Singulair 4mg Organon room and chronic bronchial asthma treatment (28 packs)

Dosage form Box of 28 packs
Specifications Montelukast

Ingredient

Composition information	Content
Montelukast	4mg

Uses

Indications

Singulair are indicated for older and 6 -month -old patients to prevent and treat chronic bronchial asthma , including prevention of both day and night asthma symptoms, treatment of sensitive people with aspirin

Singulair is indicated to reduce the day and night symptoms of allergic rhinitis (Seasonal allergic rhinitis for adults and children aged 2 years and older, and year -round allergic rhinitis for adults and children aged 6 months or older).

Pharmacology

Cysteinyl Leukotriene (LTC4, Ltd4, LTE4), which are eicosanoids with strong inflammatory potential, secreted from many types of cells, including granular cells and eosin cells.

These important mediators 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 Eosin -loving white blood cell mobilization.

In allergic rhinitis, CYSLT is secreted from the nasal mucosa after exposure to allergens in the reactions in fast and slow phases and are associated with 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 chemical and pharmacological tests, Montelukast proves high affinity and selective selection with CYSLT receptor (more prominent effects in other receptors are also important in pharmacological, such as Prostanoid, Cholinergic or β-ADRENERGIC).

Montelukast strongly inhibits the physiological effects of LTC4, LTD4, LTE4 at CYSLT1 receptor without the effect of the luck.

In asthma patients, Montelukast inhibits cysteinyl leukotriene 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 coordinated with bronchodilators by using the agonist 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.

Singulair is valid when used separately or when combined with other drugs in the prescription to treat chronic asthma. Singulair can be coordinated with inhaled corticosteroids, which will have a synergistic effect to control asthma or to reduce the dose of inhaled corticosteroids while maintaining clinical stability.

Clinical research in allergic rhinitis

For patients over 15 years old with seasonal allergic rhinitis, Singulair shows an average of 13% of eosin leukemia in peripheral blood compared to Placeboo, through dual blind treatment periods.

Singulair also shows improvement in allergic rhinitis through the patient's assessment as stated in the auxiliary criteria for global assessment of allergic rhinitis symptoms, and the overall quality assessment scale of life in conjunctivitis - nose (average score of 7 areas of activity: Sleep, non -nose symptoms - eye/ eye, problems in practice, nasal symptoms) Placebo.

pharmacokinetics

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 hungry. Born 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.

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 is also 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 - 11 liters. 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.

Biology:

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, showing 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 45 ml/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 use 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 dynamic pharmacokinetics almost linear when taken at a dose of 50 mg. There is no difference in pharmacokinetics when taking medicine in the morning or evening. When taking 10mg of Montelukast once a day, very little montetukast accumulates 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 4mg Organon room and chronic bronchial asthma treatment (28 packs)

How to use

Put the drug directly into the mouth or mix with breast milk or nourishing solution at room temperature. Do not mix nuggets into other fluids, besides breast milk and nourishing solution.

Take the drug for 15 minutes after opening the package.

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.

Children from 6 months to 2 years old have asthma and/or allergic rhinitis all year round: a pack of 4mg of nuggets a day to drink.

Children from 2 to 5 years old: a pack of 4mg of nuggets a day to drink. Or chewing tablet.

Children 6 years of age and older are suitable for using Singulair tablets.

General recommendation:

Singulair's treatment effect is based on asthma test parameters in one day. Can take tablets, chewing tablets 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.

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 treatment related to other asthma medications:

Singulair can be used in combination with other treatments. Reduce the dose of combined drugs:

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

Inhaled corticosteroids: using Singulair to bring 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 end completely. 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 do

do when overdose? In chronic asthma studies, Singulair is used daily doses to 200mg for adults for 22 weeks and short -term research with a dose of up to 900mg daily, used for about a week, there is no clinically 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.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 a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

Unwanted effects when using Singulair 4mg that you can meet.

Infections and parasites: upper respiratory infections

Blood disorders and lymphatic systems: Increasing bleeding trends, platelets.

The immune system disorder: Hypersensitivity reactions including anaphylaxis, very rare liver and leukemia, loves EOSIN

Mental disorders: agitation includes aggressive or anti -opposition, anxiety, depression, disorder, attention disorders, abnormal dreams, hallucinations, insomnia, memory impairment, mental - movement, excessive hyperactivity (including ease of excitement, restlessness, muscle vibration), sleepwalking, thought and suicidal behavior, muscle seizures.

Nervous system disorders: dizziness , drowsiness, paresthesia (abnormal sensation)/Reducing sensation, very rare convulsions.

Heart disorders: Brushing chest drums.

Respiratory disorders, chest and mediastinum: nose bleeding, lung disease increased eulogy.

Gastrointestinal disorders: diarrhea , anorexia, nausea, vomiting

Hepatic disorders: ALT and AST increases, very rarely hepatitis (including cholestatic hepatitis, liver cell inflammation, and liver damage)

Skin and subcutaneous disorders: Evana, bruising, diverse roses, erythema, itching, rash, urticaria .

musculoskeletal and connective tissue disorders: joint pain, muscle pain including cramps.

Kidney and urinary disorders: Babybumes in children

Systemic disorders and medication condition: weakness/ fatigue, edema, fever

Instructions on how to handle ADR: immediately report to your doctor or pharmacist if any symptoms above or another.

Warnings

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

Contraindicated

Singulair 4mg contraindicated in the following cases:

Hypersensitivity to any ingredients of the drug.

Caution when used

has not been valid 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 the neurological effects -the god in patients using Singulair. Because other factors 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.

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 hyperlemm, vasculitis rash, bad respiratory symptoms, heart complications and/ or neurological diseases sometimes churg-strauss syndrome, is an EOSIN system with EOSIN hypotension.

These cases are sometimes involved in corticosteroid reduction or stopping. Although the cause and effect has not been identified with the Leukotriene receptor antagonist, caution and clinical monitoring need to be closely monitored when using Singulair.

The ability to drive and operate machinery

Singulair is expected to not affect the ability to drive and operate machinery. However, each individual reaction to the drug may change. 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

Pregnancy

There is no Singulair research in pregnant women. Only use Singulair when pregnant when really necessary.

The period of breastfeeding. 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 Montelukast's recommended dose studies, Montelukast's recommended dose does not significantly affect the pharmacokinetics of the following drugs: Theophylline, Prednisone, Prednisolone, Ethinyl Estradiol/Norethindrone 35/1), Terfenadine, Digoxin and Warfarin.

Phenobarbital, a substance that causes metabolism in the liver, reduces the area under the plasma curve (AUC) of Montelukast by approximately 40% when using a single dose Montelukast 10 mg.

Do not recommend adjusting the dose of Singulair. It is necessary to perform appropriate clinical monitoring when the enzyme induction is powerful like phenobarbital or rifampicin is being simultaneously using Singulair.

Montelukast does not change the metabolism of drugs that are metabolized mainly through CYP2C8 enzyme (such as Paclitaxel, Rosiglitazone, Repaglinide).

No need to adjust the dose of Montelukast in patients with Gemfibrozil simultaneously.

Simultaneous use Montelukast with ITraconazole alone does not significantly increase Montelukast's systemic contact.

Storage

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

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