Sodium borate

Sodium borate
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

Sodium borate is a OTC pellet that is FDA approved for the treatment of Canker sores (mouth ulcers). Common adverse reactions include vomiting and diarrhoea, abdominal pain, rash.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• Canker sores (mouth ulcers)

Dosage

• Directions: (adults/children) Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved 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 Sodium borate in adult patients.

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

• Canker sores (mouth ulcers)

Dosage

• Directions: (adults/children) Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved 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 Sodium borate in pediatric patients.

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Sodium borate Contraindications in the drug label.

Warnings

• Stop use and ask a physician if symptoms persist for more than 3 days or worsen.
• Keep out of reach of children.
• Do not use if pellet-dispenser seal is broken.

Adverse Reactions

Clinical Trials Experience

• vomiting and diarrhoea, abdominal pain, rash

Postmarketing Experience

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

Drug Interactions

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

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• If pregnant or breast-feeding, ask a health professional before use.

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

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

Nursing Mothers

• If pregnant or breast-feeding, ask a health professional before use.

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral

Monitoring

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

IV Compatibility

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

Overdosage

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

Pharmacology

This image is provided by the National Library of Medicine.

Mechanism of Action

There is limited information regarding Sodium borate Mechanism of Action in the drug label.

Structure

• Active Ingredient:

HPUS Borax 30c

• Inactive Ingredients: Lactose, sucrose.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

There is limited information regarding Sodium borate How Supplied in the drug label.

Storage

• Store at room temperature.

Images

Drug Images

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Package and Label Display Panel

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 Sodium borate in the drug label.

Precautions with Alcohol

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

Brand Names

• BORAX®

Look-Alike Drug Names

There is limited information regarding Sodium borate 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.