Trusted, medically reviewed health information • Not a substitute for medical advice
Medically Verified MonographPrescriptionClass: Leukotriene Receptor Antagonists

Montelukast

Generic Name: Montelukast Sodium

Common Brand Names: Singulair
Dosage Form:Tablet, Chewable Tablet, Granules
Route:Oral
Pregnancy Category:B
Last Reviewed:9/21/2026

Seek Urgent Medical Attention If:

You experience severe allergic reaction symptoms (swelling of the face, lips, tongue, or throat causing difficulty breathing), severe rash with skin peeling, sudden intense chest pain, or symptoms of overdose. Call emergency medical services immediately.

Uses & Medical Indications

Prophylaxis and chronic treatment of asthma, allergic rhinitis

Medical Conditions Treated:

Asthma, Exercise-induced bronchoconstriction, Allergic Rhinitis

Dosage & Administration Guidelines

Adult Dosage

10 mg once daily in the evening

Pediatric Dosage

4 mg (2-5 yrs) or 5 mg (6-14 yrs) once daily

Elderly / Geriatric Considerations

Same as adult

Maximum Dose Limit

10 mg/day

Renal Impairment:

No adjustment necessary

Hepatic Impairment:

No adjustment for mild-moderate; unstudied in severe

Side Effects & Safety Warnings

Common Side Effects

Headache, abdominal pain, cough, flu-like symptoms

Serious Adverse Reactions

Neuropsychiatric events, Churg-Strauss syndrome

Contraindications:

Hypersensitivity to montelukast

Important Warnings & Precautions:

Boxed warning for serious neuropsychiatric events

Interactions (Drugs, Food & Alcohol)

Drug-Drug Interactions:

Phenobarbital, rifampin may decrease levels

Food & Dietary Interactions:

Take granules directly or mixed with specific soft foods

Alcohol Interaction Warning:

No significant interaction

Pregnancy & Breastfeeding Safety

Pregnancy Safety

Considered generally safe during pregnancy if needed

Breastfeeding / Lactation

Excreted in human milk; use with caution

Patient Counseling & Practical Advice

How to Take:

Not for acute asthma attacks. Report mood/behavior changes.

What to Do if You Miss a Dose:

Skip the missed dose and resume usual schedule.

Recommended Monitoring & Lab Tests:

Behavioral/mood changes, asthma control

Trustworthy Sources & Medical Review

Content for Montelukast was synthesized and fact-checked against standardized regulatory monographs, official pharmacopoeias, and national health authorities:

  • Central Drugs Standard Control Organization (CDSCO) — National List of Essential Medicines
  • World Health Organization (WHO) — Model List of Essential Medicines 23rd List
  • Indian Pharmacopoeia Commission (IPC) — Indian Pharmacopoeia Drug Monographs
  • National Health Service (NHS) — Medicines A to Z Clinical Guidelines
Reviewer Credentials: PharmD, Clinical PharmacologistLast Reviewed Date: 9/21/2026

The information provided on this website is for educational purposes only and is not intended as a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of a qualified healthcare provider with any questions you may have regarding a medical condition.