Singular, 4 mg 14 pcs

Singulair is an antagonist of leukotriene receptors.

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

The dose of 5 mg is sufficient to relieve LTD4-induced bronchospasm. The use of montelukast in doses exceeding 10 mg/day once/day does not increase the effectiveness of the drug.

Montelukast causes bronchodilation within 2 h after oral administration and may complement bronchodilation induced by beta2-adrenomimetics.

Indications

Active ingredient

Composition

1 tablet contains:

How to take, the dosage

The drug is taken internal once a day regardless of meals.

In bronchial asthma – 1 tablet at night.

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

For allergic rhinitis – 1 tablet per day on an individual basis, depending on the time of the greatest exacerbation of symptoms.
Singulair is prescribed for children aged from 2 to 5 years: at a dose of 4 mg (1 tablet) per day. Therapeutic effect of Singular with changes in the course of bronchial asthma develops within a day.

The elderly patients, patients with renal insufficiency, patients with mild or moderate hepatic dysfunction, as well as depending on sex no special dose adjustment is required.

Interaction

Singulair may be administered together with other drugs commonly used for prevention and long-term treatment of bronchial asthma and/or treatment of allergic rhinitis. The recommended therapeutic dose of montelukast had no clinically significant effect on the pharmacokinetics of the following drugs: theophylline, prednisone, prednisolone, oral contraceptives (ethinylestradiol/noretinodrel 35/1), terfenadine, digoxin and warfarin.

The AUC value of montelukast is decreased concomitantly taking phenobarbital by about 40%, which does not require changes in the dosing regimen of Singulair. In vitro studies have found that montelukast inhibits the cytochrome isoenzyme CYP2C8. However, in an in vivo interdrug interaction study of montelukast and rosiglitazone (metabolized with participation of the cytochrome system CYP 2C8 isoenzyme), there was no evidence that montelukast inhibits the CYP 2C8 isoenzyme. Therefore, in clinical practice the effect of montelukast on CYP 2C8-mediated metabolism of several drugs, including paclitaxel, rosiglitazone, repaglinide and others is not expected.

Combined treatment with bronchodilators: Singulair is a reasonable adjunct to monotherapy with bronchodilators if the latter do not adequately control bronchial asthma. Once a therapeutic effect has been achieved (usually after the first dose) from treatment with Singulair, a gradual reduction in the dose of bronchodilators can begin.

Combined treatment with inhaled glucocorticosteroids: Treatment with Singulair provides additional therapeutic benefit to patients using inhaled glucocorticosteroids. Once stabilization has been achieved, the dose of the corticosteroid can be reduced gradually and under medical supervision. Complete abolition of inhaled glucocorticosteroids is permitted in some cases, but abrupt replacement of inhaled corticosteroids by Singulair is not recommended.

Special Instructions

Singulair is not recommended for the treatment of acute attacks of bronchial asthma. In the acute course of bronchial asthma patients should be prescribed medicines for curative and preventive therapy. It is recommended that patients with bronchial asthma always carry emergency medications (short-acting inhaled beta-agonists). To relieve an acute attack of bronchial asthma after physical activity, a drug to relieve the attack is used, i.e., a short-acting inhaled beta-agonist.

The treatment with Singulair does not guarantee absolute prevention of exacerbations. During asthma exacerbations and the need to use emergency drugs (short-acting inhaled beta-agonists) to relieve attacks, Singular should not be discontinued.

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, does not prevent bronchoconstriction caused by NSAIDs.

The dose of inhaled glucocorticosteroids used concomitantly with Singulair is reduced gradually under medical supervision. Abrupt replacement of inhaled or oral glucocorticosteroids with Singulair is unacceptable.

In rare cases, reduction in the dose of systemic glucocorticosteroids in patients receiving concurrent anti-asthmatic drugs, including leukotriene receptor blockers, has been accompanied by the occurrence of one or more of the following complications eosinophilia, hemorrhagic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy, sometimes diagnosed as Churg-Strauss syndrome (systemic eosinophilic vasculitis).

While a causal relationship between these side effects and treatment with leukotriene receptor antagonists has not been established, caution should be exercised when reducing the dose of systemic glucocorticosteroids during treatment with Singulair, and appropriate patient monitoring should be provided. Patients with phenylketonuria should be informed that Singulair contains 1.2 mg of aspartame in one chewable tablet. There are no age-related differences in the efficacy and safety profile of Singular.

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

In patients with renal insufficiency no special dose adjustment is required.

Impact on the ability to drive vehicles and operate mechanisms:

There is no evidence that taking Singulair affects the ability to drive or operate moving machinery.

Contraindications

Hypersensitivity to the ingredients of the drug.

With caution: pregnancy, breastfeeding period.

Side effects

In general, Singulair is well tolerated. Side effects are usually mild and usually do not require withdrawal of the drug. The overall incidence of side effects when treated with Singular is comparable to that of placebo.

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

Children ages 2 to 14 years with seasonal allergic rhinitis:The clinical trials of Singulair in the age group 2 to 14 years involved 280 children. The safety profile of the drug in children was generally similar to that of adults and comparable to that of placebo. According to data from a 2-week placebo-controlled study in the treatment group, no side effects occurring with a frequency of more than 1% compared to placebo were reported in patients.
During the post-marketing use of the drug, the following side effects were reported:

blood and lymphatic system:increased bleeding.

Immune system:hypersensitivity reactions, including anaphylaxis, angioedema; very rare – eosinophilic liver infiltration.

Nervous system:drowsiness, paresthesia/hypoesthesia; very rare – seizures.

Cardiovascular system: palpitations.

The digestive system:diarrhea, dyspepsia; very rare – vomiting, pancreatitis.

Hepatobiliary system: rarely – cholestatic hepatitis, hepatocyte damage, most often with concomitant drug therapy or underlying liver pathology (alcoholic and other forms of hepatitis).

Skeletal and muscular system: arthralgia, myalgia, muscle spasms.

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

Mental and emotional:excitability, aggressive behavior, anxiety, abnormal dreams and hallucinations, depression, insomnia, irritability, suicidal thinking and behavior, tremors.

Overdose

Symptoms: Singular overdose symptoms have not been identified in patients with chronic bronchial asthma when used at a dose greater than 200 mg/day for 22 weeks and at a dose of 900 mg/day for 1 week. There have been reports of acute overdose of montelukast in children (at a dose of at least 150 mg/day).

The clinical and laboratory data in this case suggest that the safety profile of Singulair in children corresponds to the safety profile in adults and elderly patients. The most frequent adverse events were thirst, somnolence, mydriasis, hyperkinesias, and abdominal pain.

Treatment:The administration of symptomatic therapy.

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

Pregnancy use

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.

Similarities