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Singulair inhibits cysteinyl leukotriene receptors of the respiratory tract epithelium, thereby simultaneously having the ability to inhibit bronchospasm caused by 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 these asthma pills in doses exceeding 10 mg per day, taken once, the effectiveness of the drug does not increase. It causes bronchodilation within 2 hours after ingestion; and can complement bronchodilation caused by β2 -adrenoceptor agonists.
Indications for use
- Prevention and long-term treatment of asthma in adults and children 15 years old, including the prevention of day and night symptoms of the disease;
- Treatment of bronchial asthma in patients with hypersensitivity to acetylsalicylic acid and the prevention of bronchospasm caused by exercise.
- Relief of day and night symptoms of seasonal and/or year-round allergic rhinitis in adults and children from 15 years.
- Hypersensitivity to any of the drug components;
- Children’s age up to 15 years old;
- Lactase deficiency, lactose intolerance and glucose-galactose malabsorption.
Clinical studies of Singulair with the participation of pregnant women was not conducted. This drug should be used during pregnancy and lactation, only if the expected benefit to the mother outweighs the potential risk to the fetus. During the post-authorization use of the drug, the development of congenital defects of the limbs in newborns whose mothers took this drug during pregnancy was reported. Most of these women also took other drugs for the treatment of bronchial asthma during pregnancy. The causal relationship between taking this drug and the development of congenital defects of the extremities has not been established.
It is not known whether the drug penetrates the breast milk. Since many drugs are excreted in breast milk, it is necessary to take this into account when prescribing Singulair to breastfeeding mothers.
Dosage and administration
It is taken orally once a day, regardless of the meal. For the treatment of bronchial asthma, the asthma pill should be taken in the evening. When treating allergic rhinitis, the dose may be taken at any time of the day at the patient request. Patients suffering from asthma and allergic rhinitis should take one pill 1 time per day in the evening.
Adults and children aged 15 and over
The dose for adults and children over 15 years of age is prescribed one coated a 10 mg tablet per day.
The therapeutic effect on the indicators reflecting the course of asthma develops during the first day. The patient should continue to take both in the period of achieving control over bronchial asthma symptoms, and in the periods of bronchial asthma exacerbation.
For elderly patients, patients with renal insufficiency, as well as patients with mild or moderately impaired liver function, and depending on the gender, a special dose selection is not required.
Purpose of the drug along with other types of treatment of bronchial asthma
The drug can be used in combination with bronchodilators and inhaled glucocorticosteroids.
- Infectious and parasitic diseases: upper respiratory tract infections;
- Disorders of the blood and lymphatic system: increased tendency to bleeding, thrombocytopenia;
- Immune system disorders: hypersensitivity reactions, including anaphylaxis, eosinophilic liver infiltration;
- Mental disorders: agitation, including aggressive behavior or hostility, anxiety, depression, disorientation, attention disorder, pathological dreams, hallucinations, insomnia, memory disorders, psychomotor activity (including irritability, anxiety and tremor), somnambulism, suicidal thoughts and behavior ( suicidality);
- Nervous system disorders: dizziness, drowsiness, paresthesia/hypesthesia, convulsions;
- Cardiac disorders: palpitations;
- Disorders of the respiratory system, organs of the chest and mediastinum: nasal bleeding, pulmonary eosinophilia;
- Gastrointestinal disorders: diarrhea, dyspepsia, nausea, vomiting, pancreatitis;
- Disorders of the liver and biliary tract: an increase in the activity of alanine aminotransferase (ALT) and aspartate aminotransferase (ACT) in the blood, hepatitis (including cholestatic, hepatocellular and mixed liver damage);
- Violations of the skin and subcutaneous tissues: angioedema, the tendency to the formation of hematomas, erythema nodosum, erythema multiforme, pruritus, rash, urticaria;
- Disorders of the musculoskeletal and connective tissues: arthralgia, myalgia, including muscle cramps;
- Disorders of the kidneys and urinary tract: enuresis in children;
- Common disorders and disorders at the injection site: weakness, fatigue, edema, pyrexia.
There is no specific information about the treatment of overdose. Overdose symptoms were not observed during clinical studies of long-lasting (22 weeks) treatment of adult patients with bronchial asthma with daily doses of the drug up to 200 mg, or during short (about 1 week) clinical studies with daily doses up to 900 mg.
There have been cases of acute overdose (taking at least 1000 mg of the drug per day) with this medication during the post-authorization period and during clinical trials in adults and children. Clinical and laboratory data indicated that the safety profiles of Singulair were comparable in children, adults and elderly patients. The most frequent side effects were thirst, drowsiness, vomiting, agitation, headache and abdominal pain. These side effects are consistent with the safety drug profile.
Treatment for acute overdose is symptomatic.
There is no data on the effectiveness of peritoneal dialysis or hemodialysis of Singulair.
Singulair can be prescribed together with other drugs that are commonly used for the prevention and long-term treatment of bronchial asthma and/or treatment of allergic rhinitis.
The recommended therapeutic dose of this asthma drug did not have a clinically significant effect on the pharmacokinetics of the following drugs: theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol/ norethynodrel 35/1), terfenadine, digoxin and warfarin.
The AUC value of Singulair is reduced by the simultaneous administration with phenobarbital by approximately 40%, which does not require changes in the dosage regimen of the described drug.
In vitro studies have established that this asthma drug inhibits cytochrome CYP2C8 isoenzyme systems.
Combined treatment with bronchodilators: Singulair is a valid supplement to monotherapy with bronchodilators if the latter do not provide adequate control of asthma. Upon reaching the therapeutic effect (usually after the first dose) from treatment with Singulair, you can begin to gradually reduce the dose of bronchodilators.
Combined treatment with inhaled glucocorticosteroids: Treatment with this preparation 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 physician supervision. In some cases, the complete abolition of inhaled glucocorticosteroids is permissible, however, a sharp replacement of inhaled corticosteroids by Singulair is not recommended.