Index of drugs

As an aid to the treatment of asthma in patients with mild or moderate chronic asthma, in whom the outcomes of treatment with inhaled corticosteroids and short-acting β-agonists used are unsatisfactory. montelukast is also indicated for the prevention of asthma, in which the bronchospasm is mainly caused by physical effort. Table. for chewing and chewing 4 and 5 mg can be used instead of low doses of inhaled corticosteroids in patients with mild severe asthma who have recently experienced severe asthma attacks requiring the use of oral corticosteroids, and who are unable to use corticosteroids in the form inhaled. Table. powl. 10 mg - used in the treatment of bronchial asthma, can also relieve the symptoms of seasonal allergic rhinitis. Table. For chewing and chewing 4 mg are indicated for use in children 2-5 years. Table. for chewing and chewing 5 mg are indicated for use in children 6-14 years. Table. powl. 10 mg - for patients from 15 years.

1 tabl chewing and chewing contains 4 mg or 5 mg; 1 tabl powl. contains 10 mg of montelukast in the form of sodium salt. Table. chewable and chewable 4 mg and 5 mg contain aspartame. Table. powl. 10 mg contain lactose.

Antiasthmatic drug for general use, highly selective CysLT leukotriene receptor antagonist₁. Montelukast inhibits bronchoconstriction induced by inhalation LTD₄ - cysteinyl leucrienes - eicosanoids with a strong inflammatory action. Bronchodilation was observed within 2 hours of administration. The bronchodilatory action induced by montelukast enhances the effect of the β-agonist. Montelukast inhibits the early and late phase of bronchial spasm response after exposure to the allergen. Decreases the number of eosinophils in the peripheral blood and in the airways, improves clinical control of asthma. After oral administration, it is absorbed from the gastrointestinal tract. In adults after administration on an empty stomach tabl. powl. 10 mg maximum plasma concentration occurs within 3 h, the average bioavailability is 64%, the standard meal does not affect bioavailability. In adults after administration on an empty stomach tabl. For chewing and chewing 5 mg the maximum plasma concentration occurs within 2 h, the average bioavailability is 73%, the standard meal reduces it to 63%. The maximum concentration in adults after fasting a chewable tablet 5 mg occurs within 2 h. The average oral bioavailability is 73%, and a standard meal reduces it to 63%. The drug is associated with plasma proteins in over 99%. It is extensively metabolised by CYP3A4, CYP2A6 and CYP2C9. The drug and its metabolites are excreted almost exclusively in the bile.

Hypersensitivity to montelukast or any drug adjuvant.

The medicine can not be used to treat acute asthma attacks. You should not substitute for montelukast corticosteroids in inhaled or oral form. There is no evidence to suggest that the dose of oral corticosteroids may be reduced if montelukast is co-administered. Because of the risk of Churg-Strauss syndrome, caution should be used and the treatment regimen should be re-evaluated if the patient develops eosinophilia, vascular rash, worsening of lung symptoms, cardiac complications and / or neuropathy. In patients with asthma associated with hypersensitivity to Acetylsalicylic acid, the use of Acetylsalicylic acid or other NSAIDs should still be avoided despite montelukast treatment. There are no data on the use of the drug in patients with severe hepatic impairment. Montelukast is not recommended for monotherapy in patients with chronic mild asthma. The use of montelukast instead of low-dose inhaled corticosteroids in children with chronic mild asthma should only be considered in patients who have not recently had severe asthma attacks requiring oral corticosteroids and if they can not use inhaled corticosteroids.If satisfactory asthma control can not be achieved during treatment after an episode (usually within one month), additional treatment or other anti-inflammatory therapy should be considered as per the asthma treatment regimen. The degree of mastery of asthma symptoms should be periodically assessed. Table. chewing and chewing contains aspartame - they can be harmful for patients with phenylketonuria. Table. powl. 10 mg contain lactose - should not be used in patients with galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.

The drug can be used during pregnancy and breastfeeding only when it is absolutely necessary. The limited number of data from available databases on the use of the drug during pregnancy does not indicate a causal relationship between montelukast and the occurrence of congenital defects (ie limb defects) that have been rarely observed worldwide after the medicine has been introduced.

Common: in adults and adolescents from 15 years - abdominal pain and headache; in children 6-14 years - headache; in children 2-5 years - stomach ache and increased thirst. Post-marketing adverse reactions: upper respiratory tract infection, increased bleeding tendency, hypersensitivity reactions including anaphylactic reactions, eosinophilic infiltrates in the liver, sleep disorders, including nightmares, hallucinations, irritability, insomnia, somnambulism, anxiety, anxiety, agitation, including aggressive behavior, tremors, depression, suicidal thoughts and behaviors (very rarely), dizziness, drowsiness, paresthesia, hypoesthesia, convulsions, palpitations, epistaxis, diarrhea, indigestion, nausea, vomiting, dry membrane mucous oral cavity, increased serum transaminases, hepatitis (including cholestatic, hepatocellular and mixed liver damage), angioneurotic edema, bruising, urticaria, pruritus, rash, erythema nodosum, joint pain, muscle pain (including muscle spasms), swelling, weakness, fatigue, feeling unwell, fever. Very rare cases of Churg-Strauss syndrome have been reported in patients with asthma treated with montelukast.

Orally. Adults and adolescents ≥ 15 years with asthma or asthma and concurrent seasonal allergic rhinitis: 1 tablet. powl. 10 mg once a day in the evening. Children 6-14 years: 1 tabl. for chewing and chewing 5 mg once a day in the evening. Children 2-5 years: 1 tabl. for chewing and chewing 4 mg once a day in the evening. Table. chewing and chewing take 1 h before or 2 h after a meal. The 10 mg dose can be added to the previously used treatment regimen. The therapeutic effect of the preparation on asthma control parameters occurs within one day. Taking the medicine should be continued both when the symptoms are under control and during periods of exacerbation. No dose adjustment is required in patients with renal insufficiency or mild to moderate hepatic impairment. For patients aged 2-14 years with mild persistent asthma, if satisfactory asthma control can not be achieved during treatment after an attack (usually within 1 month), the need for an additional or different anti-inflammatory drug should be considered in accordance with the asthma treatment regimen . In patients aged 2-5 years, exercise-induced bronchoconstriction may be the main symptom of chronic asthma requiring treatment with inhaled corticosteroids; the patient should be evaluated after 2-4 weeks of montelukast treatment, if the response to treatment is not satisfactory, additional or different treatment should be considered.