Singuliar (montelukast) chewable tablets 4 mg. №28

Description

Singuliar (montelukast) chewable tablets 4 mg. №28

Composition

active ingredient: montelukast;

1 chewable tablet contains 4.16 mg montelukast sodium (equivalent to 4 mg montelukast);

excipients: mannitol (E 421), microcrystalline cellulose, hydroxypropyl cellulose, red iron oxide (E 172), croscarmellose sodium, cherry flavor, aspartame (E 951), magnesium stearate.

Dosage form

Chewable tablets.

Basic physical and chemical properties: 4 mg chewable tablets: pink oval biconvex tablets with the inscription “SINGULAIR” embossed on one side and “MSD 711” on the other.

Pharmacological group

Means for systemic use in obstructive respiratory diseases. Leukotriene receptor blockers.
Code ATX R03D C03.

Pharmacological properties

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.

Indications

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.

Prevention of asthma, the dominant component of which is exercise-induced bronchospasm in patients aged 2 years and over.

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.

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 should be used in children under adult supervision. Tablets should be chewed before swallowing.

• Patients with asthma and allergic rhinitis (seasonal and perennial) should take 1 chewable tablet of 4 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 2 to 5 years of age is 1 chewable tablet (4 mg) per day, in the evening. Singuliar tablets should be taken 1 hour before meals or 2 hours after meals. There is no need for dose adjustment for this age group. Singuliar tablets (4 mg) are not recommended for use in children under 2 years of age.

Children

Applied to children from 2 to 5 years.

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.