brompheniramine/pseudoephedrine (Rx)

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

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

brompheniramine/pseudoephedrine

oral liquid

  • (1mg/15mg)/5mL
  • (4mg/20mg)/5mL

oral liquid (drops)

  • (1mg/7.5mg)/1mL

oral solution

  • (1mg/15mg)/5mL

capsule

  • 4mg/60mg
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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

Alternatively: 5 mL [(4 mg/20 mg)/5 mL] PO q4-6hr; not to exceed 30 mL/24hr

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
  • (4mg/20mg)/5mL

oral liquid (drops)

  • (1mg/7.5mg)/1mL

oral solution

  • (1mg/15mg)/5mL

oral suspension

  • (6mg/30mg)/5mL

capsule

  • 4mg/60mg
more...

Nasal Congestion with Rhinitis

Capsule

  • <12 years: Safety and efficacy not established
  • >12 years: 6 mg/45 mg (1 tablet) PO q12hr PRN

oral liquid (drops)

  • 2-6 years: 1 mL [(7.5mg/1mg)/1 mL] PO q4-6hr; not to exceed 20 mL/day
  • 6-12 years: 2 mL [(7.5mg/1mg)/1 mL] PO q4-6hr; not to exceed 12 mL/day

Liquid

  • 6-12 years: 10 mL [(15mg/1mg)/5 mL] PO q4-6hr; not to exceed 40 mL/day OR 5 mL [(20 mg/4mg)/5mL] PO q4-6hr; not to exceed 20 mL/day
  • >12 years: 20 mL [(15mg/1mg)/5 mL] PO q4-6hr; not to exceed 80 mL/day OR 10 mL [(20 mg/4mg)/5mL] PO q4-6hr; not to exceed 40 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

Pseudoephedrine

  • Hypsesensitivity
  • Severe HTN, severe CAD
  • Nonselective MAO inhibitors: risk of hypertensive reaction
  • Newborns, preemies

Cautions

Pseudophedrine

  • Use with caution in mild-mod HTN, cardiac disease, asthma, cardiovascular disease, hyperthyroidism, hyperglycemia, BPH, DM, glaucoma
  • 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)
  • Lactation
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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

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

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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