Home Drug Guide Brompheniramine Maleate and Pseudoephedrine Hydrochloride

Drug Guide

Generic Name

Brompheniramine Maleate and Pseudoephedrine Hydrochloride

Brand Names Efidac 24

Classification

Therapeutic: Antihistamine and Decongestant Combination

Pharmacological: Brompheniramine - Antihistamine (H1 receptor antagonist); Pseudoephedrine - Sympathomimetic decongestant

FDA Approved Indications

Relief of nasal congestion associated with allergies or colds

Mechanism of Action

Brompheniramine blocks H1 histamine receptors, reducing allergy symptoms; Pseudoephedrine stimulates alpha-adrenergic receptors in the nasal mucosa, leading to vasoconstriction and decreased swelling.

Dosage and Administration

Adult: Typically, 1 tablet every 4-6 hours as needed; do not exceed 24 mg pseudoephedrine and 4 mg brompheniramine per dose.

Pediatric: Not generally recommended for children under 12 due to potential side effects; consult specific product labeling.

Geriatric: Use with caution; start at lower end of dosing to minimize side effects.

Renal Impairment: Adjust dose based on severity; consult specific guidelines.

Hepatic Impairment: Caution advised; monitor closely, dose adjustments may be necessary.

Pharmacokinetics

Absorption: Well absorbed orally

Distribution: Widely distributed; crossing the blood-brain barrier (brompheniramine)

Metabolism: Metabolized in the liver (pseudoephedrine minimally metabolized)

Excretion: Excreted mainly via urine

Half Life: Brompheniramine - approximately 14 hours; Pseudoephedrine - approximately 4-8 hours

Contraindications

History of hypersensitivity to antihistamines or sympathomimetics
Use with MAO inhibitors
Uncontrolled hypertension or severe coronary artery disease

Precautions

Use with caution in patients with hypertension, thyroid disorders, diabetes, urinary retention, or glaucoma.
May cause CNS depression or stimulation, caution driving or operating machinery.

Adverse Reactions - Common

Drowsiness (Common)
Nervousness (Common)
Insomnia (Less common)
Dry mouth (Common)

Adverse Reactions - Serious

Seizures (Rare)
Allergic reactions (rash, anaphylaxis) (Rare)
Elevated blood pressure (Rare)

Drug-Drug Interactions

Monoamine oxidase inhibitors (increased hypertensive crisis risk)
Other CNS depressants
Other vasoconstrictors

Drug-Food Interactions

Caffeine may potentiate stimulant effects

Drug-Herb Interactions

St. John’s Wort can increase sedative effects

Nursing Implications

Assessment: Monitor blood pressure, heart rate, and CNS effects.

Diagnoses:

Risk for decreased cardiac output
Risk for falls due to CNS effects

Implementation: Administer with food if GI upset occurs; observe for adverse reactions.

Evaluation: Assess relief of symptoms and monitor for adverse effects, adjusting therapy as needed.

Patient/Family Teaching

Instruct on potential drowsiness and avoid driving or operating machinery.
Advise on avoiding alcohol and other CNS depressants.
Teach about the importance of adhering to prescribed dosing schedule and not exceeding recommended dose.

Special Considerations

Black Box Warnings:

Pseudoephedrine can increase blood pressure and cause CNS stimulation; caution in cardiovascular disease.

Genetic Factors: No widely recognized genetic factors affecting this combination.

Lab Test Interference: No significant interference with laboratory tests.

Overdose Management

Signs/Symptoms: Severe hypertension, CNS stimulation (confusion, hallucinations), seizures

Treatment: Seek immediate medical attention; supportive care, monitoring blood pressure, seizures management, activated charcoal if ingestion recent

Storage and Handling

Storage: Store at room temperature, away from moisture and light.

Stability: Stable under recommended conditions for expiration date.