Brompheniramine

Brompheniramine
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: Ammu Susheela, M.D. [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

Brompheniramine is an anticholinergic that is FDA approved for the treatment of hay fever (allergic rhinitis) or upper respiratory allergies. Common adverse reactions include hypersensitivity, drowsiness.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Temporarily relieves these symptoms due to hay fever (allergic rhinitis) or upper respiratory allergies:

• Runny nose.
• Sneezing.
• Itching of the nose or throat.
• Itchy, watery eyes.

Off-Label Use and Dosage (Adult)

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

Hypersensitivity to any of the ingredients.

Warnings

• Ask a doctor before use if you have

• A breathing problem such as emphysema or chronic bronchitis.
• Glaucoma.
• Trouble urinating due to enlargement of the prostate gland.

• Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
• When using this product.

• Excitability may occur, especially in children.
• May cause drowsiness.
• Avoid alcoholic drinks.
• Alcohol, sedatives, and tranquilizers may increase the drowsiness effect.
• Use caution when driving a motor vehicle or operating machinery.

• 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 right away.

• Overdose may cause hallucinations, convulsions, and death.

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

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

Drug Interactions

There is limited information regarding Brompheniramine 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 Brompheniramine in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral.

Monitoring

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

IV Compatibility

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

Overdosage

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

Pharmacology

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

Mechanism of Action

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

Structure

There is limited information regarding Brompheniramine Structure in the drug label.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

• Supplied in a tight, light-resistant container with a child-resistant cap.
• Contains color additives including FD&C Yellow No. 5 (tartrazine).
• Ala-Hist IR Tablets are dark green caplet shaped, scored tablets, debossed "Poly" bisect "783" on one side and plain on the other

Storage

• Store at 15° - 30°C (59° - 86°F).

Images

Drug Images

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Package and Label Display Panel

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

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Patient Counseling Information

Directions for Use

This image is provided by the National Library of Medicine.

Precautions with Alcohol

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

Brand Names

• ALA-HIST IR ®

Look-Alike Drug Names

There is limited information regarding Brompheniramine 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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