the functional indications in the instructions of montelukast sodium granules indicate that montelukast sodium granules are suitable for the prevention and long-term treatment of asthma in children over one year old, including the prevention of asthma symptoms in the daytime and at night, the treatment of asthma patients who are sensitive to aspirin and the prevention of exercise-induced bronchoconstriction. Montelukast sodium granules are suitable for children aged 2 to 5 to relieve the symptoms caused by seasonal allergic rhinitis. However, the instructions also mentioned that the efficacy and safety of montelukast sodium granules have been studied in children aged 6 months to 14 years. The safety and efficacy of children under 6 months have not been studied.
With regard to the adverse reactions, Montelukast sodium granules are generally well tolerated, with mild adverse reactions, and there is usually no need to terminate the treatment. The total incidence of adverse reactions of montelukast sodium granules is similar to that of placebo. Children aged 6 months to 2 years have evaluated the use of montelukast sodium granules in about 175 children aged 6 months to 2 years. In a placebo-controlled 6-week clinical trial, more than 1% of patients in the montelukast sodium granule treatment group had more drug-related adverse events than those in the placebo group, such as diarrhea, hyperkinesia, asthma, eczema-like dermatitis and rash. However, there was no significant difference in the incidence of these adverse reactions between the two groups. Post-marketing experience After marketing, Montelukast sodium granules have the following reports of adverse reactions: hypersensitivity (including allergic reaction, angioneurotic edema, rash, itching, urticaria and rare eosinophilic infiltration in the liver), abnormal night dreams and hallucinations, drowsiness, excitement, irritability, including aggressive behavior, restlessness, insomnia, sensory abnormality/tactile disturbance and rare seizures, nausea, vomiting and indigestion. Joint pain, including myalgia of muscle spasm; Increased bleeding tendency, contusion; Palpitation; And edema.
In addition, montelukast sodium granules can be used in combination with other drugs commonly used for asthma prevention and long-term treatment. In the study of drug interaction, the recommended dose of montelukast sodium granules has no clinically significant pharmacokinetic effects on the following drugs: theophylline, prednisone, prednisolone, oral contraceptive (ethinyl estradiol/norethindrone 35/1), terfenadine, digoxin and warfarin. The area under the plasma concentration-time curve (AUC) of montelukast was reduced by about 4% in patients who used phenobarbital in combination. However, it is not recommended to adjust the dosage of montelukast sodium granules.