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Pronunciation:

(brome fen IR a meen & soo doe e FED rin)

U.S. Brand Names:

AccuHist® Pediatric [DSC]; Andehist NR Syrup; Brofed®; Bromaline® [OTC]; Bromaxefed RF; Bromfed® [OTC] [DSC]; Bromfed-PD® [OTC] [DSC]; Bromfenex®; Bromfenex® PD; Bromhist Pediatric; Children's Dimetapp® Elixir Cold & Allergy [OTC]; Histex™ SR; Lodrane®; Lodrane® 12D; Lodrane® LD; Rondec® Syrup; Touro™ Allergy

Synonyms:

Brompheniramine Maleate and Pseudoephedrine Hydrochloride; Brompheniramine Maleate and Pseudoephedrine Sulfate; Pseudoephedrine and Brompheniramine

Generic Available:

Yes: Excludes capsule (sustained release), liquid, tablet (extended release)

Use:

Temporary relief of symptoms of seasonal and perennial allergic rhinitis, and vasomotor rhinitis, including nasal obstruction

Pregnancy Risk Factor:

Lactation:

Enters breast milk/not recommended

Contraindications:

Hypersensitivity or idiosyncrasy to brompheniramine, pseudoephedrine, or any component of the formulation; severe hypertension, severe coronary artery disease; MAO inhibitor therapy; GI or GU obstruction; peptic ulcer disease; narrow-angle glaucoma; acute asthmatic attack

Warnings/Precautions:

Use caution with hypertension, ischemic heart disease, hyperthyroidism, increased intraocular pressure, diabetes mellitus, BPH, and patients >60 years of age. May cause decreased mental alertness; excitation in younger children; paradoxical reactions (manifested by hyperexcitability) in older children. The elderly may be more sensitive to anticholinergic and antihistamine effects and experience increased adverse effects. Not labeled for OTC use in children <6 years of age.

Adverse Reactions:

Frequency not defined.

Cardiovascular: Arrhythmias, flushing, hypertension, pallor, palpitation, tachycardia

Central nervous system: Convulsions, CNS stimulation, dizziness, excitability (children; rare), giddiness, hallucinations, headache, insomnia, irritability, lassitude, nervousness, sedation

Gastrointestinal: Anorexia, diarrhea, dyspepsia, nausea, vomiting, xerostomia

Neuromuscular skeletal: Tremors, weakness

Ocular: Diplopia

Renal: Dysuria, polyuria, urinary retention (with BPH)

Respiratory: Respiratory difficulty

Ethanol/Nutrition/Herb Interactions:

Ethanol: Avoid ethanol (may increase CNS depression).

Stability:

Store at room temperature.

Mechanism of Action:

Brompheniramine maleate is an antihistamine with H1-receptor activity; pseudoephedrine, a sympathomimetic amine and isomer of ephedrine, acts as a decongestant in respiratory tract mucous membranes with less vasoconstrictor action than ephedrine in normotensive individuals.

Pharmacodynamics/Kinetics:

See Pseudoephedrine monograph.

Brompheniramine:

Metabolism: Hepatic

Time to peak: Syrup: 5 hours

Excretion: Urine

Dosage:

Oral:

Capsule, long acting:

Based on 60 mg pseudoephedrine:

Children 6-12 years: 1 capsule every 12 hours

Children 12 years and Adults: 1-2 capsules every 12 hours

Based on 120 mg pseudoephedrine: Children 12 years and Adults: 1 capsule every 12 hours

Liquid:

Based on brompheniramine 1 mg/pseudoephedrine 15 mg per 1 mL: Children:

1-3 months: 0.25 mL 4 times/day

3-6 months: 0.5 mL 4 times/day

6-12 months: 0.75 mL 4 times/day

12-24 months: 1 mL 4 times/day

Based on brompheniramine 1 mg/pseudoephedrine 15 mg per 5 mL: Children:

6-11 months (6-8 kg): 2.5 mL every 6-8 hours (maximum: 4 doses/24 hours)

12-23 months (8-10 kg): 3.75 mL every 6-8 hours (maximum: 4 doses/24 hours)

2-6 years: 5 mL every 6-8 hours (maximum: 4 doses/24 hours)

6-12 years: 10 mL every 6-8 hours (maximum: 4 doses/24 hours)

>12 years and Adults: 20 mg every 4 hours (maximum: 4 doses/24 hours)

Based on brompheniramine 4 mg/pseudoephedrine 30 mg:

Children 2-6 years: 2.5 mL 3 times/day

Children >6 years and Adults: 5 mL 3 times/day

Brompheniramine 4 mg/pseudoephedrine 45 mg per 5 mL:

Children 2-6 years: 2.5 mL 4 times/day

Children >6 years and Adults: 5 mL 4 times/day

Tablet, extended release: Based on pseudoephedrine 45 mg:

Children 6-12 years: 1 tablet every 12 hours

Children 12 years and Adults: 1-2 tablets every 12 hours

Administration:

Do not crush, break, or chew sustained-release dosage forms.

Patient Education:

Take as directed; do not exceed recommended dose. Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. Avoid use of other depressants, alcohol, or sleep-inducing medications unless approved by prescriber. You may experience drowsiness, impaired coordination, blurred vision, or increased anxiety (use caution when driving or engaging in tasks requiring alertness until response to drug is known); or dry mouth or nausea (small, frequent meals, frequent mouth care, chewing gum, or sucking hard candy may help). Report persistent dizziness, sedation, or agitation; respiratory difficulty; changes in urinary pattern; muscle weakness; or lack of improvement or worsening or condition. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Breast-feeding is not recommended.

Dental Health: Effects on Dental Treatment:

Key adverse event(s) related to dental treatment:

Brompheniramine: Prolonged use may decrease salivary flow.

Pseudoephedrine: Xerostomia (normal salivary flow resumes upon discontinuation).

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

Use with caution since pseudoephedrine is a sympathomimetic amine which could interact with epinephrine to cause a pressor response

Mental Health: Effects on Mental Status:

Drowsiness, nervousness, insomnia, and slight stimulation are common; may cause fatigue or dizziness; may rarely cause depression or hallucinations

Mental Health: Effects on Psychiatric Treatment:

Concurrent use with psychotropics and other CNS depressants may produce additive adverse effects; tachycardia is common; use caution with clozapine and TCAs

Dosage Forms:

[DSC] = Discontinued product

Capsule, extended release: Brompheniramine maleate 6 mg and pseudoephedrine hydrochloride 60 mg; Brompheniramine maleate 12 mg and pseudoephedrine hydrochloride 120 mg

Bromfed® [DSC], Bromfenex®: Brompheniramine maleate 12 mg and pseudoephedrine hydrochloride 120 mg

Bromfed-PD® [DSC], Bromfenex® PD, Lodrane® LD: Brompheniramine maleate 6 mg and pseudoephedrine hydrochloride 60 mg

Histex™ SR: Brompheniramine maleate 10 mg and pseudoephedrine hydrochloride 120 mg

Capsule, sustained release (Touro™ Allergy): Brompheniramine maleate 5.75 mg and pseudoephedrine hydrochloride 60 mg

Elixir: Brompheniramine maleate 1 mg and pseudoephedrine hydrochloride 15 mg per 5 mL (120 mL, 480 mL)

Children's Dimetapp® Elixir Cold & Allergy: Brompheniramine maleate 1 mg and pseudoephedrine hydrochloride 15 mg per 5 mL (240 mL) [alcohol free; contains sodium benzoate; grape flavor]

Liquid (Lodrane®): Brompheniramine maleate 4 mg and pseudoephedrine hydrochloride 60 mg per 5 mL (480 mL) [alcohol free, dye free, sugar free; cherry flavor]

Liquid, oral drops (AccuHist® Pediatric [DSC], Bromhist Pediatric): Brompheniramine maleate 1 mg and pseudoephedrine hydrochloride 15 mg per 1 mL (30 mL) [contains sodium benzoate; cherry flavor]

Solution (Bromaline®): Brompheniramine maleate 1 mg and pseudoephedrine hydrochloride 15 mg per 5 mL (120 mL, 480 mL) [alcohol free; contains sodium benzoate; grape flavor]

Syrup: Brompheniramine maleate 4 mg and pseudoephedrine sulfate 45 mg per 5 mL (120 mL, 480 mL)

Andehist NR: Brompheniramine maleate 4 mg and pseudoephedrine sulfate 45 mg per 5 mL (473 mL) [raspberry flavor]

Brofed®: Brompheniramine maleate 4 mg and pseudoephedrine hydrochloride 30 mg per 5 mL(480 mL) [mint flavor]

Bromaxefed RF: Brompheniramine maleate 4 mg and pseudoephedrine hydrochloride 45 mg per 5 mL (120 mL, 480 mL) [alcohol free; cherry flavor]

Rondec®: Brompheniramine maleate 4 mg and pseudoephedrine hydrochloride 45 mg per 5 mL (120 mL, 480 mL) [cherry flavor]

Tablet, extended release (Lodrane® 12D): Brompheniramine maleate 6 mg and pseudoephedrine hydrochloride 45 mg

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