AIRFAST 5/MG 30/CHEW TAB

Indications

Approved Uses

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

Off-Label Uses

Off-label uses reported include chronic urticaria and aspirin-exacerbated respiratory disease (AERD) as adjunct; other dermatologic/allergic uses (e.g., atopic dermatitis) have limited/variable evidence.

Dosage & Administration

Dosing by Condition

For this product (5 mg chewable): children 6-14 years-Asthma: 5 mg once daily in the evening; Allergic rhinitis (SAR/PAR): 5 mg once daily (time may be individualized); EIB: 5 mg at least 2 hours before exercise (do not take an extra dose within 24 hours if already on daily therapy).

Initial Dose

5mg once daily in the evening

Maintenance Dose

5mg once daily in the evening

Maximum Dose

5mg 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. 12-23 months (for asthma): 4mg granules once daily. 6-23 months (for perennial allergic rhinitis): 4mg granules once daily.

Dose Adjustment Notes

No dose titration is required; no dosage adjustment is needed in renal impairment or in mild-to-moderate hepatic impairment; for asthma dose in the evening, and for allergic rhinitis timing may be individualized.

How to Take

Chew the 5 mg tablet thoroughly before swallowing; may be taken with or without food; for asthma give once daily in the evening; for allergic rhinitis the time of day may be individualized.

Side Effects

Common Side Effects

Common adverse effects include headache and abdominal pain; also reported: upper respiratory tract infection symptoms (e.g., cough, pharyngitis/sore throat, rhinorrhea/runny nose), fever, and diarrhea.

Side Effect Frequency

Common (≥1%): headache, abdominal pain (notably in pediatrics), and upper respiratory infection; other events may occur but frequencies vary by age/indication. Neuropsychiatric reactions (e.g., agitation, abnormal dreams, depression, suicidal ideation/behavior) are uncommon/rare but clinically significant and warrant prompt reporting; serious hypersensitivity and hepatic enzyme elevations are rare.

Safety & Warnings

Contraindications

Hypersensitivity to any component of montelukast sodium; phenylketonuria patients should note that the 5-mg chewable tablet contains phenylalanine (a component of aspartame).

Warnings & Precautions

Key warnings/precautions: not for acute asthma attacks (ensure rescue therapy); boxed warning for neuropsychiatric events-monitor and discontinue/seek care if symptoms occur; do not abruptly substitute for inhaled/oral corticosteroids and monitor for EGPA during steroid taper; patients with aspirin-sensitive asthma should continue to avoid aspirin/NSAIDs; phenylketonuria warning applies if chewable contains aspartame.

Age Restriction

AIRFAST 5 mg chewable (montelukast) is generally indicated for pediatric patients 6-14 years (dose-form/strength aligns with this age band); younger ages use 4 mg formulations (granules/chewable) and adults/adolescents ≥15 years use 10 mg tablets.

Drug Interactions

Interaction Severity

Moderate: strong enzyme inducers (e.g., rifampicin/rifampin, phenobarbital, phenytoin, carbamazepine) may decrease montelukast exposure/effect; Moderate: gemfibrozil (CYP2C8 inhibition) can increase montelukast 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. 12-23 months (for asthma): 4mg granules once daily. 6-23 months (for perennial allergic rhinitis): 4mg granules once daily.

Elderly

Elderly patients 15 years and older: 10 mg tablet once daily in the evening.

Kidney Impairment

No adjustment needed.

Liver Impairment

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

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered the same day; if it is close to the next dose, skip the missed dose and resume the regular schedule; do not double doses.

Stopping the Medicine

May be stopped without taper, but patients with asthma should consult the prescriber before stopping because asthma control may worsen; additionally, advise to seek medical advice if neuropsychiatric symptoms occur during treatment or after discontinuation.

Patient Counseling

Chew the 5 mg tablet completely before swallowing; take once daily as prescribed (typically in the evening for asthma control). This medicine is for prevention/control of asthma and allergic rhinitis symptoms and is NOT for sudden asthma attacks-keep a rescue inhaler available. Do not stop or change therapy without the prescriber. Report neuropsychiatric symptoms promptly (e.g., agitation, anxiety, depression, abnormal dreams, insomnia, suicidal thoughts/behavior). If the child has phenylketonuria, check whether the chewable contains aspartame/phenylalanine and inform the prescriber.

Monitoring Requirements

Monitor for neuropsychiatric symptoms/behavior or mood changes (including sleep disturbance, agitation, depression, suicidal ideation); no routine laboratory monitoring is required.

Pharmacology

Mechanism of Action

Selective cysteinyl leukotriene receptor (CysLT1) antagonist that blocks leukotrienes (especially LTD4) to reduce bronchoconstriction, airway edema/inflammation, and mucus secretion.

Duration of Effect

Approximately 24 hours (supports once-daily dosing).

Half-Life

2.7-5.5 hours (healthy adults).

Bioavailability

The mean oral bioavailability for the 5-mg chewable tablet is not explicitly stated in the search results; however, the 10-mg film-coated tablet has a mean oral bioavailability of 64%. The 5-mg chewable tablet achieves mean peak plasma concentration in 2 to 2.5 hours after administration.

Excretion

Primarily biliary/fecal (~86% recovered in feces); minimal urinary excretion (<0.2%).

Protein Binding

>99% protein bound.

Product Information

Available Dosage Forms

Film-coated tablet, Chewable tablet, Oral granules.

Composition per Dose

Each chewable tablet: 5mg montelukast as montelukast sodium

Symptom Target

Allergy

Sedating

No

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 12-06-2026