Chewing Singulair 5mg MSD treats chronic bronchial asthma (2 blisters x 14 tablets)

Dosage form Box of 2 blisters x 14 tablets
Specifications Montelukast

Ingredient

Composition information	Content
Montelukast	5mg

Uses

Indications

Singulair is indicated for older and 6 -month older patients to prevent and treat chronic bronchial asthma , including preventing both day and night asthma symptoms, treating ASPIRIN sensitive and preventing bronchial spasms due to exertion.

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, year -round allergic rhinitis for adults and children aged 6 months or older).

Pharmacological

cysteinyl leukotriene (LTC4, LTD4, LTE4) are eicosanoids with strong inflammatory potential, secreted from many types of cells, including granules and eosin cells. 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, secretion of mucus, increasing capillary permeability and mobilizing eucalyptus.

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 biochemical and pharmacological tests, Montelukast proves to have high affinity and selective selection with CYSLT receptor (more prominent effects in other receptors are also important in pharmacological, such as Prostanoid receptors, cholinergic or β-adrenergic). Montelukast strongly inhibits the physiological effects of LTC4, LTD4, and LTE4 at CYSLT1 receptor without the effect of march.

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 in union with bronchodilator thanks to the use of 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 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.

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 - 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.

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, 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 concentrations 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, 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 to 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 accumulates Montetukast 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 Chewing Singulair 5mg MSD treats chronic bronchial asthma (2 blisters x 14 tablets)

How to use

chew directly.

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 6 - 14 years old have asthma and/ or allergic rhinitis: 5 mg a day.

Children 2 - 5 years old have asthma and/ or allergic rhinitis: 4 mg a day.

Singulair 10mg, the form of film bags available for adults and children over 15 years old.

Singulair 4 mg, the form of nuggets available as an alternative product for patients from 2 years old - 5 years old.

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 treatments related to other asthma drugs

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 with bronchodilators. When there is a clinical response, usually after the first dose, bronchodilator can be reduced if tolerated.

Inhaled corticosteroids: Together 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 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 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

Infections and parasites: upper respiratory tract infections.

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

The immune system disorders: Hypersensitivity reactions include anaphylaxis, very rare liver infiltration of Eosin.

Mental disorders: agitation includes aggressive or opposition, anxiety, depression , disorder, attention disorders, abnormal dreams, hallucinations, insomnia, memory loss, mental - movement, excessive hyperactivity (including irritability, restless restlessness, muscle vibration), sleepwalking, suicide and behavior.

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

Heart disorders: Brushing the chest.

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

Gastrointestinal disorders: diarrhea , anorexia, nausea, vomiting

Hepatic disorders: Alt and AST increases, very rarely hepatitis (including cholestatic hepatitis, hepatitis, and multi -component liver damage).

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

Bone and connective muscle disorders: joint pain, muscle pain include cramps.

Kidney and urinary disorders: bedwetting 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

too 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 available.

may have to reduce the inhaled corticosteroids gradually with the supervision of the doctor, but not to suddenly replace oral corticosteroid or inhaled with Singulair. There have been reports on the neurological-god-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 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 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.

Phenobarbital, a substance that causes metabolism in the liver, reduces the area under the curve in plasma (AUC) of Montelukast by approximately 40% when using a single dose Montelukast 10 mg. It is not recommended to adjust the Singulair dose. Proper clinical monitoring should be performed when the enzyme induction is powerful as phenobarbital or rifampicin is being used simultaneously with Singulair.

Montelukast does not change the metabolism of drugs that are metabolized mainly through CYP2C8 enzymes (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

Store in closed packaging, dry place, avoid moisture, temperature below 300C.

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