Product Overview
[Drug Name]
Generic Name: Montelukast Sodium Chewable Tablets
Trade Name: Pingqi Montelukast Sodium Chewable Tablets 5mg*12 Tablets
Pinyin Full Code: PingQi MengLuSiTeNaJuJiaoPian 5mg*12 Tablets
[Main Ingredients]
The main ingredient is montelukast sodium.
[Indications/Main Functions]
For the prevention and long-term treatment of asthma in adults and children aged 2 years and above, 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*12 tablets (Pingqi)
[Dosage and Administration]
Once daily. Asthma patients should take the medication at bedtime. Seasonal allergic rhinitis patients can take the medication at a time of day as needed. Patients with both asthma and seasonal allergic rhinitis should take the medication once every night. Adults 15 years and older with asthma and/or seasonal allergic rhinitis should take 10 mg once daily. Children 6 to 14 years of age with asthma and/or seasonal allergic rhinitis should take 5 mg once daily. Children 2 to 5 years of age with asthma and/or seasonal allergic rhinitis should take 4 mg once daily. General Recommendations: Asthma control measures should be used to evaluate therapeutic efficacy, with the effectiveness of this medication being apparent within one day of initiation. This medication can be taken with or without food. Patients should be advised to continue taking this medication regardless of whether their asthma is under control or exacerbations. No dose adjustment is required for patients with renal insufficiency, mild to moderate hepatic impairment, or gender. Relationship between this medication and other asthma medications: This medication can be added to a patient's existing treatment regimen. Reducing the dose of concomitant medications: 1. Bronchodilators: For patients with asthma not effectively controlled with bronchodilators alone, this medication can be added to the treatment regimen. Once a clinical response is observed (usually after the first dose), the bronchodilator dose can be reduced based on the patient's tolerance. 2. Inhaled Corticosteroids: When this product is added 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 performed 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]
This product is 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 aged 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 at a higher rate (1%) in the treatment group compared with the placebo group. However, the incidence of these adverse events did not differ significantly between the two groups. In clinical studies, a total of 544 patients have been treated with this drug for at least six months, 253 patients for one year, and 21 patients for two years. The incidence of adverse events did not change with longer treatment duration. Seasonal allergic rhinitis patients aged 15 years and older: This drug's safety profile has been evaluated in 2,199 adult patients aged 15 years and older with seasonal allergic rhinitis. This drug was well tolerated when taken once daily in the morning or evening, 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 to be higher than those in the placebo group. The safety profile in the four-week, placebo-controlled clinical trials was consistent with that in the two-week trials. Across all clinical studies, the incidence of somnolence was similar to that in the placebo group. Pediatric asthma patients aged 6 to 14 years: This drug 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 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 in the placebo group. Post-marketing experience: The following adverse reactions have been reported after the 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, irritability, 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]
Montelukast sodium chewable tablets should not be used in patients with hypersensitivity to any of the ingredients.
[Drug Interactions]
Montelukast sodium chewable tablets 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 Montelukast sodium chewable tablets 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. The area under the plasma concentration-time curve (AUC) of montelukast decreased by approximately 40% in patients taking phenobarbital concomitantly. However, no dose adjustment is recommended. In vitro studies have shown that montelukast is an inhibitor of CYP2C8. However, data from a clinical drug interaction study between montelukast and rosiglitazone (a typical probe substrate primarily metabolized by CYP2C8) indicate that montelukast does 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 this oral medication for the treatment of acute asthma attacks has not been established. Therefore, it should not be used to treat acute asthma attacks. 2. Although the dose of concomitant inhaled corticosteroids can be gradually reduced under the guidance of a physician, this medication should not be used abruptly to replace inhaled or oral corticosteroids. 3. Psychoneural events have been reported in patients taking montelukast sodium chewable tablets (see Adverse Reactions). Because other factors may contribute to these events, a relationship to this medication cannot be confirmed. Physicians should discuss these adverse events with patients and/or caregivers. Patients and/or caregivers should be advised to notify their physician if these events occur. 4. In rare cases, patients receiving anti-asthma medications, including leukotriene receptor antagonists, may experience one or more of the following when the dose of systemic glucocorticoids is reduced: eosinophilia, vascular rash, worsening of 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 glucocorticoids in patients receiving this product.
[Use in Elderly Patients]
In clinical studies, there were no age-related differences in the efficacy and safety of this product.
