Givet-10 Davipharm and treatment of chronic bronchitis (4 blisters x 7 tablets)

Dosage form Box of 4 blisters x 7 tablets
Specifications Montelukast

Ingredient

Composition information	Content
Montelukast	10mg

Uses

Indications

Givet 10 products contain the main ingredient with pharmacological effects Montelukast, a Leukotrien receptor inhibitor. Leukotrien is a narrowing and swelling of the trachea in the lungs. Montelukast locked Leukotrien, thus improving bronchial asthma symptoms and helping to control bronchial asthma day and night.

Givet 10 drugs are indicated in the following cases:

Preventive and treatment of chronic bronchial asthma for adults and children 6 years of age or older, including prevention of both day and night asthma symptoms, aspirin sensitive asthma treatment and prophylaxis

Reduce day and night symptoms of allergic rhinitis (seasonal allergic rhinitis, allergic rhinitis all year round for adults and children 6 years of age and older).

Pharmacokology

Pharmacological group: Leukotrien receptor antagonist.

ATC code: R03DC03.

Cysteinyl Leukotrien (LTC₄, Ltd₄, LTE₄) are effective eicosanoids, secreted from many cells, including macrophages and eosin cells. These important intermediates are attached to cysteinyl leukotrien receptors (CYSLT1). CYSLT1 receptors, found in human airfields, include plain muscle cells and macrophages of the airway and in other pre -inflammatory cells (including eosin leukocytes and some marrow cells).

CYSLT is correlated with pathological physiology of asthma and allergic rhinitis. In asthma, Leukotrien intermediaries include a number of breathing effects such as bronchospasm, affecting mucus secretion, capillary permeability and an eosin cellular supplement. In allergic rhinitis, CYSLT is secreted from the nasal mucosa after exposure to allergens in the reactions in fast, slow and related phases related to allergic rhinitis symptoms. Cyslt in the nose will increase the airway resistance and congestion symptoms.

Montelukast oral form is anti -inflammatory and improves parameters of asthma inflammation. Based on biochemical and pharmacological tests, Montelukast proves high affinity and selective selection with CYSLT receptor (this effect is superior to other receptors that are also important in pharmacological, such as the Prostanoid, Cholinergic or -adrengic receptor). Montelukast strongly inhibits the physiological effects of LTC₄, LTD₄, LTE₄ at CYSLT1 receptor, without the effect of the luck.

In Hen Hen, Montelukast inhibits cysteinyl leukotrien receptors in the airway, showing the ability to inhibit bronchospasm due to Ltd₄ inhalation. With doses of less than 5 mg, the bronchospasm of Ltd₄ has been blocked. Montelukast causes bronchiectasis for 2 hours after drinking, these effects are in conjunction with bronchodilator by using the owner.

pharmacokinetic

absorption

After drinking, Montelukast absorbed quickly and almost completely. With 10mg film tablets, CMAX reaches 3 hours (TMAX) after adults drinking hungry. Born when drinking is 40%. Birth and cmax are not affected by a standard meal.

Distribution

Montelukast attaches more than 99% to plasma proteins. The distribution volume (VD) in the stable state of Montelukast is 8 - 11L. Research on rats with Montelukast marks a minimum distribution 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 microsom shows that Cytochrom P450 3A4 and 2C9 as catalysts for Montelukast's metabolism. Based on other results in vitro on human liver microsom, seeing the concentrations of Montelukast's treatment in plasma does not inhibit the cytochrom P450 3A4, 2C9, 1A2, 2A6, 2C19, 2D6.

Elimination

Montelukast's clearance in plasma is 45 ml in healthy adults. After taking Montelukast marking, 86% of the markers were found in the feces of a total of 5 days and less than 0.2% discharged through the urine. This shows that when taken, 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 drinking morning or evening. When taken 1 time a day with 10 mg Montelukast, it is very little accumulation of Montelukast's mother in plasma (approximately 14%).

Special subjects

No dose adjustment in the elderly and mild to moderate liver failure. No research in patients with renal failure. Because Montelukast metabolizes and eliminates through biliary tract, does not need to adjust the dose in patients with renal failure. There is no data on pharmacokinetics of drugs in patients with severe liver failure (Child-Pugh> 9).

High doses (20 and 60 times recommended on adults) reduce theophylin concentration in plasma. This impact is not seen when using the recommended dose of 10 mg/day.

Before taking Givet-10 Davipharm and treatment of chronic bronchitis (4 blisters x 7 tablets)

How to use

oral medication, can be taken with food or not.

Dosage

Take the drug once a day. To treat asthma, need to take medicine in the evening. With allergic rhinitis time, medication depends on the needs of each object.

For patients with both asthma and allergic rhinitis, should be used once a day, in the evening.

Adults, aged 15 and older with asthma and/or allergic rhinitis: 1 tablet of 10 mg/day.

Children from 6 to 14 years old have asthma and/or allergic rhinitis: 1 tablet 5 mg/day.

Children from 6 months - 5 years old with asthma and/or allergic rhinitis: Should switch to a nuggets of 4 mg/day.

General recommendation

Montelukast's effectiveness based on Hen's test parameters will reach 1 day. Patients need to continue taking the drug even when asthma attacks have been controlled, as well as in periods of severe asthma.

No dose adjustments for patients with renal impairment or patients with mild to moderate liver failure or for each gender. There is no data on drug use in patients with severe liver failure.

Alternative therapy for low -dose inhaled corticosteroids for mild persistent bronchial patients

Montelukast is not recommended to use monomers in patients with average average bronchial asthma. Only use Montelukast for replacement treatment for low -dose inhaled corticosteroids in children with mild persistent bronchial asthma if the child does not have a severe severe asthma attacks, but the use of oral corticosteroids, and in children who cannot use inhaled corticosteroids.

Small persistent bronchial asthma is the symptoms of bronchial asthma that appear more than once a week, but less than 1 time a day, night symptoms more than 2 times a month but less than once a week, the normal lung function between 2 stages. If the bronchial asthma is not well controlled (usually within 1 month), it may be needed or replaced with anti -inflammatory therapy. Patients should be periodically evaluated for asthma control.

Simultaneous use with other bronchial asthma treatment

When Montelukast is used for inhaled corticosteroid therapy, it is not sudden replacement of inhaled corticosteroids with Montelukast.

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 study, Montelukast is used at daily doses to 200 mg for adults for 22 weeks and short -term research with a dose of up to 900 mg daily, used for about 1 week, there is no important reaction in clinical.

There are also reports on acute poisoning after bringing the drug to the market and in clinical studies with Montelukast. These reports include both children and adults with the highest doses of up to 1000 mg. The results in research and clinical 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 Montelukast's safety properties including abdominal pain, drowsiness, thirst, headache, vomiting and hyperactivity.Unknown Montelukast can be separated through the peritoneal or dialysis.

If you accidentally overdose, stop taking the medication and contact the nearest doctor or medical center immediately. Carrying a pills along with the packaging so that the doctor knows what medicine you have taken and takes timely measures.

What to do when forgetting 1 dose? Do not take double the dose to compensate for the forgotten dose.

Side Effects

Unwanted effects have been commonly reported (1/100 ≤ ADR

Adults and adolescents ≥ 15 years old

Neurology: headache.

Digestive: abdominal pain.

Neuroscope: headache.

Very common (ADR ≥ 1/10)

Infection and parasitic infection: upper respiratory tract infection.

Common (1/100 ≤ ADR Digestive: diarrhea, nausea, vomiting

Immune: The hypersensitivity reaction includes anaphylaxis. and mediastinum: Nosebleeds. ADR

Blood and lymphatic system: Increasing bleeding trend.

The immune system: Interfection of eosinophilia in the liver.

Instructions on how to handle ADR

The drug can cause other unwanted effects. It is necessary to 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

Givet 10 contraindications in the following cases:

Do not take Givet 10 if you are too hypersensory to Montelukast or any ingredient of the drug.

Precautions when using

unknown effect when taking Montelukast in the treatment of acute asthma attacks. Therefore, Montelukast should not be used to treat acute asthma attacks. If you have asthma attack, follow the instructions of the doctor, you must always be available for you to treat asthma.

If bronchial asthma is worse, immediately notify the doctor.

must use all the anti -asthma drugs, the doctor prescribed. Montelukast does not replace other anti -asthma drugs.

Continue to use the drug until the doctor tells it. Do not stop the drug. Montelukast can only treat bronchial asthma when taking the drug continuously. Take the medicine as instructed by the doctor. This will help control the bronchial asthma well.

may have to reduce the inhaled corticosteroids gradually under the supervision of a doctor, but must not suddenly replace corticosteroid oral or inhaling with Montelukast.

When reducing the dose of corticosteroids using systemic sugar in patients using other anti-asthma drugs, including Leukotrien receptor antagonists, it will lead to a rare number of cases: Eosin hyperlypes, rashes, short breath, heart complications or neuropathy sometimes diagnosed as churg-strauss syndrome are systemic vascular inflammation with EOSIN. Although the cause and effect has not been identified with Leukotrien receptor antagonists, it is necessary to be cautious and closely monitor clinical when reducing the dosage of systemic corticosteroids in patients using Montelukast.

When treated with Montelukast, patients with hyperchibians are sensitive to aspirin still have to avoid using aspirin and other nonsteroidal anti -inflammatory drugs.

Notify your doctor or pharmacist about all the drugs you are using, including prescription or non -prescribing drugs, vitamins or medicinal herbs.

If the patient has symptoms such as symptoms like influenza, arms and legs such as needles or numbness, more severe and/or rashes, notify your doctor immediately.

Warning and caution related to excipients

Preparations containing lactose, patients with rare genetic diseases galactose, Lapp Lactase deficiency or glucose-Galactose absorption disorders should not be used.

Givet 10 contains polysorbat 80, tartrazin yellow, erythrosin lake color can cause allergies, castor oil can cause abdominal pain, diarrhea.

The ability to drive and operate machinery

Montelukast does not affect or affect the ability to drive and operate machinery, but in very few cases, the drug can cause dizziness and drowsiness.

Pregnancy

Animal research does not show harmful effects on pregnancy or embryo/fetal development.

After the drug circulated on the market, there was a rarely report on fetal defects (such as lack of limbs), (rarely occurred). Not enough data to conclude contact with Montelukast.

Only use drugs for pregnant women when really necessary.

Breastfeeding period

Rat research shows that Montelukast has secretion into breast milk.

In humans, it is unclear whether the drug will be secreted into breast milk or not. Because the drug can be secreted through breast milk, only use the drug when really necessary.

Drug interaction

can be used Montelukast with other commonly used drugs in preventive and chronic treatment of asthma and allergic rhinitis. In studies on drug interactions, the recommended dose in Montelukast's treatment does not significantly affect the pharmacokinetics of the following drugs: Theophylin, Prednison, Prednisolon, Ethinyl Estradiol/Norethindron 35/1), Terfenadin, Digoxin and Warfarin.

The area under the curve (AUC) of Montelukast decreased by about 40% in people with phenobarbital. Because Montelukast is metabolized by CYP 3A4, 2C8, and 2C9, it is cautious when using Montelukast together with CYP3A4, 2C8, and 2C9 induction substances such as phenytoin, phenobarbital and rifampicin, especially in children.

Montelukast does not change the metabolism of drugs that are metabolized mainly through CYP 2C8 (such as Paclitaxel, Rosiglitazon, Repaglinid).

Montelukast is the substrate of CYP 2C8, and a smaller part of 2C9 and 3A4. Gemfibrozil (CYP 2C8 and 2C9 inhibitors) increase the exposure of Montelukast's system to 4.4 times. There is no need to adjust the dose of Montelukast, however, be careful about the risk of increasing unwanted effects.

Mobile interaction with weaker CYP 2C8 inhibitors (such as trimethoprim), and iTraconazole (strong CYP 3A inhibitor).

Storage

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

To be out of reach of children.

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