Item nanme:Montelukast Sodium Tablets Item character:This product is light yellow irregular film coated tablets
Indication: This product is suitable for the prevention and long-term treatment of asthma in adults aged 15 to 15 years old, including the prevention of asthma symptoms during the day and night, the treatment of asthmatic patients sensitive to aspirin and
Prevent exercise-induced bronchoconstriction.
This product is suitable for adults aged 15 and over to reduce the seasonal allergic rhinitis symptom.
Item specifications:10mg*5tab/box
Usage and dosage:One tablet (10mg) once a day. Asthma patients should take it before going to bed. Seasonal excess
Patients with allergic rhinitis can take medicine when necessary according to their own situation.
Patients with both asthma and seasonal allergic rhinitis should be treated once a night.
Adults aged 15 years and over with asthma and / or seasonal allergic rhinitis took one tablet (1 mg) once a day.
General recommendations
Asthma control indicators were used to evaluate the therapeutic effect. The efficacy of the product appeared within one day. This product can be taken with food or separately. It should be recommended that patients should insist on taking it no matter in the stage of asthma control or deterioration.
There is no need to adjust the dose in elderly patients, patients with renal insufficiency, patients with moderate liver damage and patients of different genders.
The relationship between this product and other asthma drugs
This product can be added to the existing treatment plan of patients.
To reduce the dose of combined drugs:
Bronchodilator
Asthma patients who can not be effectively controlled by bronchodilator alone can be treated with this product. Once there is a clinical response (usually after the first dose). According to the patient's tolerance, the dose of bronchodilator can be reduced.
Inhaled corticosteroids can reduce the dose of corticosteroids according to the patient's tolerance. It should be gradually reduced under medical supervision. Some patients can gradually reduce the dosage until the inhaled corticosteroids are stopped completely. However, this product should not be used suddenly instead of inhaled corticosteroids or as directed by the doctor.
Adverse reactions The product is generally well tolerated, with mild adverse reactions, and does not need to terminate treatment. book
The total adverse reactions of the drug were similar to placebo. Asthma patients 15 years old and over
Clinical studies have been conducted in some 2600 adult patients aged 15 and over,
The use of the product was evaluated. Similar in both designs. Placebo-controlled 12 weeks
In bed test, patients with ≥ 1% of the treatment group showed higher than those in the placebo group and were in the same group as the drug
The adverse events associated with the substance are abdominal pain and headache. But the incidence of these adverse events is two
There was no significant difference between the groups.
In clinical study, 544 patients have been treated with this product for at least 6 months, 253
One patient was treated for one year and 21 patients for 2 years. With the prolongation of the treatment time
Long. The adverse events have not changed.
The clinical study of 2199 patients with seasonal rhinitis aged 15 and over has been carried out in 2199 adults aged 15 and over. The safety of this product was evaluated. The drug was well tolerated every morning or night, and the incidence of adverse reactions was similar to 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. In a 4-week placebo-controlled clinical trial, the safety was consistent with the 2-week clinical trial. In all clinical studies, the incidence of sleepiness was similar to that of placebo.
After the product was put into market, the following adverse reactions were reported: hypersensitivity (including allergic reaction, tube edema, rash, pruritus, urticaria and rare eosinophil infiltration in liver), nightdream abnormality and hallucination, sleepiness, excitement, provocation, including aggressive behavior. Restlessness, insomnia, sensory abnormality / tactile disorder and rare epilepsy, nausea, vomiting, elimination Dysplasia, diarrhea. ALT and AST increased. Rare cholestatic hepatitis: joint pain, including muscle pain in muscle spasm; increased bleeding tendency; contusion; palpitation; and edema.
Taboo: It is forbidden to be allergic to any ingredient in this product.
Matters needing attention: The efficacy of oral administration of this product in the treatment of acute asthma has not been determined. Therefore, it is not used in the treatment of acute asthma. Although the combined dose of inhaled corticosteroids can be reduced gradually under the guidance of the physician, it is not used to suddenly replace inhaled or oral corticosteroids.
Patients receiving asthma drugs, including leukotriene receptor antagonists, are reducing the systemic corticosteroid dose pairs. Few cases have one or more of the following: eosinophilia, vascular rash, worsening lung symptoms, heart complications and / or neuropathy (sometimes diagnosed as church Strauss syndrome - a systemic eosinophilic blood Phlebitis). Although the causal relationship between these conditions and leukotriene receptor antagonists has not been determined, it is suggested that attention should be paid to and appropriate clinical monitoring should be taken in patients treated with this drug to reduce the systemic corticosteroid dose.
[medication for pregnant and lactating women]
No pregnant women research data. Pregnant women should avoid taking this product unless it is clearly necessary to take the drug.
It is not clear whether the product can be secreted into milk. Because many drugs can be secreted into milk, this product should be used in lactation women carefully.
Medication for pregnant and lactating women: Safety and efficacy studies have been conducted in children aged 6 months to 14 years. For children aged 2 to 14, please refer to the usage and dosage of montelukast sodium chewable tablets. The safety and efficacy of children under 6 months of age have not been studied.
[medication for the elderly]
There is no age difference in the efficacy and safety of the product.
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