Singular pill 10 mg №28

Latin name

SINGULAIR

Dosage Form

Coated Tablets

Composition

In 1 tablet, coated, contains: montelukast 10 mg.
Excipients: microcrystalline cellulose, lactose, croscarmellose sodium, giproloza, Magnesium stearate.
Shell composition: hyprolosis, hypromellose, titanium dioxide, iron dyes, red oxide and iron oxide yellow, carnauba wax.

Mechanism of action

Singular - antagonist of leukotriene receptors. Montelukast inhibits cysteinyl of the leukotriene receptors of the respiratory tract epithelium, showing simultaneously the ability to inhibit bronchospasm due to inhalation of cysteinyl leukotriene LTD4 in patients with bronchial asthma. A dose of 5 mg is enough to relieve bronchospasm induced by LTD4. The use of montelukast in doses exceeding 10 mg / day 1 time / day does not increase the effectiveness of the drug. Montelukast causes bronchodilation within 2 hours after ingestion and can complement bronchodilation caused by beta2-adrenomimetikami.

Indications

- Prevention and long-term treatment of bronchial asthma in adults and children aged 6 years and older, including: prevention of day and night symptoms of the disease; treatment of bronchial asthma in patients with hypersensitivity to Acetylsalicylic acid; prevention of bronchospasm caused by exercise.
- Relief of day and night symptoms: seasonal allergic rhinitis in adults and children aged 6 years and older; persistent allergic rhinitis in adults and children aged 6 years and older.

Contraindications

Hypersensitivity to the drug. With care: pregnancy, the period of feeding by a breast.

Use during pregnancy and lactation

Singular should be used during pregnancy and lactation only in cases where the expected benefit to the mother outweighs the potential risk to the fetus or child.

Dosage and administration

The drug is taken orally 1 time / day, regardless of the meal.
In case of bronchial asthma: 1 pill at night.
With bronchial asthma and allergic rhinitis: 1 pill at night.
In allergic rhinitis: 1 pill per day in an individual regimen, depending on the time of the most acute exacerbation of symptoms.
The therapeutic effect of Singular on indicators reflecting the course of asthma develops during the first day. The patient should continue to take Singular as in the period to achieve control of symptoms of bronchial asthma, and in the period of exacerbation of the disease. Singular can be added to treatment with bronchodilators and inhaled GCS.
The therapeutic effect of Singulari on the indicators reflecting the severity of bronchial asthma develops within one day. The patient should continue to take Singular as in the period to achieve control of symptoms of bronchial asthma, and in the period of exacerbation of the disease.
For elderly patients, patients with renal insufficiency, patients with mild or moderately impaired liver function, and depending on the gender, special dose selection is not required.

Side effects

In general, Singular is well tolerated. Side effects are usually mild and, as a rule, do not require discontinuation of the drug. The overall frequency of side effects with treatment with Singular is comparable to their frequency with placebo.
Allergic reactions: anaphylaxis, angioedema, rash, pruritus, urticaria; very rarely, eosinophilic liver infiltrates.
From the side of the central nervous system: unusual vivid dreams, hallucinations, drowsiness, irritability, agitation, including aggressive behavior, fatigue, insomnia, paresthesia / hypesthesia, headache; very rarely - convulsive seizures.
Gastrointestinal: nausea, vomiting, dyspepsia, diarrhea, abdominal pain.
Musculoskeletal system: arthralgia, myalgia, including muscle cramps.
Other: tendency to increased bleeding, the formation of subcutaneous hemorrhages, palpitations, edema.

Special notes

Singular is not recommended for treatment of acute attacks of bronchial asthma. In the acute course of bronchial asthma, patients should be prescribed medications for stopping and preventive therapy.
Patients with bronchial asthma are advised to always carry emergency medications (short-acting inhaled beta-agonists).
For the relief of an acute attack of bronchial asthma after physical activity, a preparation is used for the relief of an attack, i.e., a short-acting inhaled beta-agonist.
Treatment with Singular does not guarantee absolute prevention of exacerbations.
In the period of asthma exacerbation and the need to use emergency medications (short-acting inhaled beta-agonists) for stopping attacks of seizures, Singular should not be taken.
Patients with confirmed allergies to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs should avoid contact with these drugs for the period of treatment with Singulair, since Cngular, improving respiratory function in patients with allergic bronchial asthma, nevertheless does not prevent bronchoconstriction caused by their NSAIDs.
The dose of inhalation glucocorticosteroids used concurrently with Singular is gradually reduced under the supervision of a physician. Sharp replacement of inhaled or oral glucocorticosteroids with Singular is unacceptable.
In rare cases, a reduction in the dose of systemic glucocorticosteroids in patients receiving simultaneously anti-asthma drugs, including leukotriene receptor blockers, was accompanied by one or more of the following complications: eosinophilia, hemorrhagic rash, worsening pulmonary symptoms, cardiac complications and / or neuropathy, sometimes diagnosed as Charg-Straus syndrome (systemic eosinophilic vasculitis).Although the cause-and-effect relationship of these side effects with treatment with leukotriene receptor antagonists has not been established, care should be taken when reducing the dose of systemic glucocorticosteroids during the period of treatment with Singulear, and to ensure adequate monitoring of the patient.
Patients with phenylketonuria should be informed that Singulyar contains aspartame in the amount of 1.2 mg in one chewable tablet.
There were no age differences in the profile of the effectiveness and safety of Singular.
Influence on ability to manage motor transport and work with mechanisms: there are no indications that taking Singular affects the ability to drive a car or moving machinery.

Interaction

Singular can be prescribed together with other drugs, which are usually used for the prevention and long-term treatment of asthma and / or treatment of allergic rhinitis.
The recommended therapeutic dose of montelukast did not have a clinically significant effect on the pharmacokinetics of the following drugs: theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol / noretinodrel 35/1), terfenadine, Digoxin and Warfarin.
The AUC value of Montelukast is reduced by simultaneous administration of phenobarbital by approximately 40%, which does not require changes in the dosage regimen of Singular.
In vitro studies have established that montelukast inhibits cytochrome CYP2C8 isoenzyme systems. However, in the study of the inter-drug interaction in vivo of montelukast and rosiglitazone (it is metabolized with the participation of the cytochrome CYP 2C8 isoenzyme), there was no evidence of montelukast inhibition of the CYP 2C8 isoenzyme. Thus, in clinical practice, Montelukast is not expected to influence CYP 2C8-mediated metabolism of a number of drugs, including Paclitaxel, rosiglitazone, repaglinide, etc.
Combined treatment with bronchodilators: A singular is a valid addition to monotreatism with bronchodilators, if the latter do not provide adequate control of asthma. Upon reaching a therapeutic effect (usually after the first dose) from treatment with Singular, a gradual reduction in the dose of bronchodilators can be started.
Combined treatment with inhaled glucocorticosteroids: Treatment with Singulin provides an additional therapeutic effect for patients using inhaled glucocorticosteroids. Once stabilization is achieved, you can begin to reduce the dose of corticosteroid - gradually and under the supervision of a doctor. In some cases, the complete abolition of inhaled glucocorticosteroids is permissible, however, a sharp replacement of inhaled corticosteroids by Singulyar is not recommended.

Overdose

Symptoms: Syngular's overdose symptoms in patients with chronic bronchial asthma when used at a dose exceeding 200 mg / day for 22 weeks and at a dose of 900 mg / day for 1 week have not been identified.
There are reports of acute overdose of montelukast in children (at a dose of at least 150 mg / day). Clinical and laboratory data at the same time testify to the compliance of Singular's safety profile in children with the safety profile in adults and elderly patients. The most frequent adverse events were feelings of thirst, drowsiness, mydriasis, hyperkinesis, and abdominal pain.
Treatment: conducting symptomatic therapy.
Data on the possibility of removal of montelukast by peritoneal dialysis or hemodialysis are not available.

Storage conditions

Store in a dry, dark place at temperatures below 30 ° C.

3 years.