Brompheniramine

Drug class: Antineoplastic Agents

Usage of Brompheniramine

Allergic Rhinitis or Other Upper Respiratory Allergies

Used in fixed combination with other agents (e.g., dextromethorphan, guaifenesin, phenylephrine, pseudoephedrine) for relief of rhinorrhea, sneezing, lacrimation, itching eyes, oronasopharyngeal itching, and/or other symptoms (e.g., nasal/sinus congestion, cough) associated with allergic rhinitis (e.g., hay fever) or other upper respiratory allergies.

Use fixed-combination preparations only when symptoms amenable to each ingredient are present concurrently.

Common Cold

Used in fixed combination with other agents (e.g., phenylephrine, pseudoephedrine) for temporary relief of rhinorrhea, sneezing, lacrimation, itching eyes, oronasopharyngeal itching, and/or other symptoms associated with the common cold (e.g., nasal congestion).

Relate drugs

How to use Brompheniramine

Administration

Oral Administration

Administer orally with food, water, or milk to minimize gastric irritation.

Brompheniramine maleate oral solution: Use only the measuring device (e.g., calibrated dropper, cup, spoon) provided by the manufacturer.

Dosage

Brompheniramine: Available as brompheniramine maleate; dosage expressed in terms of the salt.

Dexbrompheniramine: Available as dexprompheniramine maleate; dosage expressed in terms of the salt. Dexbrompheniramine maleate available only in fixed-combination preparations.

Individualize dosage according to patient’s response and tolerance.

Fixed-combination preparations do not permit individual titration of dosages. When used in fixed combination with other agents (e.g., dextromethorphan, guaifenesin, phenylephrine, pseudoephedrine), select a dosage that is within the usual therapeutic range for each ingredient. Because combinations and dosage strengths vary for fixed-combination preparations, consult manufacturer’s product labeling for appropriate dosage of the specific preparation.

Pediatric Patients

Allergic Rhinitis, Other Upper Respiratory Allergies, or the Common Cold Brompheniramine Maleate Oral

Children 2 to <6 years of age: 1 mg every 4 hours.

Self-medication in children 6 to <12 years of age: 2 mg every 4 hours.

Self-medication in children ≥12 years of age: 4 mg every 4 hours.

Adults

Allergic Rhinitis, Other Upper Respiratory Allergies, or the Common Cold Brompheniramine Maleate Oral

Self-medication: 4 mg every 4 hours.

Prescribing Limits

Pediatric Patients

Allergic Rhinitis, Other Upper Respiratory Allergies, or the Common Cold Brompheniramine Maleate Oral

Children 2 to <6 years of age: Maximum 6 mg in 24 hours.

Children 6 to <12 years of age: Maximum 12 mg in 24 hours. When used for self-medication, discontinue therapy if symptoms persist for >7 days or are accompanied by fever.

Children ≥12 years of age: Maximum 24 mg in 24 hours. When used for self-medication, discontinue therapy if symptoms persist for >7 days or are accompanied by fever.

Adults

Allergic Rhinitis, Other Upper Respiratory Allergies, or the Common Cold Brompheniramine Maleate Oral

Maximum 24 mg in 24 hours. When used for self-medication, discontinue therapy if symptoms persist for >7 days or are accompanied by fever.

Special Populations

Geriatric Patients

Patients ≥60 years of age: Select dosage with caution, starting at the lower end of the usual dosage range, because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.

Warnings

Contraindications

  • Women who are breast-feeding.
  • During or within 2 weeks of MAO-inhibitor therapy.
  • Angle-closure glaucoma, urinary retention, peptic ulcer disease, and acute asthmatic attack, according to some manufacturers.
  • Known hypersensitivity to brompheniramine, other antihistamines, or any ingredient in the formulation.

    • Warnings/Precautions

    Warnings

    Concomitant Diseases

    Use with caution in patients with increased IOP, bronchial asthma, hyperthyroidism, diabetes mellitus, cardiovascular disease (e.g., hypertension, ischemic heart disease), or prostatic hypertrophy.

    CNS Effects

    Risk of drowsiness. Concurrent use of other CNS depressants may have additive CNS depressant effects. (See CNS Depressants under Interactions and also see Advice to Patients.)

    Possible excitability (especially in children). (See Pediatric Use under Cautions.)

    General Precautions

    Anticholinergic Effects

    Possible anticholinergic effects (e.g., severe dryness of mouth, nose, and throat; dysuria; urinary retention). Use with caution, if at all, in patients with prostatic hypertrophy, pyloroduodenal obstruction, or bladder neck obstruction. (See Contraindications under Cautions.)

    Use of Fixed Combinations

    When used in fixed combination with other agents (e.g., dextromethorphan, guaifenesin, phenylephrine, pseudoephedrine), consider the cautions, precautions, and contraindications associated with the concomitant agent(s).

    Specific Populations

    Pregnancy

    Category C. Use not recommended during the third trimester because of risk of severe reactions (e.g., seizures) in neonates and premature infants.

    Lactation

    Not known if brompheniramine is distributed into milk. Discontinue nursing or the drug because of potential risk to nursing infants. (See Contraindications under Cautions.)

    Pediatric Use

    Possible paradoxical irritability or excitement (e.g., restlessness, insomnia, tremors, euphoria, nervousness, delirium, palpitation, seizures), especially in children.

    Brompheniramine maleate: Safety and efficacy of brompheniramine in fixed combination with pseudoephedrine and dextromethorphan not established in children <6 months of age. For self-medication, do not use brompheniramine in fixed combination with phenylephrine in children <6 years of age.

    Risk of overdosage and toxicity (including death) in children <2 years of age receiving OTC preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection. Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established. Therefore, FDA recommended not to use such preparations in children <2 years of age; safety and efficacy in older children under evaluation. Because children 2–3 years of age also are at increased risk of overdosage and toxicity, some manufacturers of oral nonprescription cough and cold preparations agreed to voluntarily revise the product labeling to state that such preparations should not be used in children <4 years of age. FDA recommends that parents and caregivers adhere to dosage instructions and warnings on the product labeling that accompanies the preparation and consult a clinician about any concerns. Clinicians should ask caregivers about use of nonprescription cough/cold preparations to avoid overdosage.

    Geriatric Use

    Possible increased risk of confusion, dizziness, sedation, hypotension, hyperexcitability, and anticholinergic effects (e.g., dry mouth, urinary retention [particularly in men]) in patients ≥60 years of age. (See Geriatric Patients under Dosage and Administration.)

    Common Adverse Effects

    Sedation (e.g., drowsiness, dizziness), CNS stimulation (e.g., restlessness, insomnia, anxiety, tension, nervousness), vertigo, weakness, confusion, blurred vision, nausea, dry mouth, cardiac palpitations, flushing, increased thickening of bronchial secretions.

    What other drugs will affect Brompheniramine

    Specific Drugs and Laboratory Tests

    Drug or Laboratory Test

    Interaction

    Comments

    CNS depressants (alcohol, hypnotics, sedatives, tranquilizers, tricyclic antidepressants)

    Possible additive CNS depression

    Tricyclic antidepressants prolong and intensify anticholinergic effects of antihistamines

    Avoid concomitant use

    MAO inhibitors

    MAO inhibitors prolong and intensify anticholinergic effects of antihistamines

    Contraindicated during or within 2 weeks of MAO-inhibitor therapy

    Test, antigen or histamine

    Inhalation-challenge testing with histamine or antigen: Possible suppression of test response

    Antigen skin testing: Possible suppression of wheal and flare reactions

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