Singular,10 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 hours after oral administration and may complement bronchodilation induced by beta2-adrenomimetics.

Indications

Active ingredient

Composition

One coated tablet contains:

Montelukast 10 mg.

Auxiliary substances:

Cellulose microcrystalline;

Lactose;

Croscarmellose sodium;

Hyprolose;

Magnesium stearate.

Composition of the shell:

Hyprolose;

Hypromellose;

Titanium dioxide;

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 greatest exacerbation of symptoms.
The therapeutic effect of Singulair on the indicators reflecting the course of bronchial asthma develops within the first day. The patient should continue to take Singulair both during the period of achieving control of bronchial asthma symptoms and during exacerbation of the disease. Singular may be added to treatment with bronchodilators and inhaled GCS.

The therapeutic effect of Singular 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 bronchial asthma symptoms and during exacerbation of the disease.

In elderly patients, patients with renal insufficiency, patients with mild to moderate hepatic dysfunction, and depending on gender, no special dose adjustment is required.

Interaction

Singulair may be administered together with other drugs that are 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 with phenobarbital by about 40%, which does not require changes in dosing regimen of Singulair.

In in vitro studies, montelukast was found to inhibit the cytochrome CYP2C8 isoenzyme system. However, in an in vivo interdrug interaction study of montelukast and rosiglitazone (metabolized with participation of the cytochrome system CYP 2C8 isoenzyme) no evidence of inhibition of the CYP 2C8 isoenzyme by montelukast was obtained. 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, a reduction in the dose of the corticosteroid can begin – 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 medications for curative and preventive therapy.

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

To relieve an acute attack of bronchial asthma after exercise, an attack control drug, i.e., a short-acting inhaled beta-agonist, is used.

The treatment with Singulair does not guarantee absolute prevention of exacerbations.

In the period of 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, because 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). Although 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 ensured.

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.

Influence on ability to drive and operate machinery:

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

Contraindications

Hypersensitivity to the ingredients of the drug.

With caution: pregnancy, breastfeeding period.

Side effects

Aallergic reactions:anaphylaxis, angioedema, rash, pruritus, urticaria; very rare – eosinophilic liver infiltration.

CNS side: unusual vivid dreams, hallucinations, somnolence, irritability, agitation (including aggressive behavior), fatigue, headache, suicidal thoughts and suicidal behavior (suicide), insomnia, paresthesia/hypesthesia; very rare, seizures.

Digestive system disorders:nausea, vomiting, diarrhea, abdominal pain.

Muscular system disorders: arthralgia, myalgia, including muscle cramps.

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

Others:Tendency to increase bleeding, subcutaneous hemorrhages, palpitations, edema.

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

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). Clinical and laboratory data suggest that the safety profile of Singulair in children is consistent with the safety profile in adults and elderly patients. The most frequent adverse events were thirst, somnolence, mydriasis, hyperkinesias, and abdominal pain.

Treatment: conducting 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