hydromorphone (Rx)

Brand and Other Names:Dilaudid, Dilaudid-HP, more...Exalgo
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet: Schedule II

  • 2mg
  • 4mg
  • 8mg

tablet, extended-release: Schedule II

  • 8mg
  • 12mg
  • 16mg
  • 32mg

injection solution

  • 1mg/mL
  • 2mg/mL
  • 4mg/mL

injection solution, preservative free: Schedule II

  • 10mg/mL

oral liquid: Schedule II

  • 5mg/5mL

suppository: Schedule II

  • 3mg

Prefilled syringe: Schedule II

  • 0.2 mg/mL
  • 0.6 mg/mL

Moderate-to-Severe Pain

Indicated for moderate-to-severe pain

PO

  • Immediate-release: 2-4 mg q4-6hr PRN; a gradual increase in dose may be required
  • Oral liquid (usual dose): 2.5-10 mg (2.5-10 mL) q3-6hr PRN

SC/IM

  • 1-2 mg q2-3hr PRN; adjust dose according to pain and adverse effects
  • IM dose not recommended for use as it may result in variable absorption and lag time to peak effect

IV

  • Opioid naive: 0.2-1 mg IV q2-3hr PRN; may require higher doses in patients with prior opioid exposure
  • Critically ill patients (opiate-naive patients): 0.2-0.6 mg q1-2hr PRN given slowly over 2-3 minutes; patients with previous opiate exposure may tolerate higher doses
  • Continuous infusion: 0.5-3 mg/hr, titrated to response

Patient-controlled analgesia

  • Usual concentration, 0.2 mg/mL; demand dose, 0.1-0.2 mg; dose range is 0.05-0.4 mg
  • Lockout interval: 5-10 minutes

Rectal

  • 3 mg PR q6-8hr

Chronic Severe Pain

Long-acting (Exalgo) is indicated for the management of pain in opioid tolerant patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate

Opioid tolerant patients only (extended-release:) 8-64 mg PO qDay; may administer a starting dose equivalent to patient's total daily oral hydromorphone dose administered once daily with or without food

Should address pain relief and adverse events frequently; increase dose no more frequently than q3-4days; may titrate with increases of 25-50% of current daily dose; consider increasing dose if more than 2 doses of rescue medications are needed within 24hr within 2 consecutive days

Extented-release tablets should be swallowed whole; crushing, dividing, or dissolving will release opioid content all at once and increase risk of respiratory depression and death

Converting to Exalgo

  • Conversion from other oral hydromorphone formulations: Start with equivalent total daily dose of immediate release formulation and administer once daily; may titrate q3-4days until adequate pain relief with tolerable adverse effects achieved
  • Conversion from other opioids: Start Exalgo dose at 50% of calculated daily dose q24hr; titrate until adequate pain relief with tolerable adverse effects achieved
  • Conversion from transdermal fentanyl to Exalgo: Start Exalgo 18 hr after removal of transdermal fentanyl patch at 50% of calculated total daily dose given over 24hr; for a 25 mcg/hr fentanyl patch the equianalgesic dose is 12 mg PO q24hr
  • Discontinuation of Exalgo therapy: Taper gradually by decreasing dose by 25-50% q2-3days to a dose of 8 mg PO q24hr before discontinuing

Opioid-tolerant definition

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

Cough (Off-label)

1 mg PO q3-4hr PRN

Dosing Consideration

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 for acute pain or as a 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)

Dosage Forms & Strengths

tablet: Schedule II

  • 2mg
  • 4mg
  • 8mg

oral liquid: Schedule II

  • 5mg/5mL

injection solution

  • 1mg/mL
  • 2mg/mL
  • 4mg/mL

suppository: Schedule II

  • 3mg

Pain (Off-label)

Moderate-to-severe pain

Children: 0.03-0.08 mg/kg PO q4-6hr PRN; not to exceed 5 mg/dose  

Adolescents: 1-4 mg/dose PO q4-6hr PRN

Children: 0.015 mg/kg IV q4-6hr PRN

Adolescents: 1-2 mg/dose IV/IM.SC q4-6hr

Patient Controlled Anesthesia (Off-label)

Loading dose: 8 mcg/kg IV bolus

Demand dose (initial): 2 mcg/kg IV with a lockout time of 10 min

Pain

Indicated for moderate-to-severe pain

2-4 mg PO q4-6hr PRN; a gradual increase in dose may be required

Dosing Considerations

Titrate dose to effect; oral and parenteral doses are not equivalent; because parenteral dose 5 times more potent than oral dose, administer one fifth of oral dose when changing to parenteral route

Oral dose: Initiate at low end of dosage range; consider lowering dose by 25-50% in patients >70 years

IV: Reduce initial dose to 0.2 mg q2-3hr

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Interactions

Interaction Checker

and hydromorphone

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            Contraindicated (1)

            • alvimopan

              alvimopan, hydromorphone. 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 (44)

            • benzhydrocodone/acetaminophen

              benzhydrocodone/acetaminophen, hydromorphone. 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 hydromorphone 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, hydromorphone. 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, hydromorphone. 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, hydromorphone. 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

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

            • citalopram

              hydromorphone, citalopram. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.

            • clonidine

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

            • diazepam intranasal

              diazepam intranasal, hydromorphone. 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

              hydromorphone, 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. .

            • escitalopram

              hydromorphone, escitalopram. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.

            • fentanyl

              fentanyl, hydromorphone. 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, hydromorphone. 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, hydromorphone. 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, hydromorphone. 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 hydromorphone by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug.

              hydromorphone, fluoxetine. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.

            • fluvoxamine

              fluvoxamine and hydromorphone both increase serotonin levels. Avoid or Use Alternate Drug.

            • hydrocodone

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

            • linezolid

              linezolid increases toxicity of hydromorphone 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 hydromorphone by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug.

            • methylene blue

              methylene blue and hydromorphone both increase serotonin levels. Avoid or Use Alternate Drug. If drug combination must be administered, monitor for evidence of serotonergic or opioid-related toxicities

            • metoclopramide intranasal

              hydromorphone, 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, hydromorphone. 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 hydromorphone 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 hydromorphone by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug.

              hydromorphone, paroxetine. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.

            • pentazocine

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

            • prasugrel

              hydromorphone 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 hydromorphone 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 hydromorphone by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug.

            • rasagiline

              rasagiline increases toxicity of hydromorphone 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

              selegiline increases toxicity of hydromorphone by unknown mechanism. Avoid or Use Alternate Drug. At least 14 days should elapse between the discontinuation of a MAO-inhibiting drug and the initiation of hydromorphone.

            • selegiline transdermal

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

            • selinexor

              selinexor, hydromorphone. 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.

            • sertraline

              hydromorphone, sertraline. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.

            • sodium oxybate

              hydromorphone, 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, hydromorphone. 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

              hydromorphone 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 C

            • tramadol

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

            • valerian

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

            • vortioxetine

              hydromorphone, vortioxetine. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.

            Monitor Closely (207)

            • albuterol

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

            • alfentanil

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

            • alprazolam

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

            • amiodarone

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

            • amitriptyline

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

            • amobarbital

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

            • amoxapine

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

            • apomorphine

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

            • arformoterol

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

            • aripiprazole

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

            • armodafinil

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

            • artemether/lumefantrine

              artemether/lumefantrine will increase the level or effect of hydromorphone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • asenapine

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

            • azelastine

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

            • baclofen

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

            • belladonna and opium

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

            • benperidol

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

            • benzphetamine

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

            • brexanolone

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

            • brompheniramine

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

            • buprenorphine

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

            • buprenorphine buccal

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

            • buprenorphine, long-acting injection

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

            • butabarbital

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

            • butalbital

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

            • butorphanol

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

            • caffeine

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

            • carbinoxamine

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

            • carisoprodol

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

            • celecoxib

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

            • chloral hydrate

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

            • chlordiazepoxide

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

            • chloroquine

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

            • chlorpheniramine

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

            • chlorpromazine

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

            • chlorzoxazone

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

            • cimetidine

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

            • cinnarizine

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

            • clemastine

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

            • clobazam

              hydromorphone, 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

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

            • clonazepam

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

            • clorazepate

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

            • clozapine

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

            • codeine

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

            • cyclizine

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

            • cyclobenzaprine

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

            • cyproheptadine

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

            • dantrolene

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

            • darifenacin

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

            • desflurane

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

            • desipramine

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

            • desvenlafaxine

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

            • deutetrabenazine

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

            • dexchlorpheniramine

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

            • dexfenfluramine

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

            • dexmedetomidine

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

            • dexmethylphenidate

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

            • dextroamphetamine

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

            • dextromoramide

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

            • diamorphine

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

            • diazepam

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

            • dichlorphenamide

              dichlorphenamide and hydromorphone both decrease serum potassium. Use Caution/Monitor.

            • diethylpropion

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

            • difenoxin hcl

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

            • dimenhydrinate

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

            • diphenhydramine

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

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

            • diphenoxylate hcl

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

            • dipipanone

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

            • dobutamine

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

            • dopamine

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

            • dopexamine

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

            • dosulepin

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

            • doxepin

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

            • doxylamine

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

            • dronedarone

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

            • droperidol

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

            • duloxetine

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

            • eltrombopag

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

            • ephedrine

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

            • epinephrine

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

            • epinephrine racemic

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

            • esketamine intranasal

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

            • estazolam

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

            • ethanol

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

            • etomidate

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

            • fenfluramine

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

            • flibanserin

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

            • fluphenazine

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

            • flurazepam

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

            • formoterol

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

            • gabapentin

              gabapentin, hydromorphone. 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, hydromorphone. 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 hydromorphone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

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

            • hydroxyzine

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

            • iloperidone

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

            • imipramine

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

            • isoproterenol

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

            • ketamine

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

            • ketotifen, ophthalmic

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

            • lasmiditan

              lasmiditan, hydromorphone. 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, hydromorphone. 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

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

            • levorphanol

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

            • lisdexamfetamine

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

            • lofepramine

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

            • lofexidine

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

            • loprazolam

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

            • lorazepam

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

            • lormetazepam

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

            • loxapine

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

            • loxapine inhaled

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

            • lurasidone

              lurasidone, hydromorphone. 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

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

            • maraviroc

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

            • marijuana

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

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

            • melatonin

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

            • meperidine

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

            • meprobamate

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

            • metaproterenol

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

            • metaxalone

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

            • methadone

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

            • methamphetamine

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

            • methocarbamol

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

            • methylenedioxymethamphetamine

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

            • midazolam

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

            • midazolam intranasal

              midazolam intranasal, hydromorphone. 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

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

            • mirtazapine

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

            • modafinil

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

            • morphine

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

            • motherwort

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

            • moxonidine

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

            • nabilone

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

            • nalbuphine

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

            • norepinephrine

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

            • nortriptyline

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

            • olanzapine

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

            • oliceridine

              oliceridine, hydromorphone. 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

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

            • orphenadrine

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

            • oxazepam

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

            • oxycodone

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

            • oxymorphone

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

            • paliperidone

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

            • papaveretum

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

            • papaverine

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

            • parecoxib

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

            • pegvisomant

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

            • pentazocine

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

            • pentobarbital

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

            • perampanel

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

            • perphenazine

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

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

            • phendimetrazine

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

            • phenobarbital

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

            • phentermine

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

            • phenylephrine

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

            • phenylephrine PO

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

            • pholcodine

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

            • pimozide

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

            • pirbuterol

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

            • pregabalin

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

            • prochlorperazine

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

            • promethazine

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

            • propafenone

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

            • propofol

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

            • propylhexedrine

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

            • protriptyline

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

            • quazepam

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

            • quetiapine

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

            • quinacrine

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

            • ramelteon

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

            • ranolazine

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

            • remimazolam

              remimazolam, hydromorphone. 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

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

            • ritonavir

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

            • salmeterol

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

            • scullcap

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

            • secobarbital

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

            • sertraline

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

            • sevoflurane

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

            • shepherd's purse

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

            • stiripentol

              stiripentol, hydromorphone. 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

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

            • suvorexant

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

            • tapentadol

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

            • temazepam

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

            • terbutaline

              hydromorphone 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 hydromorphone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

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

            • thiothixene

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

            • tipranavir

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

            • topiramate

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

            • tramadol

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

            • trazodone

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

            • triazolam

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

            • triclofos

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

            • trifluoperazine

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

            • trimipramine

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

            • triprolidine

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

            • venlafaxine

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

            • xylometazoline

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

            • yohimbine

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

            • ziconotide

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

            • ziprasidone

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

            • zotepine

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

            Minor (6)

            • brimonidine

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

            • dextroamphetamine

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

            • eucalyptus

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

            • lidocaine

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

            • sage

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

            • ziconotide

              ziconotide, hydromorphone. 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

            Frequency Not Defined

            Anticholinergic: Dry mouth, palpitation, tachycardia, urinary retention

            Cardiovascular: Angina pectoris, bradycardia, cardiac arrest, circulatory depression, myocardial infarction, QT-interval prolongation, severe cardiac arrhythmias, shock, ST-segment elevation, syncope, ventricular tachycardia

            Central nervous system (CNS): Agitation, coma, dizziness, dysphoria, mental clouding or depression, euphoria, faintness, nervousness, restlessness, sedation, seizures, visual disturbances, weakness

            Gastrointestinal (GI): Constipation, nausea, vomiting, anorexia, abdominal distention, bilieary tract spasm, decreased appetite, decreased intestinal motility, gastroesophageal reflux disease, paralytic ileus,

            Respiratory: Respiratory depression, respiratory arrest, hypoxia, bronchospasm, dyspnea, rhinorrhea, flu-like symptoms (Exalgo)

            Other: Flushing, pruritus, sweating, urticaria, skin rash, hyperhidrosis, warmness of face/neck/upper thorax

            Postmarketing Reports

            Confusional state, convulsions, drowsiness, dyskinesia, erectile dysfunction, fatigue, hepatic enzymes increased, hyperalgesia, hypersensitivity reaction, lethargy, myoclonus, oropharyngeal swelling, peripheral edema, and somnolence, serotonin syndrome, adrenal insufficiency, anaphylaxis, androgen deficiency

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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

            Hydromorphone high-potency formulation

            • Hydromorphone high-potency injection is highly concentrated solution of hydromorphone, a potent Schedule II controlled opioid agonist intended for use in opioid-tolerant patients; it is not to be confused with standard parenteral formulations of hydromorphone or other opioids; overdose and death could result
            • Use caution to avoid confusing the highly concentrated (Dilaudid-HP) injection with the less concentrated (Dilaudid) injectable product
            • Schedule II opioid agonists (eg, morphine, oxymorphone, oxycodone, fentanyl, methadone) have highest potential for abuse and risk of producing respiratory depression
            • Alcohol, other opioids, and CNS depressants (eg, sedative-hypnotics) potentiate respiratory depressant effects of hydromorphone, increasing risk of respiratory depression that might result in death
            • Accidental intake may lead to fatal overdose, especially in children High potential for abuse

            Risk of medication errors

            • Ensure accuracy when prescribing, dispensing, and administering oral Solution; dosing errors due to confusion between mg and mL can result in accidental overdose and death

            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

            Risks from concomitant use with benzodiazepines or other CNS depressants

            • Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
            • Reserve concomitant prescribing of oral solution or tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate
            • Limit dosages and durations to the minimum required
            • Follow patients for signs and symptoms of respiratory depression and sedation

            Contraindications

            Hypersensitivity

            Dilaudid Liquid and Tablets

            • Obstetrical analgesia
            • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
            • Known or suspected gastrointestinal obstruction, including paralytic ileus
            • Hypersensitivity to hydromorphone, hydromorphone salts, any other components of the product, or sulfite-containing medications (e.g., anaphylaxis)

            Suppository

            • Increased intracranial pressure resulting from intracranial lesion; conditions resulting in depressed ventilatory function including COPD, emphysema, status asthmaticus, kyphoscoliosis, cor pulmonale

            Dilaudid injection

            • Dilaudid HP: Paralytic ileus, opioid nontolerant patients, known ro suspected pre-existing GI surgery or diseases resulting in narrowing of GI tract loops in the GI tract or GI obstruction
            • Dilaudid HP is contraindicated in non-opioid tolerant patients

            Extended-release (Exalgo)

            • Opioid nontolerant patients
            • Paralytic ileus, opioid nontolerant patients, known ro suspected pre-existing GI surgery or diseases resulting in narrowing of GI tract loops in the GI tract or GI obstruction
            • Significant respiratory depression
            • Acute or severe bronchial asthma

            Cautions

            Dosing errors can result in accidental overdose and death; ensure dose is communicated clearly and dispensed accurately; a household teaspoon or tablespoon is not an adequate measuring device; given inexactitude of household spoon measure and possibility of using a tablespoon instead of a teaspoon, which could lead to overdosage, the enclosed measuring device should be used or a calibrated measuring device obtained from the pharmacist; health care providers should recommend a calibrated device that can measure and deliver the prescribed dose accurately, and instruct caregivers to use extreme caution in measuring the dosage

            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

            The oral solution or tablets are 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

            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

            Patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a 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; monitor such patients closely, particularly when initiating and titrating dosages

            Do not abruptly discontinue buprenorphine 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

            May impair physical or mental abilities; use caution when performing work that require mental alertness such as operating machinery or driving

            Myoclonus and seizures reported with high doses; use caution in patients with history of seizure disorders

            Use with caution in patients with hypersensitivity reactions to other phenanthrene derivative opioid agonists, including codeine, hydrocodone, levorphanol, oxycodone, oxymorphone

            May cause hyptension especially in patients with cardiovascular disease or hypovolemia; may cause severe hypertension, including orthostatic hypotension and syncope; use caution in patients taking drugs that may exagerate hypotensive effects, including phenothiazines or general anesthetics; avoid use in patients with circultory shock; may reduce cardiac output and blood pressure

            May prevent diagnosis of patients with acute abdominal conditions

            Use caution in patients with biliary tract dysfunction

            Use caution in patients with inflammatory or obstructive bowel disorder, acute pancreatitis secondary to biliary tract disease, and patients undergoing biliary surgery

            Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use; if adrenal insufficiency suspected, confirm diagnosis with diagnostic testing as soon as possible; if 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 different opioid without recurrence of adrenal insufficiency

            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

            Use cuation in delirium tremens

            Long-term opioid use may cause secondary hypogonadism, which may lead to sexual dysfunction, infertility, mood disorders, and osteoporosis

            Use caution in renal/hepatic impairment, obesity, prostatic hyperplasia/urinary stricture, psychoses, respiratory disease or thyroid dysfunction

            Use within 14 days of MAO intake not recommended

            Controlled-release formulation should only be used when continuous analgesia is required over an extended period of time; not for use PRN

            IM formulation may result in variable absorption and a lag time to peak effect

            Tailor opioid-containing analgesic regimen to each patient's needs

            May cause constipation; consider preventive measures to reduce potential of constipation; use with caution in patients with chronic constipation

            Use caution in patients who are morbidly obese

            Some formulations may contain lactose; consider lactose content prior to initiating therapy in patients with hereditary disease of galatose intolerance

            Vial stoppers of single-dose injectable vials may contain latex

            Some dosage forms may contain trace amounts of sodium metabisulfite, which may cause allergic reactions

            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)
            • Although risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed opiates; addiction can occur at recommended dosages; assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing; monitor all patients receiving therapy for the development of these behaviors and conditions; potential for these risks should not prevent proper management of pain in any given patient; intensive monitoring is necessary
            • Serious, life-threatening, or fatal respiratory depression reported with use of opioids, even when used as recommended; management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on patient’s clinical status
            • Risk of respiratory depression is greatest during initiation of therapy or following a dosage increase; monitor patients closely for respiratory depression, especially within first 24-72 hr of initiating therapy and following dosage increases
            • Accidental exposure reported, including fatalities (see Black Box Warnings)
            • Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts; advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available (see Black Box Warnings)
            • Profound sedation, respiratory depression, coma, and death may result from concomitant use with benzodiazepines or other CNS depressants; because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate; if decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe lowest effective dosages and minimum durations of concomitant use; if concomitant use is warranted, consider prescribing naloxone for emergency treatment of opioid overdose
            • 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
            • Due to risk of respiratory depression with concomitant use of skeletal muscle relaxants and opioids, consider prescribing naloxone for emergency treatment of opioid overdose

            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 category: C

            Lactation: Drug excreted in breast milk; use not recommended

            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 receptor agonist; inhibits ascending pain pathways, thus altering response to pain; main therapeutic action is analgesia

            Other pharmacologic effects include respiratory depression and sedation; suppresses cough by acting centrally in medulla

            Absorption

            Bioavailability: 62%

            Onset: 15-30 min (PO); 15 min (SC); 15 min (IM); 5 min (IV); 15-30 min (PR); 6 hr (ER)

            Duration: 3-4 hr (PO/IV); extended-release (13 hr)

            Peak plasma time: 30-60 min (PO); SC, 30-90 min; IM, 30-60 min; IV, 15-30 min; PR, 30-90 min

            Distribution

            Protein bound: 8-19%

            Vd: 4 L/kg

            Metabolism

            Metabolized in liver to CYP2D6 via conjugation with glucuronic acid to active metabolite only

            Elimination

            Half-life: 2-3 hr (immediate-release); 11 hr (extended-release)

            Excretion: Urine (primarily)

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            Administration

            IV Incompatibilities

            Additive: Sodium bicarbonate, thiopental

            Syringe: Ampicillin, diazepam, hyaluronidase, phenobarbital, phenytoin

            Y-site: Amphotericin B cholesteryl sulfate complex, diazepam, minocycline, phenobarbital, phenytoin, sargramostim, tetracycline, thiopental

            IV/IM Administration

            May be given IV, SC, or IM

            Direct injection: Dilute to 4-5 mL with NS or SWI, and administer over at least 2-3 minutes or give 2 mg over 3-5 minutes

            Intermittent administration: Dilute in 50-100 mL D5W or NS, and infuse over 15-30 minutes

            IV administration (eg, rapid IV push) has been associated with increased systemic effects, especially respiratory depression and hypotension

            Monitor patient constantly; keep resuscitation equipment and narcotic antagonist (eg, naloxone) readily available

            IV Preparation

            Direct injection: Dilute to 4-5 mL with NS or SWI

            Continuous infusion: Dilute in 100-1000 mL of D5W, NS, D5/NS, D5½NS, Ringer solution, or LR

            Solution may appear slightly yellow; this does not alter potency

            Vial stopper contains latex

            Storage

            Store at 25°C (77°F)

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            hydromorphone injection
            -
            2 mg/mL vial
            hydromorphone injection
            -
            2 mg/mL vial
            hydromorphone injection
            -
            2 mg/mL vial
            hydromorphone injection
            -
            2 mg/mL vial
            hydromorphone injection
            -
            2 mg/mL solution
            hydromorphone injection
            -
            2 mg/mL solution
            hydromorphone injection
            -
            4 mg/mL solution
            hydromorphone injection
            -
            1 mg/mL solution
            Dilaudid oral
            -
            4 mg tablet
            Dilaudid oral
            -
            2 mg tablet
            Dilaudid oral
            -
            8 mg tablet
            hydromorphone rectal
            -
            3 mg suppos
            hydromorphone oral
            -
            4 mg tablet
            hydromorphone oral
            -
            1 mg/mL liquid
            hydromorphone oral
            -
            4 mg tablet
            hydromorphone oral
            -
            2 mg tablet
            hydromorphone oral
            -
            32 mg tablet
            hydromorphone oral
            -
            12 mg tablet
            hydromorphone oral
            -
            8 mg tablet
            hydromorphone oral
            -
            16 mg tablet
            hydromorphone oral
            -
            12 mg tablet
            hydromorphone oral
            -
            4 mg tablet
            hydromorphone oral
            -
            2 mg tablet
            hydromorphone oral
            -
            4 mg tablet
            hydromorphone oral
            -
            8 mg tablet
            hydromorphone oral
            -
            2 mg tablet
            hydromorphone oral
            -
            8 mg tablet
            hydromorphone oral
            -
            2 mg tablet
            hydromorphone oral
            -
            4 mg tablet
            hydromorphone oral
            -
            8 mg tablet
            hydromorphone oral
            -
            32 mg tablet
            hydromorphone oral
            -
            16 mg tablet
            hydromorphone oral
            -
            8 mg tablet
            hydromorphone oral
            -
            8 mg tablet
            hydromorphone oral
            -
            16 mg tablet
            hydromorphone oral
            -
            8 mg tablet

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Select a drug:
            Patient Education
            hydromorphone rectal

            HYDROMORPHONE SUPPOSITORY - RECTAL

            (hye-droe-MOR-fone)

            COMMON BRAND NAME(S): Dilaudid

            WARNING: Hydromorphone has a risk for abuse and addiction, which can lead to overdose and death. Hydromorphone may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you use the smallest dose of hydromorphone that works, and use 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 use the wrong dose/strength. Using 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 use hydromorphone and what other drugs you should avoid using 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, use 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: Hydromorphone is used to treat moderate to severe pain. It acts on certain centers in the brain to give you pain relief. This medication is an opioid pain reliever.

            HOW TO USE: Wash your hands before and after using the suppository. Unwrap and insert one suppository into the rectum as directed by your doctor. Lie down on your left side with right knee bent. Gently push the suppository into the rectum with your finger. Remain lying down for a few minutes, and avoid having a bowel movement for an hour or longer so the drug will be absorbed. The suppository is for use in the rectum only.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, use the medication more frequently, or use it for a longer time than prescribed. Properly stop the medication when so directed.Pain medications work best if they are used when 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). Use 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, lightheadedness, dizziness, drowsiness, increased sweating, or dry mouth 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.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, hallucinations, confusion), difficulty urinating, vision changes, slow/fast heartbeat, severe stomach/abdominal pain, 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, seizures, 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 using hydromorphone, tell your doctor or pharmacist if you are allergic to it; or to other opioid pain medications (such as hydrocodone, morphine); 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: kidney disease, liver disease, lung disease (such as asthma, chronic obstructive pulmonary disease-COPD), a certain spinal problem (kyphoscoliosis), breathing problems (such as slow/shallow breathing, sleep apnea), certain heart problems (irregular heartbeat), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), brain disorders (such as seizures, head injury, tumor, increased intracranial pressure), underactive thyroid (hypothyroidism), difficulty urinating (for example, due to enlarged prostate or narrowed urethra), disease of the pancreas (such as pancreatitis), mental/mood disorders (such as toxic psychosis), gallbladder disease, adrenal gland problem (such as Addison's disease), intestinal disorders (such as colitis, blockage, paralytic ileus, infectious diarrhea).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).To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Before having surgery, tell your doctor or dentist that you are using this medication.Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, and 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.)This drug passes into breast milk and the effect on a nursing infant is not known. Discuss the risks and benefits with 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 butorphanol, nalbuphine, pentazocine), naltrexone, samidorphan.The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is used with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are using 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, severe drowsiness, slow heartbeat, severe dizziness, pinpoint pupils, 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 told to do so by your doctor. 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 use this medication regularly and miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store in the refrigerator between 36-46 degrees F (2-8 degrees C) away from light. Do not store in the bathroom. Keep all medicines 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. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

            Information last revised October 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.