Methylcellulose

Methylcellulose
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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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Methylcellulose is a OTC laxative that is FDA approved for the treatment of constipation. Common adverse reactions include flatulence and distension.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

helps restore and maintain regularity relieves constipation (irregularity) for constipation associated with other bowel disorders like IBS when recommended by a doctor generally produces a bowel movement in 12- 72 hours

Dosage

• Take this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may case choking. See choking warning.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Dosage

• Take this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may case choking. See choking warning.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Methylcellulose Contraindications in the drug label.

Warnings

Choking: taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.

Ask a doctor before use if you have a sudden change in bowel habits that persists for two weeks abdominal pain, nausea or vomiting

Stop use and ask a doctor if constipation lasts more than 7 days you have rectal bleeding These could be signs of a serious condition.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

• flatulence
• distension
• intestinal obstruction

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Methylcellulose 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

There is limited information regarding Methylcellulose Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Methylcellulose in women who are pregnant.
Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral

Monitoring

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

IV Compatibility

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

Overdosage

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

Pharmacology

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

Mechanism of Action

• Bulk-forming fiber laxative

Structure

• ACTIVE INGREDIENT (IN EACH CAPLET)

Methylcellulose (a non-allergenic fiber) 500mg

INACTIVE INGREDIENTS crospovidone, dibasic calcium phosphate, FD&C yellow no. 6 aluminum lake, magnesium stearate, maltodextrin, povidone, sodium lauryl sulfate

• each caplet contains: calcium 10mg

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

store below 77 oF (25 oC) protect contents from humidity keep tightly closed

Images

Drug Images

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Package and Label Display Panel

PRINCIPAL DISPLAY PANEL NDC 0135-0199-02

CITRUCEL®

METHYLCELLULOSE FIBER THERAPY FOR REGULARITY

Gentle and clinically proven effective Gives you additional fiber to help balance your diet The ONLY fiber for regularity that won’t cause excess gas 100 Fiber caplets

BETTER VALUE Per Dose than leading competition

• Based on laboratory testing. Individual results may vary.

CITRUCEL® is a registered trademark of the Sanofi group of companies and licensed by the GlaxoSmithKline group of companies.

©2012 GlaxoSmithKline

101878XA

This image is provided by the National Library of Medicine.

Ingredients and Appearance

This image is provided by the National Library of Medicine.

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Patient Counseling Information

• call toll-free 1-800-897-6081 (English/Spanish) weekdays

Precautions with Alcohol

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

Brand Names

• CITRUCEL®

Look-Alike Drug Names

There is limited information regarding Methylcellulose 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.

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