Hydromorphone (Dilaudid) is a derivative of morphine. It is a pure opioid analgesic medicine that is 8 times more potent than morphine when compared on a mg: mg basis. It is available as injections and oral immediate-release and extended-release formulations for the treatment of moderate to severe pain in chronically ill patients and those with cancers.

Hydromorphone Uses:

• Pain management:

  • Immediate-release:

    • It is used as a tablet, oral solution, injection and used in the management of pain severe enough to require an opioid analgesic and for which alternate treatments are not sufficient.
    • As an injection, it is given for management of pain severe enough to require an opioid analgesic in opioid-tolerant patients who require higher doses of opioids and for which alternate treatments are inadequate.

  • Extended-release:

    • It can also be used in 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 insufficient.
  • Limitations of use:
    • Its use is reserved in patients for whom alternative treatment options like nonopioid analgesics and opioid combination products are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Hydromorphone ER is not indicated as an as-needed analgesic.

• Moderate to severe pain:

  • Suppository:
    • It is to provide relief of moderate to severe pain such as that caused by biliary colic, burns, cancer, myocardial infarction, renal colic, surgery, and trauma i.e soft tissue and bone.

• Off Label Use of Hydromorphone in Adults:

  • It is used in patients with mechanically ventilated patients.

Hydromorphone (Dilaudid) Dose in Adults

Hydromorphone (Dilaudid) Dose in Pain management:

It is important to note that these recommendations are used as a guide and do not represent the maximum doses that may be required in all patients. Doses should be titrated to provide adequate pain relief. When changing routes of administration, oral doses and parenteral doses are NOT equivalent. The parenteral doses are up to 5 times more potent. Therefore, when administered parenterally, one-fifth of the oral dose will provide similar analgesia.

• Oral: Immediate-release:

  • Initially, it is given as 2 to 4 mg every 4 to 6 hours as needed in oral form or 2.5 mg to 10 mg every 3 to 6 hours as needed in oral solution.
  • Start at the lower end of the dosing range for opioid-naive patients. Patients with prior opioid exposure might require higher initial doses.

  • Conversion from other opioids to hydromorphone oral immediate release:

    • Initially, it is given as 1 to 2 mg every 4 to 6 hours as needed as oral tablets or 1.25 mg to 5 mg every 3 to 6 hours as needed in oral solution.

• IV:

  • Initially, for those who are opioid-naive, it is given as 0.2 to 1 mg every 2 to 3 hours as needed.
  • Start at the lower end of the dosing range for opioid-naive patients.
  • Patients with prior opioid exposure might require higher initial doses. Hydromorphone HP should NOT be used in opioid-naive patients.
  • Dose in the treatment of critically ill patients (off-label):
    • Intermittent dosing:
      • Loading dose:
        • it is given as 0.5 to 2 mg with a maintenance dose of 0.2 to 0.6 mg every 1 to 2 hours as needed or 0.5 mg every 3 hours as needed.
    • Continuous infusion:
      • The usual dosage range is 0.5 to 3 mg/hour.

• IM, SubQ (intermittent dosing):

  • It should be noted that IM administration is not recommended and should be avoided.
  • IM administration is painful and might result in variable absorption, a lag time to peak effect, a rapid fall of action compared to oral administration, and may lead to nerve injury.
  • Equianalgesic doses of morphine as 10 mg SubQ = hydromorphone 1.5 mg SubQ.
  • SubQ is a more reliable and less painful alternative route of administration compared to IM.
    • US labeling:
      • Initially, it is given as 1 to 2 mg every 2 to 3 hours as required.
      • Lower initial doses may be used in opioid-naive patients.
      • Patients with prior opioid exposure may require higher initial doses. Hydromorphone HP should NOT be used in opioid-naive patients.
    • Canadian labeling:
      • In opioid-naive patients, it is given as 2 mg every 4 to 6 hours as required.
      • It is used for severe pain and can be administered as 3 to 4 mg every 4 to 6 hours as required.
      • Hydromorphone HP or Hydromorphone HP Forte should NOT be used in opioid-naive patients.

• SubQ (continuous infusion) (off label):

  • In opioid-tolerant patients, the median doses reported from limited data is 0.167 to 4 mg/hour.
  • However, the dose should be individualized and calculated based upon the patient’s previous opioid intake and appropriate opioid analgesic equivalents.
  • It can be titrated further up, if required, based on the level of pain.

• Patient-controlled analgesia (PCA) (off-label):

It is important to note that in Opioid naive candidates consider the lower end of the dosing range. A continuous (basal) infusion is not preferred in opioid-naive patients:

• • Loading dose: 0.4 mg
  • Demand dose: Range: 0.1 to 0.4 mg
  • Lockout interval: 10 minutes

• Epidural PCA (off-label):

  • Usual concentration: 0.01 mg/mL
  • Bolus dose: 0.4 to 1 mg
  • Infusion rate: 0.03 to 0.3 mg/hour
  • Demand dose: 0.02 to 0.05 mg
  • Lockout interval: 10 to 15 minutes

• Rectal: 

  • 3 mg (1 suppository) three or four times a day as needed.

• Conversion from other opioids to hydromorphone injection:

  • If given in injection form convert the current total daily amount of opioid received to an equivalent total daily dose of hydromorphone injection and reduce by half.
  • Divide the new total amount by the number of doses permitted based on dosing interval (eg, 8 doses for every 3-hour dosing).
  • Titrate the dose according to patient response.
  • HP injection:
    • Base the starting dose for hydromorphone HP injection on the dose given before hydromorphone injection or on the prior dose of an alternate opioid.

Hydromorphone Dose in Chronic pain:

It is important to note that patients taking opioids chronically may become tolerant and require doses higher than the usual dosage range to maintain the desired effect. Tolerance to opioids can be managed by appropriate dose titration. There is no optimal or maximal dose for hydromorphone in chronic pain. The appropriate dose is one that relieves pain throughout its dosing interval without causing unmanageable side effects.

• Controlled-release capsule (Hydromorph Contin [Canadian product]): Oral:

It is important to note that a patient's hydromorphone requirement should be established using prompt release formulations. Conversion to long-acting products might be considered when chronic, continuous treatment is required. Higher doses should be reserved for use only in opioid-tolerant patients.

• • Capsule strengths of more than 18 mg or a single dose of more than 12 mg should be reserved for use only in opioid-tolerant patients requiring hydromorphone equivalent dosages greater than 36 mg daily.
  • Opioid naive or receiving low intermittent doses of weak opioids:
    • Initially, it is given as 3 mg every 12 hours.
  • Current therapy with other oral hydromorphone formulations:
    • Initially, it is initiated at the same total daily hydromorphone dosage divided into 2 equal doses every 12 hours
  • Current therapy with other opioids:
    • Initially determine equivalent oral hydromorphone daily dosage and initiate in 2 equally divided doses every 12 hours.
    • See the table below for examples of equivalent dosing (refer to manufacturer labeling for additional equivalency dosing information).

• The extended-release tablet (Exalgo):

It should be used for opioid-tolerant patients only. Patients considered opioid-tolerant are those who are receiving, for 1 week or longer, at least 60 mg of oral morphine daily, 25 mcg of transdermal fentanyl per hour, 30 mg of oral oxycodone daily, 8 mg of oral hydromorphone daily, 25 mg of oral oxymorphone daily, 60 mg oral hydrocodone daily, or an equianalgesic dose of another opioid.

• • Opioid-tolerant patients:
    • Withhold or taper all other extended-release opioids when starting therapy.
  • Individualization of dose:
    • Preferred recommendations for converting to hydromorphone ER from other analgesics are presented, but when selecting the initial dose, other characteristics like patient status, degree of opioid tolerance, concurrent medications, type of pain, risk factors for addiction, abuse, and misuse, should also be considered. Pain relief and adverse events should be assessed periodically.
  • Conversion from other oral hydromorphone formulations to hydromorphone ER:
    • Start with the equivalent total daily dose of immediate-release hydromorphone administered once a day.
  • Conversion from other opioids to hydromorphone ER:
    • Withhold all other around-the-clock opioids when therapy is initiated.
    • Substantial interpatient variability exists in relative potency. Therefore, it is preferred to underestimate a patient's daily oral hydromorphone requirement and provide breakthrough pain relief with rescue medication like immediate-release opioids than to overestimate requirements.
    • In general, start hydromorphone ER at 50% of the calculated total daily dose every 24 hours (see Conversion Factors to hydromorphone ER).
    • The following conversion ratios can be used to convert from oral opioid therapy to hydromorphone ER.
  • Conversion factors to hydromorphone ER (see table):
    • Select the opioid, sum the current total daily dose, multiply by the conversion factor on the table to calculate the approximate oral hydromorphone daily dose, then calculate the approximate starting dose for hydromorphone ER at 50% of the calculated oral hydromorphone daily does; administer every 24 hours.
    • Round down, if necessary, to the nearest strength available.
    • For patients on a regimen of more than one opioid, calculate the approximate oral hydromorphone dose for each opioid and sum the totals to obtain the approximate total hydromorphone daily dose.
    • For patients on a regimen of the fixed-ratio opioid to nonopioid analgesic medications, and only the opioid component of these medications should be used in the conversion.

Note: These conversion factors in this conversion table are only to be used for the conversion from current oral opioid therapy to hydromorphone ER. Conversion factors in this table cannot be used to convert from hydromorphone ER to another oral opioid. However, doing so may lead to fatal overdose due to overestimation of the new opioid. This is not a table of equianalgesic doses.

Conversion Factors to Hydromorphone ER

• Conversion from transdermal fentanyl to hydromorphone ER:

  • The treatment with hydromorphone ER can be initiated 18 hours after the removal of the transdermal fentanyl patch. For every fentanyl 25 mcg/hour transdermal dose, the equianalgesic dose of hydromorphone ER is 12 mg every 24 hours.
  • An appropriate starting dose is half of the calculated total daily dose given every 24 hours. If necessary, round down to the appropriate tablet strength available.
• Titration and maintenance:
  • Dose adjustments in 4 to 8 mg increments can be done every 3 to 4 days.
  • In patients experiencing breakthrough pain, consider increasing the dose of hydromorphone ER or providing rescue medication of an immediate-release analgesic at an appropriate dose.
  • It is not recommended to administer hydromorphone ER more frequently than every 24 hours.

• Extended-release tablet: Jurnista [Canadian product]:

  • It can be used concomitantly with the usual doses of nonopioid analgesics and analgesic adjuvants. If appropriate, start therapy with an immediate-release opioid formulation to establish a safe and effective dosage, then convert to an equivalent daily dose of extended-release hydromorphone.
  • Tablets of more than 16 mg are intended only for opioid-tolerant patients requiring hydromorphone equivalent dosages greater than 16 mg daily.
  • Initial:
    • Patients who are opioid-naive or receiving low intermittent doses of weak opioid analgesics (eg, < 40 mg daily oral morphine equivalents):
      • Initially, it is given as 4 mg once a day if clinically indicated, and an initial dose of 8 mg once a day can be used.
      • The maximum initial dose is 8 mg once a day.
      • Titrate the dose in increments of 4 or 8 mg as required but no sooner than every fourth dose (eg, if the first dose is administered on Tuesday, increase no sooner than on Friday).
    • Patients who are opioid-naive or receiving low intermittent doses of weak opioid analgesics (eg, <40 mg daily oral morphine equivalents):
      • Initially, it is given as 4 mg once a day if clinically indicated, and an initial dose of 8 mg once a day can be used.
      • The maximum initial dose is 8 mg once a day. Titrate the dose in increments of 4 or 8 mg as required but no sooner than every fourth dose (eg, if the first dose is administered on Tuesday, increase no sooner than on Friday).
  • Maintenance:
    • The dose is individualized based on response. One can consider dose increments of 25% to 75% of the current daily dose made no sooner than every 4th dose (eg, if the first dose is administered on Tuesday, increase no sooner than on Friday).
    • Reanalyze the need for around-the-clock pain control periodically. Supplemental analgesia for breakthrough pain should typically not exceed 10% to 25% of the equivalent daily Jurnista dose.

• Discontinuation of therapy :

  •  The dose should be gradually tapered down when it is being discontinued.
  • An optimal universal tapering schedule for all patients has not yet been established.
  • Proposed schedules range from slow (eg, 10% reductions per week) to rapid (eg, 25% to 50% reduction every few days).
  • Tapering schedules should be in an individualized manner to minimize opioid withdrawal symptoms while considering patient-specific goals and concerns as well as the pharmacokinetics of the opioid being tapered.
  • An even slower taper may be appropriate in patients who have been receiving opioids for a long duration like for years, particularly in the final stage of tapering, whereas more rapid tapers might be appropriate in patients experiencing severe adverse events.
  • Observe carefully for signs & symptoms of withdrawal.
  • If the patient displays withdrawal symptoms, consider slowing the tapering schedule. Alterations can include increasing the interval between dose reductions, decreasing the amount of daily dose reduction, pausing the taper and reinitiating when the patient is ready, and coadministration of an alpha-2 agonist (eg, clonidine) to blunt withdrawal symptoms.
  • Continue to offer nonopioid analgesics as needed for pain management during tapering. Consider nonopioid adjunctive treatments for withdrawal symptoms like GI complaints and muscle spasms as needed.

Hydromorphone (Dilaudid) Dose in the treatment of moderate to severe pain:

• Rectal:
  • US labeling: it is given as 3 mg (1 suppository) every 6 to 8 hours as indicated.
  • Canadian labeling: it is given as 3 mg (1 suppository) at bedtime as indicated.

Hydromorphone (Dilaudid) Dose in Children

Hydromorphone (Dilaudid) Dose in Acute moderate to severe pain: 

It is important to note that doses should be titrated to appropriate analgesic effects while minimizing adverse effects should be the target. When changing routes of administration, note that oral doses are less than one-half as effective as parenteral doses

• Infants >6 months weighing >10 kg:

  • Oral: Immediate release:
    • It is initially given as 0.03 mg/kg/dose every 4 hours as required.
    • The usual range is 0.03 to 0.06 mg/kg/dose
  • IV:
    • Initially, it is given as 0.01 to 0.015 mg/kg/dose every 3 to 6 hours as indicated
  • Continuous IV infusion:
    • It is given initially as 0.003 to 0.005 mg/kg/hour

• Children weighing <50 kg and Adolescents weighing <50 kg:

  • Oral: Immediate release:
    • It is administered as 0.03 to 0.08 mg/kg/dose every 3 to 4 hours as indicated.
    • The American Pain Society (2016) recommends an initial oral dose of 0.06 mg/kg for severe pain in children.
  • IV:
    • It is given as 0.015 mg/kg/dose every 3 to 6 hours as required.
  • Continuous IV infusion:
    • It is initially given as 0.003 to 0.005 mg/kg/hour with a maximum initial rate of 0.2 mg/hour.

• Children weighing ≥50 kg and Adolescents weighing ≥50 kg:

  • Oral: Immediate release:
    • It is initially given in Opioid-naive as 1 to 2 mg every 3 to 4 hours as required.
    • The patients with prior opioid exposure can tolerate higher initial doses. The usual adult dose is 2 to 4 mg. The doses up to 8 mg have been used in adults
  • IV:
    • Initially in opioid-naive, it is given as 0.2 to 0.6 mg every 2 to 4 hours as indicated. Patients with prior opioid exposure may tolerate higher initial doses.
  • Continuous IV infusion:
    • In infusion, it is given as 0.3 mg/hour.
  • IM, SubQ:
    • It is important to note that IM use can result in variable absorption and a lag time to peak effect.
    • Initially, in Opioid-naive it is given as 0.8 to 1 mg every 4 to 6 hours as indicated.
    • Patients with prior opioid exposure do require higher initial doses. The usual dosage range is 1 to 2 mg every 3 to 6 hours as required.
  • Rectal:
    • it is given as 3 mg (1 suppository) every 4 to 8 hours as needed

Hydromorphone (Dilaudid) Dose for continuous analgesia/ sedation in mechanically ventilated: Not routinely used first-line:

• Infants, Children, and Adolescents:

  • Continuous IV infusion:
    • It is given at an initial rate of 0.018 mg/kg/hour. It can be titrated carefully to the required effect. The maximum reported rate id 0.043 mg/kg/hour.

Hydromorphone (Dilaudid) Dose for continuous analgesia/sedation in mechanically ventilated and during ECMO: Not routinely used first-line:

• Infants and Children:

  • Continuous IV infusion:
    • The reported initial rate is 0.064 mg/kg/hour.
    • Titrate up carefully to the desired effect.
    • The maximum reported rate is 0.14 mg/kg/hour.

Hydromorphone (Dilaudid) Dose in Patient-controlled analgesia (PCA): Opioid-naive:

It is important to note that PCA has been used in children as young as 4 years of age. However, clinicians need to assess children 4 to 8 years of age to determine if they are able to use the PCA device correctly. All patients should receive an initial loading dose of an analgesic, to attain adequate control of pain, prior to starting PCA for maintenance. Adjust doses, lockouts, and limits based on required loading dose, age, state of health, and presence of opioid tolerance. Use of lower end of dosing range is recommended for opioid-naive patients. A continuous (basal) infusion is not preferred in opioid-naive patients. Assess patient and pain control at regular intervals and adjust settings if needed.

• Children ≥5 years weighing <50 kg and Adolescents weighing <50 kg:

  • Usual concentration: 0.2 mg/mL
  • Demand dose: it is initially given as  0.003 to 0.004 mg/kg/dose with the usual range of 0.003 to 0.005 mg/kg/dose.
  • Lockout: The initial dose is 5 doses/hour
  • Lockout interval: Range: 6 to 10 minutes
  • Usual basal rate: 0 to 0.004 mg/kg/hour

• Children weighing ≥50 kg and Adolescents weighing ≥50 kg:

  • Usual concentration: 0.2 mg/mL
  • Demand dose: it is given initially as 0.1 to 0.2 mg. The usual range is 0.05 to 0.4 mg
  • Lockout interval: It is initially given in 6 minutes. The usual duration is 5 to 10 minutes

Hydromorphone Pregnancy Category: C

• [US Boxed Warning]
  • If the mother continues to use opioids throughout pregnancy, it can lead to neonatal withdrawal symptoms that could be fatal if she does not get treatment according to neonatology experts.
• Pregnant women should be aware that prolonged opioid therapy may be necessary.
• Opioids can cross over the placenta.
• The maternal use of opioids could be linked to teratogenicity and birth defects, poor growth, stillbirth, preterm delivery, and even fetal death.
• A pregnant woman can experience withdrawal symptoms if they are exposed to chronic opioids.
• Symptoms of neonatal Abstinence Syndrome (NAS) may include autonomic symptoms (eg. fever, temperature instability), gastrointestinal symptoms (eg. diarrhea, vomiting), or neurologic (eg. high-pitched crying and hyperactivity, increased muscle tone/abnormal wakefulness/sleep pattern, irritability/seizure, tremor and yawning).
• Opioid-dependent mothers may give birth to infants who are also dependent.
• Opioids can cause respiratory depression in neonates and psycho-physiologic side effects in them. Opioids should be administered to mothers during labor.
• Hydromorphone is not the only agent that can be used to treat pain associated with pregnancy, labor, and postpartum.

Hydromorphone use during breastfeeding:

• Breast milk contains hydromorphone.
• After consuming a single dose of hydromorphone 2mg, the half-life was 10.5 + 5.2 hours in breastmilk.
• According to current recommendations, nonopioid painkillers are preferable for breastfeeding women suffering from postpartum discomfort.
• To limit the adverse effects on the mother and infant, opioids should only be administered to breastfeeding mothers. Hydromorphone might be an option.
• Infant exposure will be reduced by PCA delivery
• A single, occasional dose may be sufficient to allow breastfeeding to continue.
• It is important that you mention that extended-release formulations do not provide intermittent pain relief.
• Breastfeeding mothers who use opioids to treat postpartum pain and chronic maternal pain should be vigilant for signs of drowsiness, sedation or feeding difficulties in infants.
• If breastfeeding is stopped or withheld, withdrawal symptoms may occur.

Hydromorphone (Dilaudid) Dose in Kidney Disease:

Injectable, oral (immediate release): it should be initiated with 25% to 50% of the usual starting dose depending on the degree of impairment. Caution is advised and monitor closely for respiratory and CNS depression.

• Oral (extended-release tablet): Hydromorphone ER:

  • CrCl >60 mL/minute:
    • There are no dosage adjustments provided in the guidelines.
  • CrCl 40 to 60 mL/minute:
    • Initiate with half of the usual starting dose for patients with normal renal function. Use with caution and monitor closely for respiratory and CNS depression.
  • CrCl <30 mL/minute:
    • Initiate with one-fourth of the usual starting dose for patients with normal renal function.
    • Caution is advised and monitor closely for respiratory and CNS depression. Consider the use of an alternate analgesic with better dosing flexibility.

• Oral (extended-release capsule): Hydromorph Contin [Canadian product]:

  • Mild impairment:
    • There are no dose adjustments required.  Caution is advised and monitor closely for respiratory and CNS depression.
  • Moderate impairment:
    • Initiate at half of the initial dose for normal renal function.
    • It should be titrated cautiously. Observe closely for respiratory and CNS depression following initiation of therapy and during titration.
  • Severe impairment:
    • Initiate at one-fourth of the initial dose for normal renal function. It should be titrated cautiously. Observe closely for respiratory and CNS depression following initiation of therapy and during titration.

• Rectal suppository:

  • US labeling:
    • There are no dose adjustments required as per the literature.
    • Caution is advised and observe closely for respiratory and CNS depression.
  • Canadian labeling:
    • There are no specific dose adjustments required as per the literature.
    • However, an initial dosage reduction is preferred for severe renal impairment.
    • Caution is advised and monitor closely for respiratory and CNS depression

Hydromorphone (Dilaudid) Dose in Liver disease:

• Injectable, oral (immediate release):

  • Mild to severe impairment:
    • Initiate with 25% to 50% of the usual initiating dose depending upon the degree of impairment. Caution is advised and monitor closely for respiratory and CNS depression.

• Oral (extended-release tablet): Hydromorphone ER:

  • Mild impairment:
    • There are no dose adjustments required.
  • Moderate impairment:
    • Initiate with one-fourth of the usual starting dose for patients with normal hepatic function. Caution is advised and observe closely for respiratory and CNS depression.
  • Severe impairment:
    • Use alternate analgesic.

• Oral (extended-release capsule): Hydromorph Contin [Canadian product]:

  • Mild impairment:
    • There are no dose adjustments required. Caution is advised and monitor for respiratory and CNS depression.
  • Moderate impairment:
    • Initiate at one-fourth of the initial dose for normal hepatic function.
    • Titrate-up cautiously. Observe closely for respiratory and CNS depression after starting therapy and during titration.
  • Severe impairment:
    • Its use is not recommended because limited data is available.
    • Consideration for alternative analgesics is preferred.
    • If therapy with hydromorphone is initiated, the manufacturer recommends a more conservative dose than that recommended for moderate impairment but does not provide specific dosing recommendations.
    • Observe closely for respiratory and CNS depression.

• Rectal suppository:

  • US labeling:
    • There are no dose adjustments required.
    • Caution is advised and monitor closely for respiratory and CNS depression.
  • Canadian labeling:
    • There are no specific dose adjustments required. However, an initial dose reduction is preferred for severe hepatic impairment.
    • Caution is advised and monitor closely for respiratory and CNS depression.

Side effects of Hydromorphone (Dilaudid):

• Cardiovascular:

  • Bradycardia
  • Extrasystoles
  • Flushing (Facial)
  • Hypertension
  • Hypotension
  • Palpitations
  • Peripheral Edema
  • Peripheral Vasodilation
  • Syncope
  • Tachycardia

• Central Nervous System:

  • Abnormal Dreams
  • Abnormal Gait
  • Abnormality In Thinking
  • Aggressive Behavior
  • Agitation
  • Apprehension
  • Ataxia
  • Brain Disease
  • Burning Sensation Of Skin (Exalgo)
  • Central Nervous System Depression
  • Chills
  • Cognitive Dysfunction
  • Confusion
  • Decreased Body Temperature (Exalgo)
  • Depression
  • Disruption Of Body Temperature Regulation (Exalgo)
  • Dizziness
  • Drowsiness
  • Drug Dependence
  • Dysarthria
  • Dysphoria
  • Equilibrium Disturbance
  • Euphoria
  • Fatigue
  • Hallucination
  • Headache
  • Hyperesthesia
  • Hyperreflexia
  • Hypoesthesia
  • Hypothermia
  • Increased Intracranial Pressure
  • Insomnia
  • Lack Of Concentration
  • Lethargy
  • Malaise
  • Memory Impairment
  • Mood Changes
  • Myoclonus
  • Nervousness
  • Painful Defecation
  • Panic Attack
  • Paranoia
  • Paresthesia
  • Psychomotor Agitation
  • Restlessness
  • Sedation
  • Sleep Disorder (Exalgo)
  • Suicidal Ideation
  • Uncontrolled Crying
  • Vertigo

• Dermatologic:

  • Diaphoresis
  • Erythema (Exalgo)
  • Hyperhidrosis
  • Pruritus
  • Skin Rash
  • Urticaria

• Endocrine & Metabolic:

  • Antidiuretic Effect
  • Decreased Amylase
  • Decreased Libido
  • Decreased Plasma Testosterone
  • Dehydration
  • Fluid Retention
  • Hyperuricemia
  • Hypokalemia
  • Weight Loss

• Gastrointestinal:

  • Abdominal Distention
  • Anal Fissure
  • Anorexia
  • Bezoar Formation (Exalgo)
  • Biliary Tract Spasm
  • Constipation
  • Decreased Appetite
  • Decreased Gastrointestinal Motility (Exalgo)
  • Delayed Gastric Emptying
  • Diarrhea
  • Diverticulitis
  • Diverticulosis
  • Duodenitis
  • Dysgeusia
  • Dysphagia
  • Eructation
  • Flatulence
  • Gastroenteritis
  • Gastroesophageal Reflux Disease (Aggravated; Exalgo)
  • Hematochezia
  • Increased Appetite
  • Intestinal Obstruction
  • Intestinal Perforation (Large Intestine; Exalgo)
  • Nausea
  • Stomach Cramps
  • Vomiting
  • Xerostomia

• Genitourinary:

  • Bladder Spasm
  • Decreased Urine Output
  • Difficulty In Micturition
  • Dysuria
  • Erectile Dysfunction
  • Hypogonadism
  • Sexual Disorder
  • Ureteral Spasm
  • Urinary Frequency
  • Urinary Hesitancy
  • Urinary Retention

• Hematologic & Oncologic:

  • Oxygen Desaturation

• Hepatic:

  • Increased Liver Enzymes

• Hypersensitivity:

  • Histamine Release

• Local:

  • Pain At Injection Site
  • Post-Injection Flare

• Neuromuscular & Skeletal:

  • Arthralgia
  • Dyskinesia
  • Laryngospasm
  • Muscle Rigidity
  • Muscle Spasm
  • Myalgia
  • Tremor
  • Weakness

• Ophthalmic:

  • Blurred Vision
  • Diplopia
  • Dry Eye Syndrome
  • Miosis
  • Nystagmus

• Otic:

  • Tinnitus

• Respiratory:

  • Apnea
  • Bronchospasm
  • Dyspnea
  • Flu-Like Symptoms (Exalgo)
  • Hyperventilation
  • Hypoxia
  • Respiratory Depression
  • Respiratory Distress
  • Rhinorrhea

Contraindications to Hydromorphone (Dilaudid):

US Labeling

• Hypersensitivity reactions such as anaphylaxis of hydromorphone, hydromorphone sodiums, or any other component of the formulation are an absolute contraindication.
• Significant respiratory depression
• Acute or severe bronchial asthma.
• Unmonitored or without ventilatory support or resuscitative equipment.
• It is possible to have a gastrointestinal obstruction or paralytic ileus.

Additional product-specific contraindications Opioid-nontolerant Patients: Dilaudid HP injection

Hydromorphone ER tablets

• In Opioid-nontolerant patients.
• An earlier history of GI surgery, or other diseases that resulted in narrowing the GI tract or blind loops within the GI tract.

Suppl.

• Increased intracranial pressure is associated with intracranial lesion.
• When a ventilatory function is impaired (eg, COPD or cor pulmonale), status asthmaticus, kyphoscoliosis or status asthmaticus.
• It is rare to see cross-reactivity between opioids and allergens. Cross-sensitivity is possible due to similarities in chemical structure and pharmacologic effects.

Canadian labeling:

• Hypersensitivity to hydromorphone and any component of the formulation is an absolute contraindication.

Dilaudid, Hydromorph Contin, Jurnista:

• Known or suspected mechanical GI obstruction (eg bowel obstruction or strictures), or any disease that affects bowel transit, (eg ileus of any kind).
• Suspected surgical abdomen (eg acute appendicitis, pancreatitis).
• You can manage mild, intermittent or short-term pain with pain medication.
• Hypercarbia, acute respiratory depression, and cor Pulmonale.
• Acute alcoholism, convulsive disorders, and delirium tremens.
• Grave CNS depression, elevated cerebrospinal and intracranial pressures, and head injuries.
• Monoamine oxidase inhibits may be used in conjunction with each other or within 14 days.
• Women during pregnancy, labor and delivery or breastfeeding

Dilaudid HP:

• Patients who are not currently receiving opioids in high doses or at high levels of concentrations should consult their doctor.

Hydromorphone HP, Hydromorphone HP Forte, Hydromorphone 0.4 mg/mL injection:

• Patients who are not currently receiving opioids in high doses or at high levels of concentrations should consult their doctor.
• Any known or suspected mechanical gastrointestinal obstruction (eg bowel obstruction or strictures) and any conditions that affect bowel transit (eg ileus of any kind).
• Suspected surgical abdomen (eg acute appendicitis, pancreatitis).
• Mild pain can often be controlled with pain medication.
• Acute or severe bronchial or obstructive asthma, status asthmaticus, or chronic obstructive asthma.
• Cor pulmonale, acute respiratory depression, elevated blood carbon dioxide levels, and hypercapnia.
• Acute alcoholism, convulsive disorders, and delirium tremens.
• Grave CNS depression can lead to increased cerebrospinal and intracranial pressures, as well as head injury.
• Monoamine oxidase inhibits may be used in conjunction with other monoamine oxidase-inhibitors (within 14 days). This applies to women who are pregnant, nursing, or laboring.

Syrup, Supppository

• In the absence of resuscitative devices, respiratory depression can occur.
• Asthma acute exacerbation

Additional product-specific contraindications

Dilaudid:

• Hypersensitivity to opioid analgesics.
• Acute exacerbation or other obstructive breathing and status asthmaticus.

Hydromorphic Continu:

• Hypersensitivity to opioid analgesics.
• Acute or severe bronchial asthma, or status asthmaticus.
• Acute pain management, including outpatient and day surgery.
• Perioperative pain management

Jurnista

• Previous surgical procedures, underlying diseases that could cause a narrowing or blinding of the GI system.
• Acute asthma, other obstructive or chronic airway disease and status asthmaticus.
• Acute or perioperative pain management

Warnings and precautions

• CNS depression:

  • CNS depression can result, which could lead to impairment of mental or physical abilities. 
  • It is important to warn patients about tasks that require mental alertness, such as driving or operating machinery.

• Constipation

  • It can lead to constipation, which could be problematic for patients with unstable angina or post-myocardial injury patients.
  • To reduce constipation, you can take preventive steps.
  • Patients with chronic constipation should be cautious.

• Hypotension

  • It can lead to severe hypotension, orthostatic hypotension, and syncope. 
  • Patients with hypovolemia, heart disease, acute myocardial injury [MI], and drugs that can exacerbate hypotension (e.g. phenothiazines and general anesthetics) should be cautious.
  • After dose titration or initiation, be aware of hypotension symptoms.
  • Patients with circulatory shock should not use this product.

• Phenanthrene hypersensitivity:

  • Caution is advised in patients with hypersensitivity reactions to other phenanthrene derivative opioid agonists (codeine, hydrocodone, levorphanol, oxycodone, oxymorphone).

• Respiratory depression [US Boxed Warning]

  • Respiratory depression can be fatal, life-threatening, and even deadly.
  • Pay attention to respiratory depression during dose escalation or initiation.
  • Take ER tablets whole. Rapid release can be caused by chewing, crushing, or dissolving ER tablets.
  • The sedating effects of opioids can be exaggerated by carbon dioxide retention due to opioid-induced respiratory depression.

• Conditions abdominales:

  • Patients with acute abdominal conditions may be misdiagnosed or treated with opioids.

• Adrenocortical Insufficiency

  • Patients with adrenal insufficiency (Addison disease) should be cautious.
  • Long-term opioid abuse can lead to secondary hypogonadism.
  • This could cause infertility, sexual dysfunction, mood disorders, and osteoporosis.

• Insufficiency of the biliary tract:

  • Patients with biliary dysfunction (including acute pancreatitis) should exercise caution. Opioids could cause constriction in the sphincter Oddi.

• CNS depression/coma:

  • Patients with impaired consciousness and coma should not use it.
  • These patients are more susceptible to the intracranial effects CO retention.

• Delirium tremens:

  • Patients with delirium-tremens should be taken with caution

• GIG narrowing

  • The Hydromorphone ER tablets can be dissolved in water. 
  • Patients with severe GI narrowing, such as esophageal motility or small bowel inflammatory diseases, short gut syndrome, history peritonitis, cystic fibrosis and chronic intestinal pseudo-obstruction (Meckel's diverticulum), should not be administered Hydromorphone ER tablets. You can see obstruction.

• Head trauma

  • Patients with intracranial injuries, intracranial lesions or elevated intracranial pressure (ICP) should exercise extreme caution. An increase in ICP may occur.

• Hepatic impairment

  • Patients with hepatic impairment should exercise caution. In moderate to severe impairment, it is recommended that you reduce your dose.
  • In severe impairment, ER tablets should not be used.

• Mental health conditions

  • Patients with mental health conditions such as depression, anxiety disorders, and post-traumatic stress disorder should be cautious when using opioids for chronic pain.
  • There is a greater risk of opioid overdose and opioid use disorder. It is important to keep close track.

• Obesity:

  • Patients who are obese or morbidly so should exercise caution.

• Prostatic hyperplasia, urinary stricture

  • Patients with prostatic hyperplasia or urinary stricture should exercise caution.

• Psychosis:

  • Patients with toxic psychosis should exercise caution.

• Renal impairment

  • Patients with impaired renal function should exercise caution; dosage reduction is recommended.
  • In severe impairment, ER tablets should not be used.

• Respiratory disease

  • Patients with severe chronic obstructive lung disease (or cor pulmonale) should exercise caution and be aware of respiratory depression.
  • Even at therapeutic doses, severe respiratory depression can occur.
  • You might consider using non-opioid analgesics for these patients.

• Seizures:

  • Patients with seizure disorders should exercise caution. This can make the condition worse.

• Sleep-disordered breathing

  • Patients with sleep-disordered breathing risk factors, such as HF or obesity, should be treated with opioids.
  • Patients with severe or moderate sleep-disordered breathing should avoid opioids

• Thyroid dysfunction:

  • Patients with thyroid dysfunction should be cautious.

Hydromorphone: Drug Interaction

Monitoring parameters:

• It can be used to relieve pain, improve respiratory and mental health, and lower blood pressure.
• Bowel function.
• The signs and symptoms of abuse, misuse, and addiction.
• Signs and symptoms of hypogonadism (Brennan 2013, p.

Alternate suggestions:

• Chronic pain is long-term treatment that does not include end-of life or palliative care.
• It can also be active cancer treatment, sickle cells disease or medication-assisted opioid abuse disorder treatment.
  • Within 1 to 4 weeks after treatment initiation, and as doses increase, evaluate the benefits and risks of opioid therapy.
  • Patients at higher risk for overdose or those with opioid addiction should reevaluate the benefits and risks every three months.
  • Prior to initiating treatment, it is preferable to have your urine tested for drug use. Re-checking should occur at least once a year (includes prescription drugs and illegal drugs of abuse).
  • Clinicians should review state prescription drug monitoring program data (PDMP) prior to initiation, and periodically during therapy (frequency ranging between every prescription to every three months).
• Critically ill
  • Patients who can self-report their pain should use the Numeric Rating Scale.
  • Patients who cannot self-report pain can use the Behavioral Pain Score and the Critical Care Pain Observational Instrument in either intubated or unintubated patients.

How to administer Hydromorphone (Dilaudid)?

Parenteral:

Notification: Vial stopper may contain latex.

• It is important to not confuse the hydromorphone HP, a highly concentrated injectable product (10 mg/mL), with standard parenteral formulations containing hydromorphone 1, 2 or 4 mg/mL.
• Only opioid-tolerant patients should use Hydromorphone HP; confusion can lead to overdose and even death.

IM, SubQ

• You can give it SubQ or IM. However, IM administration should not be done. 
• IM administration can cause nerve injury by causing variable absorption, a lag between peak effect and peak, and a rapid fall in action compared with oral administration.
• Administration via SubQ is a safer and more painless alternative to IM.

IV:

• It is important to give IVP slowly, over a minimum of 2 to 3 minutes.
• Rapid IVP has been linked with increased side effects, particularly hypotension and respiratory depression.

Oral:

• Hydromorphone can be purchased in two forms: an 8 mg instant-release tablet or an 8 mg extended release tablet. Avoid confusing dosage forms by exercising extreme caution.
• Hydromorphone ER Jurnista [Canadian Product]:
  • You should swallow the tablets whole. Do not crush, break or chew the tablets. Use with or without food
• Hydromorph Contin [Canadian Product]:
  • Only for oral use. Do not crush, chew, or break the capsule.
  • You can sprinkle the contents on a tablespoon or two of applesauce or custard and then swallow it immediately without chewing. Discard if you do not consume within 30 minutes.
  • To ensure that the contents of the mouth are fully swallowed, the patient should rinse their mouth with water.
• Oral solution
  • Assure accuracy in prescribing, dispensing, or administering.
  • Accidental overdose or death can be caused by confusion between mg/mL.
  • You should use a calibrated oral syringe/dosing cups that accurately measures and delivers the prescribed dose.
  • Measure the dose with a teaspoon or a tablespoon that you have at home.

Mechanism of action of Hydromorphone (Dilaudid):

• It binds with opioid receptors in your CNS and inhibits ascending pain pathways.
• This alters the perception and response to pain. 
• It can cause cough suppression through direct central action in your medulla. 
• It can also cause generalized CNS depression.

The onset of action: Analgesic:

• Immediate-release formulations:
  • Oral: 15 to 30 minutes; Peak effect: 30 to 60 minutes
  • IV: 5 minutes; Peak effect: 10 to 20 minutes
• Extended-release tablet:
  • 6 hours; Peak effect: ~9 hours.

Duration:

• Immediate-release formulations: Oral, IV: 3 to 4 hours. A suppository may provide a longer duration of effect
• Extended-release tablet: ~13 hours.

Absorption:

• Oral: Rapidly absorbed.
• It has an extensive first-pass effect.
• Extended-release tablet: Delayed absorption. IM: Variable and delayed

Protein binding:

• ~8% to 19%

Metabolism:

• Hepatic via glucuronidation; to inactive metabolites;
• >95% is metabolized to hydromorphone-3-glucuronide.
• Minor amounts as 6-hydroxy reduction metabolites in the liver.

Bioavailability:

• Oral, immediate release: ~24%

Half-life elimination:

• Immediate-release formulations: 2 to 3 hours
• Extended-release tablets: Apparent half-life: ~11 hours (range: 8 to 15 hours)

Time to peak, plasma:

• Immediate-release tablet: ≤1 hour
• Extended-release tablet: 12 to 16 hours
• Extended-release capsule [Canadian product]: ~5 hours

Excretion:

• Urine (primarily as glucuronide conjugates);
• A minimal amount of unchanged drug is excreted in urine (~7%) and feces (1%)

International Brand Names of Hydromorphone:

• Dilaudid;
• Dilaudid-HP [DSC];
• Exalgo
• APO-HYDROmorphone
• APO-HYDROmorphone CR
• Dilaudid
• Dilaudid HP
• Hydromorph Contin
• HYDROmorphone HCl HP
• HYDROmorphone HCl HP Forte
• HYDROmorphone HP
• HYDROmorphone HP Forte
• Jurnista
• PMS-HYDROmorphone
• TEVA-HYDROmorphone
• Dilaudid
• Dilid
• Dolonovag
• Himop
• Hydal
• Jurnista
• Jurnista IR
• Jurnista SR
• Liberaxim
• Narurapid
• Narusus
• Paliadon Retardkaps
• Palladon
• Palladon OD
• Palladon Retard
• Palladone
• Palladone NR
• Palladone SR
• Palladone-SR
• Sophidone LP

Hydromorphone Brand Names in Pakistan:

No Brands Available in Pakistan.