Chewing Kipel 5 mega we care for asthma treatment, bronchial spasm (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Montelukast

Ingredient

Composition information	Content
Montelukast	5mg

Uses

indications

Kipel 5 drugs are indicated in the following cases:

Treatment:

Asthma: Montelukast is appointed to prevent and treat chronic asthma in adults and children 12 months old and older.

Bronchospasm caused by exercise: Montelukast is designated to prevent bronchospasm due to exertion in the age of 15 years of age.

Allergic rhinitis: Montelukast is indicated to relieve symptoms of allergic rhinitis (allergic rhinitis due to weather in adults and children 2 years of age and older, and chronic allergic rhinitis in adults and children 6 months and older).

Pharmacokology

Leukotrienes Cysteinyl (LTC4, Ltd4, and LTE4) are metabolic products of arachidonic acid and are released from different cells, such as mast cells and eosinophilia. The ICOSANOIDs are associated with the Leukotriene cysteinyl receptor (CYSLT). Cyslt type 1 receptor (CYSLT 1) is found in the respiratory tract (in smooth muscle cells and respiratory tract macrophages) and on other pre -inflammatory cells (such as eosinophilia and some marrow stem cells). CYSLTS is correlated with the physiology of asthma and allergic rhinitis. For asthma, the effects of Leukotrien intermediaries such as respiratory edema, smooth muscle spasms, and cell activity are changed to inflammatory processes. For allergic rhinitis, CYSLTS release nasal mucosa after exposure to allergens in both early and ending reactions and associated with the symptoms of allergic rhinitis. Stimulation in the nose with CYSLTS manifests increased resistance to nasal respiratory tract and nasal congestion symptoms.

Montelukast is an oral active compound due to high affinity and selective connection with CYSLT1 receptor (priority for other important respiratory cards in terms of other pharmacological, valid prostanoid, cholinergic, or p-adrenergic). Montelukast inhibits LTD4 physiological activity at CYSLT1 receptors without any owner activity.

Montelukast causes the receptor inhibitors of the respiratory leukotrien cystienl by the ability to inhibit the bronchospasm due to the inhaled Ltd4 in the form of asthma patients.

Pharmacokinetics

absorption

Montelukast is quickly absorbed after drinking. After taking 10 mg film tablets in adults fasting, Montelukast's average plasma concentration (CMAX) is achieved from 3 to 4 hours (TMAX). The average oral bioavailability is 64%. Oral and cmax is not affected by the main meal in the morning.

For 4 mg chewing tablets, the average cmax reaches 2 hours after drinking in children from 2 to 5 years old in fasting.

For 5 mg chewing tablets, the average cmax is reached from 2 to 2.5 hours after drinking in adults in fasting. The average oral bioavailability is 73% in fasting compared to 63% when used with the main meal in the morning.

Distribution

more than 99% Montelukast binds to plasma proteins. Montelukast's average distribution volume in a stable state 8 - 11 liters.

Metabolism

Montelukast is broad metabolism. In studies on the treatment dose, the plasma concentration of Montelukast's metabolites cannot be found in a stable state in adults and children.

Elimination

Montelukast's clearance in plasma is 45 ml/minute in healthy adults. After a dose of Montelukast oral radioactive, 86% of radioactive substances were recovered after 5 days in the feces and

In some studies, half -life sold Montelukast in the average plasma from 2.7 to 5.5 hours in healthy young people. The pharmacokinetics of Montelukast almost linear with oral dose of 50 mg. While the one -time dose daily with Montelukast 10 mg, there is a small amount of precursors accumulated in plasma (14%).

Special population

Sex: Montelukast's pharmacokinetics similar to men and women. Elderly. Half -life semi -discharged in Montelukast's plasma is slightly longer in the elderly. No need to adjust the dose in the elderly

Race: Differences in pharmacokinetics due to races have not been studied.

Hepatic failure: No dose adjustment in patients with mild to moderate liver failure. Montelukast's pharmacokinetics in severe liver failure or hepatitis has not been evaluated.

renal failure: Do Montelukast and its metabolites are not excreted in urine, no dose adjustment in these patients.

Youth and children

Montelukast's plasma concentrations after taking 10 mg film tablets in 15 -year -old teenagers and in adults are similar. 10 mg film bags are recommended for patients over 15 years old. Exposure to the average system of 4 mg chewing tablets in children from 2 to 5 years old and 5 mg chewing tablets in children 6 - 14 years old similar to exposure to the average system of 10 mg film tablets in adults. Chewing 5 mg should be used for children from 6 to 14 bait and 4 mg chewing tablets should be used for children from 2 to 5.

In children 6 - 11 months old, exposure to the system with Montelukast and change Montelukast's concentration in plasma higher than when observing in adults.

Before taking Chewing Kipel 5 mega we care for asthma treatment, bronchial spasm (3 blisters x 10 tablets)

How to use

Medicines using chewing tablets.

Dosage

asthma:

Montelukast should drink once a day in the evening. The following doses are recommended:

Adults and teenagers 15 years and older: 1 tablet 10 mg.

Children from 6 - 14 years old: 1 chewing tablet 5 mg.

Children from 2 - 5 years old: 1 chewing tablet 4 mg.

Safety and effectiveness in children under 12 months of age have not been established.

There is no clinical trial in asthma patients to assess the relative effect of the dose in the morning compared to the evening. Whether Montelukast's pharmacokinetics is similar or not when taking the drug in the morning or evening. The effect has proven asthma when using Montelukast in the evening that is not related to mealtime.

Bronchospasm caused by exercise (EIB) in patients 15 years old or older:

To prevent movement bronchospasm (EIB), using a single dose Montelukast 10 mg should be taken at least 2 hours before training. The next dose should not be taken within 24 hours of the previous dose. Patients with Montelukast every day with other indications (including chronic asthma) should take additional doses to prevent movement bronchospasm (EIB). All patients should have a short -term rescue antidote β. Safety and efficiency in children less than 15 years old have not been established. Use Montelukast daily to treat chronic asthma that has not been set to prevent acute batches of bronchospasm due to EIB.

Allergic rhinitis:

For allergic rhinitis, Montelukast should be taken once a day. The effect has been proven for weather allergic rhinitis when using Montelukast in the morning or evening without having a meal. Drinking time may vary depending on the condition of each patient.

The following doses to treat symptoms of allergic rhinitis are recommended:

Adults and teenagers aged 15 and older: 1 tablet 10 mg.

Pediatric patients from 6 to 14 years old: 1 tablet chewing 5 mg.

Children from 2 black 5 years old: 1 chewing tablet 4 mg.

Safety and effectiveness in children under 2 years of age with allergic rhinitis due to the unprocessed weather.

The following doses to treat symptoms of chronic allergic rhinitis are recommended:

Adults and teenagers for 15 or more: 1 tablet 10 mg

Pediatric patients from 6 to 14 years old: 1 tablet chewing 5 mg.

Children from 2 to 5 years old: 1 tablet chewing 4 mg

Safety and effectiveness in children under 6 months of age with unpaid chronic allergic rhinitis.

Asthma because of allergic rhinitis:

Humanity with asthma and allergic rhinitis should take a single daily dose of motelukast at night.

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? The most frequent side effects related to Montelukast's safety data include abdominal pain, drowsiness, thirst, headache, vomiting and mental activity.

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 Kipel 5, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Mental: headache, flu, weakness/fatigue, dizziness.

Respiratory: stuffy nose, cough.

digestive: abdominal pain, cough, indigestion, gastritis.

Metabolic: Increase ALT, increase AST.

Urinary tract: pus.

Other: toothache.

Not determined frequency

Disorders of blood and lymphatic systems: tendency to increase bleeding.

The immune system disorder: Hypersensitivity reaction includes anaphylactic reaction, rarely encountering liver leukemia.

Mental disorders: agitation includes aggressive behavior, fighting, fear, deep, abnormal dreams, hallucinations, insomnia, uncomfortable, restlessness, sleepwalking, will and suicide behavior (including suicide), Run.

Nervous system disorders: Sleep. Perseverance/sensory reduction, convulsions.

Cardiovascular disorders: Brushing the chest.

Respiratory disorders, chest and mediastinum: nosebleeds.

Gastrointestinal disorders: diarrhea, indigestion, nausea, very rarely pancreatitis, vomiting.

Hepatic disorders: rare cholestatic hepatitis, liver cell damage, and liver sentence damage have been reported in treatment of treatment for Montelukast. Most of these unwanted effects occur due to the combination of other jamming agents, such as using other drugs, or when, Montelukast used in patients with alcoholic liver disease or other hepatitis forms.

Skin and subcutaneous disorders: angiography, bruises, with many hard, erythema, itching, urticaria.

Muscle disorders due to connective tissue: joint pain, muscle pain are also cramps.

general disorder: edema.

In some rare cases, patients with asthma treatment with Montelukast may manifest systemic hyperlemm, sometimes manifesting clinical properties like Churg-Strauss syndrome, a condition that is often treated at low doses of systemic corticosteroids. These conditions are common, but not always associated with reducing oral corticosteroid therapy. Doctors should warn of eosinophilia, rash, worse lung symptoms, heart complications, and/or neurological diseases manifest in patients. An overhand relationship between Montelukast and this situation has not been set.

Instructions on how to handle ADR

Notice the doctor the side effects encountered when using the drug.

Warnings

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

contraindicated

Kipel 5 contraindications in the following cases:

Hypersensitivity to any component of this product.

Caution when using

Caution:

Montelukast is not indicated for use in naughty bronchial spasms in acute asthma attacks, including asthma.

Patients need to be private to have an appropriate rescue antidote. Treatment with Montelukast can be continued in acute drama for asthma. Humanity has a drama on asthma after movement, so the owner of the inhaled form is available for short -effects to rescue.

While inhaled corticosteroidal doses can be gradually reduced according to medical monitoring, Montelukast should not be used suddenly instead of inhaled or oral corticosteroids.

Patients are sensitive to aspirin should continue to avoid taking aspirin or nonsteroidal anti -inflammatory while taking Montelukast. Although Montelukast is effective in improving the respiratory function in patients with aspirin sensitive according to the document, it is not effective in cutting bronchospasm caused by aspirin and other nonsteroidal anti -inflammatory drugs in patients with aspirin sensitivity.

Mental case:

Neurological cases have been reported in older patients, teenagers, and children when using Montelukast. Cases are reported such as agitation, acts of aggression or fighting, fear, depression, abnormal dreams, hallucinations, insomnia, discomfort, restlessness, will and suicide behavior (including suicide), and tremor.

Both patients and doctors should be warned for mental cases. Patients need to notify their doctor if there is a mental change. The doctor should carefully assess the risk and benefits of continuing treatment with Montelukast if that happens.

Non -blood leukemia:

In some rare cases, patients with asthma treatment with Montelukast may manifest the system of systemic eosinophilia, sometimes manifesting the clinical characteristics of the Churg-Strauss, a condition that has been treated with systemosteroids.

phenlyketon urine:

Patients with phenlyketon urinary should be notified as chewing 5 mg and 4 mg containing phenylalanin (an ingredient of aspartam), 2.0 mg phenylalanin/chewing pill 4 mg and 2.5 phenylalanin/chewing pill 5 mg.

The ability to drive and operate machinery

There is no evidence that Montelukast affects the ability to drive and operate machinery. However, in some rare cases, there may be dizziness and drowsiness.

Pregnancy

There is no adequate and controlled research in pregnant women. Montelukast is only used for pregnant women when really necessary.

The period of breastfeeding

It is not known whether Montelukast is excreted through breast milk or not, need to be careful to use Montelukast in breastfeeding women.

Drug interaction

No need to adjust the dose when using Montelukast simultaneously with theophyllin, prednison, prednisolon, birth control pills, terfenadin, digoxin, warfarin, thyroid hormones, sedative pills, anti -inflammatory streroidal, benzodiazepin, nose and tip of enzymes P450 (CYP).

Cancer, mutations, reduced fertility

Montelukast has been shown to have no evidence of activity that causes gene mutations or cell mutations.

Storage

Store less than 30 ° C in a dry place.

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