Bismuth subsalicylate

Bismuth subsalicylate
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

Bismuth subsalicylate is a OTC antacid that is FDA approved for the treatment of diarrhea, heartburn, indigestion, nausea, upset stomach. Common adverse reactions include darkening of the stool and/or tongue.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• relieves:

• diarrhea
• heartburn
• indigestion
• nausea
• upset stomach associated with these symptoms

DIRECTIONS

• chew or dissolve in mouth
• adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
• do not take more than 8 doses (16 tablets) in 24 hours
• children under 12 years: ask a doctor
• drink plenty of fluids to help prevent dehydration which may accompany diarrhea.
• Other information: each tablet contains:

• sodium less than 1 mg
• salicylate 102 mg
• calcium 140 mg
• very low sodium
• avoid excessive heat (over 104˚F or 40˚C)

• TAMPER EVIDENT: Do not use if individual compartments are torn or missing.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Directions

• children 12 years and over: 2 tablets every 1/2 to 1 hour as needed

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Bismuth subsalicylate Contraindications in the drug label.

Warnings

Reye's syndrome:

• Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. when using this product , if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert:

• Contains salicylate. Do not take if you are

• allergic to salicylates (including aspirin)
• taking other salicylate products

• Do not use if you have

• bloody or black stools
• an ulcer
• a bleeding problem

• Ask a doctor before use if you have

• fever
• mucus in the stool

• Ask a doctor or pharmacist before use if you aretaking any drug for

• anticoagulation (thinning of the blood)
• diabetes
• gout
• arthritis

• When using this product

• a temporary, but harmless darkening of the stool and/or tongue may occur.

• Stop use and ask a doctor if

• symptoms get worse
• ringing in the ears or loss of hearing occurs
• diarrhea lasts more than 2 days

• If pregnant or breast-feeding, ask a health professional before use.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Adverse Reactions

Clinical Trials Experience

darkening of the stool and/or tongue

Postmarketing Experience

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

Drug Interactions

There is limited information regarding Bismuth subsalicylate 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 Bismuth subsalicylate in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral

Monitoring

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

IV Compatibility

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

Overdosage

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

Pharmacology

Mechanism of Action

There is limited information regarding Bismuth subsalicylate Mechanism of Action in the drug label.

Structure

ACTIVE INGREDIENT (IN EACH TABLET)=

• Bismuth subsalicylate 262 mg

• (total salicylate 102 mg per tablet)

INACTIVE INGREDIENTS

• calcium carbonate, D and C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

There is limited information regarding Bismuth subsalicylate How Supplied in the drug label.

Storage

• avoid excessive heat (over 104˚F or 40˚C)

Images

Drug Images

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Package and Label Display Panel

PRINCIPAL DISPLAY PANEL

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 Bismuth subsalicylate in the drug label.

Precautions with Alcohol

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

Brand Names

• BISMATROL®

Look-Alike Drug Names

There is limited information regarding Bismuth subsalicylate 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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