Product Overview
[Drug Name]
Generic Name: Montelukast Sodium Tablets
Trade Name: NuoYiAn Montelukast Sodium Tablets 10mg*30 Tablets
Pinyin Code: NuoYiAnMengLuSiteNaPia10mg30Pian
[Main Ingredients]
The main ingredient of this product is montelukast sodium. Chemical Name: [R-(Hydroxy)-1-[1-3-2-7-Oxo-2-quinolinyl)vinyl]phenyl]-3-{2-(1-hydroxy-1-methylethyl)phenyl]propyl]thiomethyl]cyclopropaneacetic acid, sodium. Molecular Formula: C35H35CINNaO03S Molecular Weight: 608.17
[Properties]
This product is a yellow, round tablet engraved with "OE" on one side and "680" on the other. It appears white or off-white after removing the coating.
[Indications/Main Functions]
This product is indicated for the prevention and long-term treatment of asthma in adults 15 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 indicated for the relief of symptoms associated with allergic rhinitis (seasonal and perennial allergic rhinitis in adults 15 years of age and older).
[Specifications]
10mg x 30 tablets
[Dosage]
One tablet (10mg) once daily. Asthma patients should take the drug at bedtime. Allergic rhinitis patients may take the drug as needed based on their condition. Patients with both asthma and allergic rhinitis should take the drug once nightly. Adults 15 years of age and older with asthma and/or allergic rhinitis should take the drug once daily, 10mg each time. It is generally recommended to use asthma control indicators. To evaluate the therapeutic effect, the efficacy of this product will appear within one day of taking the medicine. 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 in the exacerbation stage. 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. The relationship between Montelukast sodium tablets and other asthma treatment drugs: This product can be added to the patient's existing treatment plan. Reduce the dose of concomitant medications: For asthma patients who cannot be effectively controlled by bronchodilators alone, this product can be added to the treatment plan. Once there is a significant clinical efficacy response (usually appearing in After the first dose, the bronchodilator dose can be reduced based on the patient's tolerance. For asthma patients receiving inhaled corticosteroids, the dose of the corticosteroid can be appropriately reduced based on the patient's tolerance after adding this product. The dose should be gradually reduced under the guidance of a physician. Some patients can gradually reduce the dose until inhaled corticosteroids are completely discontinued. However, this product should not be used to abruptly replace inhaled corticosteroids.
[Adverse Reactions]
This product is generally well tolerated, with mild adverse reactions that usually do not require discontinuation of treatment. The overall incidence of adverse reactions with this product is similar to that with placebo. Asthma patients over 5 years old Clinical studies have been conducted in approximately 2,600 adult asthma patients aged 15 years and over to evaluate the safety of the original montelukast sodium tablets. In two similarly designed, placebo-controlled 12-week clinical studies, the adverse events with a drug-related incidence of >1% and higher than the placebo group in the original montelukast sodium tablets treatment group were 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 the original montelukast sodium tablets for at least 6 months, 253 patients have been treated for 1 year, and 21 The patients were treated for 2 years. As the treatment time with the original montelukast sodium tablets was extended, the occurrence of adverse events did not change. Patients with seasonal allergic rhinitis aged 15 years and above have been clinically studied in 2199 adult patients with seasonal allergic rhinitis aged 15 years and above to evaluate the safety of the original montelukast sodium tablets. The original montelukast sodium tablets taken once a day in the morning or at night were well tolerated, and the incidence of adverse reactions was similar to that of placebo. In placebo-controlled clinical studies, no drug-related incidence was found in the original montelukast sodium tablets treatment group >1%, and it was higher than Adverse events in the placebo group. In the 4-week placebo-controlled clinical study, the safety profile was consistent with that in the 2-week clinical study. Across all clinical studies, the incidence of somnolence was similar to that in the placebo group. The safety profile of the original montelukast sodium tablets was evaluated in two 6-week, placebo-controlled clinical studies in 3,235 adult patients 15 years of age and older with perennial allergic rhinitis. The original montelukast sodium tablets were well tolerated once daily, with an adverse reaction rate similar to that in the placebo group and consistent with seasonal allergies. The results of clinical studies on rhinitis are consistent. In these two clinical studies, the incidence of adverse events in the treatment group was less than 1%, and no drug-related events were found. The incidence was higher than that of the placebo group. The incidence of drowsiness was similar to that in the placebo group. A pooled analysis of clinical practice used an effective suicide behavior assessment method to pool 41 placebo-controlled clinical studies (35 studies for patients aged 15 years and above; 6 studies for children aged 6-14 years). Among 9,929 patients taking the original montelukast sodium tablets and 7,780 patients taking placebo, one had suicidal ideation. of patients took the original montelukast sodium tablets. No completed suicide, suicide attempt, or preparatory action for suicidal behavior occurred in any group. A separate pooled analysis was conducted on 46 placebo-controlled clinical studies (35 studies in patients 15 years of age and older; 11 studies in pediatric patients 3 months to 14 years of age) to evaluate behavior-related adverse events. The incidence of behavior-related adverse events in 11,673 patients taking the original montelukast sodium tablets and 8,827 patients taking placebo was 2.73% and 2.27%, respectively; the odds ratio was 1.12 (95% CI 0-14). C10.931.36). The clinical trials included in these pooled analyses were not specifically designed to examine suicide rates or behavioral-related adverse events. Postmarketing Experience: The following adverse reactions have been reported with the original montelukast sodium tablets after marketing: Infections and infections: Upper respiratory tract infections. Blood and lymphatic system disorders: Increased bleeding tendency, thrombocytopenia. Immune system disorders: Hypersensitivity reactions including allergic reactions and, very rarely, eosinophilic infiltration of the liver. Psychiatric disorders: Excitement including aggressive behavior or hostility, anxiety, depression, disorientation, difficulty concentrating, abnormal dreams, stuttering (stammering), hallucinations, insomnia, memory impairment, obsessive-compulsive symptoms, psychomotor agitation (including irritability, restlessness, and tremors), sleepwalking, suicidal thoughts and behaviors (suicidality), and convulsions. Nervous system disorders: Dizziness, somnolence, paresthesia/hypoesthesia, and, very rarely, seizures. Cardiac disorders: Palpitations. Respiratory, thoracic, and mediastinal system disorders: Nasal ulcer; pulmonary eosinophilia. Gastrointestinal disorders: diarrhea, dyspepsia, nausea, pancreatitis, vomiting. Hepatobiliary disorders: elevated ALT and AST, very rarely hepatitis (including cholestatic, hepatocellular, and mixed liver damage). Skin and subcutaneous tissue disorders: angioedema, contusions, erythema multiforme, erythema nodosum, pruritus, rash, Stevens-Johnson syndrome/toxic epidermal necrolysis, urticaria. Musculoskeletal and connective tissue disorders: arthralgia, myalgia including muscle cramps. Renal and urinary disorders: enuresis in children (occasionally). Other disorders and administration site conditions: asthenia/fatigue, edema, fever.
[Contraindications]
This product is contraindicated in patients with hypersensitivity to any of the ingredients.
[Precautions]
The efficacy of this product for the oral treatment of acute asthma attacks has not been established. Therefore, it should not be used to treat acute asthma attacks. Patients should be advised to have appropriate rescue medications available. Although concomitant use of inhaled glycosuria can be gradually reduced under the guidance of a physician, The dose of corticosteroids should be increased, but this product should not be used to suddenly replace inhaled or oral corticosteroids. In patients receiving anti-asthma medications including leukotriene receptor antagonists, rare cases of one or more of the following have occurred: eosinophilia, 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 a reduction or discontinuation of oral corticosteroid therapy. Although a causal relationship between these conditions and leukotriene receptor antagonists has not been established, it is recommended that patients taking this product be cautious and undergo appropriate clinical monitoring. Patients with rare hereditary conditions such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this drug. Montelukast may have no or minimal effect on the ability to drive and operate machines. However, there have been individual reports of drowsiness and dizziness. It has been reported that adults taking the original montelukast sodium tablets Neuropsychiatric events may occur in patients with schizophrenia, adolescents, and children. Postmarketing reports of montelukast sodium tablets include agitation, aggressive behavior or hostility, anxiety, depression, disorientation, attention deficit disorder, abnormal dreams, stuttering (stammering), hallucinations, insomnia, irritability, memory impairment, obsessive-compulsive symptoms, restlessness, sleepwalking, suicidal thoughts and behaviors (including suicide), convulsions, and tremors. Clinical details in some postmarketing reports of montelukast sodium tablets appear consistent with drug-induced effects. Psychiatric events have been reported in patients taking montelukast sodium tablets (see Adverse Reactions). Because other factors may contribute to these events, a relationship to montelukast sodium tablets cannot be confirmed. Physicians should discuss these adverse events with patients and/or caregivers. Patients and/or caregivers should be advised to notify their physicians if these events occur. Patients with known aspirin sensitivity should continue to avoid aspirin or nonsteroidal anti-inflammatory drugs while taking this product.
