This makes breathing easier and prevents asthma attacks. 3. Asthma and Lung UK is a company limited by guarantee 01863614 (England and Wales). Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. They need to know if you have any of these conditions: Take this medication by mouth with water. Epub 2006 Feb 7. Build, train, & validate predictive machine-learning models with structured datasets. Epub 2015 Apr 25. quinolines, monocarboxylic acid, aliphatic sulfide (, R03D OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, R03 DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, Cytochrome P-450 CYP2C8 Inhibitors (strength unknown), Hormones, Hormone Substitutes, and Hormone Antagonists, Predicted MS/MS Spectrum - 10V, Positive (Annotated), Predicted MS/MS Spectrum - 20V, Positive (Annotated), Predicted MS/MS Spectrum - 40V, Positive (Annotated), Predicted MS/MS Spectrum - 10V, Negative (Annotated), Predicted MS/MS Spectrum - 20V, Negative (Annotated), Predicted MS/MS Spectrum - 40V, Negative (Annotated), Solute carrier organic anion transporter family member 2B1. Enter your medication into the WebMD interaction checker. This makes it easier to breathe. Child 6-14 years 5 mg once daily, dose to be taken in the evening. Ask your pharmacist how to throw away medicines you no longer use. Contents of the pack and other information. 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: Adult and Adolescent Patients 15 years and older. We cannot reply to comments left on this form. 2004 Nov 12;324(2):815-21. Find out how montelukast works as an add-on treatment for asthma, what the benefits are, and what important side effects to look out for. Do not use this medication to treat a sudden asthma attack. Safety and efficacy were demonstrated in clinical trials where the 10 mg film-coated tablet was administered without regard to the timing of food ingestion. Patients who develop these symptoms should be reassessed and their treatment regimens evaluated. In those asthmatic patients in whom Montelukast is indicated in asthma, Montelukast can also provide symptomatic relief of seasonal allergic rhinitis. Keep this medicine out of the sight and reach of children. For the 5 mg chewable tablet, the Cmax is achieved in 2 hours after administration in adults in the fasted state. Properly discard this product when it is expired or no longer needed. The metabolism of Montelukast can be decreased when combined with Acetaminophen. The evaluation of asthma efficacy was not a primary objective in this study. [, Zhang Z, Luo J, Huang J, Liu Z, Fang S, Zhang WP, Wei E, Lu Y: [Leukotriene D4 activates BV2 microglia in vitro]. Compared with inhaled beclomethasone (200 g twice daily with a spacer device), montelukast demonstrated a more rapid initial response, although over the 12-week study, beclomethasone provided a greater average treatment effect (% change from baseline for montelukast vs beclomethasone, respectively for FEV1: 7.49% vs 13.3%; betaagonist use: -28.28% vs -43.89%). Reduction in EIB was also demonstrated in a short term study in paediatric patients (maximal fall in FEV1 18.27% vs 26.11%; time to recovery to within 5% of baseline FEV1 17.76 min vs 27.98 min). Patients and physicians should be alert for neuropsychiatric events. The brand name for this medication is Singulair. Any worsening of mood or thoughts of suicide or dying should be reported to your health care provider right away. Drug created at June 13, 2005 13:24 / Updated at June 08, 2023 10:20, Structured drug data for data science & ML, Clinical intelligence tool for your software, Search for drug interactions with our API, Get drug allergy and cross sensitivities info. This medication passes into breast milk. J Clin Pharmacol. The recommended dose for adults and adolescents 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. 5 mg chewable tablets are available for paediatric patients 6 to 14 years of age. 2002 Jan 1;30(1):412-5. The contribution of metabolites to the therapeutic effect of montelukast is minimal. This medicine is not expected to affect your ability to drive a car or operate machinery. Singulair; Descriptions. Significant reduction of exercise-induced bronchoconstriction (EIB) was demonstrated in a 12-week study in adults (maximal fall in FEV1 22.33% for montelukast vs 32.40% for placebo; time to recovery to within 5% of baseline FEV1 44.22 min vs 60.64 min). We use your comments to improve our information. These can either be sprinkled directly into the childs mouth, or placed on a spoonful of cold (or room temperature) food, for example pureed fruit or yogurt. Keep all medical and lab appointments. [, Lamoureux J, Stankova J, Rola-Pleszczynski M: Leukotriene D4 enhances immunoglobulin production in CD40-activated human B lymphocytes. Your asthma symptoms may get worse and you may increase your risk of an asthma attack. J Biol Chem. Uncommon: the following may affect up to 1 in 100 people, Rare: the following may affect up to 1 in 1,000 people, Very rare: the following may affect up to 1 in 10,000 people, Very common: the following may affect more than 1 in 10 people, Common: the following may affect up to 1 in 10 people, Very Rare: the following may affect up to 1 in 10,000 people. What Montelukast are and what they are used for, 2. Avoid life-threatening adverse drug events & improve clinical decision support. Sun Pharmaceutical Industries Europe B.V. Start typing to retrieve search suggestions. US residents can call their local poison control center at 1-800-222-1222. Side effects that you should report to your care team as soon as possible: Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): This list may not describe all possible side effects. If you take it for asthma, it's important to take it even when you have no symptoms. Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. Page last reviewed: 14 March 2023 This includes any possible side effects not listed in this leaflet. Available studies have methodologic limitations, including small sample size, in some cases retrospective data collection, and inconsistent comparator groups. It works by decreasing inflammation in the airways, making it easier to breathe. If you are taking this medication for asthma or for both asthma and allergies, take your dose in the evening. Uses Warnings Before taking Side effects Interactions Dosage What is montelukast? Asthma causes inflammation (swelling and damage) and . Granules are available for younger children. The absorption is unaffected by food. Get useful, helpful and relevant health + wellness information, 9500 Euclid Avenue, Cleveland, Ohio 44195 |, Important Updates + Notice of Vendor Data Event, An unusual or allergic reaction to montelukast, other medications, foods, dyes, or preservatives, Medications for seizures like phenytoin, phenobarbital, and carbamazepine, Allergic reactionsskin rash, itching, hives, swelling of the face, lips, tongue, or throat, Flu-like symptomsfever, chills, muscle pain, cough, headache, fatigue, Mood and behavior changes such as anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression, Pain, tingling, or numbness in the hands or feet, Sinus pain or pressure around the face or forehead. 2009 Feb;19(2):129-38. doi: 10.1097/FPC.0b013e32831bd98c. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Available data from published prospective and retrospective cohort studies with montelukast use in pregnant women evaluating major birth defects have not established a drug-associated risk. Report a suspected side effect or falsified product to the MHRA Yellow Card scheme. Adult: As conventional tab: 10 mg once daily. The CysLT type-1 (CysLT1) receptor is found in the human airway (including airway smooth muscle cells and airway macrophages) and on other pro-inflammatory cells (including eosinophils and certain myeloid stem cells). The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. Do not take a dose before exercise if you are already taking this medication daily for asthma or allergies. Epub 2009 Sep 1. Prescribers should carefully evaluate the risks and benefits of continuing treatment with montelukast if such events occur. Acta Pharmacol Sin. Studies in rats with radiolabelled montelukast indicate minimal distribution across the blood-brain barrier. [. Biochem Biophys Res Commun. [, Zhang YJ, Zhang L, Wang SB, Shen HH, Wei EQ: Montelukast modulates lung CysLT(1) receptor expression and eosinophilic inflammation in asthmatic mice. [, Mougey EB, Feng H, Castro M, Irvin CG, Lima JJ: Absorption of montelukast is transporter mediated: a common variant of OATP2B1 is associated with reduced plasma concentrations and poor response. Curr Med Chem. The metabolism of Acenocoumarol can be decreased when combined with Montelukast. If you are taking this medication to prevent breathing problems during exercise, take your dose at least 2 hours before exercise. Common side effects (affecting around 1 in 10 to 1 in 100 people) include diarrhoea, stomach-ache, sore throats and infections. Epub 2006 May 19. Keep taking it unless your care team tells you to stop. 4. Montelukast Generic name: montelukast [ mon-te-LOO-kast ] Brand name: Singulair Dosage forms: oral granule, oral tablet, oral chewable tablet Drug class: Leukotriene modifiers Medically reviewed by Carmen Pope, BPharm. Estimated Cost (Without Insurance): Accolate tends to be cheaper than Singulair. Therefore, montelukast is not anticipated to markedly alter the metabolism of medicinal products metabolised by this enzyme (e.g., paclitaxel, rosiglitazone, and repaglinide.). Montelukast is a type of medicine known as a leukotriene receptor antagonist. The first two numbers indicate the month; the last four numbers indicate the year. Montelukast - Brand name: Singulair Find out how montelukast treats symptoms of asthma and how to take it. Montelukast helps stop your airways from narrowing (caused by inflammation). In chronic asthma studies, montelukast has been administered at doses up to 200 mg/day to adult patients for 22 weeks and in short term studies, up to 900 mg/day to patients for approximately one week without clinically important adverse experiences. [, Walsky RL, Gaman EA, Obach RS: Examination of 209 drugs for inhibition of cytochrome P450 2C8. It is used to prevent breathing problems that happen with exercise. Most people with asthma do not need montelukast, but it can be a useful add-on treatment to take alongside your usual preventer inhaler. Take with or without food. This information should not be interpreted without the help of a healthcare provider. Montelukast is indicated in the treatment of asthma as add-on therapy in those patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom as-needed short acting beta-agonists provide inadequate clinical control of asthma. Tell your health care provider if your allergy or asthma symptoms do not improve. This medicinal product contains lactose. When montelukast is used to prevent breathing difficulties during exercise, it should be taken at least 2 hours before . In aspirin-sensitive asthmatic patients receiving concomitant inhaled and/or oral corticosteroids, treatment with montelukast, compared with placebo, resulted in significant improvement in asthma control (FEV1 8.55% vs -1.74% change from baseline and decrease in total beta-agonist use -27.78% vs 2.09% change from baseline). Your doctor will assess whether you can take this tablet during this time. Montelukast (Singulair) is a leukotriene receptor antagonist, meaning it blocks substances in the body called leukotrienes. Since montelukast is metabolised by CYP 3A4, 2C8, and 2C9, caution should be exercised, particularly in children, when montelukast is co-administered with inducers of CYP 3A4, 2C8, and 2C9, such as phenytoin, phenobarbital and rifampicin. Since there are other allergy medications that may be safer (see also Warning section), this medication should be used for this condition only when you cannot take other allergy medications or they do not work well.This medication must be used regularly to be effective. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Get advice on your medicines, symptoms or travelling with a lung condition, or just call us to say hello. You should take only one tablet of Montelukast once a day as prescribed by your doctor. 3 The medication is a member of the leukotriene receptor antagonist (LTRA) category of drugs. This makes breathing easier and prevents asthma attacks. If an acute attack occurs, a short-acting inhaled beta-agonist should be used. These measures will help protect the environment. Severe mental distress is an extremely rare side effect, but where it has happened it is extremely worrying and upsetting, says Dr Andy Whittamore, Asthma + Lung UKs in-house GP. [, Langlois A, Ferland C, Tremblay GM, Laviolette M: Montelukast regulates eosinophil protease activity through a leukotriene-independent mechanism. COPD (chronic obstructive pulmonary disease), Benefits and financial support when you have a lung condition. 4 mg granules are available for paediatric patients 6 months to 5 years of age. Montelukast 10 mg film-coated tablets are beige to light yellow coloured, rounded square, film-coated tablets, engraved with M10 on one side and plain on the other side. Furthermore, some formulations like chewable montelukast tablets may also be specifically indicated by particular regulatory bodies for the prophylaxis and chronic treatment of asthma, including the prevention of day and night-time symptoms, the treatment of acetylsalicylic acid based asthma, and the prevention of exercise-induced bronchoconstriction in adult and pediatric patients aged 2 and older8, between the ages 2 and 57, or between the ages of 6 and 14 years.9, Moreover, when employed for such indications montelukast is considered effective as monotherapy or when combined with other medications indicated for the maintenance treatment of chronic asthma.4,8 For instance, montelukast and inhaled corticosteroids can be used concomitantly to demonstrate additive effects to control asthma or to decrease the necessary inhaled corticosteroid dose while still maintaining clinical stability.4,8, Additionally, in patients who continue to experience asthma symptoms, montelukast can also be combined with an 'as required' short-acting beta-agonist, an inhaled corticosteroid, or inhaled corticosteroid paired with a long-acting beta-agonist.4,8, Montelukast is a leukotriene receptor antagonist that demonstrates a marked affinity and selectivity to the cysteinyl leukotriene receptor type-1 in preference to many other crucial airway receptors like the prostanoid, cholinergic, or beta-adrenergic receptors.3,4,5,6,7,8,9 As a consequence, the agent can elicit substantial blockage of LTD4 leukotriene-mediated bronchoconstriction with doses as low as 5 mg.3,4,5,6,7,8,9 Moreover, a placebo-controlled, crossover study (n=12) demonstrated that montelukast is capable of inhibiting early and late phase bronchoconstriction caused by antigen challenge by 75% and 57% respectively.3,4,5,6,7,8,9, In particular, it has been documented that montelukast can cause bronchodilation as soon as within 2 hours of oral administration.3,4,5,6,7,8,9 This action can also be additive to the bronchodilation caused by the concomitant use of a beta agonist.3,4,5,6,7,8,9 Nevertheless, clinical investigations performed with adults 15 years of age and older revealed that no additional clinical benefit is obtained when doses of montelukast greater than 10 mg a day are used.3,4,5,6,7,8,9, Additionally, in clinical trials with adults and pediatric asthmatic patients aged 6 to 14 years, it was also determined that montelukast can reduce mean peripheral blood eosinophils by about 13% to 15% from baseline in comparison to placebo during double-blind treatment periods.3,4,5,6,7,8,9 At the same time, in patients aged 15 years and older who were experiencing seasonal allergic rhinitis, the use of montelukast caused a median reduction of 13% in peripheral blood eosinophil counts when compared to placebo as well.3,4,5,6,7,8,9, Cysteinyl leukotrienes (CysLT) like LTC4, LTD4, and LTE4, among others, are eicosanoids released by a variety of cells like mast cells and eosinophils.3,4,5,6,7,8,9 When such CysLT bind to corresponding CysLT receptors like CysLT type-1 receptors located on respiratory airway smooth muscle cells, airway macrophages, and on various pro-inflammatory cells like eosinophils and some specific myeloid stem cells activities that facilitate the pathophysiology of asthma and allergic rhinitis are stimulated.3,4,5,6,7,8,9, In particular, CysLT-mediated airway bronchoconstriction, occluding mucous secretion, vascular permeability, and eosinophil recruitment are all types of effects that facilitate asthma.3,4,5,6,7,8,9 Alternatively, in allergic rhinitis, CysLTs are released by the nasal mucosa when exposed to allergens during both early and late phase reactions and participate in eliciting symptoms of allergic rhinitis like a congested nose and airway.3,4,5,6,7,8,9, Subsequently, montelukast is a leukotriene receptor antagonist that binds with high affinity and selectivity to the CysLT type 1 receptor, which consequently assists in inhibiting any physiological actions of CysLTs like LTC4, LTD4, and LTE4 at the receptor that may facilitate asthma or allergic rhinitis.3,4,5,6,7,8,9, It has been observed that montelukast is quickly absorbed following administration by the oral route.3,4,5,6,7,8,9 The oral bioavailability documented for the drug is 64%.3,4,5,6,7,8,9 Furthermore, it seems that having a regular meal in the morning or even a high fat snack in the evening does not affect the absorption of montelukast.3,4,5,6,7,8,9, The steady-state volume of distribution recorded for montelukast is an average between 8 to 11 litres.3,4,5,7,8,9, It has been determined that the protein binding of montelukast to plasma proteins exceeds 99%.3,4,5,7,8,9, It has been determined that montelukast is highly metabolized and typically so by the cytochrome P450 3A4, 2C8, and 2C9 isoenzymes.3,4,5,6,7,8,9 In particular, it seems that the CYP2C8 enzymes play a significant role in the metabolism of the drug.3,4,5,6,7,8,9 Nevertheless, at therapeutic doses, the plasma concentrations of montelukast metabolites are undetectable at steady state in adults and pediatric patients.3,4,5,6,7,8,9, Hover over products below to view reaction partners, It has been reported that montelukast and its metabolites are almost exclusively excreted in the bile and into the feces.3,4,5,6,7,8,9, Studies have demonstrated that the mean plasma half-life of montelukast varies from 2.7 to 5.5 hours when observed in healthy young adults.3,4,5,7,8,9, The plasma clearance documented for montelukast is an average of 45 mL/min when observed in healthy adults.3,4,5,7,8,9, The adverse effects associated with overdosage of montelukast include abdominal pain, somnolence, thirst, headache, vomiting, psychomotor hyperactivity, and less frequently, convulsion.3,4,5,6,7,8,9, The oral LD50 value determined for mice and rats is >5000 mg/kg.3,4,5,6,7,8,9, Montelukast has not been studied in pregnant women.3,4,5,6,7,8,9 Consequently, it should be used during pregnancy only if clearly needed.3,4,5,6,7,8,9, Additionally, as it is unknown whether montelukast is excreted into human breast milk, there is also caution regarding the use of the medication in nursing mothers.3,4,5,6,7,8,9, The plasma half-life of montelukast is somewhat prolonged in elderly patients, although no dosage adjustment is generally necessary.3,4,5,6,7,8,9. Continue typing to refine. Keep all medications away from children and pets. Consult your doctor for more details. This medicine also helps prevent the narrowing of airways triggered by exercise. These cases have been sometimes associated with the reduction or withdrawal of oral corticosteroid therapy. It is not known if this medicine appears in breast milk. Store at room temperature away from light and moisture. Reporting suspected adverse reactions after authorisation of the medicinal product is important. When montelukast is used to treat asthma, it should be taken in the evening. Like Singulair, it's a prescription-only LTRA except that the active ingredient is different (zafirlukast rather than montelukast). Int Immunopharmacol. There are different form(s) of this medicine available for paediatric patients under 18 years of age based on age range. allergic reactions including swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing, behaviour and mood related changes: agitation including aggressive behaviour or hostility, depression, combination of symptoms such as flu-like illness, pins and needles or numbness of arms and legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome) (see Section 2), behaviour and mood related changes: hallucinations, disorientation, suicidal thoughts and actions, severe skin reactions (erythema multiforme) that may occur without warning, behaviour and mood related changes: dream abnormalities, including nightmares, trouble sleeping, sleepwalking, irritability, feeling anxious, restlessness, dizziness, drowsiness, pins and needles/numbness, weakness/tiredness, feeling unwell, swelling, behaviour and mood related changes: disturbance in attention, memory impairment, uncontrolled muscle movements, tender red lumps under the skin, most commonly on your shins (erythema nodosum), behaviour and mood related changes: obsessive-compulsive symptoms, stuttering. Print patient leaflet as text only. However, this medicine should not be used to relieve an asthma attack that has already started. phenobarbital (used for treatment of epilepsy), phenytoin (used for treatment of epilepsy), rifampicin (used to treat tuberculosis and some other infections), gemfibrozil (used for treatment of high lipid levels in plasma). 2018 May;58:154-159. doi: 10.1016/j.intimp.2017.12.027. The most frequently occurring symptoms reported with overdose in adults and children included abdominal pain, sleepiness, thirst, headache, vomiting, and hyperactivity. Expert Opin Pharmacother. Or you can ask your doctor to do it for you. The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are potent inflammatory eicosanoids released from various cells including mast cells and eosinophils. Cleveland Clinic is a non-profit academic medical center. It's only available on prescription. Treatment with Montelukast can be used as add-on therapy in patients when inhaled corticosteroids plus "as needed" short acting beta-agonists provide inadequate clinical control. Montelukast 10 mg film-coated tablets contain sodium. Montelukast is also indicated in the prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction. The recommended dose is one 10 mg tablet to be taken daily in the evening. Beige coloured, rounded square shaped, film-coated tablets debossed with 'X' on one side and '54' on other side. 2015 Dec;43(12):1905-16. doi: 10.1124/dmd.115.065763. Montelukast is a medication that prevents and treats the symptoms of asthma and allergies. Is expired or no longer use: as conventional tab: 10 mg film-coated tablet was administered without to! Paediatric patients under 18 years of age based on age range side effect or product... 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