Carboxymethyl cellulose

Carboxymethyl cellulose
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

Carboxymethyl cellulose is a Ophthalmologic Agent that is FDA approved for the treatment of burning, irritation and discomfort due to dryness of the eye. Common adverse reactions include eye pain, changes in vision, irritation of the eye.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• For the temporary relief of burning, irritation and discomfort due to dryness of the eye or exposure to wind or sun.

May be used as a protectant against further irritation.

Directions

To open, TWIST AND PULL TAB TO REMOVE. Instill 1 or 2 drops in the affected eye(s) as needed and discard container.

If used for post-operative (e.g. LASIK) dryness and discomfort, follow your eye doctor’s instructions.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Carboxymethyl cellulose in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Carboxymethyl cellulose Contraindications in the drug label.

Warnings

For external use only. To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard. Do not touch unit-dose tip to eye. Do not use if solution changes color or becomes cloudy.

STOP USE AND ASK A DOCTOR If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

eye pain changes in vision irritation of the eye

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Carboxymethyl cellulose 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 Carboxymethyl cellulose 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 Carboxymethyl cellulose in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• topical ophthalmic

Monitoring

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

IV Compatibility

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

Overdosage

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

Pharmacology

There is limited information regarding Carboxymethyl cellulose Pharmacology in the drug label.

Mechanism of Action

Structure

• ACTIVE INGREDIENT

Carboxymethylcellulose sodium (CMC) 0.5% ............... Eye lubricant

INACTIVE INGREDIENTS Calcium chloride; magnesium chloride; potassium chloride; purified water; sodium chloride; and sodium lactate. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Carboxymethyl cellulose Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL- 30 STERILE SINGLE USE CONTAINERS

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

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

Precautions with Alcohol

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

Brand Names

• CARBOXYMETHYLCELLULOSE SODIUM®

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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