BROMANATE DM
Clinical safety rating: caution
Comprehensive clinical and safety monograph for BROMANATE DM (BROMANATE DM).
Dextromethorphan is an NMDA receptor antagonist and sigma-1 receptor agonist; it also inhibits serotonin reuptake and acts on the cough center. Brompheniramine is a first-generation antihistamine that antagonizes histamine H1 receptors.
| Metabolism | Dextromethorphan is metabolized by CYP2D6 to dextrorphan. Brompheniramine is metabolized primarily by CYP3A4 and CYP2D6. |
| Excretion | Brompheniramine is primarily excreted via renal elimination (approximately 70-85% as metabolites and unchanged drug). Dextromethorphan and its metabolites are excreted renally (about 60% as unchanged dextromethorphan and dextrorphan glucuronide conjugates). Biliary/fecal excretion accounts for the remainder. |
| Half-life | Brompheniramine: 24.9 ± 9.3 hours. Dextromethorphan: 3-4 hours for extensive metabolizers (CYP2D6); 24-48 hours for poor metabolizers. Clinical context: Steady state reached in ~5 days for brompheniramine; accumulation in poor metabolizers may require dose adjustment. |
| Protein binding | Brompheniramine: ~99% bound to plasma proteins, primarily albumin. Dextromethorphan: ~20-30% bound to albumin. |
| Volume of Distribution | Brompheniramine: 130-190 L (approximately 1.9-2.7 L/kg assuming 70 kg). Dextromethorphan: 5-7 L/kg (range 300-490 L for 70 kg). Clinical meaning: Large Vd indicates extensive tissue distribution. |
| Bioavailability | Oral: Brompheniramine 30-60% (due to first-pass metabolism). Dextromethorphan 11-15% in extensive metabolizers; higher in poor metabolizers due to reduced first-pass effect. |
| Onset of Action | Oral: Brompheniramine 15-30 minutes; Dextromethorphan 15-30 minutes. |
| Duration of Action | Oral: Brompheniramine 4-6 hours (immediate release); 12 hours (extended release). Dextromethorphan 4-6 hours. Clinical note: Extended-release formulations provide sustained symptom relief. |
2.5 mg orally three times daily (every 8 hours); maximum 10 mg in 24 hours.
| Dosage form | SYRUP |
| Renal impairment | GFR 30-50 mL/min: reduce dose to 50%; GFR <30 mL/min: avoid use; not dialyzable. |
| Liver impairment | Child-Pugh B: reduce dose by 50%; Child-Pugh C: avoid use. |
| Pediatric use | 2-6 years: 0.15 mg/kg orally every 8 hours; maximum 1 mg in 24 hours. 6-12 years: 0.3 mg/kg every 8 hours; maximum 3 mg in 24 hours. >12 years: same as adult. |
| Geriatric use | Start at 1.25 mg orally every 8 hours; increase cautiously to 2.5 mg every 8 hours; monitor for anticholinergic effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for BROMANATE DM (BROMANATE DM).
| Breastfeeding | Brompheniramine: Excreted into breast milk; small amounts expected. Dextromethorphan: Minimal excretion; M/P ratio not established. Both drugs may cause sedation or irritability in infants. Caution with high doses or prolonged use. |
| Teratogenic Risk | BROMANATE DM (brompheniramine and dextromethorphan) has limited human data. First trimester: Theoretical risk of minor malformations due to anticholinergic effects of brompheniramine; dextromethorphan not associated with increased major malformations. Second and third trimesters: Potential for neonatal respiratory depression, irritability, and withdrawal symptoms with chronic high-dose use near term. Avoid in third trimester for prolonged use. |
■ FDA Black Box Warning
Not applicable.
| Common Effects | Nausea Headache Dizziness Fatigue Constipation Inflammation of the nose Weakness |
| Serious Effects |
["Hypersensitivity to dextromethorphan, brompheniramine, or any component","Concurrent use of MAOIs or within 14 days of discontinuation","Neonates and infants (due to brompheniramine's anticholinergic effects)","Severe hypertension or coronary artery disease","Phenylketonuria (if product contains phenylalanine)"]
| Precautions | ["Do not exceed recommended dosage.","Use caution in patients with asthma, emphysema, or chronic bronchitis.","May cause drowsiness; avoid driving or operating machinery.","Do not use with MAOIs or for 2 weeks after discontinuing MAOIs.","Use caution in patients with hypertension, thyroid disease, diabetes, or prostatic hypertrophy."] |
| Food/Dietary |
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| Fetal Monitoring | Monitor maternal blood pressure, heart rate, and CNS effects (drowsiness, dizziness). Fetal monitoring via ultrasound for growth and amniotic fluid volume if used chronically. Neonatal observation for sedation, respiratory depression, and withdrawal symptoms if used near term. |
| Fertility Effects | No specific human data on fertility impairment. Anticholinergic effects of brompheniramine may theoretically affect cervical mucus, but no evidence of altered fertility. Dextromethorphan has no known impact on fertility. |
| Avoid alcohol and grapefruit juice (may increase side effects). No significant food interactions beyond alcohol. Take with or without food. |
| Clinical Pearls | BROMANATE DM is a combination of brompheniramine (antihistamine) and dextromethorphan (antitussive). Use with caution in patients with asthma, COPD, or respiratory insufficiency due to drying effects. Avoid in patients taking MAOIs or within 14 days of stopping them. Not recommended for chronic cough associated with smoking, asthma, or emphysema. Sedation may impair ability to drive or operate machinery. |
| Patient Advice | Do not exceed recommended dose. · Avoid alcohol and other CNS depressants. · May cause drowsiness; use caution when driving. · Do not use for persistent or chronic cough. · Consult healthcare provider if cough lasts >1 week or is accompanied by fever, rash, or persistent headache. · Keep out of reach of children. |