Montelukast Sodium Chewable Tablets

Cysteinyl leukotrienes (LTC4, LTD4, LTE4) are inflammatory mediators released by a variety of cells including mast cells and eosinophils. These important pro-asthma mediators bind to cysteinyl leukotrienes (CysLT) receptors. Cysteinyl leukotrienes type I (CysLT1) receptors are distributed in the human airways (including airway smooth muscle cells and airway macrophages) and other pro-inflammatory cells (including eosinophils and certain bone marrow stem cells). CysLTs are associated with the pathophysiological processes of asthma and allergic rhinitis. In asthma, leukotriene-mediated effects include a series of airway reactions, such as bronchoconstriction, mucus secretion, increased vascular permeability, and eosinophil aggregation. In allergic rhinitis, the nasal mucosa releases CysLTs associated with allergic rhinitis symptoms in both the immediate and delayed phase reactions after allergen exposure. Intranasal CysLTs stimulation increases nasal airway resistance and symptoms of nasal obstruction. This product can improve indicators of asthma inflammation. This product has a high affinity and selectivity for CysLT1 receptors, and can effectively inhibit the physiological effects of LTC4, LTD4 and LTE4 binding to CysLT1 receptors without any receptor agonist activity. Current studies suggest that montelukast does not antagonize CysLT2 receptors.

The main ingredient of this product is montelukast sodium, and its chemical name is: ()-1-[[[(1R)-1-[3-[(1E)-2-(7-chloro-2-quinolyl)-vinyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid monosodium salt. Molecular formula: C35H35ClNNaO3S Molecular weight: 608.18

This product is white tablets.

Prevention and long-term treatment of asthma in adults and children 2 years and older, including prevention of daytime and nighttime asthma symptoms, treatment of patients with aspirin-sensitive asthma, and prevention of exercise-induced bronchoconstriction; also used to relieve symptoms caused by seasonal allergic rhinitis.

Once a day. Asthma patients should take it before bedtime. Seasonal allergic rhinitis patients can take the medicine at the time needed according to their own conditions. Patients with both asthma and seasonal allergic rhinitis should take the medicine once every night. Adult patients aged 15 years and above with asthma and/or seasonal allergic rhinitis should take the medicine once a day, 10 mg each time. Children aged 6 to 14 years with asthma and/or seasonal allergic rhinitis should take it once a day, 5 mg each time. Children aged 2 to 5 years with asthma and/or seasonal allergic rhinitis should take it once a day, 4 mg each time. General advice: The treatment effect is evaluated by asthma control indicators. The efficacy of this product appears within one day of medication. This product can be taken with or without food. Patients should be advised to take it regardless of whether their asthma is under control or exacerbated. No dosage adjustment is required for patients with renal insufficiency, patients with mild to moderate liver damage, and patients of different genders. Relationship between this product and other asthma treatment drugs: This product can be added to the patient's existing treatment plan. Reduce the dose of combined drugs: 1. Bronchodilators: For asthma patients who cannot be effectively controlled by bronchodilators alone, this product can be added to the treatment plan. Once there is a clinical treatment response (usually after the first dose of the drug), the dose of bronchodilators can be reduced according to the patient's tolerance. 2. Inhaled corticosteroids: After adding this product to asthma patients receiving inhaled corticosteroids, the dose of corticosteroids can be appropriately reduced according to the patient's tolerance. The dose should be gradually reduced under medical supervision. Some patients can gradually reduce the dose until the inhaled corticosteroids are completely stopped. However, this product should not be used to suddenly replace inhaled corticosteroids or follow the doctor's advice.

This product is generally well tolerated, with mild adverse reactions, and usually does not require termination of treatment. The overall incidence of adverse reactions of this product is similar to that of placebo. Asthma patients aged 15 years and above: Clinical studies have been conducted in approximately 2,600 adult asthma patients aged 15 years and above to evaluate the use of this product. In two similarly designed, placebo-controlled 12-week clinical trials, 1% of patients in the treatment group of this product experienced abdominal pain and headache, which was higher than the placebo group and drug-related adverse events. However, there was no significant difference in the incidence of these adverse events between the two groups. In clinical studies, a total of 544 patients have been treated with this product for at least 6 months, 253 patients have been treated for 1 year, and 21 patients have been treated for 2 years. With the extension of the treatment time of this product, the occurrence of adverse events has not changed. Patients with seasonal allergic rhinitis aged 15 years and above: Clinical studies have been conducted in 2,199 adult seasonal allergic rhinitis patients aged 15 years and above to evaluate the safety of this product. This product is well tolerated when taken once a day in the morning or at night, and the incidence of adverse reactions is similar to that of placebo. In placebo-controlled clinical studies, the incidence of adverse events in the treatment group of this product was less than 1%, and no adverse events related to the drug were found, with an incidence higher than that of the placebo group. In the 4-week placebo-controlled clinical trial, the safety profile was consistent with the 2-week clinical trial. In all clinical studies, the incidence of drowsiness was similar to that of the placebo group. Children aged 6 to 14 years with asthma: Clinical studies have been conducted in approximately 320 children aged 6 to 14 years to evaluate the use of this product. Overall, the safety of this product in children is similar to that of adults and close to that of placebo. In a placebo-controlled 8-week clinical trial, the only drug-related adverse event that occurred in 1% of patients in the treatment group of this product was headache, which was higher than that in the placebo group. However, there was no significant difference in the incidence of headache between the two groups. A total of 143 children aged 6 to 14 years have been treated with this product for at least 3 months, and 44 patients have been treated for 6 months or longer. The occurrence of adverse events has not changed with the extension of the treatment time of this product. Asthma patients aged 2 to 5 years: The use of this product has been evaluated in approximately 573 pediatric patients aged 2 to 5 years. In a placebo-controlled 12-week clinical trial, the only drug-related adverse event that occurred in 1% of patients in the treatment group of this product was thirst. However, there was no significant difference in the incidence of thirst between the two groups. A total of 426 pediatric patients aged 2 to 5 years have been treated with this product for at least 3 months, 230 patients have been treated for 6 months or longer, and 63 patients have been treated for 12 months or longer. The occurrence of adverse events did not change with the extension of the treatment time of this product. Pediatric patients aged 2 to 14 years with seasonal allergic rhinitis In a 2-week placebo-controlled clinical trial, the safety of this product has been evaluated in 280 patients aged 2 to 14 years with seasonal allergic rhinitis. The safety of taking this product once a day in the evening was similar to that of the placebo group. In this study, the incidence of adverse reactions in the treatment group of this product was less than 1%, and no drug-related adverse reactions were found to be higher than the placebo group. Post-marketing experience: The following adverse reactions have been reported after the product was marketed: hypersensitivity reactions (including allergic reactions, angioedema, rash, itching, urticaria and rare eosinophilic infiltration of the liver), abnormal dreams and hallucinations, drowsiness, excitement, irritability, including aggressive behavior, irritability, insomnia, paresthesia/tactile disorders and rare epileptic seizures, nausea, vomiting, dyspepsia, diarrhea, increased ALT and AST, rare cholestatic hepatitis; joint pain, including myalgia with muscle cramps; increased bleeding tendency, bruises; palpitations and edema.

Do not use if you are allergic to any ingredient of this product.

Precautions for children: Safety and efficacy studies have been conducted in children aged 6 months to 14 years. Safety and efficacy studies have not been conducted in children under 6 months of age. Precautions for pregnancy and lactation: Use under the guidance of a physician. Precautions for the elderly: In clinical studies, there was no age difference in the effectiveness and safety of this product.

This product can be used in combination with other drugs routinely used for the prevention and long-term treatment of asthma and the treatment of allergic rhinitis. In drug interaction studies, the recommended dose of this product did not produce clinically significant pharmacokinetic effects on the following drugs: theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol/norethindrone 35/1), terfenadine, digoxin and warfarin. In patients taking phenobarbital concomitantly, the area under the plasma concentration-time curve (AUC) of montelukast decreased by approximately 40%. However, it is not recommended to adjust the dosage of this product. In vitro tests have shown that montelukast is an inhibitor of CYP2C8. However, data from a clinical study on the drug interaction between montelukast and rosiglitazone (a typical detection substrate that is mainly metabolized by CYP2C8) showed that montelukast had no inhibitory effect on CYP2C8 in vivo. Therefore, it is believed that montelukast will not affect drugs metabolized by this enzyme (e.g., paclitaxel, rosiglitazone, repaglinide).

Keep away from light, tightly sealed, and stored in a cool (not exceeding 20°C) and dry place.

5 mg (as montelukast)

24 months

Sichuan OTSUKA Pharmaceutical Co., Ltd.

• Founded in:

  2002-08-13

• Address:

  No. 1, Linjiang North Road, High-tech Industrial Development Zone, Leshan City, Sichuan Province

• Tax NO.:

  91511100740043436K

• Registered Funds:

  $33,627,066

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