Chewing Kipel Chewable Tablet 4mg Mega We Care for asthma treatment, bronchospasm, allergic rhinitis (4 blisters x 7 tablets)

Dosage form Box of 4 blisters x 7 tablets
Specifications Montelukast

Ingredient

Composition information	Content
Montelukast	4mg

Uses

Indications

Kipel Chewable Tablets 4mg is indicated in cases of treatment in children aged 2 -14 years:

Bronchial asthma: Preventive and treat chronic bronchial asthma.

Allergic rhinitis: Treatment of allergic rhinitis (seasonal allergic rhinitis and allergic rhinitis year -round). With a lower doses of 5mg, significantly inhibitors of Ltd4 causes trachea.

pharmacokinetic

absorption

Montelukast is quickly absorbed after drinking, in adults, after taking 10mg film tablets at an empty stomach, the average peak concentration in plasma (cmax) is achieved within 3-4 hours (TMAX). The average oral bioavailability is 64%. Oral and cmax is not affected by a standard breakfast, in children from 2-5 years old using a 4mg chewing tablet when hungry, the average CMAX is achieved within 2 hours after chewing.

In adults using a 5mg chewing tablet at hunger, the average cmax is achieved within 2 - 2.5 hours after chewing. The average oral bioavailability is 73% and 63% when used with standard breakfast.

Distribution

over 99% Montelukast is connected to plasma proteins. Distribution voltage in an average stable state from 8 - 11 liters.

Metabolism

Montelukast is widely metabolized. In adults and children taking treatment dose, the concentration of metabolic substances of Montelukast in plasma in stable state cannot be detected.

Elimination

Montelukast clearance in plasma is 45ml/minute in healthy adults. After taking Montelukast with radioactive marking, 86% of radioactive activity is found in the fertilizer collected for 5 days and less than 0.2% found in the urine. Combined with Montelukast's oral bioavailability shows that Montelukast and its metabolites are excreted mainly through the biliary tract.

Some studies show that Montelukast's average plasma sale time in healthy young people ranges from 2.7 to 5.5 hours. The pharmacokinetics of Montelukast is like linear with oral doses of up to 50mg. When using 10mg/day, only a small amount of drugs accumulated in plasma (14%).

Before taking Chewing Kipel Chewable Tablet 4mg Mega We Care for asthma treatment, bronchospasm, allergic rhinitis (4 blisters x 7 tablets)

How to use

Chewing capsules: Chewing and drinking with water.

Dosage

Chronic bronchial asthma:

Montelukast should be used once a day in the evening.

with the following doses:

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

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

Children from 12 - 23 months of age: Please consult a doctor. Safety and efficiency in children under 12 months of age have not yet been established.

Allergic rhinitis:

For allergic rhinitis, Montelukast should be used once a day. The effect has been shown for seasonal allergic rhinitis when using Montelukast in the morning or evening without having to relate to the time of meals. Time to use drugs depending on the needs of each object.

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

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

Safety and effectiveness in children under 2 years of age with unprocessed allergic rhinitis.

Bronchial asthma and allergic rhinitis:

Patients with both bronchial asthma and allergic rhinitis should take 1 tablet daily 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 to do when overdose?

The most common reactions that occur are similar to Montelukast's safety properties including abdominal pain, drowsiness, thirst, headache, vomiting and agitation.

Unknown Montelukast can be separated through the peritoneal or dialysis.

What to do when forgetting 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 Chewable Tablets 4mg, you may experience unwanted effects (ADR).

Common side effects are headache, influenza, abdominal pain, cough, indigestion, hyperka, weakness/fatigue, dizziness, fever, gastritis, toothache, stuffy nose, rash, AST hypertension, pus urine.

Also have the following adultery effects have been reported:

Disorders of hematopoietic and lymphatic systems: tend to increase bleeding.

The immune system disorder: Hypersensitivity reaction includes: Anaphylaxis, very rarely contaminated with Eosin leukemia in the liver.

Mental disorders: agitation includes aggressive attitude or opposition, or anxiety, depression, abnormal dreams, hallucinations, insomnia, irritation, hyperactivity, sleepwalking, thinking and acts of suicide (including suicide), tremor.

Nervous system disorders: drowsiness, paresthesia/decrease sensation, convulsions.

Purple disorders; Brush the chest drum.

Respiratory, chest and mediastinum disorders: Nose bleeding.

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

Hepatic disorders: rare cholestatic hepatitis, liver cell damage, and multi -component liver damage have been reported in patients treated with Montelukast. Most of these side effects occur when combined with other disturbing agents such as simultaneous use with other drugs, or using Montelukast in patients at risk of liver disease such as drinking alcohol or other hepatitis.

Skin and subcutaneous tissue disorders: Evana, bruises, erythema, itching, urticaria.

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

Systemic disorders and medication condition: edema.

Instructions on how to handle ADR

Notice immediately to the doctor or pharmacist about unwanted effects when using the drug.

Warnings

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

Contraindications

Kipel Chewable Tablets 4mg contraindicated in cases of hypersensitivity patients with any ingredients of the drug.

Precautions when using

General recommendations:

Do not use Montelukast in the treatment of bronchospasm during acute asthma attacks, including asthma. Patients should be instructed to use the appropriate treatment. Montelukast can be continued during severe asthma attacks. Patients with severe asthma due to exertion need to have inhaled-inhaled lubricants, short effects to save.

may have to reduce inhaled corticosteroids gradually under the supervision of a physician, but not to suddenly replace inhaled corticosteroids or drink with Montelukast.

In sensitive diseases with aspirin, aspirin should not be taken or other nonsteroidal anti -inflammatory drugs during Montelukast. Although Montelukast has the effect of improving the respiratory function in patients with asthma sensitive to aspirin, it has not yet been shown to be removed from the bronchospasm caused by aspirin and other nonsteroidal anti -inflammatory drugs in Aspirin sensitive asthma patients.

Neurological - mental effects:

There have been reports on neurological and mental disorders in patients who take Montelukast, including adults, teenagers and children. Symptoms have been reported including agitation, aggressive or hostile attitudes, anxiety, depression, abnormal dreams, hallucinations, insomnia, irritation, hyperactivity, sleepwalking, thoughts and actions that want to suicide (including suicide) and tremor.

Doctors and patients need to be alert of mental - mental disorders that can occur. It is necessary to guide the disease to notify your doctor if you experience these symptoms. Doctors should carefully assess the risk and benefits of continuing to appoint Montelukast when the symptoms occur.

Eosin hyperpses:

A few cases of patients with bronchial asthma treated with Montelukast may have eosin hypernagus, sometimes the symptoms of vascular inflammation of Churg-Strauss syndrome when reducing corticosteroid dose using systemic tract.

Magical phenylketon:

Patients with chemical phenylketon should be notified that in 4mg and 5mg chewing tablets containing phenylalanin (in the composition of Aspartam), each chewing tablet 4mg and 5mg contains 0.674 and 0.842mg phenylalanin.

The ability to drive and operate machinery

rarely occurs due to drugs used for treatment in children aged 2-14 years old.

Be cautious when driving because the drug can cause headaches, dizziness, fatigue, insomnia, hallucinations.

Pregnancy

rarely occurs due to drugs used for children aged 2-14 years old.

There is no complete and good control in pregnant women. Montelukast is only used for pregnant women when really necessary.

Breastfeeding period

rarely occurs due to drug used for children aged 2 -14 years old.

It is not clear that Montelukast's excretion through breast milk. Caution should be careful when taking the drug during breastfeeding.

Drug interaction

No need to adjust the dose when using Montelukast simultaneously with theophyllin, prednison, prednisolon, oral contraceptive pills, terfenadin, digoxin, warfarin, thyroid hormone, sleeping pills, non -steroid anti -inflammatory drugs, benzodiazepin, nose and nose senses Emzyme cytochrom P450 (CYP).

Storage

temperature below 30 ° C, cool dry place. Avoid light and avoid moisture.

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