brompheniramine/dextromethorphan/pseudoephedrine (Bromfed-DM)
Classes: Cough/Cold, Non-narcotic Combos; Antihistamine/Antitussive/Decongestant Combos
Dosing and uses of Bromfed-DM (brompheniramine/dextromethorphan/pseudoephedrine)
Adult dosage forms and strengths
brompheniramine/dextromethorphan/pseudoephedrine
oral syrup
- (2 mg/10mg/30mg)/5mL (Bromfed DM)
- (3 mg/30mg/50mg)/5mL (Bromdex D)
oral elixir
- (1 mg/5mg/15mg)/5mL (Bromaline DM)
Relief of Nasal Congestion & Cough
Bromfed DM: 2 teaspoonfuls (10 mL) PO q4hr; not to exceed 6 doses/day
Bromdex D: 1 teaspoonful (5 mL) PO q4hr; not to exceed 4 doses/day
Bromaline DM: 4 teaspoonfuls (20 mL) PO q4-6hr; not to exceed 4 doses/day
Pediatric dosage forms and strengths
brompheniramine/dextromethorphan/pseudoephedrine
oral syrup
- (2 mg/10mg/30mg)/5mL (Bromfed DM)
- (3 mg/30mg/50mg)/5mL (Bromdex D)
oral elixir
- (1 mg/5mg/15mg)/5mL (Bromaline DM)
Relief of Nasal Congestion & Cough
Bromaline Dm
- <6 years: As directed by physician
- 6-12 years: 2 teaspoonful (10 mL) PO q4hr; not to exceed 4 doses/day
- >12 years: 4 teaspoonfuls (20 mL) PO q4-6hr; not to exceed 4 doses/day
Bromfed-Dm
- <6 months: Safety and efficacy not established
- 6 months to 2 years: As directed by physician
- 2-6 years: 1/2 teasponful (2.5 mL) PO q4hr; not to exceed 6 doses/day
- 6-12 years: 1 teaspoonful (5 mL) PO q4hr; not to exceed 6 doses/day
- >12 years: 2 teaspoonfuls (10 mL) PO q4hr; not to exceed 6 doses/day
Bromdex d
- <6 years: As directed by physician
- 6-12 years: 2.5 mL PO q6hr prn; not to exceed 4 doses/24 hr
- >12 years: 5 mL PO q6hr prn; not to exceed 4 doses/24 hr
Bromfed-DM (brompheniramine/dextromethorphan/pseudoephedrine) adverse (side) effects
Frequency not defined
Dizziness
Drowsiness
Dry mouth, throat, and nose
Thickening of mucus in nose or throat
GI disturbances
Arrhythmia
Palpitations
Convulsion
Excitability
Tremor
Weakness
Warnings
Contraindications
Hypersensitivity
Acute asthma attack
Severe hypertension
Coronary artery disease
Narrow-angle glaucoma
Symptomatic prostate hypertrophy
Bladder-neck obstruction
Stenosing peptic ulcer
Cautions
Brompheniramine: May cause significant confusional symptoms; not for administration to premature or full-term neonates
Dextromethorphan: Do not take for persistent or chronic cough associated with smoking, asthma, or emphysema, or if it is accompanied by excessive phlegm unless directed by a healthcare provider; may decrease respiration rate
Pseudoephedrine: Caution in cardiovascular disease, diabetes mellitus, prostatic hypertrophy and increased intraocular pressure
Pregnancy and lactation
Pregnancy category: C
Lactation: excreted in breast milk/not recommended
Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Bromfed-DM (brompheniramine/dextromethorphan/pseudoephedrine)
Mechanism of action
Brompheniramine: Competitively blocks histamine from binding to H1 receptors; significant antimuscarinic activity and penetrates CNS, which causes pronounced tendency to induce sedation
Pseudoephedrine: Stimulates alpha-adrenergic receptors causing bronchodilation & vasoconstriction
Dextromethorphan: Cough suppressant that acts centrally on the cough center in medulla
Pharmacokinetics
Brompheniramine
- Onset: 15-30 min
- Duration: 3-9 hr, may last 48 hr
- Peak Plasma Time: 2-5 hr
- Vd: 11.7 L/kg (adults); 20 L/kg (children)
- Protein binding: 39-49%
- Metabolism: Mainly liver; metabolites include propionic acid derivative conjugated with glycine
- Half-Life: 11.8 (children); 25 hr (adults)
- Excretion: Urine
Pseudoephedrine
- Half-Life: 3 hr (children); 9-16 hr (adults)
- Onset: 30 min (decongestant)
- Duration: 3-8 hr
- Peak PlasmaTime: 1.97 hr
- Concentration: 422 ng/mL
- Metabolism: Liver, by N-demethylation
- Metabolites: Inactive
- Clearance: 7.3-7.6 mL/min/kg
- Excretion: Urine (43-96%)
Dextromethorphan
- Onset: 15-30 min
- Duration: 3-6 hr
- Metabolism: Hepatic P450 enzyme CYP2D6
- Excretion: Urine
- Half-life: 2-4 hr (extensive metabolizers); 24 hr (poor metabolizers)
- Peak plasma time: 2-3 hr