BRONCAST PAEDIATRIC 5/MG CHEW TAB 28/TAB

Indications

Approved Uses

Prophylaxis and chronic treatment of asthma; relief of symptoms of seasonal allergic rhinitis; relief of symptoms of perennial allergic rhinitis; prevention of exercise-induced bronchoconstriction (age-appropriate).

Dosage & Administration

Dosing by Condition

Children 6-14 years: 5 mg once daily. For asthma (or asthma + allergic rhinitis): dose in the evening. For allergic rhinitis alone: once daily at any time. For exercise-induced bronchoconstriction (EIB): 5 mg at least 2 hours before exercise; do not take an additional dose if already receiving once-daily montelukast for another indication (max 1 dose/24 hours).

Initial Dose

5 mg once daily in the evening

Maintenance Dose

5mg once daily in the evening.

Maximum Dose

5 mg per day for children aged 6-14 years

Children's Dosage

6-14 years: 5mg chewable tablet once daily. 2-5 years: 4mg chewable tablet once daily.

Dose Adjustment Notes

No dosage adjustment is necessary in renal impairment or in mild-to-moderate hepatic impairment; no titration is required (fixed once-daily dosing).

How to Take

Chew the 5 mg tablet thoroughly before swallowing. Give once daily. For asthma (and for patients who have both asthma and allergic rhinitis), administer in the evening; for allergic rhinitis alone, it may be taken once daily at any time. May be taken with or without food.

Side Effects

Common Side Effects

Common adverse effects include headache and abdominal pain; also commonly reported in children: upper respiratory tract infection/viral infection, fever, cough, diarrhea, pharyngitis/sore throat, otitis media, and rash.

Side Effect Frequency

Common (≥1%): headache, abdominal pain; other reported common events include upper respiratory infection/fever in pediatric studies. Uncommon (0.1-1%): rash/urticaria and neuropsychiatric symptoms (e.g., agitation, anxiety, sleep disturbance). Rare (<0.1%): hallucinations and suicidal thinking/behavior; very rare: eosinophilic granulomatosis with polyangiitis (Churg-Strauss).

Safety & Warnings

Contraindications

Contraindication: hypersensitivity to montelukast or any excipients (components).

Warnings & Precautions

Key warnings/precautions: not for acute asthma attacks (keep rescue bronchodilator); monitor for neuropsychiatric symptoms and counsel patients/caregivers; do not abruptly substitute for inhaled/oral corticosteroids and be cautious during steroid taper (EGPA risk); patients with aspirin-sensitive asthma should continue to avoid aspirin/NSAIDs; phenylketonuria caution only if chewable contains aspartame/phenylalanine.

Age Restriction

Approved for children 6-14 years (5 mg chewable tablet).

Drug Interactions

Drug Interactions

CYP inducers (e.g., rifampicin, phenobarbital, phenytoin/carbamazepine) may decrease montelukast exposure; CYP2C8 inhibitors (e.g., gemfibrozil) can increase exposure.

Food Interaction

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

Special Populations

Children

6-14 years: 5mg chewable tablet once daily. 2-5 years: 4mg chewable tablet once daily.

Kidney Impairment

No adjustment needed.

Storage & Patient Advice

Missed Dose

If a dose is missed, take it as soon as remembered the same day; if it is near the time of the next dose, skip the missed dose and resume the regular schedule. Do not take two doses in 24 hours.

Stopping the Medicine

Do not stop or change therapy without medical advice; stopping may worsen asthma/allergic rhinitis control; discontinue promptly and seek care if neuropsychiatric symptoms occur.

Overdose

Overdose symptoms may include abdominal pain, somnolence, thirst, headache, vomiting, mydriasis/hyperkinesia; management is supportive/symptomatic; montelukast is not expected to be removed by hemodialysis (dialysis utility unknown/limited).

Patient Counseling

Chew the tablet fully and take once daily (evening for asthma; any time for allergic rhinitis alone). It prevents symptoms and is not for sudden asthma attacks-keep a rescue inhaler available. Continue other asthma medicines unless the prescriber changes them. Watch for mood/behavior/sleep changes and report promptly. Store below 30°C in the original blister.

Monitoring Requirements

Monitor clinical control (asthma symptoms, rescue inhaler use) and for neuropsychiatric symptoms (e.g., sleep disturbance, agitation, mood/behavior changes, suicidal ideation). No routine laboratory monitoring is required.

Pharmacology

Mechanism of Action

Selective cysteinyl leukotriene receptor 1 (CysLT1) antagonist that blocks the effects of cysteinyl leukotrienes (especially LTD4; also LTC4/LTE4) to reduce airway inflammation, bronchoconstriction, and mucus production.

Onset of Action

Onset can occur within ~2 hours (including protection against exercise-induced bronchoconstriction); clinical benefit in asthma/allergic rhinitis may be noticed within the first day, with continued improvement over days.

Duration of Effect

Approximately 24 hours (supports once-daily dosing).

Half-Life

Approximately 2.7-5.5 hours (in healthy adults).

Bioavailability

Approximately 73% (5 mg chewable tablet).

Metabolism

Extensively metabolized in the liver, primarily by CYP2C8, and to a lesser extent by CYP3A4 and CYP2C9.

Excretion

Primarily biliary/fecal excretion (about 86% in feces); minimal renal excretion (<0.2% in urine).

Protein Binding

>99%

Product Information

Available Dosage Forms

Chewable tablet

Composition per Dose

Each chewable tablet: 5 mg montelukast as montelukast sodium

Generic Availability

Yes

OTC Alternatives

No OTC alternative.

Symptom Target

Allergy

Sedating

No

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