Singuliar (montelukast) coated tablets 10 mg. №28

Description

Singuliar (montelukast) chewable tablets 10 mg. №28

Composition

active ingredient: montelukast;

1 film-coated tablet contains 10.4 mg montelukast sodium (equivalent to 10 mg montelukast);

excipients: hydroxypropyl cellulose, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate;

tablet shell: hydroxypropylcellulose, methylhydroxypropylcellulose, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172), carnauba wax.

Dosage form

Film-coated tablets.

Basic physical and chemical properties: beige, square film-coated tablets with rounded edges, pressed with the inscription SINGULAIR on one side and MSD 117 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 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.

Contraindications

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.

The dose for patients (age 15 years and older) with asthma or with asthma and concomitant seasonal allergic rhinitis is 10 mg (1 tablet) per day, in the evening. To alleviate the symptoms of allergic rhinitis, the time of admission is selected individually.

General recommendations
The therapeutic effect of the drug Singulair on asthma control occurs within 1 day. The drug can be taken regardless of food. Patients should be advised to continue taking Singular® even if asthma is controlled and also during periods of asthma exacerbation. Singulair® should not be used concomitantly with medicinal products containing the active ingredient montelukast.

There is no need for dose adjustment for elderly patients with impaired renal function or impaired liver function from mild to moderate severity. There are no data on patients with severe hepatic impairment. The dosage for men and women is the same.

The use of the drug Singulair in relation to other asthma treatment.

Singulair may be added to an existing asthma treatment.

inhaled corticosteroids. Singulair may be used as adjunctive therapy in patients in whom inhaled corticosteroids, together with short-acting beta-agonists given as needed, do not provide satisfactory clinical disease control.

Singular should not abruptly replace inhaled corticosteroids.

Children

Applied to children from 15 years. Children under 15 years of age should use the drug in the form of chewable tablets.

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.