MONTEL PEDIATRIC 4/MG 28/CHEW TAB

Indications

Approved Uses

Prophylaxis and chronic treatment of asthma in adults and children 12 months and older, prevention of exercise-induced bronchoconstriction in adults and children 6 years and older, relief of symptoms of seasonal allergic rhinitis in adults and children 2 years and older, relief of symptoms of perennial allergic rhinitis in adults and children 6 months and older.

Dosage & Administration

Dosing by Condition

Asthma (chronic): 2-5 years: 4 mg once daily in the evening; 6-14 years: 5 mg once daily in the evening; ≥15 years: 10 mg once daily in the evening. Allergic rhinitis (seasonal/perennial): 2-5 years: 4 mg once daily; 6-14 years: 5 mg once daily; ≥15 years: 10 mg once daily. EIB prophylaxis: 6-14 years: 5 mg at least 2 hours before exercise; ≥15 years: 10 mg at least 2 hours before exercise (avoid an additional dose within 24 hours if on daily therapy).

Initial Dose

4mg once daily in the evening.

Maintenance Dose

4mg once daily in the evening.

Maximum Dose

4mg per day for children aged 2-5 years

Children's Dosage

Asthma: 2-5 years: 4mg chewable tablet daily. Allergic Rhinitis: 2-5 years: 4mg chewable tablet daily. 6-14 years: 5mg chewable tablet daily. Exercise-Induced Bronchoconstriction: 6 years and older: at least 2 hours before exercise.

Dose Adjustment Notes

No dose titration is required; no dosage adjustment is generally needed in the elderly, in renal impairment, or in mild-to-moderate hepatic impairment.

How to Take

Chew the 4 mg tablet thoroughly before swallowing; may be taken with or without food. For asthma (and asthma with allergic rhinitis), administer once daily in the evening. For allergic rhinitis alone, administer once daily at any time of day. For exercise-induced bronchoconstriction (EIB) in eligible ages, give a single dose 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, abdominal pain, upper respiratory tract infection, fever, cough, diarrhea, and otitis media/earache (pediatric).

Side Effect Frequency

Common (≥1/10 to <1/100): headache, abdominal pain; upper respiratory tract infection and pyrexia are commonly reported in pediatric populations. Neuropsychiatric reactions (e.g., agitation, anxiety, depression, nightmares, suicidal ideation) are uncommon/rare but clinically important; eosinophilic conditions (e.g., pulmonary eosinophilia).

Safety & Warnings

Contraindications

Contraindication: hypersensitivity to montelukast or any component; additionally, the 4 mg chewable tablet contains aspartame (phenylalanine), so it should be avoided in patients with phenylketonuria (PKU) per product excipient warning/contraindication practices.

Warnings & Precautions

Warnings/precautions: not for acute asthma attacks (ensure rescue medication); do not abruptly substitute for inhaled/oral corticosteroids; monitor for neuropsychiatric symptoms (boxed warning) and discontinue/seek care if they occur; patients with aspirin-sensitive asthma should continue avoiding aspirin/NSAIDs; chewable tablets contain phenylalanine (aspartame) so avoid/use extreme caution in PKU; rare EGPA may emerge especially during steroid taper.

Age Restriction

For this product (montelukast 4 mg chewable tablet): approved pediatric use is typically ages 2-5 years for asthma prophylaxis/chronic treatment and for allergic rhinitis; younger ages (e.g., 6-23 months) apply to 4 mg oral granules, not the chewable tablet.

Drug Interactions

Drug Interactions

Key interactions: enzyme inducers (e.g., phenobarbital, rifampin; also carbamazepine/phenytoin) can decrease montelukast exposure/efficacy; strong CYP2C8 inhibition (e.g., gemfibrozil) can increase montelukast exposure.

Food Interaction

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

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Asthma: 2-5 years: 4mg chewable tablet daily. Allergic Rhinitis: 2-5 years: 4mg chewable tablet daily. 6-14 years: 5mg chewable tablet daily. Exercise-Induced Bronchoconstriction: 6 years and older: at least 2 hours before exercise.

Elderly

Standard adult dosing; 4mg chewable tablet is indicated for pediatric use - adult dose is 10mg

Kidney Impairment

No adjustment needed.

Liver Impairment

No dose adjustment is needed in mild-to-moderate hepatic impairment; severe hepatic impairment has not been adequately studied-use with caution.

Storage & Patient Advice

Missed Dose

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

Stopping the Medicine

Do not stop or change montelukast for asthma control without clinician advice; if discontinued, asthma/allergic rhinitis symptoms may worsen and controller therapy may need adjustment.

Patient Counseling

Chew tablet completely; take once daily (evening for asthma). It is for prevention/control and does not treat acute asthma attacks-keep a rescue inhaler available and do not stop inhaled corticosteroids without medical advice. Counsel to report any mood/behavior/sleep changes promptly. Store in the original blister and do not store above 30°C.

Monitoring Requirements

Monitor for neuropsychiatric symptoms (e.g., agitation, sleep disturbance, depression, suicidal ideation). Also monitor for eosinophilia/vasculitis (e.g., Churg-Strauss/EGPA features), particularly when tapering systemic corticosteroids.

Pharmacology

Mechanism of Action

Selective cysteinyl leukotriene receptor 1 (CysLT1) antagonist that blocks leukotriene-mediated effects (e.g., LTD4) leading to reduced bronchoconstriction, airway edema/inflammation, and mucus secretion.

Onset of Action

Onset for EIB protection occurs within about 2 hours after a dose; for chronic asthma/allergic rhinitis symptom control, clinical benefit may be seen within about 1 day, with maximal rhinitis benefit potentially taking several days.

Duration of Effect

Approximately 24 hours (supports once-daily dosing).

Bioavailability

Oral bioavailability is approximately 73% for the 4 mg chewable tablet (and ~64% for the 10 mg film-coated tablet).

Excretion

Primarily excreted via bile into feces (>86%); urinary excretion is minimal (<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

OTC Alternatives

No OTC alternative

Symptom Target

Asthma, allergic rhinitis

Sedating

No

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 04-05-2026