SINGULAR CHEWABLE PILLS 4MG

Chewable tablets

1 pill of chewing contains: montelukast 4 mg.
Excipients: mannitol, microcrystalline cellulose, hyprolosis, iron oxide red, croscarmellose sodium, cherry flavoring, aspartame, Magnesium stearate.

Packing

14 pcs.

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 may complement bronchodilation caused by beta2-adrenomimetics.

Indications and usage

- 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.

Contraindications

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

Pregnancy and Breastfeeding

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.
With allergic rhinitis - 1 pill per day in an individual mode, depending on the time of the most acute exacerbation of symptoms.
Singular prescribed to children aged 2 to 5 years: at a dose of 4 mg (1 tab. chewing) per day. The therapeutic action of Singular with a change in the indices of the course of bronchial asthma develops during the day.
For elderly patients, patients with renal insufficiency, patients with mild or moderately impaired liver function, and also depending on gender no special dose selection is required.

Adverse reactions

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.
Children aged 2 to 5 years with bronchial asthma: 573 children participated in the clinical studies of Singular in the age group from 2 to 5 years.According to a 12-week placebo-controlled study in the Singular group, the only observed side effect occurring with a frequency of more than 1% compared with placebo was thirst. 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 aged 2 to 14 years with seasonal allergic rhinitis: 280 children took part in Shingular's clinical studies in the age group from 2 to 14 years. The safety profile of the drug in children was, in general, similar to the safety profile in adults and was comparable to the safety profile of placebo. According to a 2-week placebo-controlled study in the treatment group, no adverse events were observed with a frequency of more than 1% compared with placebo.
During post-marketing use of the drug, the incoming reports contained information on the following side effects identified:
Blood and Lymphatic System: increased bleeding.
Immune System: hypersensitivity reactions, including anaphylaxis, angioedema; very rarely - eosinophilic infiltration of the liver.
Nervous System: drowsiness, paresthesia / hypostezia; very rarely - seizures.
Of cardio-vascular 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 disease (alcohol and other forms of hepatitis).
Musculoskeletal System: arthralgia, myalgia, muscle spasms.
Skin and subcutaneous fat: tendency to hematoma formation, erythema nodosum, pruritus, urticaria.
Psycho-emotional sphere: excitability, aggressive behavior, anxiety, abnormal dreams and hallucinations, depression, insomnia, irritability, suicidal thinking and behavior, tremors.

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 prophylaxis 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 inhaled glucocorticosteroids used concurrently with Singular is gradually reduced under the supervision of a physician. Sharp replacement of inhaled or oral glucocorticosteroids with Singularis 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 thatthat Singular 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.
For patientswith mild or moderate hepatic impairment no special dose selection is required. There are no data on the nature of the pharmacokinetics of montelukast in patients with severe hepatic insufficiency (more than 9 points on the Child-Pugh scale).
For patients with renal insufficiency withspecial dose selection is not required.
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.

Drug Interactions

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 had no 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 the simultaneous intake of phenobarbital by about 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) did not receive confirmation of the inhibition of cytochrome isoenzyme CYP 2C8. Thus, in clinical practice, Montelukast is not supposed to affect CYP 2C8-mediated metabolism of a number of drugs, including Paclitaxel, rosiglitazone, repaglinide, etc. control 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 physician. In some cases, the complete abolition of inhaled glucocorticosteroids is permissible, however, a sharp replacement of inhaled corticosteroids by Singulyar is not recommended.

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 Shingular’s ​​safety profile in children with the safety profile of adults and elderly patients. The most frequent adverse events were feelings of thirst, drowsiness, mydriasis, hyperkinesis and abdominal pain.
Treatment: Symptomatic therapy.
Data on the possibility of removal of montelukast by peritoneal dialysis or hemodialysis are not available.

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