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
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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

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

Cough (Off-label)

1 mg PO q3-4hr PRN

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
more...

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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            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

            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

            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

            When discontinuing therapy in a physically-dependent patient, gradually taper the dosage

            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 hyptension, 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 cautioin 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

            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
            • 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
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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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            Formulary

            FormularyPatient Discounts

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            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.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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