| Transport Package: | Carton |
|---|---|
| Specification: | 10mg |
| Trademark: | Focus |
| Origin: | China |
| Customization: |
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| Product name | Montelukast sodium tablets |
| Main Ingredients | Montelukast |
| Adaptation disease | This product is thin film, white or white after removing the coating. |
| Dosage form | Troche |
| Character | The product is indicated for the prophylaxis and long-term treatment of asthma in adults 15 years and older, 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 intended to relieve the symptoms of allergic rhinitis (seasonal and perennial allergic rhinitis in adults 15 years and older). |
| Specification | 10mg |
| Usage and dosage | One tablet (10 mg), once a day. Asthma patients should take it before bed. Allergic rhinitis patients can take it when necessary according to their own conditions. Patients with both asthma and allergic rhinitis should take the medicine once a night. 10 mg once daily for adults 15 years and older with asthma and/or allergic rhinitis. |
| Storage | Keep away from light, sealed, in a cool (not more than 20 ºC) dry place |
| Origin | China |
| validity | 24 months |
| Tatoo | Allergic to any of the ingredients in this product is not allowed. |
| Notice | [Adverse reactions] This product is generally well tolerated, with mild adverse reactions and usually does not require termination of treatment. The overall rate of adverse reactions was similar to that of placebo. 1. Asthma patients aged 15 and above Clinical studies have been conducted to evaluate the safety of this product in approximately 2600 adults with asthma aged 15 years and older. In the two similarly designed, placebo-controlled 12-week trials, abdominal pain and headache were associated with a greater rate of drug-related adverse events (≥ 1%) than those in the placebo group. However, the incidence of these adverse events did not differ significantly between the two groups. In clinical studies, 544 patients have been treated with the product for at least 6 months, 253 for 1 year, and 21 for 2 years. The incidence of adverse events did not change with the prolongation of treatment time. 2. Patients aged 15 and above with seasonal allergic rhinitis Clinical studies have been conducted to evaluate the safety of this product in approximately 2199 adults 15 years and older with seasonal allergic rhinitis. It was well tolerated once every morning or night with a rate of adverse reactions similar to that of placebo. In placebo-controlled clinical studies, the incidence of drug-related events in the treatment group was ≥ 1% and higher than that in 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. 3. Patients aged 15 and above with perennial allergic rhinitis The safety of this product was evaluated in two six-week placebo-controlled clinical studies in 3235 patients 15 years and older with perennial allergic rhinitis. The once-daily dose was well tolerated, and the incidence of adverse reactions was similar to that of the placebo group, and was consistent with the clinical results of seasonal allergic rhinitis. In both clinical studies, the incidence of adverse events was less than 1% in the treatment group, and no drug-related adverse events were found to be higher than those in the placebo group. The incidence of drowsiness was similar to that of the placebo group. 4. Combined analysis of clinical practice A review of 41 placebo-controlled clinical studies using an effective assessment of suicidal behavior (35 studies in patients 15 years and older; Six studies were performed in children aged 6-14 years). Among 9929 patients taking the product and 7780 patients taking placebo, one patient with suicidal ideation received the product. There were no completed suicides, suicide attempts, or preparatory actions for suicidal behavior in any of the groups. 46 placebo-controlled clinical studies (35 studies in patients 15 years and older and 11 studies in children 3 months to 14 years) were independently pooled to evaluate behavior-related adverse events. The incidence of behavior-related adverse events was 2.73% in 11673 patients taking this product and 2.27% in 8827 patients taking placebo; The odds ratio was 1.12(95%Cl[0.93:1.36]). The clinical trials included in these pooled analyses were not specifically designed to examine suicide rates or behavior-related adverse events. 5. The following adverse reactions have been reported after the product is put on the market: Infection and transmission: upper respiratory tract infection Blood pressure and lymphatic system disorders: increased tendency to bleed. Disorders of the immune system: hypersensitivity, including allergic reactions, and rare eosinophils in the liver. Mental system disorders: including aggressive behavior or hostile excitement, anxiety, depression, abnormal night dreams, hallucinations, insomnia, irritability, restlessness, sleepwalking, suicidal thoughts and behavior (suicide), tremors. Nervous system disorders: vertigo, drowsiness, paresthesia/loss of touch, and rare seizures. Heart disorders: palpitations. Respiratory, thoracic, and mediastinal disturbances: epistaxis. Gastrointestinal disorders: diarrhea, indigestion, nausea, vomiting. Hepatobiliary disorders: elevated ALT and AST, very rare hepatitis (including cholestatic, hepatocellular, and mixed liver lesions). Skin and subcutaneous disorders: angioedema, bruising, erythema nodosum, pruritus, rash, urticaria. Musculoskeletal and connective tissue disorders: joint pain, myalgia including muscle spasms. Other disorders and administration site conditions: edema, fever. |
| 1. The efficacy of oral administration in the treatment of acute asthma attacks has not been determined. Therefore, it should not be used to treat acute asthma attacks. Patients should be informed to prepare appropriate salvage medications. Sudden substitution of inhaled or oral glucocorticoids should not be used, although the combined dose of inhaled corticosteroids may be gradually reduced under the guidance of a physician. Neuropsychiatric events have been reported in patients taking this product (see adverse reactions). As other factors may also cause these events, they cannot be confirmed to be related to this product. Physicians should discuss these adverse events with patients and/or caregivers. The patient and/or caregiver should be informed and the doctor should be notified if these conditions occur. Patients treated with antiasthmatic medications, including leukotriene receptor antagonists, rarely develop one or more of the following conditions: acidic granulocytosis, vascular rash, worsening of pulmonary symptoms, cardiac complications, and/or neuropathy (sometimes diagnosed as churg-Strauss syndrome, a systemic eosinophilic vasculitis). These conditions are sometimes associated with reduction or discontinuation of oral glucocorticoid therapy. Although the causal relationship between these conditions and leukotriene receptor antagonists has not been established, attention and appropriate clinical monitoring are recommended for patients taking singulair. 2. Medication for pregnant and lactating women Pregnant women should avoid taking this product unless explicitly required. Global post-marketing experience has shown that rare neonatal congenital limb defects have been reported after use of this product during pregnancy. The vast majority of these women also used other asthma medications during pregnancy. A causal relationship between the use of this product and these events has not been established. It is not clear whether this product can be secreted from breast milk. Since many drugs can be secreted from breast milk, lactating women should use this product with caution. 3. Medication for children Safety and efficacy studies have been conducted in children aged 6 months to 14 years. For children aged 2 to 14 years, please refer to montelukast sodium chewable tablets [Usage and dosage]. Safety and efficacy in children younger than 6 months have not been studied. Studies have shown that this product does not affect the growth rate of children. Special patient 4. There is no need to adjust the dose for the elderly, patients with renal insufficiency or patients with mild to moderate hepatic insufficiency. There was no clinical data for montelukast in patients with severe liver insufficiency (Child-pugh score >9). |
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