Bromfed DM - Drug Monograph

Introduction

Bromfed DM is a combination prescription medication containing brompheniramine maleate (an antihistamine), pseudoephedrine hydrochloride (a decongestant), and dextromethorphan hydrobromide (an antitussive). It is commonly used for the temporary relief of cough and upper respiratory symptoms associated with allergies, the common cold, or sinusitis.

Mechanism of Action

Bromfed DM exerts its therapeutic effects through three distinct mechanisms:

• Brompheniramine: Competitively antagonizes histamine at H1 receptors, reducing allergic symptoms
• Pseudoephedrine: Stimulates alpha-adrenergic receptors, producing vasoconstriction and reducing nasal congestion
• Dextromethorphan: Acts centrally on the cough center in the medulla to elevate the cough threshold

Indications

FDA-approved for the temporary relief of:

• Cough due to minor throat and bronchial irritation
• Nasal congestion
• Runny nose
• Sneezing
• Itchy, watery eyes
• Sinus congestion and pressure

Associated with the common cold, hay fever, or other respiratory allergies

Dosage and Administration

• Renal impairment: Use with caution; consider reduced dosing
• Hepatic impairment: Use with caution
• Geriatric patients: May be more sensitive to effects; consider lower dosing
• Pediatric patients <6 years: Contraindicated due to safety concerns

Pharmacokinetics

• Brompheniramine: Peak plasma concentration in 2-5 hours
• Pseudoephedrine: Peak plasma concentration in 1-3 hours
• Dextromethorphan: Peak plasma concentration in 2-3 hours

• Brompheniramine: CYP2D6, CYP3A4
• Dextromethorphan: CYP2D6 (subject to genetic polymorphism)
• Pseudoephedrine: Minimal hepatic metabolism

• Brompheniramine: Elimination half-life 12-34 hours
• Pseudoephedrine: Elimination half-life 9-16 hours
• Dextromethorphan: Elimination half-life 2-4 hours

Contraindications

• Hypersensitivity to any component
• Monoamine oxidase inhibitor (MAOI) use within 14 days
• Severe hypertension
• Severe coronary artery disease
• Narrow-angle glaucoma
• Urinary retention
• Peptic ulcer disease
• Children <6 years of age

Warnings and Precautions

• CNS depression: May impair mental and physical abilities
• Hypertensive patients: Use with caution due to pseudoephedrine
• Prostatic hypertrophy: May worsen urinary retention
• Thyrotoxicosis: May exacerbate symptoms
• Diabetes mellitus: Pseudoephedrine may affect glucose control
• Pregnancy: Category C - use only if potential benefit justifies potential risk
• Breastfeeding: Components are excreted in breast milk; not recommended

Drug Interactions

• MAO inhibitors: Risk of hypertensive crisis
• Other CNS depressants (alcohol, benzodiazepines, opioids): Additive sedation
• Sympathomimetics: Additive cardiovascular effects
• Antihypertensives: Reduced efficacy
• CYP2D6 inhibitors (fluoxetine, paroxetine): Increased dextromethorphan levels

• Anticholinergics: Additive anticholinergic effects
• Beta-blockers: Potential hypertension and bradycardia

Adverse Effects

• Drowsiness
• Dry mouth
• Dizziness
• Nausea
• Nervousness
• Insomnia

• Anaphylaxis
• Severe hypertension
• Tachycardia
• Arrhythmias
• Seizures
• Serotonin syndrome (with other serotonergic drugs)
• Angle-closure glaucoma

Monitoring Parameters

• Blood pressure and heart rate (especially in hypertensive patients)
• Mental status and CNS effects
• Urinary output (in patients with prostatic hypertrophy)
• Respiratory status
• Signs of hypersensitivity reactions
• Therapeutic efficacy of symptom relief

Patient Education

• Take exactly as prescribed; do not exceed recommended dosage
• Avoid alcohol and other CNS depressants during therapy
• May cause drowsiness - avoid driving or operating machinery
• Stay hydrated to help manage dry mouth
• Report palpitations, severe dizziness, or difficulty urinating
• Use caution in hot environments due to reduced sweating
• Do not use for persistent cough without medical evaluation
• Keep out of reach of children due to risk of accidental overdose

References

1. FDA prescribing information: Bromfed DM 2. Thorton JA, et al. Antihistamines and decongestants. In: Brunton LL, Hilal-Dandan R, Knollmann BC, eds. Goodman & Gilman's: The Pharmacological Basis of Therapeutics. 13th ed. McGraw-Hill; 2017. 3. Simons FER, Simons KJ. Histamine and H1-antihistamines: celebrating a century of progress. J Allergy Clin Immunol. 2011;128(6):1139-1150. 4. CDC. Cough and cold preparation use in children. MMWR. 2007;56(01):1-4. 5. Medsafe New Zealand Data Sheet: Bromfed DM. 2021. 6. Clinical Pharmacology [database online]. Tampa, FL: Elsevier; 2023. 7. Micromedex Solutions. Truven Health Analytics. 2023.