Hydromorphone hydrochloride (injection)

Hydromorphone hydrochloride (injection)
Black Box Warning
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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Black Box Warning

WARNING: RISK OF RESPIRATORY DEPRESSION, ABUSE, AND MEDICATION ERRORS See full prescribing information for complete Boxed Warning. HYDROMORPHONE HCl INJECTION (high potency formulation) IS FOR USE IN OPIOID-TOLERANT PATIENTS ONLY Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer. Hydromorphone HCl Injection (high potency formulation) is a more concentrated solution of hydromorphone than Hydromorphone HCl Injection, and is for use in opioid-tolerant patients only. Do not confuse Hydromorphone HCl Injection (high potency formulation) with standard parenteral formulations of Hydromorphone Hydrochloride or other opioids, as overdose and death could result. Hydromorphone HCl Injection (high potency formulation) contain hydromorphone, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. Hydromorphone HCl Injection (high potency formulation) can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing Hydromorphone HCl Injection (high potency formulation) in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion. Schedule II opioid agonists, including morphine, oxymorphone, hydromorphone, oxycodone, fentanyl, and methadone, have the highest potential for abuse and risk of producing fatal overdose due to respiratory depression. Ethanol, other opioids, and other central nervous system depressants (e.g., sedative-hypnotics, skeletal muscle relaxants) can potentiate the respiratory-depressant effects of hydromorphone and increase the risk of adverse outcomes, including death.

Overview

Hydromorphone hydrochloride (injection) is a {{{drugClass}}} that is FDA approved for the treatment of pain. There is a Black Box Warning for this drug as shown here. Common adverse reactions include lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Hydromorphone hydrochloride (injection) FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Hydromorphone hydrochloride (injection) Contraindications in the drug label.

Warnings

WARNING: RISK OF RESPIRATORY DEPRESSION, ABUSE, AND MEDICATION ERRORS See full prescribing information for complete Boxed Warning. HYDROMORPHONE HCl INJECTION (high potency formulation) IS FOR USE IN OPIOID-TOLERANT PATIENTS ONLY Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer. Hydromorphone HCl Injection (high potency formulation) is a more concentrated solution of hydromorphone than Hydromorphone HCl Injection, and is for use in opioid-tolerant patients only. Do not confuse Hydromorphone HCl Injection (high potency formulation) with standard parenteral formulations of Hydromorphone Hydrochloride or other opioids, as overdose and death could result. Hydromorphone HCl Injection (high potency formulation) contain hydromorphone, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. Hydromorphone HCl Injection (high potency formulation) can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing Hydromorphone HCl Injection (high potency formulation) in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion. Schedule II opioid agonists, including morphine, oxymorphone, hydromorphone, oxycodone, fentanyl, and methadone, have the highest potential for abuse and risk of producing fatal overdose due to respiratory depression. Ethanol, other opioids, and other central nervous system depressants (e.g., sedative-hypnotics, skeletal muscle relaxants) can potentiate the respiratory-depressant effects of hydromorphone and increase the risk of adverse outcomes, including death.

There is limited information regarding Hydromorphone hydrochloride (injection) Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

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

Drug Interactions

There is limited information regarding Hydromorphone hydrochloride (injection) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

There is no FDA guidance on use of Hydromorphone hydrochloride (injection) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Hydromorphone hydrochloride (injection) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Hydromorphone hydrochloride (injection) with respect to pediatric patients.

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

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

• Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Hydromorphone hydrochloride (injection) in the drug label.

Pharmacology

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

Mechanism of Action

Structure

File:Hydromorphone hydrochloride (injection)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Hydromorphone hydrochloride (injection) Storage in the drug label.

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 hydrochloride (injection) in the drug label.

Precautions with Alcohol

• Alcohol-Hydromorphone hydrochloride (injection) 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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