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Hydromorphone


Pronunciation

 (hye droe MOR fone)


U.S. Brand Names

 Dilaudid®; Dilaudid-HP®; Palladone™


Synonyms

 Dihydromorphinone; Hydromorphone Hydrochloride


Generic Available

 Yes: Excludes capsule, liquid, powder for injection


Canadian Brand Names

 Dilaudid®; Dilaudid-HP®; Dilaudid-HP-Plus®; Dilaudid® Sterile Powder; Dilaudid-XP®; Hydromorph Contin®; Hydromorphone HP; PMS-Hydromorphone


Use

 Management of moderate-to-severe pain


Use - Unlabeled/Investigational

 Antitussive


Restrictions

 C-II


Pregnancy Risk Factor

 C/D (prolonged use or high doses at term)


Pregnancy Implications

 Hydromorphone was teratogenic in some, but not all, animal studies; however, maternal toxicity was also reported. Hydromorphone crosses the placenta. Chronic opioid use during pregnancy may lead to a withdrawal syndrome in the neonate. Symptoms include irritability, hyperactivity, loss of sleep pattern, abnormal crying, tremor, vomiting, diarrhea, weight loss, or failure to gain weight.


Lactation

 Excretion in breast milk unknown/not recommended


Contraindications

 Hypersensitivity to hydromorphone, any component of the formulation, or other phenanthrene derivative; increased intracranial pressure; acute or severe asthma, severe respiratory depression (in absence of resuscitative equipment or ventilatory support); severe CNS depression; pregnancy (prolonged use or high doses at term)

Palladone™ is also contraindicated with known or suspected paralytic ileus.


Warnings/Precautions

 Controlled release capsules should only be used when continuous analgesia is required over an extended period of time. Palladone™ should only be used in opioid tolerant patients requiring doses of hydromorphone >12 mg/day (or equianalgesic dose of another opioid) and who have been at that dose for >7 days. Controlled release products are not to be used on an as needed basis. Hydromorphone shares toxic potential of opiate agonists, and precaution of opiate agonist therapy should be observed; use with caution in patients with hypersensitivity to other phenanthrene opiates, respiratory disease, biliary tract disease, acute pancreatitis, or severe liver or renal failure; tolerance or drug dependence may result from extended use. Those at risk for opioid abuse include patients with a history of substance abuse or mental illness.

An opioid-containing analgesic regimen should be tailored to each patient's needs and based upon the type of pain being treated (acute versus chronic), the route of administration, degree of tolerance for opioids (naive versus chronic user), age, weight, and medical condition. The optimal analgesic dose varies widely among patients. Doses should be titrated to pain relief/prevention. I.M. use may result in variable absorption and a lag time to peak effect.

Some dosage forms contain trace amounts of sodium bisulfite which may cause allergic reactions in susceptible individuals.


Adverse Reactions

 Frequency not defined.

Cardiovascular: Palpitations, hypotension, peripheral vasodilation, tachycardia, bradycardia, facial flushing

Central nervous system: CNS depression, increased intracranial pressure, fatigue, headache, nervousness, restlessness, dizziness, lightheadedness, drowsiness, hallucinations, mental depression, seizure

Dermatologic: Pruritus, rash, urticaria

Endocrine & metabolic: Antidiuretic hormone release

Gastrointestinal: Nausea, vomiting, constipation, stomach cramps, xerostomia, anorexia, biliary tract spasm, paralytic ileus

Genitourinary: Decreased urination, ureteral spasm, urinary tract spasm

Hepatic: LFTs increased, AST increased, ALT increased

Local: Pain at injection site (I.M.)

Neuromuscular & skeletal: Trembling, weakness, myoclonus

Ocular: Miosis

Respiratory: Respiratory depression, dyspnea

Miscellaneous: Histamine release, physical and psychological dependence


Overdosage/Toxicology

 Symptoms of overdose include CNS depression, respiratory depression, miosis, apnea, pulmonary edema, and convulsions. Along with supportive measures, naloxone, 2 mg I.V. with repeat administration as necessary up to a total of 10 mg, can also be used to reverse toxic effects of the opiate.


Drug Interactions

CNS depressants: Effects with hydromorphone may be additive.

Pegvisomant: Analgesics (narcotic) may diminish the therapeutic effect of pegvisomant; increased pegvisomant doses may be needed.

Phenothiazines: May enhance the hypotensive and CNS depressant effects of hydromorphone.

Selective serotonin reuptake inhibitors (SSRIs): Serotonergic effects may be additive, leading to serotonin syndrome.


Ethanol/Nutrition/Herb Interactions

Ethanol: Avoid ethanol (may increase CNS depression).

Herb/Nutraceutical: Avoid valerian, St John's wort, kava kava, gotu kola (may increase CNS depression).


Stability

 Store injection and oral dosage forms at 25°C (77°F). Protect tablets from light. A slightly yellowish discoloration has not been associated with a loss of potency; I.V. is incompatible when mixed with minocycline, prochlorperazine, sodium bicarbonate, tetracycline, thiopental.


Compatibility

 Stable in D5LR, D5W, D5 1 /2NS, D5NS, LR, 1 /2NS, NS

Y-site administration: Compatible: Acyclovir, allopurinol, amifostine, amikacin, amsacrine, aztreonam, cefamandole, cefepime, cefoperazone, cefotaxime, cefoxitin, ceftazidime, ceftizoxime, cefuroxime, chloramphenicol, cisatracurium, cisplatin, cladribine, clindamycin, cyclophosphamide, cytarabine, diltiazem, dobutamine, docetaxel, dopamine, doxorubicin, doxorubicin liposome, doxycycline, epinephrine, erythromycin lactobionate, etoposide, famotidine, fentanyl, filgrastim, fludarabine, foscarnet, furosemide, gatifloxacin, gemcitabine, gentamicin, granisetron, heparin, kanamycin, labetalol, linezolid, lorazepam, magnesium sulfate, melphalan, methotrexate, metronidazole, midazolam, milrinone, morphine, nafcillin, nicardipine, nitroglycerin, norepinephrine, ondansetron, oxacillin, paclitaxel, penicillin G potassium, piperacillin, piperacillin/tazobactam, propofol, ranitidine, remifentanil, tacrolimus, teniposide, thiotepa, ticarcillin, tobramycin, trimethoprim/sulfamethoxazole, vancomycin, vecuronium, vinorelbine. Incompatible: Amphotericin B cholesteryl sulfate complex, diazepam, minocycline, phenobarbital, phenytoin, sargramostim, tetracycline, thiopental. Variable (consult detailed reference): Ampicillin, cefazolin

Compatibility in syringe: Compatible: Albuterol, atropine, bupivacaine, ceftazidime, chlorpromazine, cimetidine, dimenhydrinate, diphenhydramine, fentanyl, glycopyrrolate, haloperidol, hydroxyzine, lorazepam, midazolam, pentazocine, pentobarbital, prochlorperazine mesylate, promethazine, ranitidine, scopolamine, thiethylperazine, trimethobenzamide. Incompatible: Ampicillin, diazepam, hyaluronidase, phenobarbital, phenytoin. Variable (consult detailed reference): Cefazolin, dexamethasone sodium phosphate, ketorolac, prochlorperazine edisylate

Compatibility when admixed: Compatible: Bupivacaine, fluorouracil, midazolam, ondansetron, promethazine, verapamil. Incompatible: Sodium bicarbonate, thiopental. Variable (consult detailed reference): Tetracaine


Mechanism of Action

 Binds to opiate receptors in the CNS, causing inhibition of ascending pain pathways, altering the perception of and response to pain; causes cough supression by direct central action in the medulla; produces generalized CNS depression


Pharmacodynamics/Kinetics

Onset of action: Analgesic: Immediate release formulations:

Oral: 15-30 minutes

Peak effect: Oral: 30-60 minutes

Duration: Immediate release formulations: 4-5 hours

Absorption: I.M.: Variable and delayed; Palladone™: Biphasic

Distribution: Vd: 4 L/kg

Protein binding: ~20%

Metabolism: Hepatic; to inactive metabolites

Bioavailability: 62%

Half-life elimination:

Immediate release formulations: 1-3 hours

Palladone™: 18.6 hours

Excretion: Urine (primarily as glucuronide conjugates)


Dosage

Acute pain (moderate to severe): Note: These are guidelines and do not represent the maximum doses that may be required in all patients. Doses should be titrated to pain relief/prevention.

Young Children 6 months and <50 kg:

Oral: 0.03-0.08 mg/kg/dose every 3-4 hours as needed

I.V.: 0.015 mg/kg/dose every 3-6 hours as needed

Older Children >50 kg and Adults:

Oral: Initial: Opiate-naive: 2-4 mg every 3-4 hours as needed; patients with prior opiate exposure may require higher initial doses; usual dosage range: 2-8 mg every 3-4 hours as needed

I.V.: Initial: Opiate-naive: 0.2-0.6 mg every 2-3 hours as needed; patients with prior opiate exposure may tolerate higher initial doses

Note: More frequent dosing may be needed.

Mechanically-ventilated patients (based on 70 kg patient): 0.7-2 mg every 1-2 hours as needed; infusion (based on 70 kg patient): 0.5-1 mg/hour

Patient-controlled analgesia (PCA): (Opiate-naive: Consider lower end of dosing range)

Usual concentration: 0.2 mg/mL

Demand dose: Usual: 0.1-0.2 mg; range: 0.05-0.5 mg

Lockout interval: 5-15 minutes

4-hour limit: 4-6 mg

Epidural:

Bolus dose: 1-1.5 mg

Infusion concentration: 0.05-0.075 mg/mL

Infusion rate: 0.04-0.4 mg/hour

Demand dose: 0.15 mg

Lockout interval: 30 minutes

I.M., SubQ: Note: I.M. use may result in variable absorption and a lag time to peak effect.

Initial: Opiate-naive: 0.8-1 mg every 4-6 hours as needed; patients with prior opiate exposure may require higher initial doses; usual dosage range: 1-2 mg every 3-6 hours as needed

Rectal: 3 mg every 4-8 hours as needed

Chronic pain: Adults: Oral: Note: Patients taking opioids chronically may become tolerant and require doses higher than the usual dosage range to maintain the desired effect. Tolerance 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 formulation (Hydromorph Contin®, not available in U.S.): 3-30 mg every 12 hours. Note: A patient's hydromorphone requirement should be established using prompt release formulations; conversion to long acting products may be considered when chronic, continuous treatment is required. Higher dosages should be reserved for use only in opioid-tolerant patients.

Extended release formulation (Palladone™): For use only in opioid-tolerant patients requiring extended treatment of pain. Initial Palladone™ dose should be calculated using standard conversion estimates based on previous total daily opioid dose, rounding off to the most appropriate strength available. Doses should be administered once every 24 hours. Discontinue all previous around-the-clock opioids when treatment is initiated. Dose may be adjusted every 2 days as needed.

Conversion from transdermal fentanyl to oral Palladone™ (limited clinical experience): Initiate Palladone™ 18 hours after removal of patch; substitute Palladone™ 12 mg/day for each fentanyl 50 mcg/hour patch; monitor closely

Conversion from opioid combination drugs: Initial dose: Palladone™ 12 mg/day in patients receiving around-the-clock fixed combination-opioid analgesics with a total dose greater than or equal to oxycodone 45 mg/day, hydrocodone 45 mg/day, or codeine 300 mg/day

Antitussive (unlabeled use): Oral:

Children 6-12 years: 0.5 mg every 3-4 hours as needed

Children >12 years and Adults: 1 mg every 3-4 hours as needed

Dosing adjustment in hepatic impairment: Should be considered


Administration

Parenteral: May be given SubQ or I.M.; vial stopper contains latex

I.V.: For IVP, must be given slowly over 2-3 minutes (rapid IVP has been associated with an increase in side effects, especially respiratory depression and hypotension)

Oral:

Hydromorph Contin®: Capsule should be swallowed whole; do not crush or chew; contents may be sprinkled on soft food and swallowed

Palladone™: Capsule must be swallowed whole; do not break open, crush, chew, dissolve, or sprinkle on food.


Monitoring Parameters

 Pain relief, respiratory and mental status, blood pressure


Patient Education

 If self-administered, use exactly as directed; do not increase dose or frequency. Drug may cause physical and/or psychological dependence. Palladone™ must be swallowed whole. While using this medication, do not use alcohol and other prescription or OTC medications (especially sedatives, tranquilizers, antihistamines, or pain medications) without consulting prescriber. Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. May cause dizziness, drowsiness, impaired coordination, or blurred vision (use caution when driving, climbing stairs, or changing position - rising from sitting or lying to standing, or when engaging in tasks requiring alertness until response to drug is known); loss of appetite, nausea, or vomiting (frequent mouth care, small, frequent meals, chewing gum, or sucking lozenges may help); or constipation (increased exercise, fluids, fruit, or fiber may help; if unresolved, consult prescriber about use of stool softeners). Report chest pain, slow or rapid heartbeat, acute dizziness, or persistent headache; swelling of extremities or unusual weight gain; changes in urinary elimination; acute headache; back or flank pain or spasms; or other adverse reactions. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Breast-feeding is not recommended.


Additional Information

 Equianalgesic doses: Morphine 10 mg I.M. = hydromorphone 1.5 mg I.M.


Anesthesia and Critical Care Concerns/Other Considerations

 When developing a therapeutic plan for pain control, scheduled, intermittent opioid dosing or continuous infusion is preferred over the "as needed" regimen. The 2002 ACCM/SCCM guidelines for analgesia (critically-ill adult) recommend fentanyl in patients who need immediate pain relief because of its rapid onset of action; fentanyl or hydromorphone is preferred in patients who are hypotensive or have renal dysfunction. Morphine or hydromorphone is recommended for intermittent, scheduled therapy. Both have a longer duration of action requiring less frequent administration. Hydromorphone does not have any active metabolites, has less protein binding than other opiates and does not cause histamine release. If the patient has required high-dose analgesia or has used for a prolonged period (~7 days), taper dose to prevent withdrawal; monitor for signs and symptoms of withdrawal.

Equianalgesic doses: Morphine 10 mg I.M. = hydromorphone 1.5 mg I.M.


Dental Health: Effects on Dental Treatment

 Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation).


Dental Health: Vasoconstrictor/Local Anesthetic Precautions

 No information available to require special precautions


Mental Health: Effects on Mental Status

 Drowsiness and dizziness are common; may cause nervousness or restlessness; may rarely cause hallucinations or depression


Mental Health: Effects on Psychiatric Treatment

 Concurrent use with psychotropics may produce additive sedation


Oncology: Vesicant

 No


Dosage Forms

 [CAN] = Canadian brand name

Capsule, controlled release (Hydromorph Contin®) [CAN]: 3 mg, 6 mg, 12 mg, 18 mg, 24 mg, 30 mg [not available in U.S.]

Capsule, extended release, as hydrochloride (Palladone™): 12 mg, 16 mg, 24 mg, 32 mg

Injection, powder for reconstitution, as hydrochloride (Dilaudid-HP®): 250 mg

Injection, solution, as hydrochloride: 1 mg/mL (1 mL); 2 mg/mL (1 mL, 20 mL); 4 mg/mL (1 mL); 10 mg/mL (1 mL, 5 mL, 10 mL)

Dilaudid®: 1 mg/mL (1 mL); 2 mg/mL (1 mL, 20 mL) [20 mL size contains edetate sodium; vial stopper contains latex]; 4 mg/mL (1 mL)

Dilaudid-HP®: 10 mg/mL (1 mL, 5 mL, 50 mL)

Liquid, oral, as hydrochloride (Dilaudid®): 1 mg/mL (480 mL) [may contain trace amounts of sodium bisulfite]

Suppository, rectal, as hydrochloride (Dilaudid®): 3 mg (6s)

Tablet, as hydrochloride (Dilaudid®): 2 mg, 4 mg, 8 mg (8 mg tablets may contain trace amounts of sodium bisulfite)


References

Agency for Health Care Policy and Research, "Acute Pain Management in Infants, Children and Adolescents: Operative and Medical Procedures," Am Fam Physician , 1992, 46(2):469-79.

"Clinical Practice Guidelines for the Sustained Use of Sedatives and Analgesics in the Critically Ill Adult. Task Force of the American College of Critical Care Medicine (ACCM) of the Society of Critical Care Medicine (SCCM), American Society of Health-System Pharmacists (ASHP), American College of Chest Physicians," Am J Health Syst Pharm , 2002, 59(2):150-78.

"Drugs for Pain," Med Lett Drugs Ther , 2000, 42(1085):73-8.

Ferrell BA, "Pain Management in Elderly People," J Am Geriatr Soc , 1991, 39(1):64-73.

Honigberg IL, and Stewart JT, "Radioimmunoassay of Hydromorphone and Hydrocodone in Human Plasma," J Pharm Sci , 1980, 69(10):1171-3.

Inturrisi CE, "Narcotic Drugs," Med Clin North Am , 1982, 66(5):1061-71.

Jacobi J, Fraser GL, Coursin DB, et al, "Clinical Practice Guidelines for the Sustained Use of Sedatives and Analgesics in the Critically Ill Adult," Crit Care Med , 2002, 30(1):119-41. Available at: http://www.sccm.org/pdf/sedatives.pdf. Accessed August 2, 2003.

Kaiko RF, Wallenstein SL, Rogers AG, et al, "Narcotics in the Elderly," Med Clin North Am , 1982, 66(5):1079-89.

Levy MH, "Pharmacologic Treatment of Cancer Pain," N Engl J Med , 1996, 335(15):1124-32.

Mokhlesi B, Leikin JB, Murray P, et al, "Adult Toxicology in Critical Care: Part II: Specific Poisonings," Chest , 2003, 123(3):897-922.

Nasraway SA, "Use of Sedative Medications in the Intensive Care Unit," Sem Resp Crit Care Med , 2001, 22(2):165-74.

"Principles of Analgesic Use in the Treatment of Acute Pain and Cancer Pain," 4th ed, Glenview, IL: American Pain Society, 1999.


International Brand Names

 Dilaudid® (AU, CA, DE); Dilaudid-HP® (CA); Dilaudid-HP-Plus® (CA); Dilaudid® Sterile Powder (CA); Dilaudid-XP® (CA); Dolonovag® (AR); Hidromorfona Clorhidrato Mallinckrodt® (AR); Hidromorfon® (RO); Hydal® (AT); Hydromorph Contin® (CA); Hydromorphone HP (CA); Opidol® (DK, SE); Palladon® (CH, DE); Palladone® (BE, GB, IE, IL, SI); PMS-Hydromorphone (CA); Sophidone® (FR)


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