Promethazine (injection)

Promethazine (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];

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Black Box Warning

WARNINGS See full prescribing information for complete Boxed Warning. Respiratory Depression – Pediatrics PHENERGAN Injection should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine in pediatric patients less than 2 years of age. Caution should be exercised when administering PHENERGAN Injection to pediatric patients 2 years of age and older. Severe Tissue Injury, Including Gangrene PHENERGAN Injection can cause severe chemical irritation and damage to tissues regardless of the route of administration. Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration. Adverse reactions include burning, pain, thrombophlebitis, tissue necrosis, and gangrene. In some cases, surgical intervention, including fasciotomy, skin graft, and/or amputation have been required (see WARNINGS - SEVERE TISSUE INJURY, INCLUDING GANGRENE). Due to the risks of intravenous injection, the preferred route of administration of PHENERGAN Injection is deep intramuscular injection. Subcutaneous injection is contraindicated. See DOSAGE AND ADMINISTRATION for important notes on administration.

Overview

Promethazine (injection) is a neuroleptic medication and first-generation antihistamine that is FDA approved for the treatment of Amelioration of allergic reactions to blood or plasma and in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include {{{adverseReactions}}}.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Promethazine (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 Promethazine (injection) in adult patients.

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Promethazine (injection) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

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

Warnings

WARNINGS See full prescribing information for complete Boxed Warning. Respiratory Depression – Pediatrics PHENERGAN Injection should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine in pediatric patients less than 2 years of age. Caution should be exercised when administering PHENERGAN Injection to pediatric patients 2 years of age and older. Severe Tissue Injury, Including Gangrene PHENERGAN Injection can cause severe chemical irritation and damage to tissues regardless of the route of administration. Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration. Adverse reactions include burning, pain, thrombophlebitis, tissue necrosis, and gangrene. In some cases, surgical intervention, including fasciotomy, skin graft, and/or amputation have been required (see WARNINGS - SEVERE TISSUE INJURY, INCLUDING GANGRENE). Due to the risks of intravenous injection, the preferred route of administration of PHENERGAN Injection is deep intramuscular injection. Subcutaneous injection is contraindicated. See DOSAGE AND ADMINISTRATION for important notes on administration.

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

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Promethazine (injection) Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Promethazine (injection) Postmarketing Experience in the drug label.

Drug Interactions

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

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Promethazine (injection) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Promethazine (injection) in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

There is no FDA guidance on the use of Promethazine (injection) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Promethazine (injection) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Promethazine (injection) in geriatric settings.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

There is limited information regarding Promethazine (injection) Administration in the drug label.

Monitoring

There is limited information regarding Promethazine (injection) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Promethazine (injection) and IV administrations.

Overdosage

There is limited information regarding Promethazine (injection) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

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

Mechanism of Action

There is limited information regarding Promethazine (injection) Mechanism of Action in the drug label.

Structure

There is limited information regarding Promethazine (injection) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Promethazine (injection) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Promethazine (injection) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Promethazine (injection) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Promethazine (injection) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Promethazine (injection) How Supplied in the drug label.

Storage

There is limited information regarding Promethazine (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 Promethazine (injection) Patient Counseling Information in the drug label.

Precautions with Alcohol

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

Brand Names

There is limited information regarding Promethazine (injection) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Promethazine (injection) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

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