Singlon chewable tablets 4mg, No. 28
Expiration Date: 05/2027
Russian Pharmacy name:
Синглон таблетки жевательные 4мг, №28
Singlon is taken orally, regardless of the meal. Adults and adolescents over 15 years old - 10 mg once a day, before bedtime. Children 6-14 years old - 5 mg / day.
Active substance:
montelukast
Hypersensitivity, childhood (up to 6 years).
pharmachologic effect
Singlon is a blocker of cysteinyl leukotriene receptors CysLT1 (leukotrienes C4, D4 and E4 are mediators of chronic persistent inflammation that maintain bronchial hyperreactivity in bronchial asthma). Prevents excessive secretion in the bronchi, edema of the mucous membrane of the respiratory tract. Reduces the severity of bronchial asthma and the frequency of asthmatic attacks. Highly effective when taken orally. Bronchodilator effect develops within 1 day and persists for a long time. It is effective in patients with mild persistent asthma not sufficiently controlled by bronchodilators alone.
Indications
Bronchial asthma (prevention and long-term treatment), complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to ASA or other NSAIDs (including in history), exercise-induced bronchial asthma, allregic rhinitis.
Contraindications
Hypersensitivity, childhood (up to 6 years).
Carefully.
Pregnancy, lactation.
special instructions
The effectiveness of oral montelukast in the treatment of acute attacks of bronchial asthma has not been established. Therefore, oral montelukast is not recommended for the treatment of acute attacks of bronchial asthma. Patients should be instructed to always carry emergency medications for asthma attacks (short-acting inhaled beta2-agonists). You should not stop taking montelukast during an exacerbation of asthma and the need to use emergency medications (short-acting inhaled beta2-agonists) to relieve attacks. Patients with a confirmed allergy to acetylsalicylic acid and other NSAIDs should not take these drugs during treatment with montelukast, since montelukast improves respiratory function in patients with allergic bronchial asthma,however, it cannot completely prevent bronchoconstriction caused by NSAIDs. The dose of inhaled corticosteroids used simultaneously with montelukast can be gradually reduced under the supervision of a physician, however, abrupt replacement of inhaled or oral corticosteroids with montelukast cannot be performed. Neuropsychiatric disorders have been described in patients taking montelukast. Given that these symptoms may have been caused by other factors, it is not known if they are related to taking montelukast. The physician should discuss these side effects with patients and / or their parents / guardians. It should be explained to patients and / or their caregivers that in the event of such symptoms, they should inform the attending physician. Reducing the dose of systemic corticosteroids in patients receiving anti-asthma drugs, including leukotriene receptor blockers,accompanied in rare cases by the appearance of one or more of the following reactions: eosinophilia, rash, worsening pulmonary symptoms, cardiac complications and / or neuropathy, sometimes diagnosed as Chard-Strauss syndrome, systemic eosinophilic vasculitis. Although the causal relationship of these adverse reactions with therapy with leukotriene receptor antagonists has not been established, when reducing the dose of systemic corticosteroids in patients receiving montelukast, caution should be exercised and appropriate clinical observation should be carried out.Although the causal relationship of these adverse reactions with therapy with leukotriene receptor antagonists has not been established, when reducing the dose of systemic corticosteroids in patients receiving montelukast, caution should be exercised and appropriate clinical observation should be carried out.Although the causal relationship of these adverse reactions with therapy with leukotriene receptor antagonists has not been established, when reducing the dose of systemic corticosteroids in patients receiving montelukast, caution should be exercised and appropriate clinical observation should be carried out.
Composition
montelukast
Method of administration and dosage
Singlon is taken orally, regardless of the meal.
Adults and adolescents over 15 years old - 10 mg once a day, before bedtime. Children 6-14 years old - 5 mg / day.
Side effects
From the side of the blood coagulation system: increased tendency to bleeding.
From the immune system: hypersensitivity reactions, incl. anaphylaxis; rarely
From the side of the psyche: agitation (including aggressive behavior or hostility), anxiety, depression, disorientation, pathological dreams, hallucinations, insomnia, irritability, anxiety, somnambulism, suicidal thoughts and behavior (suicidality), tremor.
From the nervous system: dizziness, drowsiness, paresthesia / hypesthesia; very rarely (<1/10 000) - convulsions.
On the part of the cardiovascular system: tachycardia.
From the respiratory system: nosebleeds, upper respiratory tract infections.
From the digestive system: diarrhea, dyspepsia, nausea, vomiting, pancreatitis, increased ALT and ACT activity in the blood; rarely
On the part of the skin and subcutaneous tissues: a tendency to form hematomas, erythema nodosum, erythema multiforme, itching, rash. Allergic reactions: angioedema, urticaria.
From the musculoskeletal system: arthralgia, myalgia, including muscle cramps.
On the part of the body as a whole: asthenia (weakness) / fatigue, edema, pyrexia.
Drug interactions
ѕри одновременном применении с фенобарбиталом AUC монтелукаста уменьшалась примерно на 40% (коррекци¤ режима монтелукаста не требуетс¤). ¬ исследовани¤х in vitro установлено, что монтелукаст ингибирует изофермент CYP2C8, однако при исследовании лекарственного взаимодействи¤ in vivo монтелукаста и роcиглитазона (метаболизируетс¤ с участием изофермента CYP2C8 ) не получено подтверждени¤ ингибировани¤ монтелукастом изофермента CYP2C8. ѕоэтому в клинической практике не предполагаетс¤ вли¤ние монтелукаста на CYP2—8-опосредованный метаболизм р¤да лекарственных препаратов, в т.ч. паклитаксела, росиглитазона, репаглинида. ћонтелукаст ¤вл¤етс¤ обоснованным дополнением к монотерапии бронходилататорами, если последние не обеспечивают адекватного контрол¤ бронхиальной астмы. ѕо достижении терапевтического эффекта от лечени¤ монтелукастом можно начать постепенное снижение дозы бронходилататоров. ѕрименение монтелукаста обеспечивает дополнительный терапевтический эффект у пациентов, получающих ингал¤ционные v —. ѕо достижении стабилизации состо¤ни¤, можно начать постепенное снижение дозы v — под наблюдением врача. ¬ некоторых случа¤х допустима полна¤ отмена ингал¤ционных v —, однако резка¤ замена ингал¤ционных кортикостероидов на монтелукаст не рекомендуетс¤.
Overdose
There is no specific information on the treatment of Singlon overdose. Data on the symptoms of overdose when taking the drug by adult patients with bronchial asthma at a dose exceeding 200 mg / day. within 22 weeks and at a dose of 900 mg / day. within 1 week was not revealed. There have been cases of acute overdose of montelukast in adults and children at a dose above 1000 mg (approximately 61 mg / kg for a child aged 42 months). The clinical and laboratory results obtained were consistent with the safety profile for adults and pediatric patients. The most common adverse events were consistent with the safety profile of montelukast and included abdominal pain, drowsiness, mydriasis, thirst, headache, vomiting, and psychomotor hyperactivity.There is no data on the possibility of excretion of montelukast during peritoneal dialysis or hemodialysis.
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