Paregoric

Paregoric
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

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

Overview

Paregoric is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Diarrhea

• Paregoric is useful for the treatment of diarrhea.

Usual Adult Dosage

• 5 to 10 mL (1 to 2 teaspoonfuls) 1 to 4 times a day or as directed by a physician.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Paregoric in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Paregoric in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Usual Pediatric Dosage

0.25 to 0.5 mL/kg of body weight 1 to 4 times a day or as directed by a physician.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Paregoric in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Paregoric in pediatric patients.

Contraindications

• Condition1

Warnings

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Paregoric in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Paregoric in the drug label.

Drug Interactions

• Drug

• Description

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 Paregoric in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Paregoric during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Paregoric with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Paregoric with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Paregoric with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Paregoric with respect to specific gender populations.

Race

There is no FDA guidance on the use of Paregoric with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Paregoric in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Paregoric in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Paregoric in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Paregoric in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Paregoric in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Paregoric in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Paregoric in the drug label.

Pharmacology

There is limited information regarding Paregoric Pharmacology in the drug label.

Mechanism of Action

Structure

File:Paregoric01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Paregoric in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Paregoric in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Paregoric in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Paregoric in the drug label.

How Supplied

Storage

There is limited information regarding Paregoric 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 Paregoric in the drug label.

Precautions with Alcohol

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

Brand Names

• ®

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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