Classes
DEA Class; Rx
Common Brand Names; Brompheniramine/Pseudoephedrine
- Antihistamine/Decongestant Combos
Description
Brompheniramine: Histamine H1-receptor antagonist
Pseudoephedrine: Sympathomimetic; exerts decongestant action on nasal mucosa; stimulates the alpha-adrenergic receptors causing bronchodilation and vasoconstriction
Indications
Indicated for the treatment of Nasal Congestion with Rhinitis
Contraindications
Hypersensitivity to drugs or excipients
Within 14 days of MAO inhibitor therapy
Adverse Effects
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
Use with caution in mild-mod HTN, asthma, thyroid dysfunction, hyperglycemia, BPH, DM, glaucoma, cardiovascular disease, including hypertension and ischemic heart disease
Many combo formulations are switching to phenylephrine due to 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)
May cause CNS depression, which may impair physical or mental abilities; caution patients about performing tasks requiring mental alertness, including operating heavy machinery
Medication may potentiate the effects of sedative drugs or ethanol
Pregnancy and Lactation
Pregnancy category: C; not recommended in first tri-mester or last 2 weeks of pregnancy
Lactation: Contraindicated
Maximum Dosage
Capsule (4mg/60 mg): 1 PO q4-6hr; not to exceed 4 capsules/24hr
Liquid: 20 mL [(1 mg/15 mg)/5 mL] PO q6hr; not to exceed 80 mg/24 hr
Recommended maximum dosage limits
- Brompheniramine: 24 mg PO in 24 hr
- Pseudoephedrine: 240 mg PO in 24 hr
Pediatric
Capsule
- <12 years: Safety and efficacy not established
- >12 years: 4mg/60 mg (1 capsule) PO q4-6hr; not to exceed 4 capsules/24hr
Liquid
- 6-12 years: 10 mL [(15mg/1mg)/5 mL] PO q4-6hr; not to exceed 40 mL/day
- >12 years: 20 mL [(15mg/1mg)/5 mL] PO q4-6hr; not to exceed 80 mL/day
How supplied
Brompheniramine/pseudoephedrine
oral liquid
- (1mg/15mg)/5mL
capsule
- 4mg/60mg