Product Overview
[Drug Name]
Generic Name: Montelukast Sodium Chewable Tablets
Trade Name: LeiluoShu Montelukast Sodium Chewable Tablets 5mg*10 Tablets
Pinyin Full Code: LeiLuoShu MengLuSiTeNaJuJiaoPian 5mg*10 Tablets
[Main Ingredient]
The main ingredient of this product is montelukast sodium. Chemical Name: [R-(E)]-1-[[1-[3-{[2-(7-chloro-2-quinolinyl)vinyl]phenyl-3-{2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid sodium
Molecular Formula: C35H35CINNaO3S Molecular Weight: 608.18
[Properties]
This product is a pink, round tablet.
[Indications/Main Functions]
This product is indicated for the prevention and long-term treatment of asthma in children aged 2 to 14 years, including prevention of daytime and nighttime asthma symptoms, treatment of aspirin-sensitive asthma, and prevention of exercise-induced bronchoconstriction. It is indicated for the relief of symptoms associated with allergic rhinitis (seasonal and perennial allergic rhinitis in children aged 2 to 14 years).
[Specifications]
5mg x 10 tablets
[Dosage and Administration]
Once daily. Asthma patients should take the medication at bedtime. Allergic rhinitis patients may take the medication at a later time of day depending on their condition. Patients with both asthma and allergic rhinitis should take the medication once nightly. Children aged 6 to 14 years with asthma and/or allergic rhinitis should take one 5mg tablet once daily. Children aged 2 to 5 years with asthma and/or allergic rhinitis should take one 4mg tablet once daily. Asthma control indicators are generally recommended for evaluating treatment efficacy; the efficacy of this product is apparent within one day of treatment. This product 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 exacerbated. No dosage adjustment is required for patients with renal insufficiency, mild to moderate hepatic impairment, or gender. Montelukast Sodium Chewable Tablets and Other Asthma Medications: This product can be added to a patient's existing treatment regimen. Reducing the Dosage of Concomitant Medication: For patients whose asthma is not effectively controlled with bronchodilators alone, this product can be added to their 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. For patients receiving inhaled corticosteroids for asthma, the dose of this product can be appropriately reduced based on the patient's tolerance. This dosage should be gradually reduced under the guidance of a physician. Some patients can gradually reduce the dosage 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]
See package insert for details.
[Contraindications]
This product is contraindicated in patients with allergies to any of the ingredients in this product.
[Precautions]
The efficacy of this oral medication for the treatment of acute asthma exacerbations has not been established. Therefore, it should not be used to treat acute asthma exacerbations. Patients should be advised to have appropriate rescue medications available. 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. Rarely, patients receiving anti-asthma medications, including leukotriene receptor antagonists, have experienced one or more of the following: eosinophilia, vascular rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy (sometimes diagnosed as Churg-Strauss syndrome, a systemic eosinophilic vasculitis). These events have sometimes been associated with reduction or discontinuation of oral corticosteroid therapy. Although a causal relationship between these events and leukotriene receptor antagonists has not been established, caution and appropriate clinical monitoring are recommended for patients taking this medication. Patients with phenylketonuria should be informed that the 4 mg and 5 mg chewable tablets contain 0.674 mg and 0.842 mg of the component aspartame phenylalanine, respectively. Montelukast may have little or no effect on the ability to drive or operate machinery. However, isolated cases of drowsiness and dizziness have been reported. Neuropsychiatric events have been reported in adults, adolescents, and children taking the original montelukast sodium chewable tablets. Postmarketing reports of these events with the original montelukast sodium chewable tablets include excitement, aggressive behavior or hostility, anxiety, depression, disorientation, attention deficit disorder, abnormal dreams, hallucinations, insomnia, irritability, memory impairment, restlessness, sleepwalking, suicidal thoughts and behaviors (including suicide), convulsions, and tremors. Clinical details in some postmarketing reports of the original montelukast sodium chewable tablets appear consistent with drug-induced effects. Psychiatric and neurological events have been reported in patients taking the original montelukast sodium chewable tablets (see Adverse Reactions). Because other factors may contribute to these events, a relationship to the original montelukast sodium chewable 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 use of aspirin or NSAIDs while taking this product.
