Montelukast

The label describes montelukast for long-term treatment and prevention of asthma, and for preventing exercise-induced bronchoconstriction, in people 15 years and older.

It is also described for seasonal and perennial allergic rhinitis, but reserved for people who did not respond to, or could not tolerate, other treatments. It is not for an acute asthma attack.

• Long-term asthma control
• Preventing exercise-induced bronchoconstriction
• Seasonal allergic rhinitis
• Perennial allergic rhinitis
• Not for an acute asthma attack

The label explains that cysteinyl leukotrienes are chemicals released by cells such as mast cells and eosinophils. They bind to CysLT1 receptors in the airways and are linked to asthma and allergic rhinitis.

Montelukast is a leukotriene receptor antagonist, meaning it blocks this receptor.

This page covers the US label for montelukast tablets taken by mouth, with the dosing the label gives for adults and, where the label says so, children.

This is label-level information, not personal advice. Indian pack labels may differ, and your prescriber's instruction always comes first.

For adults and adolescents 15 years and older, the label describes one 10 mg tablet. For asthma it is taken once daily in the evening, with or without food.

For preventing exercise-induced bronchoconstriction, it describes one tablet at least 2 hours before exercise, with no extra dose within 24 hours. People already taking it daily should not take an extra dose.

A person with both asthma and allergic rhinitis takes only one dose daily in the evening. A missed dose is taken at the usual time, never two together.

• One 10 mg tablet, age 15 and older
• Asthma: once daily in the evening
• Exercise: at least 2 hours before, no extra dose in 24 hours
• Never take two doses together

The boxed warning describes serious neuropsychiatric events. The label says benefits may not outweigh risks in some people, especially when symptoms are mild and other treatments work.

It says to stop montelukast and contact a healthcare provider immediately if behavior changes or suicidal thoughts occur. It is contraindicated with hypersensitivity to any component.

The label says to keep rescue medicine available, not to abruptly replace inhaled or oral corticosteroids, and that people sensitive to aspirin should keep avoiding it and NSAIDs. It also notes systemic eosinophilia, sometimes with vasculitis.

• Boxed warning: serious neuropsychiatric events
• Not for acute asthma attacks
• Do not stop steroids abruptly
• Aspirin-sensitive people keep avoiding aspirin and NSAIDs
• Contraindicated with hypersensitivity
• Watch for systemic eosinophilia

• Theophylline
• Prednisone and prednisolone
• Warfarin and digoxin
• Oral contraceptives
• The label says no dose adjustment is needed when montelukast is used with theophylline, prednisone, prednisolone, oral contraceptives, fexofenadine, digoxin, warfarin, gemfibrozil, itraconazole or thyroid hormones.
• It also lists sedative hypnotics, NSAIDs, benzodiazepines, decongestants and CYP enzyme inducers in the same statement.

No match in this label text. Ask your pharmacist about any medicine you take.

The label gives a storage range of 20 to 25 degrees C.

The label also says to protect it from light, keep it away from moisture, keep the container tightly closed.

Follow the storage line on your own pack, and keep medicines out of the reach of children.

We did not find montelukast in the Drugs Rules 1945 Schedule H, H1, X or G rows we checked, so we cannot state its Indian prescription status from our lists. Ask your pharmacist or doctor.

Montelukast is on the National List of Essential Medicines 2022. Listed forms include: (including chewable tablets) (page 105); Tablet 10 mg (page 105); Tablet 2 mg (page 105); Tablet 4 mg (page 105); Oral liquid 2 mg/5 mL (page 105).

The Jan Aushadhi (PMBJP) list we checked has 7 product rows that mention montelukast. We did not capture prices for them.

The banned fixed-dose combination list we checked has 2 entries that mention montelukast. This does not mean the single medicine is banned. Use our checker for a specific combination.

Jan Aushadhi lists montelukast products including Montelukast Sodium Tablets IP 5mg 5mg; Montelukast Sodium Tablets IP 10mg 10mg; Montelukast Sodium 10mg and Levocetirizine 5mg Tablets IP 10mg; Montelukast Sodium 10mg and Fexofenadine Hydrochloride 120 mg Tablets 10mg. We have not shown a price for them. Check the pack and the seller for the actual price.