Sandoz Montelukast FCT 10mg Treatment of bronchial asthma (2 blisters x 14 tablets)

Dosage form Box of 2 blisters x 14 tablets
Specifications Montelukast

Ingredient

Composition information	Content
Montelukast	10mg

Uses

indications

Sandoz Montelukast FCT 10 mg is indicated in the following cases:

Treatment of bronchial asthma.

As a supplementary therapy for patients with mild to moderate asthma attacks is not well controlled with inhaled corticosteroids and on patients using beta -shaped agents that are short -acted when necessary but still not controlled well asthma attacks.

In patients with bronchial asthma, the drug can also reduce the symptoms of seasonal allergic rhinitis.

Pharmacokology

Cysteine Leucotrien (LTC4, LTD4, LTE4) are eicosanoids that cause strong inflammation released from many cells including mast and eosinophilia cells. These important intermediaries are attached to Leucotrien cysteine receptors (CYSLT). CYSLT TYP 1 receptor (CYSLT1) is found in human respiratory tract (including plain muscle cells and respiratory tract macrophages) and other inflammatory cells (including eol only and some bone marrow cells). Cyslt related to pathological pathology of bronchial asthma and allergic rhinitis. In bronchial asthma, the Leucotrien causes bronchospasm, excreting mucus, increasing the permeability of the vascular wall and mobilizing eucalyptus. In allergic rhinitis, CYSLTS is released from the nasal mucosa after exposure to allergies in reactions in both early and late phase and related to the symptoms of allergic rhinitis. Using Cyslt nasal spray has shown to increase the respiratory resistance through the nose and cause obstruction symptoms.

Montelukast is an oral activity, high -grinent and selective drug on CYSLT1 receptor. In clinical trials, Montelukast inhibits bronchospasm due to inhalation Ltd4 when using low dose of 5 mg. The bronchodilator effect of beta -owners is combined by the effect of Montelukast. Montelukast treatment has the effect of inhibiting bronchospasm in both early and late phase caused by antigens. Montelukast reduces eosinophils in peripheral blood on adults and children compared to the group using Placebo. In a separate study, the treatment of Montelukast's eagle has a decrease in the significance of eucalyptus in the respiratory tract (measured in phlegm) and in the peripheral blood while improving the clinical asthma control.

In adult studies, Montelukast at a dose of 10 mg once/day improved with V means to exhal exertion in 1 second (FEV1) compared to Placeboo (10.4% change compared to 2.7% in the beginning), peak flow (PEFR) in the morning (changing 24.5 l/minute compared to 3.3 l/min) and reduces the significant amount Compared to - 4.6% initial). Improve the symptoms of day and night asthma and nights are significantly better recognized by the patient compared to Placebo.

Memorukast's adult studies on adult effects with inhaled corticosteroids (% change compared to the original when using Beclomethasone along with Montelukast compared to only Beclomethasone, equivalent to FEV1 of 5.43% compared to 1.04%; When compared to the inhaled Beclomethasone (200 µg twice a day with the inhaled tube), Montelukast showed the initial response faster, although in a 12 -week study, Beclomethasone showed that the average treatment effect was greater than the original when comparing Montelukast with Beclomethasone, corresponding to FEV1: 7.49% compared to 13.3%; Beta: - 28.28% compared to - 43.89%). However, when compared to Becomethason, a high percentage of patients treated with Montelukast achieved similar clinical response (specifically 50% of patients treated with Beclomethasone have an improvement of FEV1 about 11% or more than the original, while about 42% of patients using Montelukast achieved similar response).

A clinical study was conducted to evaluate the effectiveness of Montelukast in treating seasonal allergic rhinitis symptoms of patients aged 15 and older with bronchial asthma accompanied by seasonal allergic rhinitis. In this study, Montelukast 10 mg tablets used once a day showed that improving effects have a statistical statistically of daily rhinitis symptoms when compared to Placebo. The daily symptom of rhinitis is the average of the symptoms of daytime rhinitis (including nasal congestion, runny nose, sneezing, itching nose) and night symptoms (including nasal congestion, difficulty sleeping and night waking time). The overall assessment of allergic rhinitis has been significantly improved compared to the evidence group, performed by both patients and doctors. Evaluating the effectiveness of the drug on bronchial asthma is not the main goal in this study.

In an 8 -week study on a child (6 to 14 years old), Montelukast 5 mg used once a day, improving the meaning of respiratory function compared to Placebo (FEV1 changed 8.71% compared to 4.16% in the beginning; Am PEFR changed 27.9 l/min compared to 17.8 l/minute) and reduced the level of need to use the Beta drug owner (change - 11.7% compared to + 8.2% Initial).

The ability to reduce the meaning of bronchospasm (E1B) has been proven in a 12 -week clinical trial on adults (minimize FEV1 22.33% for Montelukast compared to 32.4% for Placebo; recovery time within 5% compared to the original of FEV1 is 44.22 minutes compared to 60.64 minutes). This effect is maintained for 12 weeks of research. The ability to reduce EIB has also been shown in a short -term study in the Children Thanh (minimize FEV1 18.27% compared to 26.11%; the recovery time within 5% compared to the original FEV1 is 17.76 minutes compared to 27.98 minutes). The effect of the drug in both studies has been shown at the end of the dosage of the drug once a day.

In patients with acetylsalicylic acidic acid asthma that is used inhaled and/or oral corticosteroids with Montelukast, which has a significant improvement in controlling asthma attacks (FEV1 changes 8.55% compared to -1.74% and reducing the total amount of Beta -used drug owner used -22.78% compared to 2.09% in the beginning).

Pharmacokinetics

absorption

Montelukast is quickly absorbed after drinking. For 10 mg film tablets, on adults, the average peak concentration in plasma (CMAX) is achieved after 3 hours (TMAX) after taking the drug when hungry. The average oral bioavailability is 64%. Oral bioavailability and cmax are not affected by normal meals. The safety and effectiveness of the drug have been proven in clinical trials when using 10 mg film tablets regardless of the digestion of food.

For 5 mg chewing tablets, on adults, the concentration of CMAX peak is achieved after 2 hours of hunger. The average oral bioavailability of the drug is 73% and is reduced to 63% due to the usual meal.

Distribution

Montelukast is attached to plasma proteins over 98%. The average distribution of Montelukast in a stable state is 8 - 11 liters. Rat -rat studies with Montelukast have radioactive, showing limited distribution through brain barriers. Moreover, the concentration of radioactive drugs after 24 hours at other tissues is the minimum.

Metabolism

Montelukast is metabolized in large proportion. In studies at the treatment dose, there is no concentration of plasma metabolites in the drug in a stable state in adults and children.

In vitro studies using human liver microsom shows that Cytochrome P450 3A4, 2A6 and 2C9 are involved in the transformation of Montelukast. In addition, at Montelukast's plasma treatment concentration does not inhibit Cytochrom P450 3A4, 2C9, 1A2, 2A6, 2C19 or 2D6. Montelukast's metabolites have little role in the treatment effect of the drug.

Elimination

Montelukast's average plasma clearance is 45 ml/minute on healthy adults. After taking a dose of radioactive Montelukast, 86% of radioactive substances were found in the fertilizer collected for 5 days later and The characteristics of patients

No need to adjust the dose in elderly patients or patients with mild to moderate liver failure. Studies in patients with renal failure have not been conducted. However, due to Montelukast and its metabolites are eliminated by biliary tract, it is not necessary to adjust the dose in these patients. There are no pharmacokinetic data of Montelukast in patients with severe liver failure (Child-Pugh> 9).

With high doses Montelukast (20 to 60 times the recommended dose on adults), observed the plasma's concentration of plasma. This effect is not recorded at the 10 mg dose recommended once/day.

Before taking Sandoz Montelukast FCT 10mg Treatment of bronchial asthma (2 blisters x 14 tablets)

How to use

Take oral use.

General recommendation:

Montelukast's treatment effect on asthma attack control parameters appear within a day. Montelukast can be used with or not food. Patients should be consulted to continue using Montelukast even when asthma attacks are controlled, as well as during the deterioration of asthma attack.

Do not use Montelukast simultaneously with other drugs with the same active ingredient Montelukast.

No need to adjust the dose for elderly patients, patients with renal impairment or liver failure mildly to the average. There are currently no data on patients with severe liver failure. The dose on male and female patients is the same.

Montelukast treatment is related to other bronchial asthma treatments:

Can add Montelukast to patients who are taking other bronchial asthma treatments.

Inhaled corticosteroids:

Can use Montelukast such as auxiliary therapy for patients using inhaled corticosteroids and beta -shaped agents when needed but still unable to control asthma attacks well. Sudden replacement of inhaled corticosteroids with Montelukast.

There is a form of chewing tablets 5 mg for children from 6 to 14 years old.

Dosage

Dosage for adults and young people 15 years or older with bronchial asthma or bronchial asthma accompanied by a seasonal allergic rhinitis is a 10 mg tablet daily used in the evening.

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 bronchial studies, Montelukast has a dose of up to 200 mg/day for adults for 22 weeks and short -term studies, doses of up to 900 mg/day for about 1 week without receiving any serious adverse reactions.

There have been reports on acute overdose after bringing the drug to the market and in clinical studies with Montelukast. These reports include reports on adults and children with a dose higher than 1000 mg (about 61 mg/kg on children 42 months). Clinical manifestations and tests are suitable for safety data on adults and children. There are no side effects in most overdose reports. The most common adverse reactions are suitable for Montelukast's safety data including abdominal pain, drowsiness, thirst, headache, vomiting and mental hyperactivity.

It is currently unknown whether Montelukast has the ability to appraise through hemons or peritoneal.

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. Do not drink twice as prescribed.

Side Effects

When using Sandoz Montelukast FCT 10mg, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Infections and parasites infection: upper respiratory tract infection.

digestive: diarrhea, nausea, vomiting. liver - bile: Transaminase (ALT, AST) rising serum.

Skin and subcutaneous tissue: Red Red.

Body and at the position of giving medicine: fever.

Uncommon, 1/1000

The immune system: Hypersensitivity reaction includes anaphylactic shock.

Mental: Abnormal dreams include nightmares, insomnia, sleepwalking, uneasiness, anxiety, restlessness, agitation including aggressive or hostile, depression.

nerve: dizziness, drowsiness, paresthesia, reducing sensation, epilepsy.

Respiratory system, chest and mediastinum: nosebleeds.

digestive: dry mouth, indigestion.

Skin and subcutaneous tissue: bruising, urticaria, itching.

Bone muscles and connective tissues: joint pain, tendon pain including cramps.

The whole body and at the position of the drug: weakness/fatigue, edema.

1/10,000

Blood and lymphatic system: The trend of increased bleeding.

Mental: Run.

heart: Brush the chest drum.

Skin and subcutaneous tissue: Evaluation.

Very rare, ADR

The immune system: Eve in liver.

Mental: Illusion, intentions and suicide behavior.

Respiratory system, chest and mediastinum: Churg - Strauss syndrome (CSS).

liver - bile: hepatitis (including biliary stasis, liver cell damage and mixed liver damage).

Skin and subcutaneous tissue: Pink button, diverse roses.

Instructions on how to handle ADR

Notify the doctor the unwanted effects when using the drug.

Warnings

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

Contraindicated

Sandoz Montelukast FCT 10 mg is contraindicated in the following cases:

Hypersensitivity to the active ingredient or any excipient.

Be cautious when using

Patients should be consulted without using Montelukast oral route to treat acute asthma attacks and should store appropriate emergency drugs in this case. If acute asthma attacks occur, the inhaled beta -shaped owner should be used. Patients should go to the doctor as soon as possible in the case of using the amount of inhaled beta -shaped drug owner more shorter than usual. Do not use Montelukast to suddenly replace oral or inhaled corticosteroids.

No data has shown to reduce oral corticosteroid dose when used with Montelukast.

In some rare cases, patients are taking asthma medications including Montelukast, which records systemic eosinophilia, sometimes clinical manifestations of vasculitis such as Churg - Strauss syndrome. These are common manifestations when treated with systemic corticosteroids. These cases are sometimes involved in reducing the dose or stopping treatment with oral corticosteroids. Although the relationship with Leucotrien receptor antagonists has not been established, the doctor should be cautious with the phenomenon of Eosin leukemia, vasculitis rash, severe symptoms of lung disease, heart and/or neurological diseases that occur in patients. Patients with these symptoms should be examined and re -evaluated for treatment regimens.

Montelukast treatment does not help use aspirin and other non -steroid anti -inflammatory drugs for patients with asthma sensitive to aspirin.

The drug contains lactose. Patients with rare genetic diseases such as galactose intolerance, Lapp Lactase enzyme deficiency or Glucose - Galactose should not use this drug.

The ability to drive and operate machinery

Montelukast does not affect the ability to drive or operate machinery. However, in some very rare cases, reported about drowsiness or dizziness.

Pregnancy

Animal studies do not show harmful drugs in pregnancy as well as fetal/fetal development. The limited data from available databases on pregnant women shows that the association between Sandoz Montelukast FCT 10 mg and deformities (such as manual defects) is rarely recorded in the world after bringing the drug to the market.

Sandoz Montelukast FCT 10 mg can only be used during pregnancy in case of really necessary.

The period of breastfeeding

studies on rats shows that Montelukast is excreted in milk. It is unknown whether Montelukast is excreted through breast milk or not.

Sandoz Montelukast FCT 10 mg can only be used during breastfeeding in case of really necessary.

Drug interaction

Montelukast can be used simultaneously with other therapies in the prevention and treatment of chronic bronchial asthma. In drug interactive studies, Montelukast dose is clinically recommended for clinical clinical significance to the pharmacokinetics of the following drugs: Theophyllin, prednison, prednisolon, oral contraceptives (Ethinyl estradiol/norethindron 35/1), Terfenadin, Digoxin and Warfarin.

Montelukast's area under the curve (AUC) decreased by about 40% in patients with drugs with phenobarbital. Because Montelukast is metabolized through CYP 3A4, 2C8 and 2C9, should be cautious, especially in children, when using Montelukast and enzyme induction drugs CYP3A4, 2C8 and 2C9 such as Phenytoin, Phenobarbital and Rifampicin.

In vitro studies show that Montelukast strongly inhibits CYP 2C8. However, data from an interactive drug - - Clinically related to Montelukast and Rosiglitazon (substrate that represents metabolic drugs mainly via CYP2C8) shows that Montelukast does not inhibit CYP2C8 In Vivo. Therefore, Montelukast does not significantly change the metabolism of drugs metabolized by this enzyme (such as Paclitaxel, Rosiglitazone and Repaglinid). In vitro studies show that Montelukast is the substrate of CYP2C8 and is noticeably less than the substrate of 2C9 and 3A4. In a clinical interactive study study related to Montelukast and Gemfibrozil (a simultaneous inhibitor 2C8 and 2C9), Gemfibrozil increases 4.4 times the level of Montelukast's systemic exposure. It is not necessary to adjust the daily dose of Montelukast when used with Gemfibrozil or other powerful CYP 2C8 inhibitors but the treating doctor should pay attention to the possibility of increasing adverse reactions.

Based on in vitro data, clinical important drug interactions with weak inhibitors CYP 2C8 (such as trimethoprim) are not predicted. Using Montelukast with Itraconazole, a strong CYP 3A4 inhibitor, does not increase the meaning of Montelukast's systemic exposure level.

Storage

Store at temperatures below 30 ° C, hold the drug in the original packaging to avoid light and humidity.

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