brompheniramine/pseudoephedrine (Bromfed, Bromfed-PD, Bromhist Pediatric Drops, Bromhist-NR Drops)

Dosing and uses of Bromfed, Bromfed-PD (brompheniramine/pseudoephedrine)

• Adult
• Pediatric

 

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