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MONTELUKAST is a brand name for Montelukast. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Montelukast 10mg Film-coated Tablets are indicated in the treatment of asthma as add-on therapy in those patients 15 years of age and older with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short acting β-agonists provide inadequate clinical…
Verbatim from this product's MHRA label. Tap a section to expand.
Method of administration:
The tablet should be swallowed with a sufficient amount of fluid. Posology The dosage for patients 15 years of age and older with asthma, or with asthma and concomitant seasonal allergic rhinitis, is one 10-mg tablet daily to be taken in the evening.
General recommendations. The therapeutic effect of Montelukast 10mg Film-coated Tablets on parameters of asthma control occurs within one day. Patients should be advised to continue taking Montelukast 10mg Film-coated Tablets even if their asthma is under control, as well as during periods of worsening asthma.
Montelukast 10mg Film-coated Tablets should not be used concomitantly with other products containing the same active ingredient, montelukast. Montelukast 10mg Film-coated Tablets may be taken with or without food. No dosage adjustment is necessary for the elderly, or for patients with renal insufficiency, or mild to moderate hepatic impairment.
There are no data on patients with severe hepatic impairment. The dosage is the same for both male and female patients. Therapy with Montelukast 10mg Film-coated Tablets in relation to other treatments for asthma. Montelukast 10mg Film-coated Tablets can be added to a patient's existing treatment regimen.
When treatment with Montelukast 10mg Film-coated Tablets is used as add-on therapy to inhaled corticosteroids. 4). Children For children 6 months to 14 years of age, other strengths and pharmaceutical forms of montelukast may be available.
5 mg chewable tablets are available for paediatric patients 6 to 14 years of age. 4 mg chewable tablets are available for paediatric patients 2 to 5 years of age. 4 mg oral granules are available for paediatric patients 6 months to 5 years of age.
Montelukast has been evaluated in clinical studies in patients with persistent asthma as follows: - 10 mg film-coated tablets in approximately 4000 adult asthmatic patients 15 years of age and older. - 10 mg film-coated tablets in approximately 400 adult asthmatic patients with seasonal allergic rhinitis 15 years of age and older.
- 5 mg chewable tablets in approximately 1750 paediatric asthmatic patients 6 to 14 years of age. - 4 mg chewable tablets in 851 paediatric patients 2 to 5 years of age. - 4 mg granules in 175 paediatric patients 6 months to 2 years of age.
Montelukast has been evaluated in clinical study in patients with intermittent asthma as follows: - 4 mg granules and chewable tablets in 1038 paediatric patients 6 months to 5 years of age. The following drug-related adverse reactions in clinical studies were reported commonly (≥1/100 to <1/10) in asthmatic patients treated with montelukast and at a greater incidence than in patients treated with placebo: Body System Class Patients 15 years and older (two 12-week studies; n=795) Paediatric Patients 6 to 14 years old (one 8-week study; n=201) (two 56-week studies; n=615) Paediatric Patients 2 to 5 years old (one 12-week study; n=461) (one 48-week study; n=278) Paediatric Patients 6 months up to 2 years old (one 6-week study; n=175) Nervous system disorders headache headache hyperkinesia Respiratory, thoracic, and mediastinal disorders asthma Gastro-intestinal disorders abdominal pain abdominal pain diarrhoea Skin and subcutaneous tissue disorders eczematous dermatitis, rash General disorders and administration site conditions thirst With prolonged treatment in clinical trials with a limited number of patients for up to 2 years for adults, and up to 12 months for paediatric patients 6 to 14 years of age, the safety profile did not change.
Cumulatively, 502 paediatric patients 2 to 5 years of age were treated with montelukast for at least 3 months, 338 for 6 months or longer, and 534 patients for 12 months or longer. With prolonged treatment, the safety profile did not change in these patients either.
The diagnosis of persistent asthma in very young children (6 months – 2 years) should be established by a paediatrician or pulmonologist. Patients should be advised never to use oral montelukast to treat acute asthma attacks and to keep their usual appropriate rescue medication for this purpose readily available.
If an acute attack occurs, a short-acting inhaled β-agonist should be used. Patients should seek their doctor’s advice as soon as possible if they need more inhalations of short-acting β-agonists than usual. Montelukast should not be abruptly substituted for inhaled or oral corticosteroids.
There are no data demonstrating that oral corticosteroids can be reduced when montelukast is given concomitantly. In rare cases, patients on therapy with anti-asthma agents including montelukast may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy.
These cases have been sometimes associated with the reduction or withdrawal of oral corticosteroid therapy. Although a causal relationship with leukotriene receptor antagonism has not been established, physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients.
Patients who develop these symptoms should be reassessed and their treatment regimens evaluated. Treatment with montelukast does not alter the need for patients with aspirin-sensitive asthma to avoid taking aspirin and other non-steroidal anti-inflammatory drugs.
Montelukast 10mg Film-coated Tablets contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The safety profile in paediatric patients 6 months to 2 years of age did not change with treatments up to 3 months. Post-marketing Experience Adverse reactions reported in post-marketing use are listed, by System Organ Class and Specific Adverse Experience Term, in the table below.
Frequency Categories were estimated based on relevant clinical trials. System Organ Class Adverse Experience Term Frequency Category * Infections and infestations upper respiratory infection † Very Common Blood and lymphatic system disorders increased bleeding tendency Rare hypersensitivity reactions including anaphylaxis UncommonImmune system disorders hepatic eosinophilic infiltration Very Rare dream abnormalities including nightmares, insomnia, somnambulism, anxiety, agitation including aggressive behaviour or hostility, depression, psychomotor hyperactivity (including irritability, restlessness and tremor**) Uncommon disturbance in attention, memory impairment Rare Psychiatric disorders hallucinations, disorientation, suicidal thinking and behaviour Very Rare (suicidality).
4) Very Rare Diarrhea ‡, nausea ‡, vomiting ‡ CommonGastro-intestinal disorders dry mouth, dyspepsia Uncommon elevated levels of serum transaminases (ALT, AST), CommonHepatobiliary disorders hepatitis (including cholestatic, hepatocellular, and mixed-pattern liver injury) Very Rare rash‡ Common bruising, urticaria, pruritus Uncommon angiooedema Rare Skin and subcutaneous tissue disorders erythema nodosum, erythema multiforme Very Rare Musculoskeletal and connective tissue disorders arthralgia, myalgia including muscle cramps Uncommon pyrexia ‡ CommonGeneral disorders and administration site conditions asthenia/fatigue, malaise, oedema Uncommon * Frequency Category: Defined for each Adverse Experience Term by the incidence reported in the clinical trials data base: Very Common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1000 to <1/100), Rare (≥1/10,000 to <1/1000), Very Rare (<1/10,000).
**Frequency: rare † This adverse experience, reported as Very Common in the patients who received montelukast, was also reported as Very Common in the patients who received placebo in clinical trials. ‡ This adverse experience, reported as Common in the patients who received montelukast, was also reported as Common in the patients who received placebo in clinical trials.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard