brompheniramine/pseudoephedrine (Bromfed, Bromfed-PD, Bromhist Pediatric Drops, Bromhist-NR Drops)
Classes: Antihistamine/Decongestant Combos
Dosing and uses of Bromfed, Bromfed-PD (brompheniramine/pseudoephedrine)
Adult dosage forms and strengths
brompheniramine/pseudoephedrine
extended release capsule
- 12mg/120mg
- 10mg/120mg
- 6mg/60mg
extended release tablet
- 6mg/45mg
oral liquid
- (6mg/30mg)/5mL
- (4mg/60mg)/5mL
- (4mg/45mg)/5mL
- (4mg/30mg)/5mL
oral suspension
- (6mg/30mg)/5mL
tablet
- 4mg/60mg
Nasal Congestion with Rhinitis
Extended-release capsule or tablet: 6-12 mg PO q12 hr
Tablet: 4 mg PO 4-6hr, up to 16 mg PO in 24 hr
Oral suspension: 5-20 mL PO q12hr, up to 40 mL in 24 hr
Oral liquids: 5 mL-20 mL PO q4-8hr, not to exceed maximum dosage limits
Recommended maximum dosage limits
- Brompheniramine: 24 mg PO in 24 hr
- Pseudoephedrine: 240 mg PO in 24 hr
Other Information
Refer to manufacturer information for dosing details; multiple strengths available
Administer liquids with special measuring device for accurate dose
Use caution in patients with hepatic empairment
CrCl<30 mL/min: reduce initial pseudoephedrine dose by 50%; maximum 120 mg PO q24h
Pediatric dosage forms and strengths
brompheniramine/pseudoephedrine
extended release capsule
- 12mg/120mg
- 10mg/120mg
- 6mg/60mg
extended release tablet
- 6mg/45mg
oral liquid
- (6mg/30mg)/5mL
- (4mg/60mg)/5mL
- (4mg/45mg)/5mL
- (4mg/30mg)/5mL
oral suspension
- (6mg/30mg)/5mL
tablet
- 4mg/60mg
Nasal Congestion with Rhinitis
Extended release tablet
- <6 years: safety and efficacy not established
- 6-12 years: 6 mg/45 mg (1 tablet) PO q12hr PRN
Regular release tablet
- <6 years: safety and efficacy not established
- 6-11 years: 1/2 tablet PO q4-6h, up to 2 tablets in 24 hr to reach maximum dosage limits (3 tablets per day per manufacturer)
Oral suspension
- <6 years: safety and efficacy not established
- 6-12 years: 5-10 mL PO q12hr, not to exceed 20 mL in 24 hr
Oral solution
- <2 years: individualize, not to exceed recommnded maximum dosage limits
- 2-5 years: 1.25-2.5 mL PO q6-8hr, under healthcare professional direction, not to exceed recommended maximum dosage limits
- 6-11 years: 2.5-5 mL Po q6-8hr, not to exceed recommended maximum dosage limits
Oral drops
- Neonates: safety not established
- Infants 1-3 months: 0.25 mL PO QID
- Infants 3-6 months: 0.5 mL PO QID
- Infants 6-12 months: 0.75 mL PO QID
- Children 12-24 months: 1 mL PO QID
Nonprescription solution (2 mg/30 mg per 5 mL)
- <2 years: safety not established
- 2-5 years: individualize, under health care professional direction
- 6-11 years: 5 mL PO q4-6hr, up to QID
Recommended maximum dosage limits
- Neonates: Do not use
- Infants 1-3 months: 1 mg/7.5 mg PO in 24 hr
- Infants 3-6 months: 2 mg/15 mg PO in 24 hr
- Infants 6-12 months: 3 mg/22.5 mg PO in 24 hr
- 12-24 months: 4 mg/30 mg PO in 24 hr
- 2-5 years: 6 mg/60 mg PO in 24 hr
- 6-11 years: 12 mg/120 mg PO in 24 hr
- 12 years and older: 24 mg/240 mg PO in 24 hr
Other Information
Nonprescription products not recommended in <24 months of age
Bromfed, Bromfed-PD (brompheniramine/pseudoephedrine) adverse (side) effects
Frequency not defined
Brompheniramine (Common)
- Anticholinergic effects (blurred vision, dry mouth/nose, throat,
- Drowsiness, dizziness, decreased coordination, headache
- Constipation, stomach upset
Pseudoephedrine (Common)
- CNS (tremor, restlessness, etc)
- Insomnia
- Nausea
- Vomiting
Warnings
Contraindications
Pseudoephedrine
- Hypsesensitivity
- Severe HTN, severe CAD
- Nonselective MAO inhibitors: risk of hypertensive reaction
- Newborns, preemies
Cautions
Pseudophedrine
- Mild-mod HTN, cardiac dz, hyperthyroidism, hyperglycemia, BPH, DM, glaucoma
- Many combo formulations are switching to phenylephrine d/t restrictions arising from easy conversion to methamphetamine (The Combat Methamphetamine Epidemic Act of 2005 bans OTC sales of cold medicines that contain ingredients commonly used to make methamphetamine such as pseudoephedrine)
- Lactation
Pregnancy and lactation
Pregnancy category: C; not recommended in first tri-mester or last 2 weeks of pregnancy
Lactation: Contraindicated
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, Bromfed-PD (brompheniramine/pseudoephedrine)
Brompheniramne
Half-Life: 11.8-34.7 hr
Onset: 30 min
Duration: 3-9 hr, may last 48 hr
Peak Plasma Time: 2-5 hr
Vd: 11.7 L/kg
Metabolism: mainly liver
Metabolites: propionic acid derivative conjugated with glycine
Excretion: urine
Antihistamine activity: high
Sedative effect: low
Anticholinergic effects: moderate
Pseudoephedrine
Half-Life: 5-8 hr
Onset: 30 min
Duration: 4-6 hr
Peak PlasmaTime: 1.97 hr
Concentration: 422 ng/mL
Metabolism: liver, by N-demethylationMetabolites: inactive
Clearance: 7.3-7.6 mL/min/kg
Excretion: urine
Mechanism of action
Brompheniramine: Histamine H1-receptor antagonist
Pseudoephedrine: Alpha adrenergic agonist