Crofelemer

Crofelemer
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: Rabin Bista, M.B.B.S. [2]

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Overview

Crofelemer is a anti-diarrheal that is FDA approved for the treatment of non-infectious diarrhea in adult patients with HIV/AIDS. Common adverse reactions include upper respiratory tract infection, bronchitis, cough, flatulence and increased bilirubin.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

FULYZAQ is indicated for symptomatic relief of non-infectious diarrhea in patients with HIV/AIDS on anti-retroviral therapy.

Dosage

The recommended dose of FULYZAQ is one 125 mg delayed-release tablet taken orally two times a day, with or without food. FULYZAQ tablets should not be crushed or chewed. Tablets should be swallowed whole.

3 DOSAGE FORMS AND STRENGTHS FULYZAQ is a white, oval, enteric-coated 125 mg delayed-release tablet printed on one side with 125SLXP.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

The safety and effectiveness of FULYZAQ have not been established in pediatric patients less than 18 years of age.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

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

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

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

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

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 Crofelemer in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

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

• Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

File:Crofelemer01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Crofelemer Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

{{#ask: Label Page::Crofelemer |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Crofelemer in the drug label.

Precautions with Alcohol

• Alcohol-Crofelemer 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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