Montelukast Sodium Tablets

Cysteinyl leukotrienes (LTC4, LTD4, LTE4) are potent inflammatory mediators released by a variety of cells including mast cells and eosinophils. These important pro-asthmatic mediators bind to cysteinyl leukotriene (CysLT) receptors. Cysteinyl leukotriene 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 responses such as bronchoconstriction, mucus secretion, increased vascular permeability, and eosinophil accumulation. In allergic rhinitis, the nasal mucosa releases CysLTs that are 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 is a potent oral preparation that can significantly improve asthma inflammation indicators. Biochemical and pharmacological bioassays show that montelukast has a high affinity and selectivity for CysLT1 receptors (compared with other pharmacologically important airway receptors such as prostanoids, cholinergic and beta-adrenergic receptors). Montelukast can effectively inhibit the physiological effects of LTC4, LTD4 and LTE4 binding to CysLT1 receptors without any receptor agonist activity. Current studies believe that montelukast does not antagonize CysLT2 receptors. Toxicological studies: Carcinogenicity: Studies in rats with oral doses of up to 200 mg/kg/day for 106 weeks and mice with oral doses of up to 100 mg/kg/day for 92 weeks have not found montelukast sodium to be carcinogenic. These doses are equivalent to 1000 times and 500 times the recommended adult dose*. Mutagenicity: In vitro microbial mutation tests and V-79 mammalian cell mutation tests, the test results of this product are negative. Negative results were obtained in the in vitro rat hepatocyte alkaline elution test and the Chinese hamster ovary cell chromosome aberration test. When male or female mice were orally administered with this product up to 1200 mg/kg (3600 mg/m2) (6000 times the recommended daily dose for adults*), no effect of inducing chromosomal abnormalities in bone marrow cells was found. Reproductive toxicity: No effects on fertility and reproductive performance were found in studies of oral administration of montelukast sodium up to 800 mg/kg/day in male rats and 100 mg/kg/day in female rats, which are 4000 times and 500 times higher than the recommended dose for adults, respectively*. In the developmental toxicity study, no treatment-related adverse effects were observed when montelukast sodium was administered to rats at doses up to 400 mg/kg/day and to rabbits at doses up to 100 mg/kg/day. There was indeed a case of fetal exposure to montelukast sodium in rats and rabbits, and montelukast sodium was significantly detected in the milk of lactating rats. (*Based on adult weight of 50 kg)

The main ingredient of this product is montelukast sodium.

This product is suitable for the prevention and long-term treatment of asthma in adults aged 15 years and over, including the prevention of daytime and nighttime asthma symptoms, the treatment of aspirin-sensitive asthma patients, and the prevention of exercise-induced bronchoconstriction. This product is suitable for adults aged 15 years and over to relieve the symptoms caused by seasonal allergic rhinitis.

Patients aged 15 years and above with asthma and/or seasonal allergic rhinitis should take one tablet (10 mg) once daily. Asthma patients should take it before bedtime. Patients with seasonal allergic rhinitis can take the medicine when needed according to their own conditions. Patients with both asthma and seasonal allergic rhinitis should take the medicine once a night. General advice: Use asthma control indicators to evaluate the therapeutic effect. The efficacy of this product will appear 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. Elderly patients, patients with renal insufficiency, patients with mild to moderate liver damage, and patients of different genders do not need to adjust the dose. Relationship between Montelukast Sodium Tablets and other asthma treatment drugs This product can be added to the patient's existing treatment plan. Reduction

This product is generally well tolerated, with mild adverse reactions, and usually no termination of treatment is required. 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, ge; 1% of patients in the treatment group of this product experienced drug-related adverse events that were higher than those in the placebo group, namely abdominal pain and headache. 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. As the treatment time of this product is extended

It is contraindicated for those who are allergic to any ingredient in 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 seasonal allergic rhinitis. In drug interaction studies, the recommended dose of this product does 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 who are taking phenobarbital in combination, the area under the plasma concentration-time curve (AUC) of montelukast is reduced by approximately 40%. However, it is not recommended to adjust the dosage of this product.

Keep tightly closed in a cool, dark and dry place.

10 mg