Montelukast — uses, dosing, side effects & the brands that sell it · pharmaranks
Montelukast: uses, dosing, side effects & brands
Montelukast is a leukotriene receptor antagonist sold in the U.S. under 2 brand and generic names, for asthma and perennial allergic rhinitis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
By the pharmaranks editorial team·Reviewed against the FDA (openFDA label, NDC Directory & Enforcement) sources·How we research
From the FDA label for Montelukast Sodium (application ANDA209011). Other montelukast products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Administration (by indications): Asthma: Once daily in the evening for patients 12 months and older ( 2.1 ). Acute prevention of EIB: One tablet at least 2 hours before exercise for patients 6 years of age and older ( 2.2 ). Seasonal allergic rhinitis: Once daily for patients 2 years and older ( 2.3 ) Perennial allergic rhinitis: Once daily for patients 6 months and older ( 2.3 ). Dosage (by age): 15 years and older: one 10-mg tablet ( 2 ). 6 to 14 years: one 5-mg chewable tablet ( 2 ). 2 to 5 years: one 4-mg chewable tablet or one packet of 4-mg oral granules ( 2 ). 6 to 23 months: one packet of 4-mg oral granules ( 2 ). Patients with both asthma and allergic rhinitis should take only one dose daily in the evening ( 2.4 ). For oral granules: Must administer within 15 minutes after opening the packet (with or without mixing with food) ( 2.5 ). 2.1 Asthma For asthma, administer montelukast sodium orally once daily in the evening, with or without food. There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing. The following doses are recommended: Table 1: Recommended Dosage in Asthma Age Dose Adult and adolescent patients 15 years of age and older one 10 mg tablet Pediatric patients 6 to 14 years of age one 5 mg chewable tablet Pediatric patients 2 to 5 years of age one 4 mg chewable tablet or one packet of oral…
Montelukast side effects
Most common adverse reactions (incidence ≥5% and greater than placebo listed in descending order of frequency): upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis, otitis ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following clinically significant adverse reactions are described elsewhere in the labeling: • Neuropsychiatric Events [see Warnings and Precautions ( 5.1 )] . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In the following description of clinical trials experience, adverse reactions are listed regardless of causality assessment. The most common adverse reactions (incidence ≥5% and greater than placebo; listed in descending order of frequency) in controlled clinical trials were: upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis, otitis. Adults and Adolescents 15 Years of Age and Older with Asthma Montelukast sodium has been evaluated for…
Every montelukast product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Montelukast pill imprints
Imprint
Strength
Colour
Shape
Maker
MT1
4 mg
pink
round
—
MT2
5 mg
pink
round
—
MO1
10 mg
brown
round
—
1079;4
4 mg
pink
oval
—
I;113
5 mg
pink
round
—
I;113
5 mg
pink
How long montelukast stays in your system
The elimination half-life of montelukast is about 2.7 to 5.5 hours. This is the mean range in healthy young adults; the half-life is somewhat longer in older adults and in people with mild-to-moderate liver impairment (about 7.4 hours). No active metabolite with a materially longer half-life is present.
Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Frequently asked questions
What is montelukast?
Montelukast sodium, the active ingredient in montelukast sodium tablets USP and montelukast sodium oral granules USP, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1 receptor. Montelukast sodium is described chemically as [ R-(E) ]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl] cyclopropaneacetic acid, monosodium salt. The empirical formula is C 35 H 35 ClNNaO 3 S, and its molecular weight is 608.18. The structural formula is: Montelukast sodium is a hygroscopic, optically active, white to off-white powder. Montelukast sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile. Each 10-mg film-coated montelukast sodium tablet USP contains 10.4 mg montelukast sodium, which is equivalent to 10 mg of montelukast, and the following inactive ingredients: croscarmellose sodium, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and titanium dioxide. Each 4-mg and 5-mg chewable montelukast sodium tablet USP contains 4.2 and 5.2 mg montelukast sodium, respectively, which are equivalent to 4 and 5 mg of montelukast, respectively. Both chewable tablets contain the following inactive ingredients: aspartame, cellulose…
What kind of drug is montelukast?
The FDA classifies montelukast as a leukotriene receptor antagonist. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
How long does montelukast stay in your system?
The elimination half-life of montelukast is about 2.7 to 5.5 hours — that is how long the body takes to clear half of a dose. This is the mean range in healthy young adults; the half-life is somewhat longer in older adults and in people with mild-to-moderate liver impairment (about 7.4 hours). No active metabolite with a materially longer half-life is present. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.
Can you take montelukast with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run montelukast against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Who shouldn’t take montelukast
Hypersensitivity to any component of montelukast sodium ( 4 ). Montelukast sodium is contraindicated in patients with hypersensitivity to any of its components.
Montelukast drug interactions
No dose adjustment is needed when montelukast sodium is co-administered with theophylline, prednisone, prednisolone, oral contraceptives, fexofenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, and Cytochrome P450 (CYP) enzyme inducers [see Clinical Pharmacology ( 12.3 )] .
We track 2 montelukast-containing products in the U.S.: Montelukast Sodium and Singulair. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does montelukast come in?
Across the brands we track, montelukast is currently marketed as powder, tablet and tablet, chewable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic montelukast?
Yes. Our catalog lists 1 generic montelukast product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.