Professional Information

Hydromorphone Hydrochloride

Pronunciation: (HYE-droe-MOR-fone HYE-droe-KLOR-ide)
Class: Opioid analgesic

Trade Names:
Dilaudid
- Tablets 2 mg
- Tablets 4 mg
- Tablets 8 mg
- Injection 1 mg/mL
- Injection 2 mg/mL
- Injection 4 mg/mL
- Suppositories 3 mg
- Oral liquid 1 mg/mL

Trade Names:
Dilaudid-HP
- Injection 10 mg/mL
- Powder for Injection, lyophilized 250 mg

Dilaudid-HP Plus (Canada)
Dilaudid Sterile Powder (Canada)
Dilaudid-XP (Canada)
Hydromorph Contin (Canada)
Hydromorphone HP 10 (Canada)
Hydromorphone HP 20 (Canada)
Hydromorphone HP 50 (Canada)
Hydromorphone HP Forte (Canada)
PMS-Hydromorphone (Canada)

Pharmacology

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Relieves pain by stimulating opiate receptors in CNS; also causes respiratory depression, inhibition of cough reflex, peripheral vasodilation, inhibition of intestinal peristalsis, sphincter of Oddi spasm, stimulation of chemoreceptors that cause vomiting, and increased bladder tone.

Pharmacokinetics

Absorption

Rapidly absorbed after oral administration. C _max is 5.5 mg, T _max is 0.74 h, and AUC is 23.7 ng•h/mL (8 mg tablet).

Distribution

8% to 19% bound to plasma proteins. Vd at steady state is 302.9 L (IV bolus).

Metabolism

Hydromorphone is metabolized in the liver as glucuronidated conjugate (major metabolite) and 6-hydroxy (minor metabolite).

Elimination

Systemic clearance is approximately 1.96 L/min. Terminal elimination t _½ is 2.3 h (IV). The mean t _½ is approximately 2.64 h. Hydromorphone is excreted primarily as the glucuronidated conjugate.

Onset

Onset of hydromorphone is 15 min (parenterally) and 30 min (oral).

Peak

Time to peak effect is 0.5 to 1 h.

Duration

Duration is longer than 5 h.

Special Populations

Renal Function Impairment

C _max and AUC _0-48 is increased 2-fold in patients with moderate (CrCl 40 to 60 mL/min) and 3-fold in patients with severe (CrCl less than 30 mL/min) renal function impairment.

Hepatic Function Impairment

C _max and AUC _0-t is increased 4-fold in patients with moderate (Child-Pugh group B) hepatic function impairment.

Gender

Women appear to have a 25% higher C _max than men.

Indications and Usage

Relief of moderate to severe pain in opioid-tolerant patients such as because of biliary colic, burns, cancer, MI, renal colic, surgery, or trauma of soft tissue and bone.

Contraindications

Hypersensitivity to similar compounds; depressed ventilatory function; acute asthma; patients not already receiving large amounts of parenteral narcotics; patients with respiratory depression without access to resuscitative equipment; labor.

Dosage and Administration

Adults Oral tablets

PO Usual starting dosage is 2 mg every 4 to 6 h as needed. For more severe pain, give 4 mg every 4 to 6 h. If the pain increases in severity, analgesia is not adequate, or tolerance occurs, a gradual increase in dosage may be necessary.

Oral liquid

Usual dosage is 2.5 to 10 mg (2.5 to 10 mL) every 3 to 6 h, depending on the clinical situation. A gradual increase in dose may be required if analgesia is inadequate, tolerance develops, or pain severity increases.

Adults

Suppositories One inserted rectally every 6 to 8 h.

Adults

IM / Subcutaneous Usual starting dosage is 1 to 2 mg every 4 to 6 h as needed. Adjust dose according to severity of pain, underlying disease, age, and size of the patient.

Adults

IV Administer slowly, over at least 2 to 3 min. A gradual increase in dose may be necessary if analgesia is inadequate, tolerance occurs, or pain severity increases. Note concentration and do not confuse with other standard, less concentrated formulations.

General Advice

Reconstitute powder with 25 mL of sterile water for injection immediately prior to use.

Storage/Stability

Tablets, liquid, injection

Store at 59° to 86°F. Protect from light.

Suppositories

Store in refrigerator between 36° and 46°F.

Drug Interactions

CNS depressants (eg, alcohol, general anesthetics, hypnotics, phenothiazines, sedatives, tranquilizers, tricyclic antidepressants)

Additive CNS and respiratory depression.

Neuromuscular blocking agents

Pharmacologic effects may be enhanced, producing increased respiratory depression.

Opioid agonist/antagonist analgesics (eg, buprenorphine, butorphanol, nalbuphine, pentazocine)

Use with caution; analgesic effect of hydromorphone may be reduced and withdrawal symptoms may be precipitated.

Laboratory Test Interactions

None known.

Adverse Reactions

Cardiovascular

Bradycardia; cardiac arrest; circulatory depression; faintness; flushing of the face; hypertension; hypotension; orthostatic hypotension; palpitations; peripheral circulatory collapse; shock; syncope; tachycardia.

CNS

Agitation; anxiety; disorientation; dizziness; drowsiness; dysphoria; euphoria; fear; hallucination; headache; impaired physical performance; increased intracranial pressure; insomnia; lethargy; light-headedness; mental clouding; mental impairment; mood change (including apprehension, depression, dreams, floating feeling, nervousness); muscle rigidity; muscle tremor; paresthesia; psychic dependence; sedation; tremor; uncoordinated muscle movement; weakness.

Dermatologic

Pruritus; rash; sweating; urticaria.

EENT

Blurred vision; diplopia; miosis; nystagmus; visual disturbances.

GI

Anorexia; biliary tract spasm; constipation; cramps; diarrhea; dry mouth; ileus; nausea; taste alterations; vomiting.

Genitourinary

Antidiuretic effect; spasm of vesical sphincters; ureteral spasm; urinary hesitancy; urinary retention.

Local

Pain at injection site; wheal and flare over the vein with IV injection.

Respiratory

Apnea; bronchospasm; irregular and periodic breathing; laryngospasm; respiratory depression; respiratory arrest.

Miscellaneous

Chills.

Precautions

Warnings

Hydromorphone injection is available as a highly concentrated solution (10 mg/mL) intended for use in narcotic-tolerant patients. Do not confuse with other standard, less concentrated formulations. Overdose and death could occur.

Abuse

Hydromorphone is a potent opioid agonist with a high potential for abuse and risk of producing respiratory depression.

Monitor

During dose titration, closely monitor patients with hepatic or renal function impairment.

Pregnancy

Category C .

Lactation

Excreted in breast milk.

Children

Safety and efficacy not established.

Elderly

Use with caution, usually starting at the low end of the dosage range, because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy.

Renal Function

May need to reduce dose.

Hepatic Function

May need to reduce dose.

Special Risk Patients

Use with caution in the elderly or debilitated and those with severe impairment of hepatic, pulmonary, or renal function; myxedema or hypothyroidism; adrenocortical insufficiency (eg, Addisons disease); CNS depression or coma; toxic psychosis; circulatory shock; prostatic hypertrophy or urethral stricture; gall bladder disease; pulmonary disease; acute alcoholism; delirium tremens; kyphoscoliosis; or following surgery.

Sulfite Sensitivity

Use with caution in patients known to be sensitive to sulfites, as some products contain bisulfites.

Acute abdominal conditions

Diagnosis and clinical course may be obscured.

Biliary surgery

Use with caution in patients undergoing biliary tract surgery since drug may cause spasm of the sphincter of Oddi.

Head injury and increased intracranial pressure

Cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or preexisting increase in intracranial pressure.

Hypotension

Severe hypotension may occur; orthostatic hypotension may occur in ambulatory patients.

Latex allergy

The 500 mg per 50 mL single-use vial contains rubber latex.

Respiratory depression

Respiratory depression is the chief hazard of hydromorphone injection. It occurs more frequently in elderly patients, in debilitated patients, and in patients suffering from hypoxia or hypercapnia. Even therapeutic doses may dangerously decrease pulmonary ventilation. Use with extreme caution in patients with COPD or cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression.

Seizures

Mild to severe seizures and myoclonus may occur.

Tolerance and physical dependence

Both tolerance and physical dependence may occur.

Overdosage

Symptoms

Apnea; bradycardia; cardiopulmonary arrest; circulatory collapse; cold, clammy skin; constricted pupils; death; hypotension; respiratory depression; skeletal muscle flaccidity; somnolence progressing to stupor or coma.

Patient Information

Instruct patient to take medication before pain becomes severe.
Advise patient to take medication with food or milk to decrease stomach upset.
Advise patient that drug may cause drowsiness and to use caution while driving or performing other tasks requiring mental alertness.
Advise patient to eat high-fiber diet and to maintain adequate fluid intake. A stool softener or bulk laxative may be recommended to prevent constipation.
Instruct patient to avoid intake of alcoholic beverages or other CNS depressants.
Instruct patient to discontinue drug and notify health care provider if difficulty in breathing or persistent nausea, vomiting, or constipation occurs.
When medication is used for acute pain, caution patient about potential for addiction and explain that medication should be for short-term use only.