Manufacturer: Netherlands, Belgium
As an add-on treatment for asthma in patients aged 2 to 5 years with mild to moderate persistent asthma that is not adequately controlled with inhaled corticosteroids, and with insufficient clinical control of asthma with short-acting β-adrenergic agonists.
As an alternative treatment to low-dose inhaled corticosteroids for patients aged 2 to 5 years with mild persistent asthma who have not had a recent severe asthma attack requiring oral corticosteroids and cannot use inhaled corticosteroids.
Singuliar (montelukast) chewable tablets 5 mg. №28
active ingredient: montelukast;
1 chewable tablet contains 5.2 mg montelukast sodium (equivalent to 5 mg montelukast);
excipients: mannitol (E 421), microcrystalline cellulose, hydroxypropyl cellulose, red iron oxide (E 172), croscarmellose sodium, cherry flavor, aspartame (E 951), magnesium stearate.
Basic physical and chemical properties: 5 mg chewable tablets: pink round biconvex tablets with “SINGULAIR” embossed on one side and “MSD 275” on the other.
Means for systemic use in obstructive respiratory diseases. Leukotriene receptor blockers.
Code ATX R03D C03.
The specified drug Singuliar belongs to the group of cystenyl-leukotriene receptor blockers, which play an important role in the development of broncho-obstructive syndrome.
As a result, the drug is effective in the treatment of obstructive diseases that develop in the lower parts of the respiratory system.
Montelukast, which is the main active ingredient of the drug, has the property, when applied, to bind to cystenyl-leukotriene receptors (CysLT1 receptors), which are responsible for the occurrence of bronchospasm, sputum secretion from the bronchi, and other symptoms accompanying obstructive bronchitis.
Capable of inhibiting bronchoconstriction in patients with asthma.
It has the property of stopping the arising bronchospasm at all stages of its development, due to the ability to reduce the body’s response to allergic antigens.
The use of montelukast leads to a decrease in the number of eosinophils in the airways.
As adjunctive treatment for asthma in patients with mild to moderate persistent asthma not adequately controlled with inhaled corticosteroids, and with insufficient clinical asthma control with short-acting β-adrenergic agonists, used as needed.
As an alternative treatment to low-dose inhaled corticosteroids for patients with mild persistent asthma who have not had a recent severe asthma attack requiring oral corticosteroids and cannot use inhaled corticosteroids.
Prevention of asthma, the dominant component of which is exercise-induced bronchospasm.
Relief of symptoms of seasonal and perennial allergic rhinitis. The risks of neuropsychiatric symptoms in patients with allergic rhinitis may outweigh the benefits of using Singulair, so Singulair should be used as a reserve drug in patients with an inadequate response or intolerance to alternative therapy.
Hypersensitivity to the components of the drug.
Application during pregnancy and lactation
Treatment of pregnant women is carried out with every possible care, only for serious indications.
Breastfeeding should be suspended during treatment.
Method of administration and dosage
Tablets should be chewed before swallowing.
Patients with asthma and allergic rhinitis (seasonal and year-round) should take 1 chewable tablet of 5 mg 1 time per day. To alleviate the symptoms of allergic rhinitis, the time of admission is selected individually.
For the treatment of asthma, the dose for children 6 to 14 years of age is 1 chewable tablet (5 mg) per day, in the evening. Singulair should be taken 1 hour before meals or 2 hours after meals. There is no need for dose adjustment for this age group.
The therapeutic effect of the drug Singuliar chewable tablets on asthma control occurs within 1 day. Patients should be advised to continue taking Singulair even if asthma is controlled and also during periods of asthma exacerbation.
There is no need for dose adjustment for patients with impaired renal function or with mild to moderate hepatic impairment. There are no data on patients with severe hepatic impairment. The dosage for boys and girls is the same.
As an alternative treatment to low-dose inhaled corticosteroids for mild persistent asthma. Montelukast is not recommended as monotherapy for patients with moderate persistent asthma. The use of montelukast as an alternative to low-dose inhaled corticosteroids in children with mild persistent asthma should only be considered in patients who have not had a recent severe asthma attack requiring oral corticosteroids and who cannot use inhaled corticosteroids. Mild persistent asthma is defined as the occurrence of asthma symptoms more than once a week but less than once a day, the occurrence of nighttime symptoms more than twice a month but less than once a week, normal lung function in the periods between episodes. If sufficient asthma control is not achieved later (usually within 1 month), the need for additional or different anti-inflammatory therapy should be determined based on a consistent asthma management system. Patients should be periodically assessed for asthma control.
The use of the drug Singulair in relation to other asthma treatment. When Singuliar chewable tablets is used as adjunctive therapy to inhaled corticosteroids, Singulair should not be abruptly replaced with inhaled corticosteroids.
Applied to children from 6 to 14 years.
Overdose with this drug does not cause any particular adverse events. In rare cases, the following were observed:
- drowsiness, psychomotor hyperactivity;
Symptomatic therapy is recommended.
Usually the drug is well tolerated. Side effects can occur only in rare cases. In particular, there may be observed:
- anaphylactic reactions, hypersensitivity reactions, including anaphylactic shock;
- upper respiratory tract infections;
- headache, abdominal pain, thirst, nausea, vomiting, dyspepsia;
- increased bleeding;
- sleep disturbances, nightmares, hallucinations, insomnia, irritability, anger, agitation, hostility, depression, disorientation, suicidal thoughts;
- lethargy, dizziness, paresthesia, hypersthesia, palpitations;
- hepatitis, increased levels of hepatic transaminases;
- arthralgia, myalgia, including muscle cramps;
- asthenia / fatigue, discomfort, swelling, fever;
- nose bleed.