Montelukast STADA
Leukotriene receptor antagonist for asthma and allergic rhinitis
Quick Facts: Montelukast STADA
Key Takeaways
- Montelukast STADA blocks leukotrienes to reduce airway inflammation, bronchoconstriction and allergic symptoms in asthma and seasonal allergic rhinitis.
- Take one 10 mg tablet once daily in the evening, with or without food, even during symptom-free periods.
- It is a controller medication – always keep your rescue inhaler available for acute asthma attacks.
- Neuropsychiatric side effects (mood changes, depression, sleep disturbances) have been reported – contact your doctor immediately if these occur.
- Known drug interactions include phenobarbital, phenytoin, rifampicin and gemfibrozil – inform your doctor of all medications you take.
What Is Montelukast STADA and What Is It Used For?
Quick Answer: Montelukast STADA is a leukotriene receptor antagonist that blocks inflammatory substances called leukotrienes, helping to control asthma symptoms and relieve seasonal allergic rhinitis. It is taken as a once-daily oral tablet and is used as add-on therapy when other asthma medications alone are not sufficient.
Montelukast STADA contains the active substance montelukast (as montelukast sodium). It belongs to a class of medicines known as leukotriene receptor antagonists (LTRAs). These medications work by selectively blocking the CysLT1 receptor, which is the binding site for cysteinyl leukotrienes (LTC4, LTD4, and LTE4) in the airways and other tissues throughout the body.
Leukotrienes are potent inflammatory mediators released by mast cells and eosinophils during allergic and inflammatory responses. In the lungs, they cause bronchoconstriction (narrowing of the airways), increased mucus secretion, enhanced vascular permeability (leading to airway swelling), and recruitment of inflammatory cells such as eosinophils. By blocking the action of these leukotrienes, montelukast reduces airway inflammation and bronchoconstriction, improving breathing and reducing asthma symptoms.
Approved Indications
Montelukast STADA 10 mg is indicated for adults and adolescents aged 15 years and older in the following situations:
- Asthma treatment: As add-on therapy for patients with mild to moderate persistent asthma who are not adequately controlled on inhaled corticosteroids alone and whose short-acting beta-agonist provides insufficient clinical control. In these patients, montelukast helps prevent both daytime and nighttime asthma symptoms.
- Exercise-induced bronchoconstriction (EIB): Montelukast can prevent the narrowing of airways that occurs during or after physical activity, a condition affecting up to 90% of people with asthma.
- Seasonal allergic rhinitis (hay fever): In patients who also have asthma, montelukast can relieve nasal symptoms including congestion, runny nose, sneezing and itching, as well as eye symptoms such as watering, redness and swelling.
Understanding Asthma
Asthma is a chronic inflammatory disease of the airways characterized by reversible airflow obstruction, airway hyperresponsiveness and underlying inflammation. The Global Initiative for Asthma (GINA) estimates that approximately 262 million people worldwide are affected by asthma. Symptoms include recurrent episodes of wheezing, breathlessness, chest tightness and coughing, particularly at night or early morning. The airways of people with asthma are hypersensitive and react to triggers such as allergens (pollen, dust mites, pet dander), cigarette smoke, cold air, exercise and respiratory infections.
Montelukast addresses one of the key inflammatory pathways in asthma – the leukotriene pathway – which is complementary to the pathways targeted by inhaled corticosteroids and bronchodilators. This makes it a valuable addition to a comprehensive asthma management plan, particularly when inhaled therapy alone is insufficient.
Understanding Seasonal Allergic Rhinitis
Seasonal allergic rhinitis, commonly known as hay fever, is an allergic reaction triggered by airborne pollen from trees, grasses or weeds. It affects an estimated 10–30% of the global population. Symptoms include nasal congestion, rhinorrhea (runny nose), sneezing, nasal itching, and ocular symptoms (watery, swollen, red and itchy eyes). In patients who have both asthma and seasonal allergic rhinitis, montelukast can provide relief for both conditions simultaneously, as leukotrienes play a role in both the upper and lower airway inflammation associated with allergic disease.
What Should You Know Before Taking Montelukast STADA?
Quick Answer: Do not take Montelukast STADA if you are allergic to montelukast or any of its excipients. Be aware of potential neuropsychiatric side effects, inform your doctor of all medications you take, and never use montelukast as a rescue medication for acute asthma attacks.
Contraindications
Montelukast STADA should not be used if you have a known hypersensitivity (allergy) to montelukast sodium or to any of the other ingredients in the formulation. The inactive ingredients in Montelukast STADA 10 mg film-coated tablets include microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, disodium edetate, and magnesium stearate, with a film coating containing hypromellose, hydroxypropylcellulose, titanium dioxide (E171), and red and yellow iron oxides (E172).
If you have previously experienced an allergic reaction to montelukast or any product containing it, do not take this medication. Signs of an allergic reaction may include rash, itching, swelling of the face, lips, tongue or throat, and difficulty breathing or swallowing. If any of these symptoms occur, seek immediate medical attention.
Warnings and Precautions
Neuropsychiatric events have been reported in patients of all ages taking montelukast. These include agitation (including aggressive behavior or hostility), depression, sleep disturbances (including nightmares, insomnia and sleepwalking), hallucinations, disorientation, obsessive-compulsive symptoms, stuttering, suicidal thinking and behavior. Monitor yourself or your family member closely and contact your doctor immediately if you notice any behavioral or mood changes.
Before starting montelukast, you should be aware of the following important precautions:
- Not for acute attacks: Montelukast is not intended for the treatment of acute asthma attacks. If an attack occurs, follow your doctor's instructions and use your rescue inhaler (short-acting bronchodilator) immediately. Always carry your rescue inhaler with you.
- Continue other medications: Do not stop taking any other asthma medications prescribed by your doctor when starting montelukast. It is intended as an add-on therapy, not a replacement for inhaled corticosteroids or other controller medications.
- Aspirin sensitivity: If your asthma is worsened by aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs), continue to avoid these medications while taking montelukast.
- Churg-Strauss syndrome: In very rare cases, patients receiving anti-asthma treatments, including montelukast, have developed a combination of symptoms resembling eosinophilic granulomatosis with polyangiitis (formerly Churg-Strauss syndrome). These include flu-like symptoms, numbness or tingling in the arms or legs, worsening respiratory symptoms, and/or skin rash. Contact your doctor immediately if you develop any of these symptoms.
- Lactose content: This medication contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
- Sodium content: This medicine contains less than 1 mmol (23 mg) sodium per tablet, meaning it is essentially sodium-free.
Pregnancy and Breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking Montelukast STADA.
Pregnancy: There is limited clinical data on the use of montelukast during pregnancy. Animal studies have not shown harmful effects on fertility or fetal development, but animal data does not always predict human outcomes. Your doctor will carefully assess whether the potential benefits of continuing montelukast outweigh any theoretical risks during pregnancy. In general, poorly controlled asthma during pregnancy poses greater risks to both mother and baby than the use of established asthma medications.
Breastfeeding: It is not known with certainty whether montelukast passes into human breast milk. In animal studies, montelukast was excreted in milk. Consult your doctor before using this medication while breastfeeding or if you plan to breastfeed.
Driving and Using Machines
Montelukast STADA is not expected to affect your ability to drive or operate machinery. However, individual responses to medications may vary. In very rare cases, dizziness and drowsiness have been reported, which could impair the ability to drive or operate machinery in some patients. If you experience these symptoms, do not drive or use machines until you know how montelukast affects you.
How Does Montelukast STADA Interact with Other Drugs?
Quick Answer: Montelukast has relatively few clinically significant drug interactions, but certain CYP enzyme inducers (phenobarbital, phenytoin, rifampicin) can reduce its effectiveness by increasing its metabolism. Gemfibrozil can increase montelukast levels. Always inform your doctor about all medications you are taking.
Before starting Montelukast STADA, tell your doctor or pharmacist about all medications you are currently taking, have recently taken, or might take. This includes prescription medicines, over-the-counter drugs, herbal products and dietary supplements. Some medications can affect how montelukast works, and montelukast may affect how other medications work.
Major Interactions
| Drug | Category | Effect on Montelukast | Clinical Significance |
|---|---|---|---|
| Phenobarbital | Anticonvulsant (CYP3A4 inducer) | Decreases montelukast plasma levels by approximately 40% | May reduce efficacy; monitor asthma control |
| Phenytoin | Anticonvulsant (CYP3A4 inducer) | Decreases montelukast plasma levels | May reduce efficacy; monitor asthma control |
| Rifampicin | Anti-tuberculosis (potent CYP inducer) | Significantly decreases montelukast plasma levels | May substantially reduce efficacy; consider alternatives |
| Gemfibrozil | Lipid-lowering (CYP2C8 inhibitor) | Increases montelukast plasma levels by approximately 4.4-fold | Increased exposure; monitor for side effects |
Minor Interactions and Additional Information
Montelukast is primarily metabolized by cytochrome P450 enzymes CYP3A4 and CYP2C9, with minor involvement of CYP2C8. It is a potent inhibitor of CYP2C8 in vitro, although clinical studies have shown that montelukast does not significantly affect the metabolism of drugs metabolized by CYP3A4, CYP2C9, CYP1A2, CYP2A6 or CYP2C19 at therapeutic concentrations.
Montelukast can be taken together with other commonly prescribed asthma medications, including inhaled corticosteroids, inhaled beta-agonists (both short-acting and long-acting), and oral theophylline. No dose adjustment is needed when montelukast is used alongside these treatments. Clinical studies have confirmed that montelukast does not alter the pharmacokinetics of theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol/norethindrone), terfenadine, digoxin or warfarin at therapeutic doses.
Montelukast STADA 10 mg can be taken with or without food. Food does not have a clinically significant effect on the bioavailability of the film-coated tablet formulation. There are no known interactions with alcohol, although moderation is always advisable when taking any medication.
What Is the Correct Dosage of Montelukast STADA?
Quick Answer: The recommended dose for adults and adolescents aged 15 years and older is one 10 mg tablet taken once daily in the evening, with or without food. Take it consistently every day, including during symptom-free periods. Do not take a double dose if you miss one.
Always take Montelukast STADA exactly as your doctor or pharmacist has told you. If you are unsure about your dosage, check with your healthcare provider. Take only one tablet per day and do not exceed this dose. It is important to continue taking montelukast daily as prescribed, both during symptom-free periods and during periods when your asthma worsens.
Adults and Adolescents (15 Years and Older)
Standard Dosage
Dose: One 10 mg film-coated tablet
Frequency: Once daily, in the evening
Administration: Swallow whole with water, with or without food
Duration: Continue as long as prescribed by your doctor
The evening dosing is recommended because clinical studies demonstrated optimal efficacy when montelukast was taken in the evening, which correlates with the circadian pattern of leukotriene production being highest during nighttime hours. This timing helps to best control both nighttime and early morning asthma symptoms. Montelukast should not be used in combination with any other product that contains the same active ingredient, montelukast.
Children and Adolescents Under 15 Years
Montelukast STADA 10 mg film-coated tablets are not suitable for children under 15 years of age. Different formulations and strengths of montelukast are available for younger patients, based on age group:
| Age Group | Dosage Form | Dose | Frequency |
|---|---|---|---|
| 15 years and older | Film-coated tablet | 10 mg | Once daily, evening |
| 6–14 years | Chewable tablet | 5 mg | Once daily, evening |
| 2–5 years | Chewable tablet / granules | 4 mg | Once daily, evening |
| 6 months–2 years | Granules | 4 mg | Once daily, evening |
Elderly Patients
No dose adjustment is required for elderly patients. Pharmacokinetic studies have shown that the pharmacokinetic profile of montelukast in elderly patients is similar to that of younger adults. The 10 mg once-daily dose is appropriate for elderly patients with asthma or allergic rhinitis. As with all patients, continue to take montelukast as directed and report any side effects to your doctor.
Missed Dose
If you forget to take your daily dose of Montelukast STADA, simply resume your regular schedule by taking one tablet the following evening. Do not take a double dose to make up for a missed dose. If you frequently forget to take your medication, consider setting a daily reminder or associating the dose with your evening routine.
Overdose
Contact your doctor, hospital emergency department, or poison control center immediately for assessment and advice. Do this even if no symptoms are present.
In the majority of reported overdose cases, no adverse effects were observed. The most commonly reported symptoms in adults and children who took excessive amounts of montelukast included abdominal pain, drowsiness, thirst, headache, vomiting and psychomotor hyperactivity. There is no specific antidote for montelukast overdose. Treatment is supportive and symptomatic. It is not known whether montelukast is removable by dialysis.
What Are the Side Effects of Montelukast STADA?
Quick Answer: The most common side effects are abdominal pain and headache. Importantly, neuropsychiatric effects (behavioral changes, depression, sleep disturbances) have been reported at all frequencies and should be monitored closely. Serious allergic reactions are uncommon but require immediate medical attention.
Like all medicines, Montelukast STADA can cause side effects, although not everybody gets them. In clinical trials, the most commonly reported side effects in patients taking montelukast 10 mg were abdominal pain and headache, which were generally mild and occurred more frequently than with placebo.
Side Effects by Frequency
Very Common
May affect more than 1 in 10 people (post-marketing)
- Upper respiratory tract infection
Common
May affect up to 1 in 10 people
- Abdominal pain
- Headache
- Diarrhea, nausea, vomiting
- Skin rash
- Fever (pyrexia)
- Elevated liver enzymes (ALT, AST)
Uncommon
May affect up to 1 in 100 people
- Allergic reactions (including facial, lip, tongue and/or throat swelling that may cause breathing or swallowing difficulty)
- Behavioral and mood changes: agitation (including aggressive behavior or hostility), depression
- Abnormal dreams, nightmares, insomnia, sleepwalking, irritability, restlessness, anxiety
- Dizziness, drowsiness, numbness and tingling (paresthesia)
- Nosebleed
- Dry mouth, indigestion
- Bruising, itching, urticaria (hives)
- Joint or muscle pain, muscle cramps
- Bedwetting in children
- Tiredness, malaise, swelling (edema)
- Seizures
Rare
May affect up to 1 in 1,000 people
- Increased tendency to bleed
- Tremor
- Palpitations (awareness of heartbeat)
- Attention disturbance, memory impairment
- Involuntary muscle movements (tics)
Very Rare
May affect up to 1 in 10,000 people
- Eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome) – combination of flu-like symptoms, numbness/tingling in limbs, worsening respiratory symptoms and/or skin rash
- Decreased platelet count (thrombocytopenia)
- Hallucinations, disorientation, suicidal thinking and behavior
- Pulmonary eosinophilia (lung inflammation)
- Severe skin reactions (erythema multiforme)
- Liver inflammation (hepatitis)
- Tender red nodules under the skin (erythema nodosum)
- Obsessive-compulsive symptoms, stuttering
Serious Side Effects Requiring Immediate Medical Attention
Contact your doctor immediately or seek emergency medical care if you experience any of the following:
- Severe allergic reaction: Swelling of the face, lips, tongue, or throat; difficulty breathing or swallowing; widespread rash or hives
- Neuropsychiatric changes: Significant mood changes, feelings of depression, suicidal thoughts, hallucinations, aggressive or hostile behavior
- Churg-Strauss-like symptoms: Flu-like illness combined with numbness/tingling in extremities, worsening respiratory symptoms and skin rash
- Liver problems: Yellowing of the skin or eyes (jaundice), dark urine, persistent nausea, abdominal pain in the upper right area
- Severe skin reactions: Widespread blistering or peeling of the skin
If you experience any side effects, including any not listed above, talk to your doctor or pharmacist. You can also report side effects directly to your national medicines regulatory authority. By reporting side effects, you help provide more information on the safety of this medicine.
How Should You Store Montelukast STADA?
Quick Answer: Store at room temperature, out of sight and reach of children. Use before the expiry date on the packaging. No special storage conditions are required.
Keep Montelukast STADA out of the sight and reach of children at all times. Do not use this medicine after the expiry date stated on the blister pack and outer carton after "EXP." The expiry date refers to the last day of the stated month. No special storage conditions are required for this medicine – simply store it at room temperature, away from excessive heat and moisture.
Do not dispose of medications via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. These measures help to protect the environment. Never share your medication with other people, even if they have similar symptoms, as it may harm them.
What Does Montelukast STADA Contain?
Quick Answer: Each tablet contains 10 mg montelukast (as montelukast sodium) as the active ingredient, plus inactive excipients including lactose monohydrate. The tablets are beige, round, biconvex film-coated tablets.
Active Ingredient
Each film-coated tablet contains montelukast sodium, equivalent to 10 mg montelukast.
Inactive Ingredients (Excipients)
Tablet core: Microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, disodium edetate, magnesium stearate.
Film coating: Hypromellose, hydroxypropylcellulose, titanium dioxide (E171), red and yellow iron oxides (E172).
Appearance and Pack Sizes
Montelukast STADA 10 mg is a beige, round, biconvex film-coated tablet. It is available in Nylon/Alu/PVC–Aluminium blisters in various pack sizes: 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100, 126, 154 and 250 tablets. It is also available in HDPE bottles in pack sizes of 10, 20, 30, 50, 60, 90, 100 and 250 tablets. Not all pack sizes may be marketed in every country.
Manufacturer
Montelukast STADA is manufactured by STADA Arzneimittel AG, Stadastrasse 2–18, 61118 Bad Vilbel, Germany, and produced at several manufacturing sites across Europe including facilities in Ireland, Italy, Belgium, Austria, Slovakia and Spain.
Frequently Asked Questions About Montelukast STADA
Montelukast is used to treat asthma in adults and adolescents aged 15 years and older who are not adequately controlled on existing asthma therapy. It helps prevent both daytime and nighttime asthma symptoms by blocking leukotrienes, which are inflammatory substances that cause airway narrowing and swelling. It is also used to prevent exercise-induced bronchoconstriction and to relieve symptoms of seasonal allergic rhinitis (hay fever) in patients who also have asthma.
Take one 10 mg tablet once daily in the evening, swallowed whole with water. You can take it with or without food. It is important to take it every day, even when you are feeling well and during symptom-free periods, to maintain continuous asthma control. Do not take more than one tablet per day and do not combine it with other montelukast-containing products.
Yes. Neuropsychiatric events have been reported in patients of all ages taking montelukast. These include agitation, aggression, depression, anxiety, sleep disturbances (nightmares, insomnia, sleepwalking), hallucinations, disorientation, and in very rare cases, suicidal thinking and behavior. Regulatory agencies including the FDA and EMA have issued warnings about these effects. If you or a family member notice any behavioral or mood changes, contact your doctor immediately. Your doctor may decide to discontinue montelukast and switch to an alternative treatment.
No. Montelukast is a controller (preventive) medication that is taken daily to reduce underlying airway inflammation. It is not a rescue medication and does not work quickly enough to relieve acute asthma attacks. You must always keep your short-acting bronchodilator inhaler (such as salbutamol/albuterol) available for sudden asthma symptoms. Continue taking all other asthma medications prescribed by your doctor alongside montelukast.
There is limited data on montelukast use in pregnancy. Animal studies have not shown harmful effects, but the decision to use montelukast during pregnancy should be made by your doctor after weighing the benefits against potential risks. Uncontrolled asthma during pregnancy carries its own risks to mother and baby. It is not known whether montelukast passes into human breast milk. Consult your doctor before taking montelukast while breastfeeding.
If you forget to take your daily dose, simply skip the missed dose and resume your regular schedule by taking one tablet the following evening. Do not take a double dose to make up for a missed one. If you find yourself frequently forgetting doses, try setting a daily alarm or keeping the medication next to something you use every evening, such as your toothbrush.
References
- European Medicines Agency (EMA). Montelukast – Summary of Product Characteristics. Available at: www.ema.europa.eu
- Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention, 2024 Update. Available at: ginasthma.org
- U.S. Food and Drug Administration (FDA). Montelukast sodium prescribing information and boxed warning regarding neuropsychiatric events. Updated 2020.
- British National Formulary (BNF). Montelukast. National Institute for Health and Care Excellence. Available at: bnf.nice.org.uk
- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd List, 2023. Geneva: WHO; 2023.
- Drazen JM, Israel E, O'Byrne PM. Treatment of asthma with drugs modifying the leukotriene pathway. N Engl J Med. 1999;340(3):197–206. doi:10.1056/NEJM199901213400306
- Haarman MG, et al. Montelukast in allergic rhinitis: a review. Expert Opin Pharmacother. 2016;17(18):2399–2409.
- Philip G, et al. Montelukast for treating seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial. Ann Allergy Asthma Immunol. 2002;88(6):592–600.
- Aldea Perona A, et al. Neuropsychiatric adverse reactions of montelukast: a review of the evidence. Eur J Clin Pharmacol. 2021;77(10):1423–1434.
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This article is reviewed and updated regularly to reflect the latest evidence, regulatory changes and prescribing information updates. Last medical review: . Next scheduled review: June 2026.