Singulair 10mg Organon Pharma medicine for persistent asthma treatment from mild to medium (2 blisters x 14 tablets)

Dosage form Box of 2 blisters x 14 tablets
Specifications Montelukast

Ingredient

Composition information	Content
Montelukast	10mg

Uses

Indications

Singulair 10 is indicated in the treatment of asthma in the form of additional therapy in patients with persistent persistent asthma from mild to moderate not fully controlled when taking inhaled corticosteroids and in patients with bronze drugs β short -effect "when needed" but not controlled in full on clinical asthma.

In patients with asthma that Singulair is indicated in asthma, Singulair can also help reduce the symptoms of seasonal allergic rhinitis.

Singulair is also indicated in the treatment of asthma prevention, which is mainly bronchospasm.

Singulair is indicated to reduce the symptoms of seasonal allergic and allergic rhinitis all year round.

Pharmacology

Pharmacological group: Singulair® (Montelukast Sodium) is a receptor -selected antagonistic oral medication (receptor) of Leukotriene, inhibiting Cysteinyl Leukotriene Cyslt.

ATC code: R03D C03

Cysteinyl Leukotriene (LTC, Ltd, LTE,) are eicosanoids that have the potential to cause strong inflammation, secreted from many types of cells, including granules and eosin cells. These important mediators are attached to the cysteinyl leukotriene receptors (CYSLT). Cyslt type 1 receptors (CYSLT,) are found in human altar, including slippery muscle cells and macrophages of the airway and in other pre -inflammatory cells (including eosin leukocytes 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 mobilizing eosin blood cells. 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 receptors, Cholinergic or B-adrenerg).

Montelukast strongly inhibits the physiological effects of LTC, Ltd, LTE, at CYSLT receptor, without the effect of the luck.

In asthma patients, Montelukast inhibits the cysteinyl leukotriene receptors in the airway to prove through the ability to inhibit bronchospasm due to Ltd inhalation. With doses of less than 5 mg, it has been closed by bronchospasm of Ltd. Montelukast causes bronchiectasis for 2 hours after falling; These effects are coordinated with bronchodilators by using the agonist β.

Pharmacokinetics

absorption

After drinking, Montelukast absorbed quickly and almost completely. With 10 mg 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 5 mg chewing tablets, cmax reaches 2 hours after adults drinking.

Bioions when drinking is 73%. Food does not have a great influence in clinical when taking long -term drugs.

With 4 mg chewing tablets, CMAX concentration reaches 2 hours after drinking for children 2-5 years old, taking medicine at hunger.

4 mg oral nuggets are biological equivalent with 4 mg chewing tablets 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.He/ml with or without apple sauce and 1191.8 compared to 1148.5 ng.

Effect and safety have been shown through clinical studies, when using 4 mg chewing tablets, 5 mg chewing tablets, 10 mg film tablets, orally, regardless of meal time. The safety of Singulair is also proven in clinical research for drinking 4 mg 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 - 11 liters. Research on rats with Montelukast marks that the drug is very little distributed through cerebral blood rows. 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.

In vitro research, using human liver microsome, shows that Cytochrome P450 3A4 and 2C9 participates in Montelukast's metabolism. Based on other results in vitro on human liver microsome, seeing the concentrations of Montelukast's treatment in plasma does not inhibit cytochromes P450 3A4, 2C9, 1A2, 246, 2C19 or 2D6.

Elimination

Montelukast's purification in plasma is 45 ml/minute in healthy adults. After taking Montelukast, 86% of the markers are found in 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 some studies, Montelukast's plasma sale time is 2.7 - 5.5 hours in healthy young people. Montelukast's pharmacokinetics almost linear when taken to a dose of 50 mg. There is no difference in pharmacokinetics when taking medicine in the morning or evening.

When taking 10 mg Montelukast once a day, very little maxelukast mother'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. There is no clinical evidence in patients with severe liver failure (Child-Pugh> 9).

Before taking Singulair 10mg Organon Pharma medicine for persistent asthma treatment from mild to medium (2 blisters x 14 tablets)

How to use

Singulair 10 oral drug.

Dosage

recommended dose for adults and adolescents aged 15 and older with asthma, or asthma with seasonal allergic rhinitis, 1 tablet of 10 mg daily taken in the evening.

recommended dose for adults and teenagers aged 15 and older with allergic rhinitis (seasonal and/or year round) is 1 tablet 10 mg, 1 time/day.

Effective for seasonal allergic rhinitis has been proven when using Montelukast in the morning or evening without having to use food time. Time to take the drug can be adjusted to each patient to suit the needs of the patient.

Patients with both asthma and allergic rhinitis should only take a dose of Singulair every day in the evening.

General recommendation

Singulair's treatment effect on Hen control parameters recorded within a day of Singulair treatment can be used or not with food. It is recommended that patients continue to use Singulair even when their asthma has been controlled, as well as in severe asthma time. Do not use Singulair simultaneously with other products with the same active ingredient Montelukast.

No need to adjust the dose for the elderly, either for patients with renal impairment or mild to moderate liver failure. No data on patients with severe liver failure. The dosage is the same for both male and female patients.

Singulair treatment is related to other asthma treatments

Singulair can be added to the patient's current treatment regimen.

Inhaled corticosteroids: Singulair treatment can be used as an additional therapy in patients when using inhaled corticosteroids plus short -shaped B medication with short "when needed" without clinical asthma control. Do not suddenly replace corticosteroid inhaled with Singulair.

Group of children's patients

Do not use Singulair 10 mg film tablets for children under 15 years old. Safety and effectiveness of Singulair 10 mg film tablets in children under 15 years old have not been determined.

There are 5 mg chewing tablets for children from 6 - 14 years old.

There are 4 mg chewing tablets for children from 2 to 5 years old.

Currently, the form of 4 mg nuggets for children from 6 months to 5 years old.

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 do

do when overdose? In chronic appointment studies, Singulair is used daily to 200 mg for adults for 22 weeks and short -term research with a dose of up to 900 mg daily, used for about a week, no clinical side reactions.

There are also reports on acute poisoning after taking the drug to the mayor and in clinical studies with Singulair. These reports include both children and adults with the highest doses of up to 1000 mg. The results of the laboratory and clinical room are in accordance with the overview of safety in 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.Unknown Montelukast can be separated through the peritoneal or dialysis.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget 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

Montelukast has been evaluated in clinical studies in persistent asthma patients:

10 mg film tablets in about 4,000 adults and teenagers aged 15 and older.

4 mg chewing tablets in 851 patients from 2-5 years old.

nuggets and chewing tablets 4 mg at 1,038 children from 6 months to 5 years old.

10 mg film tablets in about 400 adults and teenagers aged 15 and older. Agency system group adult patients and teenagers aged 15 and older (2 studies 12 weeks; n = 795) Children patients aged 6-14 (1 study 8 weeks; n = 201) (2 Studies 56 weeks; n = 615) Study 48 weeks; n = 278) Patients from 6 months - 2 years old (1 study 6 weeks; n = 175) Respiratory, chest and mediastinum

Ecezema dermatitis, rash

Over the number of patients limited to 2 years for adults and up to 12 months for children from 6 to 14 years old, the record for safety does not change.

Overall, 502 children from 2-5 years old are treated with Montelukast for at least 3 months, 338 patients for 6 months or longer and 534 patients for 12 months or longer. With prolonged treatment, safety records have not changed in these patients.

Safety records in children from 6 months - 2 years old have not changed when treatment up to 3 months.

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 and older with seasonal allergic rhinitis

There have been a study of Singulair over 2199 adults aged 15 and over to treat seasonal allergic rhinitis in clinical studies. Use Singulair once a day in the morning or evening often tolerated with safety properties equivalent to the Placebo group. In control clinical studies with Placebo, non -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.

Adults aged 15 and older have allergic rhinitis all year round

There have been two Singulair evaluation studies on 3235 adults and adolescents aged 15 and older with allergic rhinitis all year round for 6 weeks, the control of Placebo. Use Singulair once a day in general well tolerated, data is consistent with the group of patients with seasonal allergic rhinitis and equivalent to the Placebo group.

In these two studies, drug -related adverse effects are recorded in 21% 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

Please see more information about drugs in the instructions for the use of drugs attached.

Warnings

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

contraindicated

Singulair 10 contraindicated drug in the following cases:

Hypersensitivity to any ingredients of the drug.

Be cautious when using 2>

unknown 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 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 have been reports on mental - mental effects in patients using Singulair. 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 guide the patient and/or the patient's care for the notification to the doctor if these effects occur.

In some rare cases, patients taking asthma medication, including Leukotriene receptor antagonists, have encountered one or more of the following reactions: Eosin hyperps, vasculitis rash, worse lung symptoms, complications in search and neurological disease are sometimes diagnosed with Churg - Strauuss syndrome, EOSIN hypotension. These cases are sometimes involved in oral corticosteroid reduction or stopping. Although the causal relationship has not been identified with the Leukotriene receptor antagonist, it is necessary to be cautious and closely monitor clinical when using Singulair.

Montelukast treatment still requires to avoid using aspirin and other non-puroid anti-inflammatory drugs in patients with aspirin sensitive asthma.

Patients with rare genetic problems in galactose tolerance, Lapp Lactase deficiency or Glucose-Galactose should not be used.

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

Singulair is expected to not affect the ability to drive and operate machinery. However, each individual reaction to the drug may vary. Some side effects (such as dizziness and drowsiness) have been reported to Singulair that can affect the ability to drive and operate machinery on some patients.

Use drugs for women during pregnancy and lactation

Pregnant women

Only use Singulair when pregnant when really necessary. Data available from research and rescue team studies have been published with the use of Montelukast in pregnant women assessing great birth defects that do not establish drug -related risks. The studies are available in terms of methods, including small samples, in some cases of rescue data collection and inconsistent comparison groups.

breastfeeding women

It is unclear Singulair's excretion through breast milk. Because this drug 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 interaction, the recommended dose in Montelukast's treatment does not have a significant clinical impact on the pharmacokinetics of the following drugs: Theophylline, prednisone, prednisolone, contraceptive drugs (Ethinyl estradiol/norethindrone 35/1), Terfenadine, Digoxin and Warfarin.

Montelukast's area under the curve (AUC) decreases by about 40% in users with phenobarbital. No need to adjust the dosage Singulair.

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

Storage

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

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