brompheniramine/dextromethorphan/pseudoephedrine (Bromfed-DM)

Dosing and uses of Bromfed-DM (brompheniramine/dextromethorphan/pseudoephedrine)

• Adult
• Pediatric

 

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