brompheniramine/pseudoephedrine (Rx)

Brand and Other Names:Bromfed, Bromfed-PD, more...Bromhist Pediatric Drops, Bromhist-NR Drops
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

brompheniramine/pseudoephedrine

oral liquid

  • (1mg/15mg)/5mL

capsule

  • 4mg/60mg

Nasal Congestion with Rhinitis

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

Administration

Refer to manufacturer information for dosing details; multiple strengths available

Administer liquids with special measuring device for accurate dose

Dosage Forms & Strengths

brompheniramine/pseudoephedrine

oral liquid

  • (1mg/15mg)/5mL

capsule

  • 4mg/60mg

Nasal Congestion with Rhinitis

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
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Adverse 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
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Warnings

Contraindications

  • Hypersensitivity to drugs or excipients
  • Within 14 days of MAO inhibitor therapy

Cautions

  • 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
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Pregnancy & 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.

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Pharmacology

Mechanism of Action

Brompheniramine: Histamine H1-receptor antagonist

Pseudoephedrine: Sympathomimetic; exerts decongestant action on nasal mucosa; stimulates the alpha-adrenergic receptors causing bronchodilation and vasoconstriction

Brompheniramne

Half-Life: 11.8-34.7 hr

Onset: 30 min

Protein binding: 39-49%

Duration: 3-9 hr, may last 48 hr

Peak Plasma Time: 2-4 hr (adults): 3-3.5 hr (children)

Vd: 11.7 L/kg (adults); 20 L/kg (children)

Metabolism: Mainly liver

Metabolites: Propionic acid derivative conjugated with glycine

Excretion: Urine

Antihistamine activity: Jigh

Sedative effect: Low

Anticholinergic effects: Moderate

Pseudoephedrine

Half-Life: 3 hr (children); 3-16hr (adults)

Onset: 30 min

Absorption: Rapid

Duration: 3-8 hr

Peak Plasma Time: 1-3 hr (adults); 2hr (children)

Peak Plasma Concentration: 422 ng/mL

Clearance: 7.3-7.6 mL/min/kg

Excretion: Urine

Vd: 2.5 L/kg (children); 2.64-3.51 L/kg (adults)

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Images

No images available for this drug.
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Patient Handout

A Patient Handout is not currently available for this monograph.
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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.