BROMFED-DM
Clinical safety rating: caution
Comprehensive clinical and safety monograph for BROMFED-DM (BROMFED-DM).
Brompheniramine is a first-generation alkylamine antihistamine that competitively antagonizes histamine at H1 receptors, reducing allergic symptoms. Pseudoephedrine is a sympathomimetic amine that directly stimulates alpha-adrenergic receptors, causing vasoconstriction and decongestion. Dextromethorphan is an NMDA receptor antagonist and sigma-1 receptor agonist that acts on the medullary cough center to suppress cough.
| Metabolism | Brompheniramine is primarily metabolized via CYP450 enzymes (including CYP2D6). Pseudoephedrine undergoes limited hepatic metabolism (N-demethylation) and is largely excreted unchanged in urine. Dextromethorphan is extensively metabolized by CYP2D6 to dextrorphan, an active metabolite. |
| Excretion | Renal: 60–70% unchanged (brompheniramine); hepatic metabolism and renal excretion of metabolites (dextromethorphan: O-demethylation; pseudoephedrine: 70–90% unchanged in urine). Biliary/fecal: <5%. |
| Half-life | Brompheniramine: 24–36 h; pseudoephedrine: 5–8 h; dextromethorphan: 2–4 h (CYP2D6 extensive metabolizers) or up to 24 h (poor metabolizers). |
| Protein binding | Brompheniramine: 85–90% (albumin); pseudoephedrine: 20–30%; dextromethorphan: 60–70% (albumin and α-1-acid glycoprotein). |
| Volume of Distribution | Brompheniramine: 1.8–2.5 L/kg; pseudoephedrine: 2.6–3.5 L/kg; dextromethorphan: 5–6 L/kg. |
| Bioavailability | Oral: brompheniramine 80–90%; pseudoephedrine ~100%; dextromethorphan: extensive first-pass metabolism, bioavailability ~11% (extensive metabolizers) to ~50% (poor metabolizers). |
| Onset of Action | Oral: 30–60 min for antihistamine/decongestant/antitussive effects. |
| Duration of Action | Brompheniramine: 4–6 h (antihistamine); pseudoephedrine: 4–6 h; dextromethorphan: 4–6 h. Extended-release formulation provides up to 12 h. |
1 capsule (brompheniramine maleate 6 mg, dextromethorphan HBr 30 mg) orally every 6 hours, not to exceed 4 capsules per 24 hours.
| Dosage form | SYRUP |
| Renal impairment | GFR 30 mL/min or greater: No adjustment necessary. GFR less than 30 mL/min: Avoid use due to accumulation of active metabolites. |
| Liver impairment | Child-Pugh Class A or B: No adjustment necessary. Child-Pugh Class C: Avoid use due to reduced clearance of brompheniramine. |
| Pediatric use | Children 6 to under 12 years: 0.4 mL/kg of oral solution (brompheniramine 2 mg, dextromethorphan 7.5 mg per 5 mL) every 6 hours, maximum 4 doses per 24 hours. Children under 6 years: Not recommended due to safety concerns. |
| Geriatric use | Initiate with 1 capsule every 12 hours; increase cautiously to every 6 hours if tolerated. Monitor for anticholinergic effects (e.g., confusion, urinary retention). |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for BROMFED-DM (BROMFED-DM).
| Breastfeeding | Brompheniramine, pseudoephedrine, and dextromethorphan are excreted into breast milk in small amounts. M/P ratio not established for combination. Potential for irritability, drowsiness, or decreased milk supply due to pseudoephedrine. Use with caution; monitor infant for sedation and feeding difficulties. |
| Teratogenic Risk | Pregnancy Category C. First trimester: Limited data; potential risk of neural tube defects due to antihistamine component (brompheniramine). Second and third trimesters: Decongestant (pseudoephedrine) may cause uterine vasoconstriction, reducing placental perfusion; antitussive (dextromethorphan) has shown developmental toxicity in animal studies at high doses. Avoid use in pregnancy unless benefits outweigh risks. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to brompheniramine, pseudoephedrine, dextromethorphan, or any components","Concurrent use or within 14 days of monoamine oxidase inhibitors (MAOIs)","Severe hypertension or coronary artery disease","Narrow-angle glaucoma","Urinary retention (e.g., due to prostatic hypertrophy)","Children under 6 years of age (due to risk of serious side effects)","Breastfeeding (pseudoephedrine may reduce milk production; dextromethorphan and brompheniramine may be excreted in breast milk)","Do not use in patients with phenylketonuria (if product contains phenylalanine)"]
| Precautions | ["Do not use with MAOIs or for 2 weeks after stopping MAOIs","Avoid in patients with hypertension, heart disease, diabetes, thyroid disease, or difficulty urination due to prostatic hypertrophy (pseudoephedrine component)","May cause sedation and impair ability to drive or operate machinery (brompheniramine)","Use caution in patients with asthma, COPD, or chronic bronchitis (dextromethorphan may suppress cough reflex)","Do not exceed recommended dosage or use for more than 7 days","Avoid alcohol and other CNS depressants"] |
| Food/Dietary |
Loading safety data…
| Fetal Monitoring | Monitor maternal blood pressure, heart rate, and fetal heart rate if used in late pregnancy. Assess for signs of uterine hyperstimulation or reduced fetal movements. In neonates, observe for respiratory depression or jitteriness if used near term. |
| Fertility Effects | No specific human studies. Antihistamines can cause anticholinergic effects that may theoretically affect cervical mucus or ovulation. Dextromethorphan may impair spermatogenesis in animal studies. Impact on fertility is unlikely at therapeutic doses. |
| Avoid alcohol. Limit caffeine intake as it may compound stimulant effects of pseudoephedrine. No specific food interactions; take with food if GI upset occurs. |
| Clinical Pearls | Brompheniramine is a first-generation antihistamine with anticholinergic effects; may cause sedation and should be used cautiously in elderly or those with BPH, glaucoma, or asthma. Dextromethorphan is an NMDA receptor antagonist; at therapeutic doses it suppresses cough, but high doses can cause dissociative effects and should be avoided in MAOI use. Pseudoephedrine is a sympathomimetic; caution in hypertension, hyperthyroidism, and cardiac disease. Product contains multiple active ingredients; avoid duplicating with other cold medications. |
| Patient Advice | Take only as directed; do not exceed 6 doses in 24 hours. · May cause drowsiness; avoid driving or operating machinery. · Avoid alcohol and other sedatives. · Do not use if you are taking an MAO inhibitor or have stopped within 14 days. · Stop use and consult doctor if symptoms persist >7 days or accompanied by fever. · Do not crush or chew extended-release tablets. |