Singulair, Chewable tablets 4mg, 14pcs

Composition

1 tablet contains:

Active ingredient: Montelukast 4 mg. Auxiliary substances: Mannitol; Microcrystalline cellulose; Hyprolose; Red iron oxide; Croscarmellose sodium; Cherry flavor;Aspartame; Magnesium stearate.

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, starting from 2 years of age, control of day and night symptoms of the disease.
• Relief of symptoms of allergic rhinitis (seasonal and year-round) in children, starting from 2 years of age.

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

In general, Singulair is well tolerated. Side effects are usually mild and usually do not require discontinuation of the drug. The overall incidence of adverse events with Singulair is comparable to that with placebo.

Children aged 2 to 5 years with bronchial asthma: 573 children in the age group from 2 to 5 years participated in clinical studies of Singulairum. According to a 12-week placebo-controlled study in the Singulair treatment group, the only observed side effect occurring with a frequency of more than 1% compared to placebo was thirst. The difference between the two treatment groups was not statistically significant. With a longer follow-up (12 months or more), the side effect profile did not change.

Children aged 2 to 14 years with seasonal allergic rhinitis: 280 children in the age group from 2 to 14 years participated in clinical trials of Singulaire. The safety profile of the drug in children was generally similar to that of adults and comparable to that of placebo. According to a 2-week placebo-controlled study in the treatment group, no side effects were reported with a frequency of more than 1% compared to placebo in patients. During the period of post-marketing use of the drug, the received reports contained information about the following identified side effects from:

Blood and lymphatic system: increased bleeding.

The immune system: hypersensitivity reactions, including anaphylaxis, angioedema; very rarely-eosinophilic liver infiltration.

The nervous system: drowsiness, paresthesia/hyposthesia; very rarely convulsions.

Cardiovascular system: heartbeat.

Digestive system: diarrhea, dyspepsia; very rarely – vomiting, pancreatitis.

Hepatobiliary system: rarely-cholestatic hepatitis, damage to hepatocytes, most often against the background of concomitant drug therapy or underlying liver pathology (alcoholic and other forms of hepatitis).

Musculoskeletal system: arthralgia, myalgia, muscle spasms.

Skin and subcutaneous fat: tendency to form hematomas, erythema nodosum, pruritus, urticaria.

Psycho-emotional sphere: excitability, aggressive behavior, anxiety, abnormal dreams and hallucinations, depression, insomnia, irritability, suicidal thinking and behavior, tremor.

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 at night.

For bronchial asthma and allergic rhinitis – 1 tablet at night.

For allergic rhinitis – 1 tablet per day in an individual mode, depending on the time of the greatest exacerbation of symptoms. Singulair is prescribed for children aged 2 to 5 years:  in a dose of 4 mg (1 tab. chewing liquid) per day. The therapeutic effect of Singulair with changes in the parameters of the course of bronchial asthma develops during the day.

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.

No special dose adjustment is required for patients with mild or moderate hepatic impairment. There are no data on the pharmacokinetics of montelukast in patients with severe hepatic insufficiency (more than 9 points on the Child-Pugh scale).

No special dose adjustment is required for patients with renal insufficiency.

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

Chewable tablets.

Storage conditions

Store in a dry place, protected from light, at a temperature of 15-30 °C.

Shelf

life is 2 years.

Active ingredient

Montelukast

Conditions of release from pharmacies

By prescription

Dosage form

tablets for resorption

Purpose

Adults as prescribed by a doctor, Children over 2 years of age, Children as prescribed by a doctor

Indications

Allergic Rhinitis, Bronchospasm, and Bronchial asthma