BRONCAST PAEDIATRIC 4/MG CHEW TAB 28/TAB

Indications

Approved Uses

Prophylaxis and chronic treatment of asthma in patients 2 years of age and older; Relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older; Relief of symptoms of perennial allergic rhinitis in patients 2 years of age and older.

Dosage & Administration

Dosing by Condition

Asthma (2-5 years): 4mg once daily in the evening. Allergic rhinitis (2-5 years): 4mg once daily. Asthma + allergic rhinitis (2-5 years): 4mg once daily in the evening

Initial Dose

4mg once daily in the evening

Maintenance Dose

4mg once daily in the evening

Maximum Dose

4mg once daily for children aged 2-5 years.

Children's Dosage

Ages 2-5 years: 4mg chewable tablet once daily in the evening. Ages 6-14 years: 5mg chewable tablet once daily in the evening. Ages ≥15 years: 10mg tablet once daily in the evening.

Dose Adjustment Notes

No dose titration is required; no dosage adjustment is needed in renal impairment or in mild-to-moderate hepatic impairment. Use caution/insufficient data in severe hepatic impairment.

How to Take

Chew the 4 mg chewable tablet thoroughly before swallowing; give once daily. For asthma, administer in the evening; for allergic rhinitis, the dosing time may be individualized. May be taken with or without food; do not use for acute bronchospasm.

Side Effects

Common Side Effects

Common: headache, abdominal pain, diarrhea, nausea; upper respiratory tract infection/fever; cough/pharyngitis; rash (less common).

Side Effect Frequency

Montelukast 4 mg chewable (pediatric): Common (≥1% to <10%): upper respiratory tract infection, fever, headache, abdominal pain, diarrhea, nausea, rash. Uncommon/Rare (<1%): neuropsychiatric reactions (e.g., agitation, anxiety, sleep disturbance, depression, hallucinations, suicidal ideation/behavior), hypersensitivity reactions (including angioedema/anaphylaxis), eosinophilic granulomatosis with polyangiitis (Churg-Strauss).

Safety & Warnings

Contraindications

Contraindication: hypersensitivity to montelukast or any component of the product; additionally, the chewable tablet contains aspartame-avoid/use caution in phenylketonuria per excipient warnings (often listed as a contraindication/major warning depending on local labeling).

Warnings & Precautions

Warnings/precautions: not for acute asthma attacks; counsel and monitor for neuropsychiatric symptoms (boxed warning) and discontinue/seek medical advice if they occur; do not abruptly substitute for or taper inhaled/oral corticosteroids; aspirin-sensitive asthma patients should continue to avoid aspirin/NSAIDs; chewable tablets may contain aspartame/phenylalanine-use caution/avoid in PKU.

Age Restriction

Approved for pediatric use from 2 years of age and older for the 4 mg chewable tablet formulation (not for <2 years; younger children use oral granules).

Drug Interactions

Drug Interactions

Clinically relevant interactions: enzyme inducers (e.g., phenobarbital, rifampin, carbamazepine, phenytoin) may decrease montelukast exposure/efficacy; strong CYP2C8 inhibitors (e.g., gemfibrozil) can increase montelukast exposure.

Interaction Severity

MODERATE: strong enzyme inducers (e.g., rifampicin, phenobarbital, phenytoin, carbamazepine) may decrease montelukast exposure/efficacy. MODERATE: gemfibrozil (CYP2C8 inhibition) can increase montelukast exposure-monitor for adverse effects.

Food Interaction

No restriction - can be taken with or without food

Special Populations

Children

Ages 2-5 years: 4mg chewable tablet once daily in the evening. Ages 6-14 years: 5mg chewable tablet once daily in the evening. Ages ≥15 years: 10mg tablet once daily in the evening.

Kidney Impairment

No adjustment needed.

Storage & Patient Advice

Missed Dose

If a dose is missed, skip it and take the next dose at the regular time; do not take a double dose.

Stopping the Medicine

Can be stopped without tapering, but patients/caregivers should consult the prescriber before stopping asthma controller therapy because symptoms may worsen/return; do not stop or reduce inhaled/oral corticosteroids abruptly when on montelukast.

Overdose

Overdose: commonly reported symptoms include abdominal pain, somnolence, thirst, headache, vomiting; other reported effects include mydriasis and hyperkinesia-manage with supportive/symptomatic care and seek urgent medical attention; hemodialysis is not expected to be useful.

Patient Counseling

Chew thoroughly and take once daily (evening for asthma; flexible timing for rhinitis); can be taken with or without food. Not for sudden asthma attacks-keep a rescue inhaler. Continue regularly even when well unless prescriber advises otherwise. Counsel to report neuropsychiatric symptoms (sleep disturbance, agitation, mood changes, suicidal thoughts). Store below 30°C in the original blister (per verified API data).

Monitoring Requirements

Monitor for neuropsychiatric symptoms and behavioral changes throughout treatment. No routine laboratory monitoring required.

Pharmacology

Mechanism of Action

Selective cysteinyl leukotriene receptor 1 (CysLT1) antagonist that blocks LTC4/LTD4/LTE4-mediated effects, reducing bronchoconstriction, airway edema, mucus secretion, and inflammatory cell recruitment in asthma/allergic rhinitis.

Onset of Action

Onset can occur within ~2 hours (bronchoprotection), but clinically meaningful symptom control typically requires days of regular use.

Duration of Effect

24 hours.

Half-Life

Elimination half-life ~2.7-5.5 hours (reported in healthy adults).

Bioavailability

Oral bioavailability is formulation-dependent: ~64% (10 mg film-coated tablet) and ~73% (chewable tablets, including 4-5 mg).

Metabolism

Extensive hepatic metabolism primarily via CYP2C8, with contributions from CYP3A4 and CYP2C9; metabolites are not clinically active at therapeutic concentrations.

Excretion

Primarily excreted via bile into feces (~86%); urinary excretion is negligible (<0.2%).

Protein Binding

>99%

Product Information

Available Dosage Forms

Chewable tablet; film-coated tablet; oral granules.

Composition per Dose

Each chewable tablet: 4mg montelukast as montelukast sodium

Generic Availability

Yes

Symptom Target

Allergy

Sedating

No

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