymorphone by pharmacodynamic synergism. Minor/Significance Unknown. Increased CNS depression.

            • dextroamphetamine

              dextroamphetamine increases effects of oxymorphone by unspecified interaction mechanism. Minor/Significance Unknown.

            • eucalyptus

              oxymorphone and eucalyptus both increase sedation. Minor/Significance Unknown.

            • lidocaine

              lidocaine increases toxicity of oxymorphone by pharmacodynamic synergism. Minor/Significance Unknown. Risk of increased CNS depression.

            • sage

              oxymorphone and sage both increase sedation. Minor/Significance Unknown.

            • ziconotide

              ziconotide, oxymorphone. Mechanism: unspecified interaction mechanism. Minor/Significance Unknown. Additive decreased GI motility. Additive analgesia. Ziconotide does NOT potentiate opioid induced respiratory depression.

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            Adverse Effects

            >10%

            Nausea (19%)

            Pyrexia (14%)

            1-10%

            Somnolence (9%)

            Vomiting (9%)

            Pruritus (8%)

            Headache (7%)

            Dizziness (7%)

            Constipation (4%)

            Confusion (3%)

            1 to <10%

            • 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

            <1%

            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

            Dermatitis

            Dyspepsia

            Dysphoria

            Edema

            Euphoric mood

            Hallucination

            Hypertension

            Insomnia

            Miosis

            Nervousness

            Palpitation

            Postural hypotension

            Syncope

            Dyspnea

            Respiratory depression

            Respiratory distress

            Respiratory rate decreased

            Oxygen saturation decreased

            Difficult micturition

            Urinary retention

            Urticaria

            Vision blurred

            Visual disturbances

            Weakness

            Appetite decreased

            Weight decreased

            Postmarketing Reports

            Nervous system disorder: Amnesia, convulsion, memory impairment

            Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs

            Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use

            Anaphylaxis: Anaphylaxis

            Immune system disorders: Angioedema, and other hypersensitivity reactions

            Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids

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            Warnings

            Black Box Warnings

            Opioid analgesic risk evaluation and mitigation strategy (REMS)

            • To ensure that benefits of opioid analgesics outweigh risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products; under requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers
            • Healthcare providers are strongly encouraged to
              • Complete a REMS-compliant education program
              • Counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products
              • Emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist
              • Consider other tools to improve patient, household, and community safety

            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 central nervous system (CNS) depressants

            • Coadministration with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death
            • Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation
            • Instruct patients not to consume alcoholic beverages or use alcohol-containing drug products while taking morphine due to risk of additive sedation and respiratory depression
            • Co-ingestion 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

            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

            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

            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

            Therapy may increase frequency of seizures in patients with seizure disorders and in other clinical settings associated with seizures; monitor patients for worsened seizure control during therapy

            Warn patients not to drive or operate dangerous machinery unless they are tolerant to effects of drug and know how they will react to medication

            While serious, life-threatening, or fatal respiratory depression can occur at any time during therapy, risk is greatest during initiation of therapy or following dosage increase; monitor patients closely for respiratory depression, especially within first 24 to 72 hr of initiating therapy with and following dosage increases; accidental ingestion of even one dose, especially by children, can result in respiratory depression and death due to overdose of opioid

            Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia; opioid use increases risk of CSA in a dose-dependent fashion; in patients who present with CSA, consider decreasing opioid dosage using best practices for opioid taper

            Use in patients with acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment is contraindicated; patients with significant chronic obstructive pulmonary disease or cor pulmonale, and with substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages

            Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients; monitor closely

            Do not abruptly discontinue therapy in a patient physically dependent on opioids; when discontinuing therapy, in a physically dependent patient, gradually taper the dosage; rapid tapering in a patient physically dependent on opioids may lead to a withdrawal syndrome and return of pain

            Cases of adrenal insufficiency reported with opioid use, more often following greater than one month of use; symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure; if adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids; wean patient off of opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers; other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency

            Use caution when selecting dosage for an elderly patient, usually starting at low end of dosing range, reflecting greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy; because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and may be useful to monitor renal function

            Opioid pharmacokinetics may be altered in patients with renal failure; clearance may be decreased and metabolites may accumulate much higher plasma levels in patients with renal failure as compared to patients with normal renal function; start with a lower than normal dosage or with longer dosing intervals and titrate slowly while monitoring for signs of respiratory depression, sedation, and hypotension

            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

            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

            Drug interaction overview

            • Monoamine oxidase inhibitors (MAOIs) may potentiate effects of opioid, opioid’s active metabolite, including respiratory depression, coma, and confusion; therapy should not be administered within 14 days of initiating or stopping MAOIs
            • Profound sedation, respiratory depression, coma, and death may result from concomitant administration with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol); because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate; if concomitant use with benzodiazepine or muscle relaxant is warranted, consider prescribing naloxone for the emergency treatment of opioid overdose
            • If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response; follow patients closely for signs and symptoms of respiratory depression and sedation
            • Avoid use of mixed agonist/antagonist (eg, pentazocine, nalbuphine, and butorphanol) or partial agonist (eg, buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic; mixed agonist/antagonist and partial agonist analgesics may reduce analgesic effect and/or precipitate withdrawal symptoms; when discontinuing therapy in physically-dependent patient, gradually taper dosage; do not abruptly discontinue therapy in these patients
            • Cases of serotonin syndrome, a potentially life-threatening condition, reported with concomitant use of serotonergic drugs; this may occur within the recommended dosage range; the onset of symptoms generally occur within several hours to a few days of concomitant use, but may occur later than that; discontinue therapy immediately if serotonin syndrome is suspected
            • Coadministration with anticholinergic drugs may increase risk of urinary retention
            • Opioids may reduce efficacy of diuretics by inducing antidiuretic hormone release
            • Cimetidine can potentiate opioid-induced respiratory depression

            Opioid analgesic risk evaluation and mitigation strategy (REMS)

            • To ensure that benefits of opioid analgesics outweigh risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products
            • Discuss the safe use, serious risks, and proper storage and disposal of opioid analgesics with patients and/or their caregivers every time these medicines are prescribed; use the following link to obtain the Patient Counseling Guide (PCG): www.fda.gov/OpioidAnalgesicREMSPCG
            • Emphasize to patients and their caregivers the importance of reading the Medication Guide that they will receive from their pharmacist every time an opioid analgesic is dispensed to them
            • Consider using other tools to improve patient, household, and community safety, such as patient-prescriber agreements that reinforce patient-prescriber responsibilities
            • To obtain further information on opioid analgesic REMS and for a list of accredited REMS CME/CE, call 1-800-503-0784, or log on to www.opioidanalgesicrems.com; the FDA Blueprint can be found at www.fda.gov/OpioidAnalgesicREMSBlueprint

            Patient access to naloxone for emergency treatment of opioid overdose

            • Assess potential need for naloxone; consider prescribing for emergency treatment of opioid overdose
            • Consult on availability and ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines
            • Educate patients regarding the signs and symptoms of respiratory depression and to call 911 or seek immediate emergency medical help in the event of a known or suspected overdose
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            Pregnancy & Lactation

            Pregnancy

            Prolonged use of opioid analgesics during pregnancy can cause neonatal opioid withdrawal syndrome; there are no available data in pregnant women to inform a drug associated risk for major birth defects and miscarriage; published studies with morphine use during pregnancy have not reported a clear association with morphine and major birth defects

            Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth; the onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of drug by newborn; observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly

            Observe newborns for symptoms of neonatal opioid withdrawal syndrome (eg, poor feeding, diarrhea, irritability, tremor, rigidity, and seizures), and manage accordingly

            Labor or delivery

            • Opioids cross placenta and may produce respiratory depression and psycho-physiologic effects in neonates; an opioid antagonist, such as naloxone, must be available for reversal of opioid induced respiratory depression in neonate; drug is not recommended for use in women during and immediately prior to labor, when use of shorter-acting analgesics or other analgesic techniques are more appropriate; opioid analgesics can prolong labor through actions that temporarily reduce strength, duration, and frequency of uterine contractions; however, this effect is not consistent and may be offset by an increased rate of cervical dilatation, which tends to shorten labor; monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression

            Infertility

            • Due to effects of androgen deficiency, chronic use of opioids may cause reduced fertility in females and males of reproductive potential; it is not known whether effects on fertility are reversible

            Lactation

            Unknown if excreted in breast milk; many drugs, including some opioids, are excreted in human milk

            If opioid must be used; monitor infant closely for excess sedation and respiratory depression; withdrawal symptoms can occur when breastfeeding or maternal opioid is stopped

            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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            Administration

            Oral Administration

            Take on empty stomach, at least 1 hr before or 2 hr after eating

            Do not stop abruptly if opioid tolerant; taper gradually to stop treatment

            Extended-release tablets

            • Swallow tablet whole; do not crush, chew, or dissolve
            • Altering tablet (ie, crushing, chewing, or dissolving) will result in uncontrolled delivery of oxymorphone and can lead to overdose or death

            Safe reduction or discontinuation

            • Do not abruptly discontinue in patients who may be physically dependent on opioids; rapid discontinuation in physically dependent patients has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide; also associated with attempts treat their pain or withdrawal symptoms with illicit opioids
            • Consider all factors when decreasing dose or discontinuing therapy (eg, dose, duration of treatment, type of pain, patient’s physical and psychological profile)
            • Gradual tapering
              • There are no standard opioid tapering schedules that are suitable for all patients
              • Good clinical practice dictates a patient-specific plan to taper the dose of the opioid gradually
              • For patients who are physically opioid-dependent, initiate taper by small increment (eg, no greater than 10-25% of total daily dose) to avoid withdrawal symptoms, and proceed with dose-lowering at q2-4week interval
              • It may be necessary to provide lower dosage strengths to accomplish successful tapering
              • Reassess frequently to manage pain and withdrawal symptoms
              • When managing patients taking opioid analgesics, particularly those who have been treated for a long duration and/or with high doses for chronic pain, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place before initiating tapering
              • Multimodal approach to pain management may optimize the treatment of chronic pain, and assist with successful tapering
            • Withdrawal symptoms
              • Restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis
              • Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate
              • If withdrawal symptoms arise, it may be necessary to pause the taper for a period of time or raise analgesic opioid dose, and then proceed with a slower taper
              • Monitor patients for any changes in mood, emergence of suicidal thoughts, or use of other substances
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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            oxymorphone oral
            -
            10 mg tablet
            oxymorphone oral
            -
            5 mg tablet
            oxymorphone oral
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            10 mg tablet
            oxymorphone oral
            -
            5 mg tablet
            oxymorphone oral
            -
            5 mg tablet
            oxymorphone oral
            -
            10 mg tablet
            oxymorphone oral
            -
            15 mg tablet
            oxymorphone oral
            -
            40 mg tablet
            oxymorphone oral
            -
            30 mg tablet
            oxymorphone oral
            -
            20 mg tablet
            oxymorphone oral
            -
            10 mg tablet
            oxymorphone oral
            -
            5 mg tablet
            oxymorphone oral
            -
            7.5 mg tablet
            oxymorphone oral
            -
            10 mg tablet
            oxymorphone oral
            -
            5 mg tablet
            oxymorphone oral
            -
            10 mg tablet
            oxymorphone oral
            -
            5 mg tablet
            oxymorphone oral
            -
            10 mg tablet
            oxymorphone oral
            -
            10 mg tablet

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            oxymorphone oral

            OXYMORPHONE EXTENDED-RELEASE - ORAL

            (OX-i-MOR-fone)

            COMMON BRAND NAME(S): Opana ER

            WARNING: Oxymorphone has a risk for abuse and addiction, which can lead to overdose and death. Oxymorphone may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you take the smallest dose of oxymorphone that works, and take it for the shortest possible time. See also How to Use section for more information about addiction.The risk for severe breathing problems is higher when you start this medication and after a dose increase, or if you take the wrong dose/strength. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death. Be sure you know how to take oxymorphone and what other drugs you should avoid taking with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.This medication must be swallowed whole. Do not break, chew, dissolve, or crush the medication. This may cause a rapid release of the medication that may be fatal. Also, do not drink alcohol or take any products that contain alcohol while taking this medication. This may cause an increase of the medication in your body that may be fatal.Keep this medicine in a safe place to prevent theft, misuse, or abuse. If someone accidentally swallows this drug, get medical help right away.Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Babies born to mothers who use this drug for a long time may develop severe (possibly fatal) withdrawal symptoms. Tell the doctor right away if you notice any symptoms in your newborn baby such as crying that doesn't stop, slow/shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or difficulty gaining weight.

            USES: Oxymorphone extended-release is used to help relieve severe ongoing pain. It belongs to a class of drugs known as long-acting opioid analgesics. It works in the brain to change how your body feels and responds to pain.Do not use the extended-release form of oxymorphone to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.

            HOW TO USE: See also Warning section.Read the Medication Guide provided by your pharmacist before you start taking oxymorphone extended-release and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication on a regular schedule as directed by your doctor, not as needed for sudden (breakthrough) pain.Take this medication by mouth without food (at least 1 hour before or 2 hours after eating) as directed by your doctor, usually every 12 hours. Swallow the tablets whole. Do not break, chew, dissolve, or crush them. Do not pre-soak, lick, or wet the tablets before putting them in your mouth. Take one tablet at a time with enough water to completely swallow the tablet. If you have nausea, ask your doctor or pharmacist about ways to decrease nausea (such as lying down for 1 to 2 hours with as little head movement as possible).The dosage is based on your medical condition and response to treatment. Do not increase your dose or use this drug more often or for longer than prescribed because your risk of side effects may increase. Properly stop the medication when so directed.Before you start using this medication, ask your doctor or pharmacist if you should stop or change how you use your other opioid medication(s). Other pain relievers (such as acetaminophen, ibuprofen) may also be prescribed. Ask your doctor or pharmacist about using oxymorphone safely with other drugs.Suddenly stopping this medication may cause withdrawal, especially if you have used it for a long time or in high doses. To prevent withdrawal, your doctor may lower your dose slowly. Tell your doctor or pharmacist right away if you have any withdrawal symptoms such as restlessness, mental/mood changes (including anxiety, trouble sleeping, thoughts of suicide), watering eyes, runny nose, nausea, diarrhea, sweating, muscle aches, or sudden changes in behavior.When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.Tell your doctor if your pain does not get better or if it gets worse.

            SIDE EFFECTS: See also Warning section.Nausea, vomiting, headache, constipation, dry mouth, mild itching, lightheadedness, dizziness, or drowsiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Sometimes a soft mass that looks like the tablet may appear in your stool. This effect is harmless because your body has already absorbed the medication.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: interrupted breathing during sleep (sleep apnea), mental/mood changes (such as agitation, confusion, hallucinations), stomach/abdominal pain, vision changes, slow/fast heartbeat, difficulty urinating, difficulty swallowing this medication (such as choking, gagging), signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss).Get medical help right away if you have any very serious side effects, including: slow/shallow breathing, fainting, seizure, severe drowsiness/difficulty waking up.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking oxymorphone, tell your doctor or pharmacist if you are allergic to it; or to other opioid pain medications (such as codeine, morphine, oxycodone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), gallbladder disease, kidney disease, liver disease, mental/mood disorders (such as confusion, depression, thoughts of suicide), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), stomach/intestinal problems (such as blockage, surgery, constipation, diarrhea due to infection, paralytic ileus), cancer of the esophagus or colon, difficulty swallowing, disease of the pancreas (pancreatitis), difficulty urinating (such as due to enlarged prostate).This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be more sensitive to the side effects of the drug, especially confusion, dizziness, drowsiness, slow/shallow breathing.During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. (See also Warning section.)It is unknown if this drug passes into breast milk. However, similar drugs pass into breast milk and may have undesirable effects on a nursing infant. Tell the doctor right away if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: See also Warning section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: products that contain alcohol (such as cough-and-cold syrups), certain pain medications (mixed opioid agonist-antagonists such as pentazocine, nalbuphine, butorphanol), naltrexone.The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.This medication may interfere with certain laboratory tests (including amylase and lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, give them naloxone if available, then call 911. If the person is awake and has no symptoms, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, slow heartbeat, coma.

            NOTES: Do not share this medication with others. Sharing it is against the law.This medication has been prescribed for your current condition only. Do not use it later for another condition unless your doctor directs you to do so. A different medication may be necessary in that case.Ask your doctor or pharmacist if you should have naloxone available to treat opioid overdose. Teach your family or household members about the signs of an opioid overdose and how to treat it.

            MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. See also Warning section.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. For more details, read the Medication Guide, or consult your pharmacist or local waste disposal company.

            Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • 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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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.