Singulair 5mg Organon prophylaxis and chronic bronchial treatment (2 blisters x 14 tablets)

Dosage form Box of 2 blisters x 14 tablets
Specifications Montelukast

Ingredient

Composition information	Content
Montelukast	5mg

Uses

indicated

Singulair is appointed for elderly and children over 6 months old to prevent and treat chronic bronchial asthma, including preventing both day and night asthma symptoms, treating aspirin sensitive people, and preventing bronchial spasms due to exertion. (Seasonal allergic rhinitis for adults and children 2 years of age and older, and allergic rhinitis year -round for adults and children from 6 months of age and older). Leukotriene CYSLT1.

Cysteinyl Leukotriene (LTC4, LTD4, LTE4), which are eicosanoids that have the potential to cause strong inflammation, are secreted from many types of cells, including granules and eosinophilia. These important intermediates are attached to cysteinyl leukotriene receptors (CYSLT1). Cyslt type 1 receptors (CYSLT1) are found in human airway, including smooth muscle cells and macrophages of the airway and in other pre -inflammatory cells (including eosin leukocytes and some bone marrow stem cells). In asthma, the intermediate effects of Leukotriene include a number of effects on the airway, such as bronchospasm, mucus secretion, increased capillary permeability and canceling Eosin leukemia. In allergic rhinitis, CYSLT is secreted from the nasal mucosa after exposure to allergens in the reactions in fast and slow phases and is related to allergic rhinitis symptoms. Cyslt in the nose will increase the obstruction of the airway and obstruction symptoms in the nose. Based on biochemical and pharmacological tests, Montelukast proves to have high affinity and selective selection with CYSLT receptor (this effect is superior to other receptors that are also important in pharmacological, such as Prostanoid, Cholinergic or β-adrenergic. Montelukast strongly inhibits the physiological effects of LTC4, LTD4, LTT4, LTT4

In asthma patients, Montelukast inhibits cysteinyl leucotriene receptors in the airway to prove through the ability to inhibit bronchial spasm due to Ltd4 inhalation. β.

Clinical research in asthma

In clinical studies, Singulair takes effect in adults and children to prevent and treat chronic asthma, including preventing bronchospasm due to exercise. copper to control asthma or to reduce the dose of inhaled corticosteroids while maintaining clinical stability.

People aged 15 and older

In two double blind studies, 12 weeks, with a control, similarly designed, in patients aged 15 years and older with asthma, using Singulair to take 1 -dose per day in the evening, showing significant improvement in the parameters of asthma control through asthma symptoms, asthma, respiratory function and "need for" use. Good daily symptoms through the patient's report and wake up at night, compare with Placebo. The specific consequences of asthma, including the appearance of asthma attacks, need the help of corticosteroids, stop the drug due to asthma attacks worse, asthma drama and the number of days from asthma are improved compared to Placeboo. The general assessment of doctors and patients about asthma, as well as the specific quality of life quality assessments with asthma (in all fields, including daily normal activities and asthma symptoms) are significantly better than in the control group. Demand for drug owners β when compared to Placebo. The therapeutic effect is also stable when used continuously once a day in tests that lasts up to 1 year. Stop the drug after taking Singulair for 12 weeks without causing reverse reaction to make asthma worse. However, the group using Singulair has a high percentage of clinical response to the inhaled form

Children 6 - 14 years old, using a 5mg chewing tablet in the evening reduces a significant drama of asthma, improves the evaluation of specific quality of life comparison with Placebo. Singulair also improves the morning FEV1 in the morning, reducing the total "need" of the day of the day of the owner of the agonist β. The effectiveness achieved after the first dose and stable up to 6 months continuously, once a day.

growth in children with asthma

Two control clinical studies show that Montelukast does not affect the ability to develop the body in children before puberty has asthma. In a study in children from 6 years old to 11 years old, the body development is assessed by the development of the leg length, the group using Montelukast 5mg once a day in 3 weeks of the results is similar to the placebo group, and in the group using Budesonide gas (200µg twice a day) for 3 weeks is lower in a statistical manner compared to the place of placebo. In a 56 -week study in children from 6 to 8 years old, the graph development in children using Montelukast 5mg once a day is similar to the placebo group (the average LS value for Montelukast and the regard for the corresponding place: 5.67 and 5.64cm/year), and in the group using Beclomethasone gas (200µg, twice a day), this value is lower than the average value. 4.86cm/year) in children using aerosol, compared to the placebo group [difference of the average value of LS (with 95%reliability) is: -0.78 (-1.06; -0.49) cm/year]. Both Montelukast and Beclomethasone give clinical benefits in the treatment of mild asthma patients in a significant way compared to the placebo group.

Children from 6 months to 5 years old

In the 12 -week study, the control of Placebo in children 2-5 years old, gave Singulair once a day 4mg, improved sustainably asthma control parameters, regardless of treatment in combination with asthma vaccine, compared to Placebo. 60% of patients do not use other asthma control treatment. Singulair improves daytime symptoms (including cough, wheezing, breathing disorders and limited activity) and night symptoms when compared to Placebo. Singulair also significantly reduces the "demand" of agonized drugs β and corticosteroids for emergency compared to Placebo. Patients using Singulair have more and more asthma that is statistically significant compared to the patient in the Placebo group. The treatment effect immediately after the first dose. In addition, the number of eosin leukemia in the whole blood also decreased significantly.

Singulair's effectiveness in children from 6 months to 2 years of age is extracted from results in children over 2 years of age with asthma and based on similar dynamic pharmacokinetics as well as on the pathology, pathophysiology and the effect of the drug basically equivalent when comparing the two age groups above.

For patients with corticosteroids inhaled inhalation

Separated studies in adults show that Singulair is used in combination with inhaled corticosteroids that have a clinical coordinates and allows a decrease in steroid dose when used in combination. In the study with the control of Placebo, the beginning of the patient takes inhaled corticosteroids at a dose of about 1600µg per day, during the use of Placebo, it has reduced the rate of steroid use by about 37%. Moreover, Singulair also helps to reduce 47% of inhaled corticosteroid dose compared to 30% in the Placebo group. In another study, Singulair brings clinical benefits plus the maintenance objects but is not controlled appropriately with inhaled corticosteroids (daily use 400µg of Beclomethasone). Completely stop and suddenly beclomethasone in patients used to combine Singulair with Beclomethasone causing clinical harm in some cases, proving that the drug should gradually stop with tolerance rather than sudden stopping. For people who are sensitive to aspirin, most of them are when combined with corticosteroids with inhaled and oral forms, Singulair has improved significantly on asthma control parameters.

For patients with bronchospasm due to exertion

Singulair takes 10mg once a day will prevent bronchospasm due to exertion in people aged 15 and older. In a 12 -week study, Singulair showed significant inhibition of FEV level and time, more than 60 minutes after exertion, the percentage of FEV1 reduced maximum after exertion and 5% recovery time of FEV, before exertion. This protective effect is a constant during the treatment process, proving that there is no familiar condition. In a separate diagonal study, this protective effect is achieved after 2 days of taking the drug, drinking once a day. For children 6-14 years old, giving 5mg chewing tablets, in a similar cross -study, also found the protective effect as in adults and this protection is maintained throughout the dose distance (24 hours).

Effects on inflammation in asthma

In clinical studies, Singulair has been shown to inhibit both bronchospasm in early phase and late phase due to allergens. Because inflammatory cell infection (Eosin -like leukemia) is an important characteristic of asthma, surveyed Singulair's effects on eucalyptus loves EOSIN in peripheral blood and airway. In clinical studies in Phase IIB/III, Singulair shows a significant reduction in eosin -loving leukocytes in peripheral blood, down 15% compared to the starting and compared to Placeboo, in children from 6 to 14 years old Singulair, EOSIN leukemia in peripheral blood 13% over 8 weeks of treatment compared to Placebo. Singulair also significantly reduces Eosin leukemia in the airway, in sputum compared to the Placebo group. In this study, the amount of eosinophilia liked the peripheral blood and the clinical assessment criteria for asthma improvement in the treatment group with Singulair.

Clinical research - Allergic rhinitis

Singulair's effectiveness in the treatment of seasonal allergic rhinitis is studied in random, double -blind, 2 -week -long tests, with Placeboo control, over 4924 patients (with 1751 Singulair users). Patients aged 15 years and older, have a history of seasonal allergic rhinitis, positive skin test in at least one season of allergens and have clear symptoms of seasonal allergic rhinitis at the beginning of the study. During the day and clinical manifestations (such as nasal congestion, runny nose, itching, sneezing); The index of night symptoms (such as nasal congestion, difficulty sleeping, waking up many times at night); The summary index of symptoms (including both day and night nasal symptoms); And through the general assessment of the patient and the doctor about allergic rhinitis compared to Placebo. Moreover, the entire 4 -week validity is also consistent with the results of 2 weeks. For patients over 15 years old with seasonal allergic rhinitis, Singulair shows an average of 13% of eosin leukemia in the peripheral blood compared to Placebo, through dual blind treatment periods. Singulair users). The age of the patient is 15 - 82 years old with a history of allergic rhinitis all year round, skin testing positive for allergens year -round (including housewares, animal hairs, mold spores) and there are outstanding symptoms of allergic rhinitis year -round at the beginning of treatment. (Nose congestion, runny nose, sneezing) compared to Placebo. Singulair also shows that improving allergic rhinitis through patients' assessment as stated in the side criteria for global assessment of allergic rhinitis symptoms by patients, and the overall quality assessment scale of life in conjunctivitis-nose (average score of 7 fields of activity: sleep, non-non-mosaic symptoms/air-mosaies, problems in practice, symptoms in nose, emotional symptoms) of Singulair in the treatment of seasonal allergic rhinitis 2-14 years old and in the treatment of allergic rhinitis year -round in patients 6 months -14 years old is proven by extrapolate from the effect of this drug in patients> 15 years old with allergic rhinitis along with the assumption that the disease, pathology and the effect of the drug are basically the same in these populations. Thu

After drinking, Montelukast absorbed quickly and almost completely. With 10mg film tablets, CMAX concentration reaches 3 hours (TMAX) after taking adults, taking medicine when hungry. Born when taking oral medication is 64%. Birth and CMAX are not affected by a standard meal. With 5mg chewing tablets, CMAX reached 2 hours after adults drinking when hungry. Born when drinking is 37%. Food does not have a great influence in clinical use when taking long -term drugs. With 4mg chewing tablets, CMAX concentration reaches 2 hours after drinking for children 2-5 years old, taking medicine when hungry. 4mg oral nuggets are biological equivalent with chewing tablets 4mg when used for adults when hungry. The use of Montelukast in the form of grain nuggets with apple sauce or during a standard meal does not significantly affect the pharmacokinetics of the drug determined by the area under the AUC curve (1225.7 compared to 1223.1 ng-ml with or without apple sauce and 1191.8 compared to 1148.5 ng-ml/ml with or without standard meals). Clinical, when using 4mg chewing tablets, 5mg chewing tablets, 10mg film tablets, orally, do not include meal time. Singulair's safety has also been proven in clinical research for 4mg grain nuggets without meal time.

Distribution

more than 99% Montelukast binds to plasma proteins. The distribution volume (VD) in the stable state of Montelukast is 8-11 liters. Research on rats with Montelukast marks that the drug is very little distributed through the bloody brain barrier. Moreover, the concentration of oil -based oil after drinking 24 hours is minimum in all other tissues.

Metabolism

Montelukast metabolizes very strongly. In studies with treatment dose, plasma concentrations of Montelukast's metabolites are not found in a stable state in adults and children. Research in vitro, using human liver microsome, shows that Cytochrome P450 3A4 and 2C9 as catalysts for Montelukast's metabolism. Based on other results in vitro on human liver microsome, seeing the concentration of Montelukast's treatment in plasma does not inhibit cytochromes P450 3A4, 2C9, 1A2, 2A6, 2C19 or 2D6.

Elimination

Montelukast's purification in plasma is 45ml/minute in healthy adults. After taking Montelukast, 86% of the markers are found in the feces of a total of 5 days and less than 0.2% discharged through the urine. This, along with the bioavailability of Montelukast oral, shows that Montelukast and the metabolites of the drug are almost entirely through the bile. In many studies, Montelukast's plasma sale time is 2.7 - 5.5 hours in healthy young people. Montelukast's pharmacokinetics almost linear when taken at a dose of 50mg. There is no difference in pharmacokinetics when taking medicine in the morning or evening. When taking 10mg of Montelukast once a day, very little accumulation of Montelukast's mother in plasma (approximately 14%).

Characteristics of patients

No dose adjustments for older patients, patients with renal impairment or mild to moderate liver failure.

Before taking Singulair 5mg Organon prophylaxis and chronic bronchial treatment (2 blisters x 14 tablets)

How to use

How to use grain nuggets to drink

Singulair seeds for drinking can be allowed directly to the tongue or mouth, sprinkle into a spoon of soft food (for example, apple sauce), with room temperature, or dissolve in a teaspoon (5ml) breast milk or nourishing solution, at room temperature. Just before using the medicine package. After opening the package, the entire Singulair dosage must be mixed as above and immediately used (within 15 minutes). When mixed with food or breast milk, the solution nourishes the baby, is not kept for the next time. Singulair seeds are not mixed with other fluids, besides breast milk and nourishing solution. However, after taking the medicine, it is possible to take other fluids.

General recommendation

Singulair's treatment effect is based on asthma test parameters that will reach a day, can take the tablet, chewing and nuggets of Singulair seeds with or without food. It is necessary to tell patients to continue using Singulair although asthma attacks have been controlled, as well as in periods of severe asthma. There is no need to adjust the dose for children in each age group, for the elderly, people with kidney failure, mild and medium liver failure, or for each gender.

Singulair treatments related to other asthma drugs

Singulair can be used in combination with other treatments.

Dose of combined drugs:

Bronchodilators: Singulair can be added to the treatment regimen for patients who have not been fully controlled only with bronchodilators. When there is a clinical response, usually after the first dose, it is possible to reduce bronchodilators if tolerated. Corticosteroid dose can be reduced if tolerated. However, the dose of corticosteroids must gradually decrease under the supervision of the doctor. In some patients, the inhaled corticosteroid dose can be completely withdrawn. Sudden replacement of inhaled corticosteroids with Singulair. To treat asthma, need to take medicine in the evening. With allergic rhinitis, the time to use the drug depends on the needs of each object.

For patients with both asthma and allergic rhinitis, should use a dose every day, in the evening.

Adults, aged 15 years and older with asthma and/or allergic rhinitis: The dose for people aged 15 and older is 10mg every day. One chewing 4mg or 1 pack of 4mg of grain nuggets to drink. Best.

What to do when forgetting a dose?

Side Effects

generally Singulair tolerates well. The adverse effects are usually mild and often do not need to stop the drug. The overall ratio of Singulair's adultery effects is equivalent to the Placebo group.

adults aged 15 years and older with asthma

Multi -rating Singulair on about 2600 adults with asthma, aged 15 and over in clinical studies. In the same two studies, clinical trials are controlled with Placebo for 12 weeks, adverse effects related to drugs in> 1% of the patients use Singulair and have a higher rate than the Placebo group is only abdominal pain and headache. The ratio of these phenomena is not significant statistically when comparing two groups of treatment. On the case of prolonged treatment, the experience of adultery effects has been not changed.

Review Singulair on about 475 patients with asthma, from 6 years old to 14 years old shows the safety of the drug in children in general similar to adult groups of drugs and placo. The rate of headache has no statistical significance when comparing the two groups of treatment. go up. In the case of prolonged treatment, the experience of adultery effects has been not changed.

Singulair is rated over 573 children with asthma, from 2 years to 5 years old. In a 12 -week clinical trial with a control of Placebo, the adverse effects related to the drug are recorded in> 1% of the pediatric patients using Singulair and have a higher rate than the Placebo group is only thirsty. The ratio of thirst has no statistical significance when comparing two groups of treatment. When the treatment lasts long, the experience of adverse effects has been not changed.

Singulair is rated over 175 children with asthma, from 6 months to 2 years old. In a 6 -week clinical trial with Placebo control, adultery effects related to the drug are recorded in> 1% of patients using Singulair and have a higher rate than the Placebo group is diarrhea, excitement, eczema, eczema and rash. The ratio of these reactions has no statistical significance between the two treatment groups.

adults aged 15 years and older with seasonal allergic rhinitis

There was a study of Singulair on 2199 patients over 15 years old to treat seasonal allergic rhinitis in clinical studies. Use Singulair once a day in the morning or afternoon often tolerated with safety attributes equivalent to the Placebo group. In control clinical studies with Placebo, drug -related adverse effects are recorded in> 1% of the patient using Singulair and has a higher rate than the Placebo group. In a 4 -week study, there is a clinical reference to the clinical, appropriate safety as in the 2 -week studies. In all studies, the drowsiness rate is similar to the placebo group.

Children from 2 years old to 14 years old with seasonal allergic rhinitis

There was a study of Singulair on 280 children 2-14 years old to treat seasonal allergic rhinitis in clinical studies with reference Placebo for 2 weeks. Use Singulair once a day in the morning or afternoon often tolerated with safety attributes equivalent to the Placebo group. In this study, drug -related adverse effects were recorded in> 1% of the patient using Singulair and has a higher rate than the Placebo group.

adults aged 15 and older with allergic rhinitis all year round

There have been two Singulair evaluation studies on 3235 adults and adolescents over 15 years old with allergic rhinitis all year round for 6 weeks, the control of Placebo. Use Singulair once a day in general well tolerated, safety in the patient group using drugs equivalent to the Placebo group. In these two studies, non -drug -related adverse effects are recorded in> 1% of Singulair patients and have a higher rate than the Placebo group. Sleeping rate is similar to the placebo group.

General analysis from clinical trial experience

has conducted a general analysis of 41 clinical trials with a control of Placebo (including 35 studies in patients> 15 years old and 6 studies in children 6-14 years old) by a valid assessment of suicide status. Of the 9929 patients using Singulair and 7780 patients who use Placebo in these studies, only one patient with suicide ideas in the Singulair group. There are no cases that have committed suicide or plotting to commit suicide or taking actions to prepare for suicidal behavior in both treatment groups. 11 studies in children from 3 to 14 years old to evaluate adverse effects related to behavior (Brae). Of the 11,673 patients using Singulair and 8,827 patients who use Placebo in these studies, the proportion of patients with at least 1 bra in the group using Singulair and Placebo are 2.73% and 2.27% respectively; With a difference of 1.12 (95% Cl [0.93; 1.36]). The clinical trials in these synthetic analysis are not specially designed to evaluate suicide behavior or Brae.

There are the following adverse effects when bringing the drug to the market:

Infections and parasites: Upper respiratory tract infections. I am abnormal, hallucinations, insomnia, memory impairment, mental - excessive hyperactivity (including ease of excitement, restless restlessness, muscle vibration), sleepwalking, thoughts and suicide behavior. and mediastinum: Nasal bleeding, lung disease increased eosinophilia. Ban, urticaria. Another.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Hypersensitivity to any ingredients of the drug.

Be cautious when using

Unrelated effect when taking Singulair in the treatment of acute asthma attacks. Therefore, Singulair should not be used for oral forms to treat acute asthma attacks. Patients need to be told to use the appropriate treatment. Because there are other factors that can contribute to these effects, it is still unknown whether these effects are related to Singulair. Doctors should discuss these adverse effects with patients and/or patients care. Should instruct patients and/or patients to notify the doctor if these effects occur. Churg-Strauss, is a systemic vasculitis with eosinophilia. These cases are sometimes related to corticosteroid reduction or stopping. Although the cause and effect has not been identified with Leukotrien receptor antagonists. Need to be cautious and closely monitor when using Singulair.

Use for children

Singulair has been studied on children from 6 months to 14 years old (see more dosage and usage). There is no study on the safety and effectiveness of the drug in children under 6 months old. Studies show that Singulair does not affect children's development rates.

Used for the elderly

In clinical studies, there is no difference in the safety and effectiveness of Singulair related to age.

The effect of the drug on driving and operating machinery

No data.

Using drugs for women during pregnancy and lactation

pregnancy

Not studying Singulair in pregnant women. Only use Singulair during pregnancy when really necessary. Most mothers also use other asthma medications during pregnancy. The causal relationship of these events with the unchanged use of Singulair.

breastfeeding

It is unclear Singulair's excretion through breast milk. Because many drugs can be excreted through breast milk, the mother needs to be cautious when using Singulair during breastfeeding.

Drug interaction

drug interactions can affect the activity of the drug or cause side effects.

Patients should notify the doctor or pharmacist a list of the drugs and functional foods you are using. Do not use or increase or decrease the dose of the drug without the guidance of a doctor.

Storage

Leave a cool place, avoid light, temperatures below 30⁰C.

To be out of reach of children, read the instructions carefully before use.

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