BRONCAST 10/MG TAB 28/TAB

Indications

Approved Uses

Prophylaxis and chronic treatment of asthma; symptomatic relief of seasonal allergic rhinitis; symptomatic relief of perennial allergic rhinitis; prevention of exercise‑induced bronchoconstriction (EIB).

Dosage & Administration

Dosing by Condition

Adults/adolescents (≥15 years): Asthma (prophylaxis/chronic): 10 mg once daily in the evening. Seasonal or perennial allergic rhinitis: 10 mg once daily (any time). Asthma with allergic rhinitis: 10 mg once daily in the evening. EIB prevention: 10 mg at least 2 hours before exercise (avoid an additional dose within 24 hours; if on daily therapy, do not take an extra pre‑exercise dose).

Initial Dose

10 mg once daily

Maintenance Dose

10 mg once daily

Maximum Dose

10mg once daily.

Children's Dosage

Not applicable for 10mg film-coated tablet; lower strengths (chewable/granules) used: Asthma: 6-14 years: 5mg daily; 2-5 years: 4mg daily; 12-23 months: 4mg (granules) daily. Allergic Rhinitis (Seasonal): 6-14 years: 5mg daily; 2-5 years: 4mg daily. Allergic Rhinitis (Perennial): 6-14 years: 5mg daily; 2-5 years: 4mg daily; 6-23 months: 4mg (granules) daily. Exercise-Induced Bronchoconstriction: 6 years and older: 10mg.

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 as it has not been adequately studied in severe hepatic impairment.

How to Take

Swallow the 10 mg film‑coated tablet whole with water, with or without food. For asthma (or asthma with allergic rhinitis), take once daily in the evening. For allergic rhinitis alone, take once daily at any time of day. For prevention of exercise‑induced bronchoconstriction (EIB), take 10 mg at least 2 hours before exercise (do not take an extra dose if already on once‑daily therapy).

Side Effects

Common Side Effects

Common adverse effects include headache and abdominal pain; also reported are diarrhea/nausea, upper respiratory tract infection/pharyngitis, and fever/cough in some populations.

Side Effect Frequency

Common: headache; abdominal pain and gastrointestinal upset (e.g., diarrhea/nausea) and upper respiratory symptoms/infections can occur. Neuropsychiatric reactions (e.g., agitation, anxiety, depression, insomnia, abnormal dreams/nightmares, suicidal ideation/behavior) are uncommon/rare but clinically significant; hypersensitivity reactions (including angioedema) are rare; eosinophilic granulomatosis with polyangiitis (Churg-Strauss) is very rare.

Safety & Warnings

Contraindications

Contraindication: hypersensitivity to montelukast (montelukast sodium) or any excipients in the product.

Warnings & Precautions

Key warnings/precautions: not for acute asthma attacks; do not abruptly substitute for or discontinue inhaled/oral corticosteroids; monitor for neuropsychiatric symptoms and discontinue/evaluate if they occur; aspirin-sensitive asthma patients should continue to avoid aspirin/NSAIDs; rare EGPA (Churg-Strauss) may emerge during steroid taper; counsel on boxed warning for mental health effects and reserve for allergic rhinitis when alternatives fail.

Age Restriction

This 10 mg film‑coated tablet is intended for adults and adolescents ≥15 years; it is not the appropriate strength/formulation for children <15 years (use age-appropriate 4 mg/5 mg formulations per indication).

Driving Warning

Safe

Drug Interactions

Interaction Severity

Clinically important interactions: CYP enzyme inducers (e.g., rifampicin/rifampin, phenobarbital, phenytoin) may decrease montelukast exposure and reduce efficacy; strong CYP2C8 inhibitors (e.g., gemfibrozil) can increase montelukast exposure-use caution/monitor. Routine warfarin interaction is not generally clinically significant but monitor INR if clinically indicated.

Food Interaction

No clinically significant food restriction; may be taken with or without food.

Alcohol Interaction

Safe

Special Populations

Children

Not applicable for 10mg film-coated tablet; lower strengths (chewable/granules) used: Asthma: 6-14 years: 5mg daily; 2-5 years: 4mg daily; 12-23 months: 4mg (granules) daily. Allergic Rhinitis (Seasonal): 6-14 years: 5mg daily; 2-5 years: 4mg daily. Allergic Rhinitis (Perennial): 6-14 years: 5mg daily; 2-5 years: 4mg daily; 6-23 months: 4mg (granules) daily. Exercise-Induced Bronchoconstriction: 6 years and older: 10mg.

Elderly

Standard adult dosing.

Kidney Impairment

No adjustment needed.

Storage & Patient Advice

Stopping the Medicine

May be stopped without taper, but do not stop or substitute for other asthma controller therapy (e.g., inhaled corticosteroids) without prescriber advice; symptoms may recur after stopping.

Overdose

Overdose typically causes abdominal pain, somnolence, thirst, headache, vomiting, and psychomotor hyperactivity (± mydriasis); management is supportive/symptomatic (consider GI decontamination if appropriate), no specific antidote, and montelukast is not expected to be removed by hemodialysis-seek urgent medical care.

Patient Counseling

Take 1 tablet (montelukast 10 mg) by mouth once daily as prescribed; for asthma, it is usually taken in the evening. Use it regularly even when you feel well. It is for prevention/control of asthma and allergic rhinitis symptoms and will not treat a sudden asthma attack-keep a fast-acting reliever inhaler available. Do not stop or change therapy without your prescriber. Seek medical advice promptly for new or worsening mood/behavior changes (e.g., agitation, anxiety, depression, abnormal dreams, insomnia) or suicidal thoughts. If you have aspirin/NSAID-sensitive asthma, continue to avoid aspirin/NSAIDs as advised. Store below 30°C in the original blister.

Monitoring Requirements

No routine laboratory monitoring is required; counsel and monitor for neuropsychiatric symptoms (e.g., agitation, sleep disturbance, depression, suicidal ideation) and consider evaluation for eosinophilia/vasculitis if systemic symptoms occur.

Pharmacology

Mechanism of Action

Selective cysteinyl leukotriene receptor 1 (CysLT1) antagonist that blocks leukotrienes (LTC4, LTD4, LTE4), reducing bronchoconstriction, airway edema, mucus secretion, and inflammation.

Half-Life

Approximately 2.7-5.5 hours (in healthy adults).

Bioavailability

Approximately 64% (10 mg film-coated tablet).

Metabolism

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

Product Information

Available Dosage Forms

Film-coated tablet, Chewable tablet, Oral granules.

Composition per Dose

Each film-coated tablet: 10.4 mg montelukast sodium equivalent to 10 mg montelukast

Generic Availability

Yes

OTC Alternatives

No OTC equivalent to montelukast (it is prescription-only per SFDA). For allergic rhinitis symptoms, OTC alternatives include oral antihistamines (e.g., cetirizine, loratadine) and intranasal corticosteroids (e.g., fluticasone, budesonide).

Symptom Target

Allergy

Sedating

No

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