AIRFAST 10/MG FC TAB 30/FC TAB

Indications

Approved Uses

Prophylaxis and chronic treatment of asthma in adults and adolescents (including prevention of daytime and nighttime symptoms); relief of symptoms of seasonal allergic rhinitis; relief of symptoms of perennial allergic rhinitis; prevention of exercise-induced bronchoconstriction (EIB) in patients ≥15 years of age. Reserve allergic rhinitis use for patients with inadequate response or intolerance to alternative therapies.

Dosage & Administration

Dosing by Condition

Asthma (≥15 years): 10 mg once daily in the evening. Allergic rhinitis (seasonal or perennial, ≥15 years): 10 mg once daily (time of day flexible). EIB prevention (≥15 years): 10 mg at least 2 hours before exercise; do not take an additional dose within 24 hours of a daily dose.

Initial Dose

10mg once daily.

Maintenance Dose

10mg once daily.

Maximum Dose

10mg per 24 hours.

Children's Dosage

Not applicable for this 10mg film-coated tablet formulation (indicated for patients 15 years and older only).

Dose Adjustment Notes

No dose titration is required; adults/adolescents ≥15 years use a fixed 10 mg once-daily dose. No dosage adjustment is required in the elderly, renal impairment, or mild-to-moderate hepatic impairment.

How to Take

Swallow 1 tablet (10 mg) once daily with water; may be taken with or without food. For asthma, dose should be taken in the evening. For allergic rhinitis, it may be taken at any time of day, but should be taken at the same time each day.

Side Effects

Common Side Effects

Common: headache and abdominal pain; also reported: diarrhea, nausea, upper respiratory tract infection, cough/pharyngitis, fever (more common in pediatrics), and rash.

Side Effect Frequency

Common (≥1% to <10%): headache, abdominal pain; also reported: diarrhea, pyrexia, upper respiratory infection. Neuropsychiatric reactions (e.g., agitation, anxiety, depression, sleep disturbance/nightmares, suicidal ideation/behavior) are uncommon/rare but clinically critical and require counseling.

Safety & Warnings

Contraindications

Contraindication: hypersensitivity to montelukast (or any excipients). Not indicated for relief of acute asthma attacks (not a rescue medication), but this is a warning/limitation of use rather than a formal contraindication.

Warnings & Precautions

Key warnings/precautions: not for acute asthma attacks; do not substitute abruptly for inhaled/oral corticosteroids; counsel and monitor for serious neuropsychiatric symptoms and discontinue/evaluate if they occur; caution with aspirin-sensitive asthma (continue avoiding aspirin/NSAIDs); consider EGPA risk during steroid taper; product excipients (e.g., lactose) may matter in intolerance.

Age Restriction

AIRFAST 10 mg film-coated tablet is intended for adults and adolescents ≥15 years; it is not appropriate for children <15 years (use age-appropriate montelukast formulations/strengths instead).

Drug Interactions

Drug Interactions

Clinically relevant interactions: CYP inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin) may decrease montelukast exposure/efficacy; gemfibrozil (CYP2C8 inhibitor) can increase montelukast exposure; no common 'major' interactions otherwise.

Food Interaction

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

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Not applicable for this 10mg film-coated tablet formulation (indicated for patients 15 years and older only).

Elderly

Standard adult dosing.

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 near the time of the next dose, skip the missed dose and resume the regular schedule. Do not double the dose.

Stopping the Medicine

May be stopped without tapering, but patients using it for asthma control should consult their clinician before stopping and seek review if asthma/allergy symptoms worsen.

Patient Counseling

Take 10 mg by mouth once daily; for asthma, take in the evening and continue daily even when well. This is a controller medicine and will not relieve an acute asthma attack-keep a rescue inhaler available. Do not stop or reduce other asthma medicines unless your prescriber tells you. Report any neuropsychiatric symptoms (e.g., agitation, anxiety, depression, sleep disturbance/nightmares, suicidal thoughts/behavior) promptly. If you have aspirin-exacerbated respiratory disease, continue to avoid aspirin/NSAIDs as previously advised.

Monitoring Requirements

No routine laboratory monitoring is required; clinically monitor asthma/allergic rhinitis control and monitor for neuropsychiatric symptoms/behavior changes (and other hypersensitivity reactions).

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 bronchoprotection can occur within ~2 hours after a dose; improvement in asthma control may be seen within about 1 day, with continued benefit over days of regular use.

Duration of Effect

Approximately 24 hours (supports once-daily dosing).

Bioavailability

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

Excretion

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

Protein Binding

>99% protein bound.

Product Information

Available Dosage Forms

For montelukast products generally: film-coated tablets (10 mg), chewable tablets (4 mg, 5 mg), and oral granules (4 mg). For AIRFAST specifically (verified API): 10 mg film-coated tablet.

Composition per Dose

Each film-coated tablet: 10mg montelukast as montelukast sodium.

Generic Availability

Yes

OTC Alternatives

No OTC equivalent to montelukast; for allergic rhinitis symptom relief, OTC options include non-sedating oral antihistamines (e.g., cetirizine, loratadine, fexofenadine) and intranasal corticosteroids (e.g., fluticasone).

Symptom Target

Asthma and allergic rhinitis

Sedating

No

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 13-07-2026