Hydromorphone (rectal)

Hydromorphone (rectal)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

Hydromorphone (rectal) is a analgesic that is FDA approved for the treatment of pain. Common adverse reactions include anxiety, fear, dysphoria, dizziness, Orthostatic hypotension,urinary retention, nausea, vomiting and pruritus.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Hydromorphone hydrochloride is indicated for the relief of moderate to severe pain such as that due to:

• Surgery
• Trauma(Soft tissue and bone)
• Burns
• Cancer
• Biliary Colic
• Myocardial Infarction
• Renal Colic

Dosage

• Hydromorphone Hydrochloride Suppositories (3 mg) may provide longer duration of relief which could obviate additional medication during the sleeping hours. The usual adult dose is one (1) suppository inserted rectally every 6 to 8 hours or as directed by physician.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Hydromorphone (rectal) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Hydromorphone (rectal) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Hydromorphone (rectal) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Hydromorphone (rectal) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Hydromorphone (rectal) in pediatric patients.

Contraindications

• Hydromorphone hydrochloride is contraindicated in patients with a known hypersensitivity to hydromorphone; in the presence of an intracranial lesion associated with increased intracranial pressure; and whenever ventilatory function is depressed (chronic obstructive pulmonary disease, cor pulmonale, emphysema, kyphoscoliosis, status asthmaticus).

Warnings

Respiratory Depression:

• Hydromorphone hydrochloride produces dose-related respiratory depression by acting directly on brain stem respiratory centers. Hydromorphone hydrochloride also affects centers that control respiratory rhythm, and may produce irregular and periodic breathing.

Head Injury and Increased Intracranial Pressure:

• The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce effects which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions:

• The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Hydromorphone (rectal) in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Hydromorphone (rectal) in the drug label.

Drug Interactions

• Patients receiving other narcotic analgesics, general anesthetics, phenothiazines, tranquilizers, sedative-hypnotics, tricyclic antidepressants or other CNS depressants (including alcohol) concomitantly with hydromorphone hydrochloride may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): Pregnancy Category C

• Hydromorphone hydrochloride has been shown to be teratogenic in hamsters when given in doses 600 times the human dose. There are no adequate and well-controlled studies in pregnant women. Hydromorphone hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects:

• Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritablity and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal. Chlorpromazine 0.7 to 1.0 mg/kg q6h, phenobarbital 2 mg/kg q6h, and paregoric 2 to 4 drops/kg q4h, have been used to treat withdrawal symptoms in infants. The duration of therapy is 4 to 28 days, with the dosages decreased as tolerated.

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Hydromorphone (rectal) in women who are pregnant.

Labor and Delivery

• As with all narcotics, administration of hydromorphone hydrochloride to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used.

Nursing Mothers

• It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hydromorphone hydrochloride, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

• Safety and effectiveness in children have not been established.

Geriatic Use

There is no FDA guidance on the use of Hydromorphone (rectal) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Hydromorphone (rectal) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Hydromorphone (rectal) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Hydromorphone (rectal) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Hydromorphone (rectal) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Hydromorphone (rectal) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Hydromorphone (rectal) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Rectal

Monitoring

There is limited information regarding Monitoring of Hydromorphone (rectal) in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Hydromorphone (rectal) in the drug label.

Overdosage

Signs and Symptoms:

• Serious overdosage with hydromorphone hydrochloride is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, particularly the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur.

Treatment:

• Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. The narcotic antagonist naloxone hydrochloride is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, including hydromorphone hydrochloride. Therefore, naloxone hydrochloride should be administered as described under adverse reactions in conjunction with ventilatory assistance.

• Since the duration of action of hydromorphone hydrochloride may exceed that of the antagonist, the patient should be kept under continued surveillance; repeated doses of the antagonist may be required to maintain adequate respiration. An antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated.

Pharmacology

There is limited information regarding Hydromorphone (rectal) Pharmacology in the drug label.

Mechanism of Action

Structure

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Hydromorphone (rectal) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Hydromorphone (rectal) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Hydromorphone (rectal) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Hydromorphone (rectal) in the drug label.

How Supplied

• Rectal Suppositories: 3 mg Suppositories

• Boxes of 6 NDC 0574-7224-06

Storage

• Hydromorphone Hydrochloride Suppositories should be stored in a refrigerator. Protect from light.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Hydromorphone (rectal) in the drug label.

Precautions with Alcohol

• Alcohol-Hydromorphone (rectal) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• HYDROMORPHONE HYDROCHLORIDE®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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