Description
Release form
film-coated tablets.
Packing
14 pcs.
Pharmacological action
Singular is an antagonist of leukotriene receptors.
Montelukast inhibits cysteinyl of the leukotriene receptors of the epithelium of the respiratory tract, while simultaneously exhibiting the ability to inhibit bronchospasm due to inhalation of LTD4 cysteinyl-leukotriene in patients with asthma.
A dose of 5 mg is sufficient 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 supplement bronchodilation caused by beta2-adrenergic agonists.
Contraindications
Hypersensitivity to the components of the drug.
Precautions: Pregnancy, lactation period.
Use during pregnancy and lactation
The singular should be used during pregnancy and lactation only when the expected benefits to the mother outweigh the potential risk to the fetus or baby.
Special instructions
The singular is not recommended for the treatment of acute attacks of bronchial asthma. In acute asthma, patients should be prescribed medications for relief and preventive therapy.
Patients with asthma are advised to always have emergency medications (short-acting inhaled beta-agonists).
To stop an acute attack of bronchial asthma after exercise, use a drug to stop the attack, i.e., a short-acting inhaled beta-agonist.
Treatment with Singular does not guarantee absolute prevention of exacerbations.
During the period of exacerbation of asthma and the need to use emergency drugs (short-acting inhaled beta-agonists) to stop seizures, you should not stop taking Singular.
Patients with a confirmed allergy to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs should avoid contact with these drugs during the treatment with Singular, since C ngulyar, improving respiratory function in patients with allergic bronchial asthma, nevertheless, does not prevent bronchoconstriction caused by them.
The dose used simultaneously with the Singular inhaled glucocorticosteroids is gradually reduced under the supervision of a doctor. A sharp replacement of inhaled or oral glucocorticosteroids with a Singular is unacceptable.
In rare cases, a decrease in the dose of systemic glucocorticosteroids in patients receiving simultaneously anti-asthma drugs, including leukotriene receptor blockers, was accompanied by the appearance of one or more of the following complications: eosinophilia, hemorrhagic rash, worsening pulmonary symptoms, cardiological complications and / or neuropathy, sometimes diagnosed as Charge-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 lowering the dose of systemic glucocorticosteroids during treatment with Singular, as well as ensure appropriate monitoring of the patient.
Patients with phenylketonuria should be informed that Singular contains 1.2 mg aspartame in one chewable tablet.
There are no age-related differences in the profile of the effectiveness and safety of the Singular.
Influence on the ability to drive vehicles and work with mechanisms: facts, evidence that the reception of the Singular affects the ability to drive a car or moving machinery has not been identified.
Composition of
In 1 coated tablet contains:
Montelukast 10 mg.
Excipients:
Microcrystalline cellulose
Lactose
Croscarmellose sodium
Hyprolose
Magnesium stearate.
Shell composition:
Hyprolose
Hypromellose
Titanium dioxide
Dyes iron oxide red and iron oxide yellow
Carnauba wax.
Dosage and administration
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 regimen, depending on the time of the greatest exacerbation of symptoms.
The therapeutic effect of Singular on indicators reflecting the course of bronchial asthma develops during the first day. The patient should continue to take Singular both during the period of achieving control of symptoms of bronchial asthma, and during the period of exacerbation of the disease. The singular can be added to treatment with bronchodilators and inhaled corticosteroids.
The therapeutic effect of the Singular on indicators reflecting the severity of bronchial asthma, develops in one day. The patient should continue to take Singular both during the period of achieving control of symptoms of bronchial asthma, and during the period of exacerbation of the disease.
For elderly patients, patients with renal insufficiency, patients with mild or moderate impaired liver function, as well as gender-specific special dose selection is not required.
Shelf life
1.5 years
From the side of the central nervous system: unusual vivid dreams, hallucinations, drowsiness, irritability, agitation (including aggressive behavior), fatigue, headache, suicidal thoughts and suicidal behavior (suicidality), insomnia, paresthesia / hypesthesia is very rare – convulsive seizures.
From the digestive system: nausea, vomiting, diarrhea, abdominal pain.
From the musculoskeletal system: arthralgia, myalgia, including muscle cramps.
Dermatological reactions: erythema nodosum, tendency to form subcutaneous hemorrhages.
Other: a tendency to increase bleeding, subcutaneous hemorrhage, palpitations, edema.
In general, Singular ® is well tolerated. Side effects are usually mild and, as a rule, do not require discontinuation of treatment. The overall incidence of side effects reported with the use of Singular is comparable to that for placebo.
Drug Interactions
The singular can be prescribed together with other drugs 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 montelukast AUC value decreases while taking phenobarbital by about 40%, which does not require a change in the dosage regimen of Singular.
In vitro studies have found that montelukast inhibits the cytochrome CYP2C8 isoenzyme system. However, in a study of the in vivo inter-drug interaction of montelukast and rosiglitazone (metabolized with the participation of the CYP 2C8 isoenzyme of the cytochrome system), the inhibition of the CYP 2C8 isoenzyme by montelukast was not confirmed. Thus, in clinical practice, the effect of montelukast on the CYP 2C8-mediated metabolism of a number of drugs, including paclitaxel, rosiglitazone, repaglinide, etc. is not assumed.
Combined treatment with bronchodilators: The singular is a reasonable complement to bronchodilators monotreapia, if the latter do not provide adequate control of bronchial asthma. Upon reaching a therapeutic effect (usually after the first dose) from treatment with Singular, a gradual reduction in the dose of bronchodilators can begin.
Combined treatment with inhaled glucocorticosteroids: Treatment with Singular provides an additional therapeutic effect to patients using inhaled glucocorticosteroids. Once stabilization is achieved, you can begin to reduce the dose of corticosteroid – gradually and under the supervision of a doctor. In some cases, a complete cancellation of inhaled glucocorticosteroids is permissible, however, a sharp replacement of inhaled corticosteroids with a singular is not recommended.
overdose
Symptoms: Symptoms of Singular overdose in patients with chronic bronchial asthma when administered at a dose greater than 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 an acute overdose of montelukast in children (at a dose of at least 150 mg / day). Clinical and laboratory data thus indicate that the safety profile of Singular in children has a safety profile in adults and elderly patients. The most common undesirable effects were thirst, drowsiness, mydriasis, hyperkinesis, and abdominal pain.
Treatment: carrying out symptomatic therapy.
There are no data on the possibility of montelukast withdrawal by peritoneal dialysis or hemodialysis.
Storage Conditions
Store in a dry, dark place at temperatures below 30 ° C.
Shelf life
3 years.
Deystvuyushtee substance
Montelukast
Conditions of release from drugstores
Prescription
dosage form
tablets
Prescribing
Prescribing
Children over 6 years old, Children as prescribed by a doctor, Adult on doctor’s prescription
Merck Sharp & Doom BV, Netherlands
