Description
Release form
Chewable tablets
Packing
14 pcs.
Pharmacological action
Blocker of cysteinyl leukotriene receptors CysLT1 (leukotrienes C4, D4 and E4 – mediators of chronic persistent inflammation, supporting bronchial hyperreactivity in asthma).
Prevents excessive secretion in the bronchi, swelling of the mucous membrane of the respiratory tract. Reduces the severity of bronchial asthma and the frequency of asthmatic attacks. Highly effective when taken orally.
Bronchodilator action develops within 1 day and lasts a long time.
Effective in patients with mild persistent asthma, not sufficiently controlled by bronchodilators alone.
Contraindications
Hypersensitivity, children’s age (up to 6 years).
Use during pregnancy and lactation
with caution
Special instructions
It is recommended that you continue to take it after you have achieved a significant improvement.
Should not be used to relieve acute asthmatic attacks, does not replace inhaled bronchodilators.
Composition
1 tablet contains:
Active ingredient: montelukast sodium 5.2 mg (equivalent to montelukast 5 mg, respectively)
Excipients: mannitol – 194.9 mg, microcrystalline cellulose – 66 mg, croscarmellose sodium hyperfrolose – 15 mg, EX mg (15 mg) ) – 9 mg, cherry flavor – 2.4 mg (contains 0.07% of charming red dye Allura red AC (E129)), aspartame – 1. 2 mg, cherry flavoring – 0.6 mg, dye of iron (III) oxide red – 0.45 mg, magnesium stearate – 5.25 mg.
Dosage and Administration
Inside, regardless of the meal.
Adults and teenagers over 15 years of age – 10 mg once a day, at bedtime.
Children 6-14 years old – 5 mg / day (one chewable tablet).
Side effects
Abdominal pains, headache, nausea, flu-like syndrome, cough, sinusitis, pharyngitis, increased activity of liver transgenic reactions.
Drug Interactions
Montelukast can be prescribed along with other drugs traditionally used for the prevention and long-term treatment of bronchial asthma, such as bronchodilators and inhaled corticosteroids.
When a therapeutic effect is achieved with montelukast therapy, the dose of bronchodilators and corticosteroids can be gradually reduced.
The dose of corticosteroids should be reduced gradually, under the supervision of a physician. In some patients, inhaled corticosteroids may be completely canceled. A sharp replacement of inhaled corticosteroids therapy with montelukast is not recommended.
The recommended therapeutic dose of montelukast did not have a clinically significant effect on the pharmacokinetics of the following drugs: theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol / norethindrone 35/1), terfenadine, digoxin and warfarin. AUC decreases in individuals simultaneously receiving phenobarbital (approximately 40%), however, such patients do not need to adjust the dosage regimen of montelukast.
In vitro studies have shown that montelukast is a potential inhibitor of the CYP2C8 isoenzyme, however, clinical trials of the drug-drug interaction, including montelukast and rosiglitazone (a preliminary substrate of a representative of drugs that are primarily metabolized by the CYP2C8 isoenzyme), showed that doses of montelukast do not inhibit the CYP2C8 isoenzyme in vivo. Therefore, montelukast does not significantly affect the metabolism of drugs metabolized by this enzyme (e.g. paclitaxel, rosiglitazone and repaglinide).
Since montelukast is metabolized by the CYP3A4 isoenzyme, caution should be exercised (especially in children) if montelukast is also prescribed with drugs that induce the CYP3A4 isoenzyme, such as phenytoin, phenobarbital and rifampicin.
Overdose
No evidence of overdose symptoms with montelukast in patients with bronchial asthma at a dose exceeding 200 mg / day for 22 weeks and at a dose of 900 mg / day for 1 week has not been established.
There are reports of acute overdose of montelukast in children (at least 1000 mg / day). Clinical and laboratory data thus indicate that the safety profile of montelukast in children is consistent with that of adults and elderly patients.
Symptoms: the most common – thirst, drowsiness, vomiting, mydriasis, hyperkinesis, psychomotor agitation, headache and abdominal pain.
Treatment: carrying out symptomatic therapy. There are no data on the possibility of excretion of montelukast by peritoneal dialysis or hemodialysis.
Storage Conditions
In a place protected from light and moisture, at a temperature not exceeding 30 ° C.
Keep out of the reach and sight of children.
Shelf life
2 years
Deystvuyushtee substance
Montelukast
Terms and conditions
prescription
Dosage form
resorption tablets
Prescribing
Prescribing
Children over 2 years old, Children as prescribed by a doctor, Adults prescribed by a doctor
Sandoz, Switzerland
