MONTEL 10/MG FC TAB 28/FC TAB

Indications

Approved Uses

For the 10 mg film-coated tablet (adults/adolescents): prophylaxis and chronic treatment of asthma; relief of symptoms of seasonal allergic rhinitis; relief of symptoms of perennial allergic rhinitis; and prevention of exercise-induced bronchoconstriction (EIB) in appropriate patients.

Dosage & Administration

Dosing by Condition

Asthma (adults/adolescents): 10 mg orally once daily in the evening. Allergic rhinitis (seasonal or perennial) (adults/adolescents): 10 mg orally once daily (time of day flexible). Asthma with concomitant allergic rhinitis: 10 mg once daily in the evening. EIB prevention (adults/adolescents): 10 mg as a single dose at least 2 hours before exercise (max 10 mg in 24 hours).

Initial Dose

10mg once daily in the evening for asthma or at any time for allergic rhinitis.

Maintenance Dose

10mg once daily.

Maximum Dose

10mg per 24 hours.

Children's Dosage

This 10mg film-coated tablet is for patients 15 years and older only.

Dose Adjustment Notes

No dose titration is required. No dosage adjustment is generally necessary in the elderly, in renal impairment, or in mild-to-moderate hepatic impairment; avoid/use caution in severe hepatic impairment due to limited data.

How to Take

Swallow 1 tablet whole with water; may be taken with or without food. For asthma, take once daily in the evening. For allergic rhinitis, take once daily at any time of day. For prevention of exercise-induced bronchoconstriction (EIB), take a single dose at least 2 hours before exercise (do not take an additional dose within 24 hours if already on once-daily therapy).

Side Effects

Common Side Effects

Common adverse effects include headache and abdominal pain; also reported are diarrhea, nausea/dyspepsia, fatigue, fever/flu-like symptoms, and upper respiratory tract infection symptoms (e.g., cough, pharyngitis).

Safety & Warnings

Contraindications

Contraindication: hypersensitivity to montelukast or any excipients/components of the product.

Warnings & Precautions

Key warnings/precautions: not for acute asthma attacks (ensure rescue therapy); do not abruptly substitute for inhaled/oral corticosteroids; monitor for neuropsychiatric symptoms and discontinue/evaluate if they occur; aspirin-sensitive asthma patients should continue to avoid aspirin/NSAIDs; be alert for EGPA/Churg-Strauss especially when tapering systemic steroids.

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).

Drug Interactions

Drug Interactions

Clinically relevant interactions: strong enzyme inducers (e.g., phenobarbital, rifampicin) can decrease montelukast exposure; strong CYP2C8 inhibitors (e.g., gemfibrozil) can increase exposure-monitor clinical response/adverse effects; routine dose adjustment is usually not required but may be considered based on control/tolerability.

Food Interaction

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

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

This 10mg film-coated tablet is for patients 15 years and older only.

Elderly

Standard adult dosing.

Kidney Impairment

No adjustment needed.

Liver Impairment

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

Storage & Patient Advice

Stopping the Medicine

May be stopped without taper, but should not be stopped or substituted for controller therapy without clinician advice; asthma/allergic symptoms may recur and it is not for acute attacks.

Patient Counseling

Take exactly as prescribed (typically 10 mg once daily; evening for asthma). It is a controller medicine and does not treat acute asthma attacks-keep a rescue inhaler available. Report any mood/behavior changes or suicidal thoughts promptly. Do not stop or change other asthma medicines (especially corticosteroids) without medical advice. May be taken with or without food; store below 30°C in original blister.

Monitoring Requirements

Monitor for neuropsychiatric symptoms (e.g., agitation, depression, suicidal ideation). Also monitor for eosinophilia/vasculitic features and worsening respiratory symptoms, particularly when tapering inhaled/systemic corticosteroids; no routine lab 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 and LTE4) in the airways, reducing bronchoconstriction and inflammation.

Onset of Action

For asthma symptom control, clinical effect can be seen within about 1 day. For EIB, protection begins within ~2 hours, with peak effect around 2-4 hours after a dose.

Duration of Effect

24 hours.

Bioavailability

Oral bioavailability for the 10 mg film-coated tablet is approximately 64%.

Product Information

Available Dosage Forms

Film-coated tablet, chewable tablet, oral granules.

Composition per Dose

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

Generic Availability

Yes

Symptom Target

Asthma, allergic rhinitis

Sedating

No

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 31-05-2026