Product Overview
[Drug Name]
Generic Name: Montelukast Sodium Chewable Tablets
Trade Name: Taiyue Montelukast Sodium Chewable Tablets, 5mg x 7 tablets
[Main Ingredient]
Montelukast sodium.
[Appearance]
This product is white tablets.
[Indications/Main Functions]
For the prevention and long-term treatment of asthma in adults and children 2 years of age and older, including prevention of daytime and nighttime asthma symptoms, treatment of aspirin-sensitive asthma, and prevention of exercise-induced bronchoconstriction. It is also used to relieve symptoms of seasonal allergic rhinitis.
[Specifications]
5mg x 7 tablets
[Dosage and Administration]
Once daily. Asthma patients should take the drug at bedtime. Seasonal allergic rhinitis patients can take the drug at a time of day as needed. Patients with both asthma and seasonal allergic rhinitis should take the drug once every night. Adults 15 years of age and older with asthma and/or seasonal allergic rhinitis should take the drug once daily, 10mg each time. For children aged 6 to 14 years with asthma and/or seasonal allergic rhinitis, take 5 mg once daily. For children aged 2 to 5 years with asthma and/or seasonal allergic rhinitis, take 4 mg once daily. General recommendations: Asthma control indicators should be used to evaluate the therapeutic effect. The efficacy of this product is evident within one day of medication. This product can be taken with or without food. Patients should be advised to take this product consistently regardless of whether their asthma is under control or exacerbated. No dosage adjustment is required for patients with renal insufficiency, mild to moderate liver damage, or patients of different genders. Relationship between this product and other asthma medications: This product can be added to the patient's existing treatment plan. Reducing the dose of concomitant medications: 1. Bronchodilators: For patients with asthma that is not effectively controlled by bronchodilators alone, this product can be added to the treatment plan. Once there is a clinical response to treatment (usually after the first dose), the bronchodilator dose can be reduced based on the patient's tolerance. 2. Inhaled Corticosteroids: When adding this product to asthma treatment for patients receiving inhaled corticosteroids, the corticosteroid dose can be appropriately reduced based on the patient's tolerance. This reduction should be done gradually under medical supervision.Some patients can gradually reduce the dose until inhaled corticosteroids are completely discontinued. However, this product should not be used abruptly to replace inhaled corticosteroids or as directed by a physician.
[Adverse Reactions]
Montelukast sodium chewable tablets are generally well tolerated, with mild adverse reactions that generally do not require discontinuation of treatment. The overall incidence of adverse reactions with this product is similar to that with placebo. Asthma Patients 15 Years and Older: This product has been evaluated in clinical studies in approximately 2,600 adult asthma patients 15 years and older. In two similarly designed, placebo-controlled, 12-week clinical trials, abdominal pain and headache were reported as drug-related adverse events, occurring at a higher rate (1%) in the montelukast sodium group compared with the placebo group. However, the incidence of these adverse events was not significantly different 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 for 1 year, and 21 patients for 2 years. The incidence of adverse events did not change with longer treatment duration. Seasonal allergic rhinitis patients aged 15 years and older: This product's safety has been evaluated in 2,199 adult patients aged 15 years and older with seasonal allergic rhinitis. This product, taken once daily in the morning or evening, was well tolerated, with an adverse reaction rate similar to that of placebo. In placebo-controlled clinical studies, the incidence of adverse events in the treatment group was less than 1%, and no drug-related adverse events were found, with an incidence higher than that of the placebo group. In four-week, placebo-controlled clinical trials, the safety profile was consistent with that in two-week clinical trials. Across all clinical studies, the incidence of somnolence was similar to that of the placebo group. Pediatric asthma patients aged 6 to 14 years: This product has been evaluated in approximately 320 pediatric patients aged 6 to 14 years. The overall safety profile of levofloxacin in pediatric patients is similar to that of adults and close to that of placebo. In an 8-week placebo-controlled clinical trial, the only drug-related adverse event reported at a higher rate in 1% of patients treated with levofloxacin compared to placebo was headache. However, the incidence of headache did not differ significantly between the two treatment groups. A total of 143 pediatric patients aged 6 to 14 years have been treated with levofloxacin for at least 3 months, and 44 patients have been treated for 6 months or longer. The adverse event profile did not change with longer treatment duration. For pediatric asthma patients aged 2 to 5 years: levofloxacin has been evaluated in approximately 573 pediatric patients aged 2 to 5 years. In a 12-week placebo-controlled clinical trial, the only drug-related adverse event reported at a higher rate in 1% of patients treated with levofloxacin compared to placebo was thirst. However, the incidence of thirst did not differ significantly between the two treatment groups. A total of 426 pediatric patients aged 2 to 5 years have been treated with levofloxacin 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 incidence of adverse events did not change with extended treatment with this product. The safety profile of this product was evaluated in 280 children aged 2 to 14 years with seasonal allergic rhinitis in a two-week, placebo-controlled clinical trial. The safety profile of this product, taken once daily in the evening, was similar to that of the placebo group. In this study, the incidence of adverse reactions in the group treated with this product was less than 1%, and no drug-related adverse reactions were found. The incidence was higher than that of the placebo group. Post-marketing experience: The following adverse reactions have been reported with post-marketing use of this product: hypersensitivity reactions (including anaphylaxis, angioedema, rash, pruritus, urticaria, and rarely, eosinophilic infiltration of the liver; abnormal dreams and hallucinations; drowsiness, excitement, irritability, including aggressive behavior; restlessness; insomnia; paresthesia/tactile disturbances and rarely, seizures; nausea, vomiting, dyspepsia, diarrhea; elevated ALT and AST; rarely, cholestatic hepatitis; arthralgia, including myalgia with muscle cramps; increased bleeding tendency; bruises; palpitations; and edema.
[Contraindications] Contraindications]
Montelukast sodium chewable tablets are contraindicated in patients with allergies to any of the ingredients.
[Drug Interactions]
This product can be used in combination with other medications commonly 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 concomitant phenobarbital, the area under the plasma concentration-time curve (AUC) of montelukast was reduced by approximately 40%. However, dose adjustment of this product is not recommended. In vitro studies have shown that montelukast is an inhibitor of CYP2C8. However, data from a clinical study investigating the drug-drug interaction between montelukast and rosiglitazone (a typical substrate-drug metabolized primarily by CYP2C8) showed that montelukast did not inhibit CYP2C8 in vivo. Therefore, montelukast is not expected to affect drugs metabolized by this enzyme (e.g., paclitaxel, rosiglitazone, repaglinide).
[Precautions]
1. The efficacy of oral montelukast sodium chewable tablets in the treatment of acute asthma attacks has not been established. Therefore, it should not be used to treat acute asthma attacks. 2. Although concomitant use can be gradually reduced under the guidance of a physician, 3. There have been reports of psychoneurological events in patients taking this product (see Adverse Reactions). Since other factors may also cause these events, it cannot be confirmed whether they are related to this product. The doctor should discuss these adverse events with the patient and/or caregiver. The patient and/or caregiver should be informed that if these situations occur, the doctor should be notified. 4. In patients receiving anti-asthma drugs including leukotriene receptor antagonists, when reducing the dose of systemic corticosteroids, one or more of the following situations may occur in rare cases: eosinophilia, vascular dermatitis Rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy (sometimes diagnosed as Chrg-Strauss syndrome, a systemic eosinophilic vasculitis). Although a causal relationship between these conditions and leukotriene receptor antagonists has not been established, caution and appropriate clinical monitoring are recommended when reducing the dose of systemic corticosteroids in patients receiving this drug.
[Pediatric Use]
Safety and efficacy studies have been conducted in children aged 6 months to 14 years. Safety and efficacy have not been studied in children under 6 months of age.
[Elderly Use]
In clinical studies, no age-related differences in the efficacy and safety of this drug were observed.
