Chewing Singulair 5mg MSD treats chronic bronchial asthma (4 blisters x 7 tablets)

Dosage form Box of 4 blisters x 7 tablets
Specifications Montelukast

Ingredient

Composition information	Content
Montelukast	5mg

Uses

Indications

Singulair is indicated in the following cases:

Singulair is appointed for older and 6 -month -old patients to prevent and treat chronic bronchial asthma, including preventing both day and night asthma symptoms, treating aspirin sensitive asthma, and preventing bronchospasm due to exertion. From 2 years of age and older, and allergic rhinitis all year round for adults and children aged 6 months and older). EOSIN. 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 grit of the airway and in other pre -inflammatory cells (including eosine leukemia and some bone marrow stem cells).

CYSLT is associated with the pathogenesis of asthma and allergic rhinitis. 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 congestion symptoms.

Montelukast oral form is anti -inflammatory substance, improving inflammatory parameters in asthma. 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 transport.

In asthma patients, Montelukast inhibits cysteinyl leucotriene receptors in the airway proving through the ability to inhibit bronchospasm due to Ltd4 inhalation. With doses of less than 5mg, the bronchospasm of the bronchospasm is given by LTD4. Montelukast causes bronchiectasis for 2 hours after drinking, these effects are in union with bronchodilator thanks to the use of the agonist β.

pharmacokinetic

absorption

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. Birth when drinking is 37%.

Food does not have a great influence in clinical 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 at a standard meal does not significantly affect the pharmacokinetics of the drug determined by the area under the AUC curve (1225.7 compared to 1223.1ng - hour/ml with apple sauce and 1191.8 compared to 1148.5ng - hour/ml with or without standard meals).

Effect and safety have been shown through clinical studies, when using 4mg chewing tablets, 5mg chewing tablets, 10mg film tablets, orally regardless of the meal time. Singulair's safety has also been proven in clinical research for drinking 4mg grain nuggets without including meal time.

Distribution

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

Before taking Chewing Singulair 5mg MSD treats chronic bronchial asthma (4 blisters x 7 tablets)

How to use

Chew the pill before swallowing.

Dosage

Use Singulair once a day.

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 and older with asthma or allergic rhinitis

The dose for people aged 15 and older is 10mg every day.

Children 6 - 14 years old with asthma or allergic rhinitis

Dosage for children 6 - 14 years old is a chewing 5mg.

Children 2 - 5 years old with asthma or allergic rhinitis

Dosage for children 2 - 5 years old is a chewing tablet 4mg or 1 pack of 4mg of grain nuggets to drink.

Children from 6 months to 2 years of age or allergic rhinitis all year round

Dosage for children 6 months to 2 years old is a pack of 4mg of seeds a day to drink.

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

can add Singulair to the treatment regime for people who have not been fully controlled only with bronchodilators. When there is a clinical evidence, usually after the first dose, bronchodilator can be reduced if tolerated.

inhaled corticosteroids

Together with Singulair, it has more treatment benefits for patients who are using inhaled corticosteroids. 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. Do not suddenly replace corticosteroids inhales with Singulair.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? In chronic asthma studies, Singulair is used daily to 200mg daily for adults for 22 weeks and short -term research at a dose of up to 9mg daily, used for about a week, there is no key important reaction.

There are also reports on acute poisoning after bringing the drug to the market and in clinical studies with Singulair. These reports include both children and adults with the highest doses of up to 1000mg. The results of the laboratory and clinical room are in line with the overview of the safety of adults and children. In most overdose reports, no harmful reactions. The most common reactions are similar to Singulair's safety properties including abdominal pain, drowsiness, thirst, headache, vomiting and excitement. It is unclear whether Montelukast can be separated through peritoneal or dialysis.

What to do when forgetting 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

When using Singulair, you may experience unwanted effects (ADR).

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 have asthma

Evaluate Singulair on about 2600 adults with asthma, aged 15 and older 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 different from statistical significance when comparing two treatment groups.

Total in clinical trials with 544 patients treated with Singulair for at least 6 months, 253 people to a year and 21 people to 2 years. In the case of prolonged treatment, the experience of adultery effects is not changed.

Children from 6 years old to 14 years old with asthma

Review Singulair on about 475 children with asthma, from 6 years to 14 years old shows the safety of the drug in children in general similar to adult groups taking drugs and placo.

In 8 -week clinical trials with pot control, adverse effects related to drugs recorded in> 1% of the patient using Singulair and have a higher rate than the Placebo group is just a headache. The rate of headache has no statistical significance when comparing the two treatment groups.

In evaluation studies, it affects the growth, safety attributes on these children are similar to that of Singulair's previous described safety attribute.

Total in clinical trials with 263 children from 6 years old to 14 years old are treated with Singulair at least 3 months, 164 children to 6 months or more. In the case of prolonged treatment, the experience of adultery effects is not changed.

Children from 2 years old to 5 years old have asthma

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 thirst ratio has no statistical significance when comparing the two treatment groups.

A total of 426 patients with asthma, from 2 years old to 5 years old using Singulair lasting for at least 3 months, 230 children used for more than 6 months, 63 children used for more than 12 months. When the treatment lasts long, the experience of adultery is not changed.

Children from 6 months to 2 years old have asthma

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 have 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 have 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

conducted a combined analysis of 41 clinical trials with Placebo control (including 35 studies in patients> 15 years old and 6 studies in children 6-14 years old) by a valid assessment of suicide. 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 suicide or taking actions to prepare for suicide in both treatment groups.

conducted another separate synthetic analysis from 46 clinical trials with reference Placebo (35 studies in patients> 15 years old, 11 studies in children from 3 months to 14 years old) assessing adverse effects related to behavior; 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 is 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.

Experience after bringing the drug to the market

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

Bacterial and parasitic diseases: upper respiratory tract infections

Blood disorders and lymphatic systems: Increasing bleeding trend, platelet reduction. Unusual, unusual dreams, hallucinations, insomnia, memory impairment, mental - excessive hyperactive movement (including easily agitated, restless restlessness, muscle tremor), sleepwalking, thoughts and suicide behavior. Steaming, chest and mediastinum: Nasal bleeding, lung disease increased eosinophilia. Itching, rash, urticaria. Another.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

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

Contraindicated

Singulair drugs are contraindicated in the following cases: Hypersensitivity to any ingredients of the drug.

Precautions when used

Unknown effectiveness 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 instructed to use the appropriate treatment.

may have to reduce the inhaled corticosteroids gradually with the supervision of a doctor, but not to suddenly replace oral corticosteroids or inhales with Singulair.

There has been a report on mental - mental effects in patients using Singulair (see side effects). Because there are other factors that can contribute to these effects, it is still unknown whether these effects are related to Singulair. The doctor should discuss these adverse effects with patients or patients. Should guide patients or caregivers patients informing the doctor if these effects occur.

In some rare cases, patients use other anti-asthma drugs, including Leukotriene receptor antagonists who have experienced one or several of the following phenomena: Eosin hypernagus, vasculitis rash, bad respiratory symptoms, heart complications or neurological diseases sometimes diagnosed as Churg-Strauss syndrome, systemic vasculitis with EOSIN hypercertia. 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 clinical when using Singulair.

The ability to drive and operate machinery

There is no basis to prove Singulair affects the ability to drive and operate the machine.

Pregnancy

has not studied Singulair in pregnant people. Only use Singulair when pregnant when really necessary.

In the process of circulating products on the market, there have been rare reports on cases of birth defects in children of mothers using Singulair during pregnancy. Most mothers also use other asthma medications during pregnancy. The causal relationship of these events with the unprocessed Singulair's use.

Breastfeeding period

unknown excretion of Singulair 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

can use Singulair with other commonly used drugs in preventive and chronic treatment of asthma and allergic rhinitis treatment. In studies on drug interactions, the recommended dose of Montelukast's treatment does not significantly affect the pharmacokinetics of the following drugs: Theophylline, Prednisone, Prednisolone, Ethinyl Estradiol/Norethindrone 35/1), Terfenadine, Digoxin and Warfarin.

The area under the curve (AUC) of Montelukast decreased by about 40% in people with phenobarbital. No need to adjust the dosage Singulair.

In vitro studies show that Montelukast is a CYP 2C8 inhibitor. However, data from medical interactive studies with each other clinically by Montelukast and Rosiglitazone (a substrate that represents drugs that are metabolized mainly by CYP2C8) shows that Montelukast does not inhibit CYP2C8 in Vivo. Therefore, Montelukast does not change the metabolism of drugs that are metabolized mainly through this enzyme (such as Paclitaxel, Rosiglitazone, Repaglinide).

In vitro studies show that Montelukast is a substrate of CYP 2C8, 2C9 and 3A4. Data from a clinical interactive study study with the participation of Montelukast and Gemfibrozil (a inhibitor both CYP 2C8 and 2C9) shows that Gemfibrozil increases Montelukast's systemic contact level 4.4 times. Simultaneous use of Itraconazole, a strong CYP 3A4 inhibitor with Gemfibrozil and Montelukast does not increase Montelukast's systemic contact.The effect of Gemfibrozil on Montelukast's body contact is not considered clinical significance based on clinical safety data with a greater dosage of more than 10mg approved for adults (200mg/day in adult patients for 22 weeks and up to 900mg/day for nearly a week), does not observe unwanted effects of clinical significance. Therefore, there is no need to adjust the dose of Montelukast in patients to use simultaneously with Gemfibrozil. Based on in vitro data, important drug interactions with known CYP 2C8 inhibitors (such as trimethoprim) are not predicted. In addition, simultaneous use of Montelukast with Itraconazole alone does not significantly increase Montelukast's body contact.

Storage

Singulair film tablets are below 30 ° C (86 ° F), avoid moisture and avoid light.

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