Expiration date: 07/2025
Description
Indications for use
Children 2-5 years:
Long-term treatment and prevention of bronchial asthma , including:
Prevention of daytime and nighttime symptoms.
The treatment of asthma in patients with hypersensitivity to acetylsalicylic acid and prevention of bronchospasm physical effort.
Contraindications
Severe violations of liver function.
Phenylketonuria (it contains aspartame ).
Children up to age 2 years.
Hypersensitivity to the active substance or to any of the excipients.
With caution:
The drug should be used concurrently with CYP 3A4 inducers.
Overdose
Symptoms: no specific information on the treatment of overdose Single. Data about the symptoms of an overdose while taking the drug adult patients with bronchial asthma in a dose exceeding 200 mg / day for 22 weeks and at a dose of 900 mg per day for 1 week were not revealed. There have been cases of acute overdose of montelukast in adults and children the dose above 1000 mg (approximately 61 mg/kg for a child at the age of 42 months). The received clinical and laboratory results were consistent with the safety profile for adults and pediatric patients. The most common adverse events were consistent with the safety profile of montelukast and included abdominal pain, somnolence, Mediatrade, headache, vomiting and psychomotor hyperactivity.
Treatment: symptomatic. No data on the possible excretion of montelukast in peritoneal dialysis or hemodialysis.
Composition
1 chewable tablet contains:
The active ingredient
Montelukast sodium of 4.16 mg.
That corresponds to the content of montelukast 4 mg.
Excipients
Mannitol - 161.34 mg microcrystalline cellulose 101 - 52.8 mg, hyprolose - 7.2 mg croscarmellose sodium 7.2 mg, flavor cherry (powder) - 3.6 mg, aspartame - 1.2 mg, dye iron oxide yellow (E172) - 0.1 mg, magnesium stearate - 2.4 mg.
In blister packs of 7 chewable tablets. In a carton of 4 blister.
Method of application
Method of application and doses
Inside. 1 hour before or 2 hours after a meal.
Children aged 2-5 years the preparation appoint 1 Single chewable tablets of 4 mg daily in the evening.
Children under 2 years of age: safety and efficacy not established.
General guidelines
The therapeutic effect of the drug Single develops within one day after priema. The patient should continue taking the drug Single in controlled bronchial asthma and in the periods of deterioration of disease.
Therapy drug Single in combination with other drugs for the treatment of asthma
If the drug Single assigned in patients receiving inhaled corticosteroids, you should not abruptly substitute for inhaled corticosteroids drug Single.
Use in special clinical cases
In patients with renal insufficiency mild or moderate severity dose adjustment is not required.
In patients with mild or moderate hepatic insufficiency dose adjustment is not required.
Data for patients with severe hepatic insufficiency are not available.
Dose not depend on sex of the patient.
