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Patient Education

Medication Counseling



  • Tell patient to report symptoms of respiratory depression [14][10]
  • Instruct patient to avoid activities requiring mental alertness or coordination until drug effects are realized [8][4][25][10].
  • Tell patient to report symptoms of serotonin syndrome [14].
  • Side effects may include headache, nausea, vomiting, somnolence, pruritus, dizziness, or insomnia [14].
  • Instruct patient to report constipation and hypotension [25][10].
  • Advise patient to report symptoms of adrenal insufficiency [14].
  • Tell patient to report symptoms of gastrointestinal blockage [14].
  • With long-term use, advise patient against sudden discontinuation of drug. [8][4][25][10]
  • Tell patient to swallow controlled-release tablet whole Crushing, chewing, cutting or dissolving the tablet may cause rapid release and absorption of a potentially fatal dose[14].
  • Instruct patient to avoid drinking alcohol or using other CNS depressants during drug therapy. [8][4][25][10]
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    Medication Safety

    Black Box Warning

    See 'In-Depth Answers' for detailed results.


    Injection (Powder for Solution; Solution)
    • Dilaudid-HP(R) and Dilaudid(R) (HYDROmorphone hydrochloride injection high potency formulation (HPF)) are highly concentrated solutions of HYDROmorphone that are intended for use only in opioid-tolerant patients. Do not confuse Dilaudid-HP(R) or Dilaudid (R) (HYDROmorphone hydrochloride injection high potency formulation (HPF)) with standard parenteral formulations of HYDROmorphone or other opioids, as overdose and death could result. HYDROmorphone hydrochloride exposes users to risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing, and monitor regularly for development of these behaviors or conditions. Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Prolonged use of HYDROmorphone hydrochloride during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. 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. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options. Limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation [18][22].

    Oral (Solution; Tablet)
    • Ensure accuracy when prescribing, dispensing, and administering HYDROmorphone oral solution; dosing errors due to confusion between mg and mL can result in accidental overdose and death. HYDROmorphone has the potential for addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing, and monitor for development of these behaviors or conditions. Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Accidental ingestion of HYDROmorphone, especially by children, can result in fatal overdose of HYDROmorphone. Prolonged use of HYDROmorphone during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. 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. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options. Limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation [19].

    Oral (Tablet, Extended Release)
    • HYDROmorphone hydrochloride exposes users to risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing, and monitor regularly for development of these behaviors or conditions. Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Instruct patients to swallow HYDROmorphone hydrochloride extended-release tablets whole to avoid exposure to a potentially fatal dose of HYDROmorphone. Accidental consumption of HYDROmorphone hydrochloride, especially in children, can result in a fatal overdose. Prolonged use of HYDROmorphone hydrochloride during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. 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. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options. Limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation [14].
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      About

      Storage & Stability



      A) Hydromorphone Hydrochloride
      1) Preparation
      a) Subcutaneous route
      1) Preparation
      a) Reconstitute the high-potency formulation immediately prior to use with 25 mL sterile water for injection to a concentration of 10 mg/mL for IV, IM, or subQ administration [14][2].
      2) Administration
      a) Oral: Extended-release (ER) HYDROmorphone tablets/capsules (Exalgo(R), Palladone(R)) are to be swallowed whole, with or without food. To avoid rapid release and absorption of a potentially fatal dose, do not break, chew, dissolve, or crush. Do not administer ER HYDROmorphone more often than every 24 hours [12][4].
      b) Intravenous: Administer HYDROmorphone solution for injection slowly over at least 2 to 3 minutes [14][2].
      c) Intramuscular and subcutaneous: Administer high-potency HYDROmorphone solution for injection immediately after reconstitution with 25 mL sterile water for injection to a concentration of 10 mg/mL [14][2].
      B) Injection route
      1) Store at controlled room temperature in original container between 20 and 25 degrees C (68 to 77 degrees F), with excursions permitted between 15 and 30 degrees C (59 and 86 degrees F); protect from light [42].
      2) A slight yellowish discoloration of the solution can develop, but this does not affect potency [42].
      C) Oral route
      1) Solution/Tablet/Tablet, Extended Release
      a) Tablets and solution should be stored at controlled room temperature, 25 degrees C (77 degrees F), with excursions permitted between 15 and 30 degrees C (59 and 86 degrees F); protect from light [16][48].
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      Medication Safety

      Monitoring

      See 'In-Depth Answers' for detailed results.

    • Adequate analgesia is indicative of clinical efficacy.
    • Adequate pain management: Following initial dosing and periodically thereafter [14][8][4]
    • Need for continued opioid use: Throughout chronic therapy [14][6]
    • Opioid withdrawal: When converting patients to extended-release tablets [14][6]
    • Signs of addiction, abuse, or misuse: At baseline and regularly thereafter [14][6]
    • Respiratory depression: Especially within 24 to 72 hours following treatment initiation and after dose increases, and particularly in high risk patient (eg, elderly, cachectic, debilitated, preexisting respiratory depression or otherwise significantly reduced respiratory reserve, concomitant other CNS depressants) [14][6]
    • (Oral) Severe hypotension: Ambulatory patients following initiation and with dose titration, especially when ability to maintain blood pressure is compromised [14][6]
    • Sedation and respiratory depression: Patients susceptible to the intracranial effects of carbon dioxide retention (eg, increased intracranial pressure, brain lesion), particularly during initiation of therapy [14][6].
    • Exacerbation of biliary tract disease [14][6].
    • Worsened seizure control: Patients with a history of seizure disorders [14][6].
    • Respiratory or CNS depression: Elderly and patients with renal or moderate hepatic impairment during initiation of therapy and dose titration [14][6]
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    Medication Safety

    Adverse Effects

    See 'In-Depth Answers' for detailed results.

    Common
    • Dermatologic: Flushing (extended-release, less than 2% ), Pruritus (extended-release, 1% to 8% ), Sweating
    • Gastrointestinal: Constipation (extended-release, 7% to 31% ), Nausea (extended-release, 9% to 28% .), Vomiting (extended-release, 6% to 14% )
    • Neurologic: Asthenia (1% to 11% ), Dizziness (1% to 11% ), Headache (1% to 12% ), Somnolence (less than 2% )
    Serious
    • Cardiovascular: Hypotension (less than 2% ), Syncope (less than 2% )
    • Endocrine metabolic: Adrenal insufficiency
    • Neurologic: Coma, Myoclonus (less than 2% ), Raised intracranial pressure, Seizure (Less than 2% )
    • Psychiatric: Suicidal thoughts (extended-release, less than 2% )
    • Respiratory: Apnea (less than 1% ), Respiratory arrest, Respiratory depression (Less than 2% )
    • Other: Drug dependence (less than 1% ), Drug withdrawal (less than 1% ), Drug withdrawal syndrome in neonate of dependent mother
    Black Box Warning

    Dosing/Administration

    Administration

    See 'In-Depth Answers' for detailed results.


    Intramuscular
    • (high-potency formulation) reconstitute immediately prior to use with 25 mL sterile water for injection to a concentration of 10 mg/mL [4]

    Intravenous
    • (high-potency formulation) reconstitute immediately prior to use with 25 mL sterile water for injection to a concentration of 10 mg/mL [4]
    • administer slowly over at least 2 to 3 minutes [8][4]

    Oral
    • (extended-release) do not break, chew, dissolve, or crush [21][6]
    • (extended-release) may take with or without food [21][6]
    • (extended-release) do not dose more frequently than once every 24 hours [21][6]

    Subcutaneous
    • (high-potency formulation) reconstitute immediately prior to use with 25 mL sterile water for injection to a concentration of 10 mg/mL [4]
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      Dosing/Administration

      Dose Adjustments

      See 'In-Depth Answers' for detailed results.

    • (Injection) Renal impairment: Reduce initial dose by one-fourth to one-half [8][4]
    • (Oral immediate-release) Renal impairment: Reduce initial dose for moderate impairment; use even lower dosing or alternative analgesic in severe impairment [10]
    • (Oral extended-release) Renal impairment, moderate: Initiate at 50% of the normal dose for moderate impairment [14][6]
    • (Oral extended-release) Renal impairment, severe: Initiate at 25% of the normal dose or consider an alternative analgesic to permit a more flexible dosing interval [14][6]
    • (Oral immediate-release) Hepatic impairment: Reduce initial dose for moderate impairment; use even lower dosing or consider alternate agents in severe impairment [10]
    • (Oral extended-release) Hepatic impairment, moderate: Reduce the initial dose to 25% of the normal dose for moderate impairment; use alternative analgesic for severe impairment [14][6]
    • (Oral extended-release) Hepatic impairment, severe: Use alternative analgesic [14][6]
    • (Injection) Hepatic impairment, Child-Pugh B: Reduce initial dose by one-fourth to one-half; use in severe hepatic impairment, reduced initial dose is recommended, but has not been studied [8][4]
    • (Injection) Hepatic impairment, severe: Consider a reduced initial dose; this has not been studied [8][4]
    • (Oral immediate-release) Geriatric: Initiate at low end of dosing range [10].
    • (Exalgo(R) oral extended-release) Geriatric: Initiate at low end of dosing range and titrate slowly [14].
    • (Injection) Geriatric: Reduce the initial dose to 0.2 mg [8][4].
    • Concomitant use with benzodiazepines or other CNS depressants: If concomitant use is necessary, limit dosages and durations to the minimum required [18][19][14][20].
    • Special risk patients: Reduce initial dose in debilitated patients, in patients with myxedema, hypothyroidism, severe pulmonary impairment, adrenocortical insufficiency (eg, Addison disease), CNS depression or coma, toxic psychoses, prostatic hypertrophy or urethral stricture, acute alcoholism, delirium tremens, or kyphoscoliosis associated with respiratory disease [8][4]
    • Print
      Medication Safety

      Adverse Effects

      See 'In-Depth Answers' for detailed results.

      Common
      • Dermatologic: Flushing (extended-release, less than 2% ), Pruritus (extended-release, 1% to 8% ), Sweating
      • Gastrointestinal: Constipation (extended-release, 7% to 31% ), Nausea (extended-release, 9% to 28% .), Vomiting (extended-release, 6% to 14% )
      • Neurologic: Asthenia (1% to 11% ), Dizziness (1% to 11% ), Headache (1% to 12% ), Somnolence (less than 2% )
      Serious
    Dosing/Administration

    FDA Uses

    See 'In-Depth Answers' for detailed results.

    • Pain, When opioid analgesics are appropriateView additional information.
    • Pain (Moderate to Severe), Opioid-tolerantView additional information.
    • Pain (Severe), in opioid-tolerant patients requiring a long-term daily around-the-clock opioid analgesicView additional information.
    Medication Safety

    Contraindications

    See 'In-Depth Answers' for detailed results.


  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [19][18][22][6][21]
  • Hypersensitivity to HYDROmorphone, HYDROmorphone salts, or any of component of the products, including sulfites [6][19][18][22]
  • Known or suspected gastrointestinal obstruction, including paralytic ileus [14][19][18][22]
  • Opioid non-tolerant patients; increased risk of fatal respiratory depression [18][6][21]
  • Patients with or at increased risk of gastrointestinal narrowing or obstruction due to underlying disease or surgical procedure or who have "blind loops" of the gastrointestinal tract [19][21]
  • Significant respiratory depression [19][18][22][6][21]
    • Dosing/Administration

    Adult Dosing

    See 'In-Depth Answers' for detailed results.


    Important Note
    • Confusion between the different concentrations of HYDROmorphone and HYDROmorphone HP may result in accidental overdose and death. When prescribing, provide both the total dose in mg and the total volume in mL [3][4].
    • To avoid medication errors, prescribers and pharmacists need to be aware that HYDROmorphone 8 mg tablets are available as both immediate-release and extended-release [5].
    • High-potency (HP) and extended-release formulations of HYDROmorphone (Dilaudid-HP(R) Injection, Exalgo(R) Extended-Release tablets, Palladone(R) Extended-Release capsules) are for use in opioid-tolerant patients only. An opioid-tolerant patient is defined as using at least 60 mg of oral morphine daily, 25 mcg transdermal fentanyl/hr, 30 mg oral oxycodone/day, 8 mg oral HYDROmorphone/day, 25 mg oral oxymorphone/day or an equianalgesic dose of another opioid, for a week or longer [5][6][3][4].
    • Beers Criteria: Use caution or avoid use as potentially inappropriate in older adults [7].
    • Orphan drug designation: Intrathecal treatment of complex regional pain syndrome

    General Dosage Information
    • Rectal suppository formulation has not been found by the US Food and Drug Administration (FDA) to be safe and effective, and the drug product labeling has not been approved

    Pain, When opioid analgesics are appropriate
    • 1 to 2 mg IM/subQ every 2 to 3 hours as needed; may reduce in opioid-naïve [8]
    • 0.2 to 1 mg IV over at least 2 to 3 minutes every 2 to 3 hours as needed [8]
    • patient-controlled analgesia (opioid-naïve patients), concentration 0.2 mg/mL; usual initial dose is 0.2 mg (range, 0.05 to 0.4 mg) with lockout period of 6 minutes (range, 5 to 10 min) [9]
    • (immediate-release oral liquid) 2.5 to 10 mg (2.5 to 10 mL) ORALLY every 3 to 6 hours as needed; higher doses may be required in some cases [10]
    • (immediate-release oral tablet) 2 to 4 mg ORALLY every 4 to 6 hours as needed; gradually increase until adequate analgesia [10]
    • (rectal suppository) 3 mg RECTALLY every 6 to 8 hours [11] OR 3 to 6 mg RECTALLY every 3 to 4 hours [12][13]

    Pain (Moderate to Severe), Opioid-tolerant
    • do not use HYDROmorphone HP if the amount of HYDROmorphone required cannot be delivered accurately with this formulation; never administer HYDROmorphone HP injection to opioid-naïve patients; use HYDROmorphone HP only if higher concentration and lower total volume are required [4]
    • conversion from HYDROmorphone to HYDROmorphone HP: Initiate with an equipotent dose based on previous HYDROmorphone requirement and administer IV/IM/subQ in divided doses; titrate gradually based on response and tolerability [4]
    • conversion from other opioids: Initiate with one-half the estimated daily HYDROmorphone dose based on previous 24-hour analgesic requirement; administer IV/IM/subQ in divided doses; may titrate dose gradually based on response and tolerability [4]

    Pain (Severe), in opioid-tolerant patients requiring a long-term daily around-the-clock opioid analgesic
    • Individualize dose; after all other extended-release or around-the-clock opioids have been discontinued, initial dose selection must take into account patient's prior analgesic treatment experience and risk factors for addiction, abuse, and misuse; due to substantial interpatient variability in relative potency of different opioid products, when converting it is safer to underestimate a patient's 24-hour oral HYDROmorphone dosage and provide rescue medication than to overestimate the dosage. When converting from methadone, consider that methadone exposure may accumulate due to its long half-life; therefore, the dose equivalency ratio varies widely with prior dose exposure [14][6]
    • (Exalgo(R), conversion from oral immediate-release HYDROmorphone) Initiate dose equal to total daily HYDROmorphone dose orally once daily; may titrate by increments of 4 to 8 mg every 3 to 4 days as needed [14]
    • (Exalgo(R), conversion from other oral opioids) Initiate with one-half the estimated daily HYDROmorphone dose orally once daily. Calculate the estimated daily HYDROmorphone dose using the following conversion factors: HYDROmorphone, 1; codeine, 0.06; hydrocodone, 0.4; methadone, 0.6; morphine, 0.2; oxycodone, 0.4; oxymorphone, 0.6. Divide the calculated dose by 2 and administer once daily. Round down to available Exalgo(R) tablet strength; provide rescue medication as needed and titrate by increments of 4 to 8 mg every 3 to 4 days as needed [14]
    • (Palladone(R), conversion from other oral opioids) Initiate with one-half the estimated daily HYDROmorphone dose orally once daily using the following conversion factors to Palladone(R): HYDROmorphone, 1; codeine, 0.04; hydrocodone, 0.22; methadone, 0.38; morphine, 0.12; oxycodone, 0.25; provide rescue medication as needed and titrate by increments of 4 to 8 mg every 3 to 4 days as needed [6]
    • (Exalgo(R) or Palladone(R), conversion from transdermal fentanyl) Initiate 18 hours after removal of the fentanyl patch. Use a conversion factor of 25 mcg/hr fentanyl transdermal patch to 12 mg of HYDROmorphone, then divide by 2 and administer orally once daily; provide rescue medication as needed and titrate by increments of 4 to 8 mg every 3 to 4 days as needed [14][6]
    • Discontinuing therapy: Gradually titrate downward by 25% to 50% every 2 to 3 days [14][6]

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