tapentadol (Rx)

Brand and Other Names:Nucynta, Nucynta ER
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet, immediate release: Schedule II

  • 50mg
  • 75mg
  • 100mg

tablet, extended release: Schedule II

  • 50mg
  • 100mg
  • 150mg
  • 200mg
  • 250mg

Acute Moderate-to-Severe Pain

Immediate-release tablet or oral solution: 50-100 mg PO q4-6hr PRN; not to exceed 700 mg on day 1 and 600 mg/day thereafter

Chronic (extended-release tablet)

  • 50-250 mg PO q12hr PRN; not to exceed 500 mg/day
  • Opioid-naive patients: 50 mg PO q12hr; titrated to optimal dosage as needed; not to exceed 500 mg/day

Chronic Severe Pain

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

50-250 mg PO q12hr PRN; not to exceed 500 mg/day

Opioid-naive patients: 50 mg PO q12hr; titrated to optimal dosage as needed; not to exceed 500 mg/day

Opioid-naive definition

  • Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression
  • Patients who are opioid tolerant are those receiving, for 1 week or longer, at least 60 mg/day PO morphine, 25 mcg/hr transdermal fentanyl, 30 mg/day PO oxycodone, 8 mg/day PO hydromorphone, 25 mg/day PO oxymorphone, or an equianalgesic dose of another opioid

Limitations of use

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

Diabetic Peripheral Neuropathy

Treatment of pain associated with diabetic peripheral neuropathy when continuous, around-the-clock opioid analgesic is needed for extended period

Extended release: 50 mg PO q12hr initially; titrated to balance individual tolerance with efficacy; typical range, 100-250 mg PO q12hr

Dosage Modifications

Renal impairment

  • CrCl ≥30 mL/min : Dosage adjustment not required
  • CrCl <30 mL/min: Not recommended

Hepatic impairment

  • Mild: Dosage adjustment not required
  • Moderate: 50 mg immediate release q8hr initially; dosing frequency not to exceed 3 times daily; alternatively, 50 mg PO q24hr extended release; not to exceed 100 mg/day
  • Severe: Not recommended

Dosing considerations

Conversion from immediate release to extended release formulation

  • Use same total daily dose but divide into 2 equal doses and administer q12hr

Conversion from other opioids to tapentadol extended release

  • 50 mg PO q12hr initially

Conversion from methadone to extended release tapentadol

  • Ratio between methadone and other opioid agonists varies widely; close monitoring required when converting methadone to another opioid as methadone has a long half-life and can accumulate in plasma

Discontinuation of therapy

  • Decrease previous daily dose by 25-50% each day every 2-4 days; monitor for signs or symptoms of withdrawal; in the event of withdrawal symptoms, increase dose to previous level and then reduce dose more gradually by increasing interval between dose reductions, increasing amount of daily dose reduction or both

Dose titration

  • Titrate every 3 days to effective dose in increments of 50 mg

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

Initiate dosage at lower end of range

Next:

Interactions

Interaction Checker

and tapentadol

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (4)

            • alvimopan

              alvimopan, tapentadol. 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.

            • rasagiline

              rasagiline increases toxicity of tapentadol by unknown mechanism. Contraindicated. Concomitant MAOI therapy within the last 14 days is contraindicated. Risk of hypotension, hyperpyrexia, somnolence, or death. .

            • safinamide

              tapentadol, safinamide. Either increases toxicity of the other by serotonin levels. Contraindicated. Concomitant use could result in life-threatening serotonin syndrome.

            • selegiline

              selegiline increases toxicity of tapentadol by unknown mechanism. Contraindicated. At least 14 days should elapse between the discontinuation of a MAO-inhibiting drug and the initiation of tapentadol.

            Serious - Use Alternative (30)

            • benzhydrocodone/acetaminophen

              benzhydrocodone/acetaminophen, tapentadol. 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.

            • buprenorphine

              buprenorphine, tapentadol. 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, tapentadol. 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, tapentadol. 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

              tapentadol, 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 tapentadol by decreasing metabolism. Avoid or Use Alternate Drug.

            • clonidine

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

            • diazepam intranasal

              diazepam intranasal, tapentadol. 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

              tapentadol, 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, tapentadol. 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, tapentadol. 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, tapentadol. 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, tapentadol. 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.

            • hydrocodone

              hydrocodone, tapentadol. 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 tapentadol by unknown mechanism. Avoid or Use Alternate Drug. Risk of hypotension, hyperpyrexia, somnolence, or death; separate by 14 d.

            • linezolid

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

            • metoclopramide intranasal

              tapentadol, 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, tapentadol. 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 increases toxicity of tapentadol by 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.

            • pentazocine

              pentazocine, tapentadol. 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 tapentadol by unknown mechanism. Avoid or Use Alternate Drug. Risk of hypotension, hyperpyrexia, somnolence, or death; separate by 14 d.

            • procarbazine

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

            • selegiline transdermal

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

            • selinexor

              selinexor, tapentadol. 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

              tapentadol, 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, tapentadol. 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.

            • tedizolid

              tedizolid, tapentadol. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • tramadol

              tramadol, tapentadol. 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 tapentadol by unknown mechanism. Avoid or Use Alternate Drug. Risk of hypotension, hyperpyrexia, somnolence, or death; separate by 14 d.

            • valerian

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

            Monitor Closely (218)

            • albuterol

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

            • alfentanil

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

            • almotriptan

              almotriptan and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • alprazolam

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

            • amitriptyline

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

              amitriptyline and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • amobarbital

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

            • amoxapine

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

              amoxapine and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • apomorphine

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

            • arformoterol

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

            • aripiprazole

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

            • armodafinil

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

            • azelastine

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

            • baclofen

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

            • belladonna and opium

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

            • benperidol

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

            • benzphetamine

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

            • brexanolone

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

            • brompheniramine

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

            • buprenorphine

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

            • buprenorphine buccal

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

            • buprenorphine, long-acting injection

              tapentadol 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.

            • bupropion

              bupropion and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • butabarbital

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

            • butalbital

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

            • butorphanol

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

            • caffeine

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

            • carbinoxamine

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

            • carisoprodol

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

            • cenobamate

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

            • chloral hydrate

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

            • chlordiazepoxide

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

            • chlorpheniramine

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

            • chlorpromazine

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

            • chlorzoxazone

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

            • cinnarizine

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

            • citalopram

              citalopram and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • clemastine

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

            • clobazam

              tapentadol, clobazam. Other (see comment). Use Caution/Monitor. Comment: Concomitant administration can increase the potential for CNS effects (e.g., increased sedation or respiratory depression).

            • clomipramine

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

              clomipramine and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • clonazepam

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

            • clorazepate

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

            • clozapine

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

            • codeine

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

            • cyclizine

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

            • cyclobenzaprine

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

              cyclobenzaprine and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • cyproheptadine

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

            • dantrolene

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

            • desflurane

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

            • desipramine

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

              desipramine and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • desvenlafaxine

              desvenlafaxine and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • deutetrabenazine

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

            • dexchlorpheniramine

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

            • dexfenfluramine

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

            • dexmedetomidine

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

            • dexmethylphenidate

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

            • dextroamphetamine

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

            • dextromoramide

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

            • diamorphine

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

            • diazepam

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

            • diethylpropion

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

            • difenoxin hcl

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

            • dimenhydrinate

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

            • diphenhydramine

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

            • diphenoxylate hcl

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

            • dipipanone

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

            • dobutamine

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

            • dopamine

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

            • dopexamine

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

            • dosulepin

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

            • doxepin

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

              doxepin and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • doxylamine

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

            • droperidol

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

            • duloxetine

              duloxetine and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • eletriptan

              eletriptan and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • eltrombopag

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

            • ephedrine

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

            • epinephrine

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

            • epinephrine racemic

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

            • escitalopram

              escitalopram and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • esketamine intranasal

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

            • estazolam

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

            • ethanol

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

              ethanol, tapentadol. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Monitor for additive respiratory and CNS depressant effects (hypoventilation, hypotension, sedation) during concomitant use; reduce dose of each agent.

            • etomidate

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

            • fenfluramine

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

            • flibanserin

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

            • fluoxetine

              fluoxetine and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • fluphenazine

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

            • flurazepam

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

            • fluvoxamine

              fluvoxamine and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • formoterol

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

            • frovatriptan

              frovatriptan and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • gabapentin

              gabapentin, tapentadol. 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, tapentadol. 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

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

            • hydromorphone

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

            • hydroxyzine

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

            • iloperidone

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

            • imipramine

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

              imipramine and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • isocarboxazid

              isocarboxazid and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • isoproterenol

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

            • ketamine

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

            • ketotifen, ophthalmic

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

            • lasmiditan

              lasmiditan, tapentadol. 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, tapentadol. 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

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

            • levomilnacipran

              levomilnacipran and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • levorphanol

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

            • linezolid

              linezolid and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • lisdexamfetamine

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

            • lofepramine

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

            • lofexidine

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

            • loprazolam

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

            • lorazepam

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

            • lormetazepam

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

            • loxapine

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

            • loxapine inhaled

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

            • lurasidone

              lurasidone, tapentadol. 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

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

            • marijuana

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

            • melatonin

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

            • meperidine

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

              meperidine and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • meprobamate

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

            • metaproterenol

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

            • metaxalone

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

            • methadone

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

            • methamphetamine

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

            • methocarbamol

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

            • methylene blue

              methylene blue and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • methylenedioxymethamphetamine

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

            • midazolam

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

            • midazolam intranasal

              midazolam intranasal, tapentadol. 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

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

            • milnacipran

              milnacipran and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • mirtazapine

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

              mirtazapine and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • modafinil

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

            • morphine

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

            • motherwort

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

            • moxonidine

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

            • nabilone

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

            • nalbuphine

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

            • naratriptan

              naratriptan and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • nefazodone

              nefazodone and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • norepinephrine

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

            • nortriptyline

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

              nortriptyline and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • olanzapine

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

            • oliceridine

              oliceridine, tapentadol. 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.

              tapentadol, oliceridine. Either increases effects of the other by serotonin levels. Modify Therapy/Monitor Closely.

            • opium tincture

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

            • orphenadrine

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

            • oxazepam

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

            • oxycodone

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

            • oxymorphone

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

            • paliperidone

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

            • papaveretum

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

            • papaverine

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

            • paroxetine

              paroxetine and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • pegvisomant

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

            • pentazocine

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

            • pentobarbital

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

            • perampanel

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

            • perphenazine

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

            • phendimetrazine

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

            • phenelzine

              phenelzine and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • phenobarbital

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

            • phentermine

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

            • phenylephrine

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

            • phenylephrine PO

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

            • pholcodine

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

            • pimozide

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

            • pirbuterol

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

            • pregabalin

              pregabalin, tapentadol. 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 tapentadol both increase sedation. Use Caution/Monitor.

            • prochlorperazine

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

            • promethazine

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

            • propofol

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

            • propylhexedrine

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

            • protriptyline

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

              protriptyline and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • quazepam

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

            • quetiapine

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

            • ramelteon

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

            • rasagiline

              rasagiline and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • remimazolam

              remimazolam, tapentadol. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely. aCoadministration 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

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

            • rizatriptan

              rizatriptan and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • salmeterol

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

            • scullcap

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

            • secobarbital

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

            • selegiline

              selegiline and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • selegiline transdermal

              selegiline transdermal and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • sertraline

              sertraline and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • sevoflurane

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

            • shepherd's purse

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

            • stiripentol

              stiripentol, tapentadol. 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

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

            • sumatriptan

              sumatriptan and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • sumatriptan intranasal

              sumatriptan intranasal and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • suvorexant

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

            • temazepam

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

            • terbutaline

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

            • thioridazine

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

            • thiothixene

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

            • topiramate

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

            • tramadol

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

              tramadol and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • tranylcypromine

              tranylcypromine and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • trazodone

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

              trazodone and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • triazolam

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

            • triclofos

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

            • trifluoperazine

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

            • trimipramine

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

              trimipramine and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • triprolidine

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

            • venlafaxine

              venlafaxine and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • verapamil

              verapamil and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • vilazodone

              vilazodone and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • xylometazoline

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

            • yohimbine

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

            • ziconotide

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

            • ziprasidone

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

            • zolmitriptan

              zolmitriptan and tapentadol both increase serotonin levels. Modify Therapy/Monitor Closely.

            • zotepine

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

            Minor (6)

            • brimonidine

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

            • dextroamphetamine

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

            • eucalyptus

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

            • lidocaine

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

            • sage

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

            • ziconotide

              ziconotide, tapentadol. 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 (30%)

            Dizziness (24%)

            Vomiting (18%)

            Somnolence (15%)

            1-10% (selected)

            Constipation (8%)

            Pruritus (5%)

            Xerostomia (4%)

            Fatigue (3%)

            Hyperhidrosis (3%)

            Anorexia (2%)

            Dyspepsia (2%)

            Insomnia (2%)

            Postmarketing Reports

            Anaphylaxis, angioedema, anaphylactic shock

            Psychiatric disorders: Hallucinations, suicidal ideation, panic attack

            Nervous system disorders: Headache

            Gastrointestinal disorders: Diarrhea

            Cardiac disorders: Palpitations

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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 alcohol

            • Instruct patients not to consume alcoholic beverages or use prescription or nonprescription products that contain alcohol
            • Coingestion of alcohol may cause rapid release of opioid content from long-acting tablet/capsule and result in increased plasma levels and a potentially fatal overdose

            Interaction with benzodiazepines and other 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

            Contraindications

            Hypersensitivity (eg, anaphylaxis, angioedema)

            Significant respiratory depression

            Acute or severe asthma

            Hypercarbia in unmonitored setting or in absence of resuscitative equipment

            Gastrointestinal obstruction, including suspected paralytic ileus

            Coadministration with monoamine oxidase inhibitors (MAOIs) or use within 14 days

            Cautions

            Conditions with risk for respiratory depression (particularly in patients who are elderly or debilitated or have comorbid conditions with hypoxia, hypercarbia, or airway obstruction)

            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

            Avoid dosing errors that may result from confusion between mg and mL when prescribing, dispensing, and administering oral solution; ensure the dose is communicated clearly and dispensed accurately; always use the enclosed calibrated syringe when administering drug to ensure the dose is measured and administered accurately; do not use teaspoon or tablespoon to measure a dose; a household teaspoon or tablespoon is not an adequate measuring device; health care providers should recommend a calibrated device that can measure and deliver prescribed dose accurately, and instruct caregivers to use extreme caution in measuring dosage

            In patients who may be susceptible to intracranial effects of CO2 retention (e.g., 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

            May cause drowsiness (use with caution when driving or operating machinery)

            Instruct patients not to consume alcoholic beverages or use prescription or nonprescription products containing alcohol, other opioids, or drugs of abuse

            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

            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 (e.g., 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

            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

            May prevent/obscure diagnosis of acute abdominal conditions

            Avoid use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., 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

            Addiction can occur in patients appropriately prescribed therapy; addiction can occur at recommended dosages and if drug is misused or abused

            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

            Profound sedation, respiratory depression, coma, and death may result from concomitant administration with benzodiazepines or other CNS depressants (e.g., 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

            Abrupt discontinuance may precipitate withdrawal symptoms (eg, anxiety, sweating, insomnia, rigors, pain, nausea, tremors, hallucinations)

            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 in CNS depression, hepatic/renal impairment, hypothyroidism, prostatic hyperplasia, respiratory disease, or seizures

            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

            Long-acting opioids

            • Schedule II opioid analgesics expose users to the risks of addiction, abuse, and misuse; there is a greater risk for overdose and death with extended-release opioids due to the larger amount of active opioid present (see Black Box Warnings)
            • Addiction, abuse, and misuse risks are increased in patients with a personal or family history of substance abuse or mental illness (eg, major depression); the potential for these risks should not, however, prevent the prescribing of proper pain management in any given patient; intensive monitoring is necessary
            • Serious, life-threatening, or fatal respiratory depression reported; 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
            • Accidental exposure reported, including fatalities
            • Neonatal opioid withdrawal syndrome reported with long-term use during pregnancy
            • Interactions with CNS depressants (eg, alcohol, sedatives, anxiolytics, hypnotics, neuroleptics, other opioids) can cause additive effects and increase risk for respiratory depression, profound sedation, and hypotension
            • Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients

            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 opioids 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 Severe fetal bradycardia reported when administered during labor; naloxone may reverse these effects; although there are no reports of fetal bradycardia earlier in pregnancy, it is possible it may occur; drug should be used in pregnancy only if clearly needed, if potential benefit outweighs risk to fetus, and if appropriate measures such as fetal monitoring are taken to detect and manage potential adverse effect on fetus

            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

            Drug is present in breast milk; published lactation studies report variable concentrations of drug in breast milk with administration of immediate-release formulation to nursing mothers in early postpartum period

            The developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy; capsules and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition

            Monitor infants exposed to drug through breast milk for excess sedation and respiratory depression; withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast- feeding 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

            Mu-opioid agonist; inhibits ascending pain pathways, thus altering response to pain; produces analgesia, respiratory depression, and sedation; also inhibits reuptake of norepinephrine, which also affects ascending pain pathways

            Absorption

            Bioavailability: 32% (single dose, fasting)

            Peak plasma time: Immediate release, 1.25 hr; extended release, 3-6 hr

            Distribution

            Protein bound: 20%

            Vd: 540 L (IV)

            Metabolism

            Metabolized via glucuronidation (97%)

            Elimination

            Half-life: Immediate release, 4 hr; extended release, 5-6 hr

            Excretion: Urine (99%)

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            Nucynta oral
            -
            50 mg tablet
            Nucynta oral
            -
            75 mg tablet
            Nucynta oral
            -
            100 mg tablet
            Nucynta ER oral
            -
            150 mg tablet
            Nucynta ER oral
            -
            100 mg tablet
            Nucynta ER oral
            -
            50 mg tablet
            Nucynta ER oral
            -
            200 mg tablet
            Nucynta ER oral
            -
            250 mg tablet

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            Patient Handout

            Patient Education
            tapentadol oral

            TAPENTADOL - ORAL

            (ta-PEN-ta-dol)

            COMMON BRAND NAME(S): Nucynta

            WARNING: Tapentadol has a risk for abuse and addiction, which can lead to overdose and death. Tapentadol may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you take the smallest dose of tapentadol 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 tapentadol 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.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: Tapentadol is used to help relieve moderate to severe short-term pain (such as pain from an injury or after surgery). It belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain.

            HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking tapentadol and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth as directed by your doctor. You may take this drug with or without food. If you have nausea, it may help to take this drug with food. Ask your doctor or pharmacist about other 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. Properly stop the medication when so directed.Pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.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, constipation, 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.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: confusion, interrupted breathing during sleep (sleep apnea), stomach/abdominal pain, difficulty urinating, 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 serious side effects, including: slow/shallow breathing, fainting, seizures, severe drowsiness/difficulty waking up.This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.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 tapentadol, tell your doctor or pharmacist if you are allergic to it; 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 seizures, head injury, tumor), 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, constipation, diarrhea due to infection, paralytic ileus), 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 this drug, especially slow/shallow breathing, confusion, constipation, dizziness, and drowsiness.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 medication passes into breast milk. It 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: certain pain medications (mixed opioid agonist-antagonists such as pentazocine, nalbuphine, butorphanol), naltrexone.Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/"ecstasy," St. John's wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.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 (amylase/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, seizures, 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.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.