Release form and ingredients of the preparation: Round, oval and square chewable tablets. The active substance is Montelukast, which in 1 tablet of chewing "Singular" - 4 mg; the instruction indicates the content of auxiliary ingredients in the composition: mannitol, microcrystalline cellulose, hyprolose, iron oxide red, croscarmellose sodium, cherry flavor, aspartame, magnesium stearate. The package contains 2 blisters, 7 tablets each. In addition, the "Singular" is available in the form of tablets of 5 mg and 10 mg, in a hard shell, which are taken orally.
Indications for use "Singular": The instruction prescribes the appointment of a remedy for asthma (for prevention and treatment), in adults and children, from the age of 2 years. Also, tablets are prescribed to alleviate the symptoms of allergic rhinitis in children older than 2 years of any etiology (seasonal and year-round); to prevent symptoms of the disease during the day and night; for the treatment of asthma in people with hypersensitivity to acetylsalicylic acid; to prevent bronchospasm due to physical exertion.
Pharmaceutical action of the tablets “Singular”: The instruction indicates that montelukast is an antagonist of leukotriene receptors. It suppresses cysteinyl leukotriene endings of the epithelial receptors in the airways, while bronchospasm due to the penetration of cysteinyl-leukotriene into the respiratory system of patients with bronchial asthma is also inhibited.
Contraindications to the use of "Singular": The instruction prohibits the use of the drug with hypersensitivity to its ingredients.
Interaction: "Singular®" can be taken simultaneously with other agents traditionally used for bronchial asthma. Montelukast did not have a clinically pronounced effect on the effect of drugs: theophylline, prednisone, prednisone, some oral contraceptives, terfenadine, warfarin and digoxin. AUC of montelukast in patients simultaneously taking phenobarbital decreased by about 40%.
Treatment with "Singular" leads to an additional therapeutic effect in people taking inhaled corticosteroids. The dose of corticosteroids should be reduced gradually under the supervision of a doctor. In some patients, after improvement, treatment with inhaled GCS can be canceled.
In vitro experiments revealed that montelukast has the ability to inhibit the CYP2C8 isoenzyme. But in an in vivo study of the drug interaction of montelukast and rosiglitazone, there was no evidence of montelukast inhibition of this isoenzyme. Thus, in practice, it is not expected that montelukast will affect the metabolism mediated by the CYP2C8 isoenzyme in a number of drugs, including rosiglitazone, paclitaxel, repaglinide.
Use during pregnancy and lactation of the drug "Singular": The instruction recommends using the drug only when the expected positive effect for the mother prevails over the possible risk to the health of the fetus or baby.
Side effects: Possible manifestation of allergic reactions in the form of: anaphylaxis, angioedema, rash, itching, urticaria; in rare cases, in the form of eosinophilic infiltrates in the liver. In the central nervous system, side effects in the form of: unusual vivid dreams, hallucinations, drowsiness, irritability, arousal, including aggressive behavior, fatigue, insomnia, paresthesia / hypesthesia, headache; very rarely in the form of convulsive seizures. In the digestive system in the manifestations of: nausea, vomiting, dyspepsia, diarrhea, abdominal pain. In the musculoskeletal system - symptoms: arthralgia, myalgia, including muscle cramps. Other side effects in the trends: increased bleeding, the formation of subcutaneous infiltrates.
Method of use of the drug "Singular": Instructions for use prescribes to be taken orally, preferably before going to bed, for adults and children over 15 years old - 10 mg / day; children 6-14 years old - 5 mg / day.
Storage conditions: Store in a non-humid place, with a temperature not exceeding 25 ° C. The tablets are usable for 2 years.