Singulair, pills 10mg, 14pcs

Composition

1 coated tablet contains:

Montelukast 10 mg.

Auxiliary substances:

Microcrystalline cellulose;

Lactose;

Croscarmellose sodium;

Giprolose;

Magnesium stearate.

Shell composition:

Giprolose;

Hypromellose;

Titanium dioxide;

Iron oxide red and iron oxide yellow colorants;

Carnauba wax.

Pharmacological action

Singulair is a leukotriene receptor antagonist.

Montelukast inhibits cysteinyl leukotriene receptors in the airway epithelium, while simultaneously showing the ability to inhibit bronchospasm caused by inhalation of cysteinyl leukotriene LTD4 in patients with bronchial asthma.

A dose of 5 mg is sufficient to relieve LTD4-induced bronchospasm. 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 oral use and may supplement the bronchodilation caused by beta-2-adrenomimetics.

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 exercise-induced bronchospasm.
• Relief of day and night symptoms: seasonal allergic rhinitis in adults and children aged 6 years and older; permanent allergic rhinitis in adults and children aged 6 years and older.

Use during pregnancy and lactation

Singulair should be used during pregnancy and lactation only when the expected benefit to the mother exceeds the potential risk to the fetus or child.

Contraindications

Hypersensitivity to the components of the drug.

With caution: pregnancy, breast-feeding period.

Side effects

Allergic reactions: anaphylaxis, angioedema, rash, pruritus, urticaria; very rarely-eosinophilic liver infiltration.

From the central nervous system: unusual vivid dreams, hallucinations, drowsiness, irritability, agitation (including aggressive behavior), fatigue, headache, suicidal thoughts and suicidal behavior (suicidality), insomnia, paresthesia/hypesthesia; very rarely – convulsive seizures.

From the digestive system: nausea, vomiting, diarrhea, abdominal pain.

Musculoskeletal disorders: arthralgia, myalgia, including muscle cramps.

Dermatological reactions: erythema nodosum, tendency to form subcutaneous hemorrhages.

Others: tendency to increase bleeding, subcutaneous hemorrhage, palpitations, edema.

In general, Singulaire® is well tolerated. Side effects are usually mild and usually do not require discontinuation of treatment. The overall frequency of side effects reported with Singulair is comparable to that of placebo.

Interaction

Singulair can be prescribed together with other medications that are usually used for the prevention and long-term treatment of bronchial asthma and/or the 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 /norethinodrel 35/1), terfenadine, digoxin and warfarin.

The AUC value of montelukast is reduced by approximately 40% with simultaneous use of phenobarbital, which does not require changes in the dosage regimen of Singulair.

In vitro studies have shown that montelukast inhibits the cytochrome CYP2C8 isoenzyme system. However, in the study of drug-drug interaction in vivo montelukast and rosiglitazona (metabolized with the participation of isoenzyme CYP 2 8 cytochrome) have not received confirmation of montelukast inhibition of CYP isoenzyme 2 From 8. So, in clinical practice are not expected effect of montelukast on 2 of 8 CYP-mediated metabolism of several drugs, including paclitaxel, rosiglitazona, Repaglinide etc.

Combined treatment with bronchodilators: Singulair is a reasonable adjunct to monotherapy with bronchodilators, if the latter do not provide adequate control of bronchial asthma. When the therapeutic effect is achieved (usually after the first dose) from treatment with Singulair, you can start gradually reducing the dose of bronchodilators.

Combined treatment with inhaled glucocorticosteroids: Treatment with Singulair provides an additional therapeutic effect for patients using inhaled glucocorticosteroids. When stabilization is achieved, you can start reducing the dose of corticosteroid – gradually and under the supervision of a doctor. In some cases, complete withdrawal of inhaled glucocorticosteroids is acceptable, but abrupt replacement of inhaled corticosteroids with Singulair is not recommended.

How to take, course of use and dosage

The drug is taken orally 1 time/day, regardless of food intake.

For bronchial asthma:  1 tablet per night.

For bronchial asthma and allergic rhinitis:  1 tablet per night.

For allergic rhinitis:  1 tablet per day in an individual mode, depending on the time of the greatest exacerbation of symptoms. The therapeutic effect of Singulair on indicators reflecting the course of bronchial asthma develops during the first day. The patient should continue to take Singulair both during the period of achieving control of symptoms of bronchial asthma, and during the period of exacerbation of the disease. Singulair can be added to treatment with bronchodilators and inhaled corticosteroids.

The therapeutic effect of Singulair on indicators reflecting the severity of the course of bronchial asthma develops within one day. The patient should continue to take Singulair both during the period of achieving control of symptoms of bronchial asthma, and during the period of exacerbation of the disease.

For elderly patients, patients with renal insufficiency, patients with mild or moderate hepatic impairment, as well as depending on gender, special dose adjustment is not required.

Overdose

Symptoms:  symptoms of Singulair overdose 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 were not detected.

There are reports of acute overdose of montelukast in children (at a dose of at least 150 mg / day). Clinical and laboratory data indicate that the safety profile of Singulaire in children corresponds to the safety profile in adults and elderly patients. The most common adverse events were thirst, drowsiness, mydriasis, hyperkinesis, and abdominal pain.

Treatment:  conducting symptomatic therapy.

There are no data on the possibility of elimination of montelukast by peritoneal dialysis or hemodialysis.

Special instructions

Singulair is not recommended for the treatment of acute asthma attacks. In the acute course of bronchial asthma, patients should be prescribed medications for cupping and preventive therapy.

Patients with bronchial asthma are advised to always carry emergency medications (short-acting inhaled beta-agonists).

To stop an acute attack of bronchial asthma after physical exertion, a drug is used to stop the attack, i. e., a short-acting inhaled beta-agonist.

Treatment with Singulair does not guarantee absolute prevention of exacerbations.

During the period of exacerbation of asthma and the need to use emergency medications (short-acting inhaled beta-agonists) to stop taking Singulairum.

Patients with confirmed allergies to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs should avoid contact with these drugs during treatment with Singulair, since Singulair, while improving respiratory function in patients with allergic bronchial asthma, nevertheless does not prevent bronchoconstriction caused by NSAIDs.

The dose of inhaled glucocorticosteroids used simultaneously with Singulair is gradually reduced under the supervision of a doctor. Abrupt replacement of inhaled or oral glucocorticosteroids with Singulair is unacceptable.

In rare cases, a reduction in the dose of systemic glucocorticosteroids in patients receiving concomitant anti-asthmatic medications, including leukotriene receptor blockers, was accompanied by one or more of the following complications: eosinophilia, hemorrhagic rash, worsening of pulmonary symptoms, cardiac complications, and/or neuropathy, sometimes diagnosed as Charg-Strauss syndrome (systemic eosinophilic vasculitis). Although the causal relationship of these side effects with treatment with leukotriene receptor antagonists has not been established, caution should be exercised when reducing the dose of systemic glucocorticosteroids during treatment with Singulair, as well as ensuring appropriate monitoring of the patient.

Patients with phenylketonuria should be informed that Singulair contains 1.2 mg of aspartame in one chewable tablet.

There were no age-related differences in the efficacy and safety profile of Singulair.

Influence on the ability to drive vehicles and work with mechanisms:

There are no facts indicating that the use of Singulaire affects the ability to drive a car or moving mechanisms.

Form of production

Coated tablets.

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 30 °C

Shelf

life is 3 years.

Active ingredient

Montelukast

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

Adults as prescribed by a doctor, Children over 6 years of age, Children as prescribed by a doctor

Indications

Bronchospasm, Allergic rhinitis, Bronchial asthma