WarningsThere are no Warnings available.
Imprint: TV 7424
Montelukast is a prescription medication used to treat the symptoms of asthma and itchy, stuffy, or runny nose caused by allergies. Montelukast belongs to a group of drugs called leukotriene inhibitors which work by blocking leukotrienes, natural substances responsible for swelling in the airways, and tightening of muscles of airways, as well as nasal symptoms caused by allergies.
This medication comes in tablet, granule, and chewable tablet forms. It is usually taken once daily, with or without food.
Common side effects of montelukast include cough, fever, headache, and sore throat.
Uses of Montelukast
Montelukast is a prescription medication used to treat symptoms of asthma and itchy, stuffy, or runny nose caused by allergies.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Montelukast Brand Names
Montelukast may be found in some form under the following brand names:
Montelukast Drug Class
Montelukast is part of the drug class:
Side Effects of Montelukast
The most common side effects of montelukast include:
- upper respiratory infection
- sore throat
- stomach pain
- earache or ear infection
- runny nose
- sinus infection
Other side effects of montelukast include:
- increased bleeding tendency, low blood platelet count
- allergic reactions [including swelling of the face, lips, tongue, and/or throat (which may cause trouble breathing or swallowing), hives and itching]
- dizziness, drowsiness, pins and needles/numbness, seizures (convulsions or fits)
- nose bleed, stuffy nose
- diarrhea, heartburn, indigestion, inflammation of the pancreas, nausea, stomach or intestinal upset, vomiting
- bruising, rash, severe skin reactions (erythema multiforme) that may occur without warning
- joint pain, muscle aches and muscle cramps
- tiredness, swelling
Montelukast may cause serious side effects. See "Drug Precautions".
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of montelukast. For more information ask your healthcare provider or pharmacist.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:
- seizure medicines (carbamazepine, phenobarbital, phenytoin)
- Rifamycin antibiotics (rifabutin, rifampin, rifapentine)
This is not a complete list of montelukast drug interactions. Ask your doctor or pharmacist for more information.
Do not take montelukast if you are allergic to any of its ingredients.
Montelukast may cause serious side effects.
- Behavior and mood-related changes. Tell your doctor right away if you have mood-related changes.
- Increase in certain white blood cells (eosinophils) and possible inflamed blood vessels throughout the body (systemic vasculitis). Rarely, this can happen in people with asthma who take montelukast. This usually, but not always, happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered.
If you have asthma and aspirin makes your asthma symptoms worse, continue to avoid taking aspirin or other medicines called non-steroidal anti-inflammatory drugs (NSAIDs) while taking montelukast.
Montelukast Food Interactions
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of montelukast, there are no specific foods that you must exclude from your diet when receiving montelukast.
Before receiving montelukast, tell your healthcare provider if you:
- are allergic to aspirin
- have phenylketonuria. Montelukast chewable tablets contain aspartame, a source of phenylalanine
Tell your healthcare provider about all of your medical conditions, including if you are pregnant or breastfeeding.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Montelukast and Pregnancy
Tell your doctor if you are pregnant or plan to become pregnant.
The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.
Montelukast falls into category B. There are no well-done studies that have been done in humans with montelukast. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.
Montelukast and Lactation
Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if montelukast is excreted in human breast milk or if it will harm your nursing baby.
For anyone who takes montelukast:
- Take montelukast exactly as prescribed by your healthcare provider. Your healthcare provider will tell you how much montelukast to take, and when to take it.
- Do not stop taking montelukast or change when you take it without talking with your healthcare provider.
- You can take montelukast with food or without food.
- If you or your child misses a dose of montelukast, just take the next dose at your regular time. Do not take 2 doses at the same time.
- If you take too much montelukast, call your healthcare provider or a Poison Control Center right away.
For adults and children 12 months of age and older with asthma:
- Take montelukast one time each day, in the evening. Continue to take montelukast every day for as long as your healthcare provider prescribes it, even if you have no asthma symptoms.
- Tell your healthcare provider right away if your asthma symptoms get worse, or if you need to use your rescue inhaler medicine more often for asthma attacks.
- Do not take montelukast if you need relief right away from a sudden asthma attack. If you get an asthma attack, you should follow the instructions your healthcare provider gave you for treating asthma attacks.
- Always have your rescue inhaler medicine with you for asthma attacks.
- Do not stop taking or lower the dose of your other asthma medicines unless your healthcare provider tells you to.
For people 6 years of age and older for the prevention of exercise-induced asthma:
- Take montelukast at least 2 hours before exercise.
- Always have your rescue inhaler medicine with you for asthma attacks.
- If you take montelukast every day for chronic asthma or allergic rhinitis, do not take another dose to prevent exercise-induced asthma. Talk to your healthcare provider about your treatment for exercise-induced asthma.
- Do not take 2 doses of montelukast within 24 hours (1 day).
For adults and children 2 years of age and older with seasonal allergic rhinitis, or for adults and children 6 months of age and older with perennial allergic rhinitis:
- Give montelukast oral granules to your child exactly as instructed by your healthcare provider.
- Do not open the packet until ready to use.
- Take montelukast 1 time each day, at about the same time each day.
Montelukast 4-mg oral granules can be given:
- right in the mouth; or
- dissolved in 1 teaspoonful (5 mL) of cold or room temperature baby formula or breast milk; or
- mixed with 1 spoonful of one of the following soft foods at cold or room temperature: applesauce, mashed carrots, rice, or ice cream.
Give the child all of the mixture right away, within 15 minutes.
Do not store any leftover montelukast mixture (oral granules mixed with food, baby formula, or breast milk) for use at a later time. Throw away any unused portion.
Do not mix montelukast oral granules with any liquid drink other than baby formula or breast milk. Your child may drink other liquids after swallowing the mixture.
Take montelukast exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.
The dose of montelukast prescribed for you or your child's condition is based on age:
- 6 to 23 months: one packet of 4-mg oral granules.
- 2 to 5 years: one 4-mg chewable tablet or one packet of 4-mg oral granules.
- 6 to 14 years: one 5-mg chewable tablet.
- 15 years and older: one 10-mg tablet.
If you take too much montelukast, call your local Poison Control Center or seek emergency medical attention right away.
- Store montelukast at 59°F to 86°F (15°C to 30°C).
- Keep montelukast in the container it comes in.
- Keep montelukast in a dry place and away from light.
Related Clinical Trials
- Inflammatory Response to Anti Inflammatory Therapy in Children With Sleep Disordered Breathing
- Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens
- The Effect of Montelukast in Patients With Chronic Cough and Bronchial Hyperreactivity
- Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)
- Trial of Montelukast in Eosinophilic Esophagitis
- Exercise Induced Bronchospasm in Children
- Montelukast With Status Asthmaticus, Ages 2-5
- BI671800 in Asthmatic Patients on Inhaled Corticosteroids
- Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fed Conditions
- Ventilatory Heterogeneity in Participants With Asthma (MK-0476-513)
- Study Of Patients With Allergic Rhinitis And Asthma
- Effects of Mometasone Furoate Dry Powder Inhaler, Fluticasone Propionate, and Montelukast on Bone Mineral Density in Asthmatics (Study P03418AM4)(COMPLETED)
- Effects of Leukotriene Modulator Montelukast on Cough Variant Asthma
- Montelukast Back to School Asthma Study
- Montelukast With Status Asthmaticus, Ages 6-18
- A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years
- The Safety and Effectiveness of MK0476 (Montelukast) in Patients With Chronic Asthma
- Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant
- A Clinical Trial to Test How Well Two Drugs, QAW039 and Montelukast Work Both Individually and Together, to Target Allergic Rhinitis Using an Environmental Exposure Chamber
- Comparison of Asthma-related Outcomes and Costs in Pediatric Subjects That Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population
- Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily
- A Placebo and Active Controlled Study of ONO-6950 in Asthmatic Patients
- A Mechanistic Study to Evaluate the Efficacy of Montelukast on Airway Function in Asthma
- Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 3
- Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing
- The Effects of Montelukast on Smokers With Asthma
- Predicting the Response to Montelukast by Genetic Variation in Asthmatics
- Dose Finding Trial to Assess the Efficacy and Safety of SOTB07 in Persistent Asthma
- Efficacy and Safety of add-on Montelukast to Inhaled Budesonide in the Treatment of Nonasthmatic Eosinophilic Bronchitis
- Acute Montelukast in Asthma
- MK0524 Asthma POC Study
- Study of the Arachidonate 5-Lipoxygenase Enzyme in Affecting the Risk for Coronary Heart Disease
- Bioequivalence Study of Montelukast 10 mg Tablets
- Bioequivalency Study of Montelukast 10 mg Tablets Under Fasted Conditions
- Trial of Asthma Patient Education (TAPE)
- Add-on Salmeterol Versus Montelukast in Arg/Arg-16 Asthmatics
- Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone
- A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled Montelukast (MK-0476) in Participants With Mild or Moderate Asthma (MK-0476-380 AM3)(COMPLETED)
- Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation in Children With Allergic Rhinitis
- Study of MK0476 in Adult Patients With Acute Asthma
- Childhood Asthma Research and Education (CARE) Network Trial - Best Add-On Therapy Giving Effective Response (BADGER)
- Sputum Matrix Metalloproteinases (MMP) mRNA and Montelukast
- A Study to Evaluate the Safety of Combination Montelukast/Loratadine in Mexican Patients With Allergic Rhinitis (MK-0476A-484)
- Effect of Addition of Oral Montelukast to Standard Treatment in Acute Moderate to Severe Asthma in Children
- Montelukast for Children With Chronic Otitis Media With Effusion (COME): A Double-blind, Placebo-controlled Study
- Montelukast as a Controller of Atopic Syndrome
- Effect of Montelukast on the Expression and Variation of TGF-β for Children With Mild Persistent Asthma
- Change of Airway Hyperresponsiveness to Mannitol and Methacholine in Patients With Asthma
- A Study to Evaluate Efficacy and Safety of ADC3680 in Subjects With Inadequately-Controlled Asthma
- Montelukast in Very Low Birthweight Infants
- A Dose-Ranging Study of MK-1029 in Adults With Persistent Asthma (MK-1029-012 AM2)
- Open-label Study of the Effects of Montelukast in Patients With Chronic Cough
- Efficacy and Safety of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride in Perennial Allergic Rhinitis (PAR) Patients
- Investigation to Identify Predictors of Response to a Treatment With Montelukast
- Montelukast in the Treatment of Duodenal Eosinophilia
- Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds
- Role of Leukotriene Receptor Antagonists in Treatment of Chronic Periodontitis
- Effect of Different Anti-Asthmatic Treatments on Lung Function and on Exercise-Induced Bronchoconstriction in Children With Asthma
- Time-Effect of Montelukast Protection
- Airborne Ultrafine and Fine Particulate Matter: A Cause for Endothelial Dysfunction in Man?
- Individualized Therapy For Asthma in Toddlers
- Montelukast in Acute RSV Bronchiolitis
- A Trial of Montelukast for Maintenance Therapy of Eosinophilic Esophagitis in Children
- Montelukast for Early Life Wheezing
- A Placebo and Active Controlled Study of ONO-6950 Following Allergen Challenge in Patients With Asthma
- The Effect of Montelukast Treatment in Wheezy Infants
- A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children
- Montelukast for Persistent Cough in Young People and Adults
- Bioequivalency Study of Montelukast 10 mg Tablets Under Fed Conditions
- The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia
- Pilot Study Testing a New Strategy for Management of Spontaneous Preterm Birth
- Montelukast in Exercise-Induced Bronchospasm - 2004 (0476-275)(COMPLETED)
- Wheeze and Intermittent Treatment
- Evaluation Montelukast in the Treatment of Status Asthmaticus
- Childhood Asthma Research and Education (CARE) Network Trial - Montelukast or Azithromycin for Reduction of Inhaled Corticosteroids in Childhood Asthma (MARS)
- Safety and Efficacy Study Adding GSK2190915 to Mid-dose Inhaled Corticosteroid/Long Acting Beta Agonist Combination Treatment for Asthma
- The Effect of Montelukast on Asthma Control in Obese Asthmatic Children and Adolescents
- Study Of Allergic Rhinitis In Patients Who Also Have Asthma
- Study of Inhaled Corticosteroid Plus Montelukast Compared With Inhaled Corticosteroid Therapy Alone in Patients With Chronic Asthma (0476-386)
- Safety and the Pharmacokinetic Study of Characteristics of MKT-N2 (Montelukast) and Singulair® (Montelukast Sodium)to Treat Asthma
- Use of Montelukast to Treat Children With Mild to Moderate Acute Asthma
- Montelukast Post-Marketing Comparative Study With Theophyline Added to Inhaled Corticosteroid
- A Study To Assess The Effect Of PF-03893787 On Lung Function Following An Allergen Challenge In Asthmatic Subjects
- Comparison of Combination Therapy: Montelukast and Inhaled Steroid on Exercise Induced Bronchoconstriction
- Early Airway Response to Allergen in Asthmatics (MK-0000-176)
- Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma Subjects > or = 12 Years of Age
- Montelukast in Bronchiolitis Obliterans Syndrome
- Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED)
- Effects of Montelukast in Asthmatic Children With and Without Food Allergy
- Asthma Control in Elderly Patients With Montelukast
- Effects of Montelukast on Airway Regulatory T Cells in Asthma
- The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis
- Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fasted Conditions
- Randomized, Placebo Controlled, Crossover Study in an Environmental Challenge Chamber to Assess Safety & Efficacy of Three Oral Doses of BI 671800 Versus Fluticasone Propionate and Montelukast in Sensitive Seasonal Allergic Rhinitis Patients Out of Season
- Effect of Montelukast on Remodelling Markers in Asthmatic Children
- A Study to Evaluate the Effectiveness of JNJ 40929837 for the Treatment of Asthma Using a Bronchial Allergen Challenge Model
- Comparison of Daily Mometasone Furoate Nasal Spray Alone Versus a Combination With Montelukast for Treatment of Chronic Rhinosinusitis With Asthma After Functional Endoscopic Sinus Surgery
- Montelukast Compared With Placebo and Salmeterol in Exercise-Induced Bronchoconstriction
- Montelukast in Exercise-Induced Bronchospasm - 2003
- The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis
- Montelukast in Children With Wheezing
- Singulair Use in Non-Allergic Rhinitis Eosinophil Syndrome (NARES)
- The Role of Montelukast in Rhinitis and Sleep
- Effect of Montelukast Therapy in Obstructive Sleep Apnea(OSA) Children
- Effect of Montelukast on Experimentally-Induced RV16 Infection in Asthma
- Leukotriene Receptor Antagonists or Steroids in Pre-School Asthma
- A Drug Interaction Study of Montelukast and Levocetirizine
- Short- and Long Term Growth in Children With Asthma
- Management of Asthma in School-age Children on Therapy
- Controlled Trial on Effect of Montelukast Treatment in Children With Obstructive Sleep Apnea Syndrome
- Ramatroban/Montelukast Versus Montelukast/Placebo on the Early Allergic Reaction in Asthma Sensitive to House Dust Mite
- Moderate to Persistent Asthma in the Obese Subject
- Roflumilast Plus Montelukast in Adults With Severe Asthma
- The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial (The LOCCS Trial)