Singlon (montelukast) chewable tablets 4 mg. №28

Description

Singlon (montelukast) chewable tablets 4 mg. №28

Composition

active substance: montelukast;

• 1 chewable tablet of 4 mg contains 4 mg of montelukast (in the form of montelukast sodium – 4.16 mg);
• 1 chewable tablet of 5 mg contains 5 mg of montelukast (in the form of montelukast sodium – 5.2 mg);

Excipients: mannitol (E 421), microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, cherry flavor (maltodextrin, modified starch, maltol), aspartame (E 951), iron oxide yellow (E 172, mag).

Dosage form

Chewable tablets.

Basic physical and chemical properties:

• Singlon, chewable tablets, 4 mg: chewable tablets, cream, oval, biconvex, embossed “R 13” on one side; approximately 11 mm long and approximately 8 mm wide;
• Singlon, chewable tablets, 5 mg: chewable tablets, cream color, round, biconvex, embossed “R 14” on one side; with a diameter of about 10 mm.

Pharmacotherapeutic group

Means for systemic use in obstructive airways diseases. Leukotriene receptor antagonists.
ATX code R03D C03.

Pharmacological properties

The specified drug 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.

Indications

Singlon, chewable tablets, 4 mg is indicated for children aged 2 to 5 years.

Singlon, chewable tablets, 5 mg is indicated for children aged 6 to 14 years.

Treatment of bronchial asthma:

• As adjunctive therapy for bronchial asthma in patients with mild to moderate persistent asthma that is insufficiently controlled by inhaled corticosteroids, and in patients with insufficient clinical control of asthma with short-acting β-adrenoceptor agonists.
• As an alternative treatment to low-dose inhaled corticosteroids for patients with persistent mild asthma who have not had a recent history of severe asthma attacks requiring oral corticosteroids and who are unable to use inhaled corticosteroids.

Asthma prevention.
Prevention of asthma, the dominant component of which is exercise-induced bronchospasm in patients over 2 years of age.

Relief of symptoms of seasonal and perennial allergic rhinitis.

The risks of psychoneurological symptoms in patients with allergic rhinitis may outweigh the benefits of Singlon, so Singlon should be used as a reserve drug in patients with inadequate response or intolerance to alternative therapies.

Contraindications

You should not use the specified drug if the patient has had a previous hypersensitivity (allergy) with respect to one of the components that are part of the drug – both main and auxiliary.
In pediatrics, it is used from 2 years of age.

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

The drug is used for asthma and allergic rhinitis (both seasonal and year-round), 1 tablet 1 time per day.
In the treatment of asthma – in the evening, 1-2 hours after the evening meal. For the treatment of allergic rhinitis, the time of taking the drug can be selected on an individual basis.
Children aged 2 to 5 years take the drug in a dosage of 4 mg of montelukast, children aged 6 to 14 years – in a dosage of 5 mg of montelukast.

Overdose

Overdose with this drug does not cause any particular adverse events. In rare cases, the following were observed:

• drowsiness, psychomotor hyperactivity;
• thirst;
• headache;
• vomiting.

Symptomatic therapy is recommended.

Side effects

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.