Singulair Montelukast Sodium Oral Granules

1. Indications and Usage
Asthma: Prophylaxis and chronic treatment of asthma in patients 12 months of age and older.
Allergic Rhinitis: Relief of symptoms of seasonal and perennial allergic rhinitis in patients 6 months of age and older.
Exercise-Induced Bronchoconstriction: Prevention of exercise-induced bronchoconstriction in patients 6 years of age and older.
2. Dosage and Administration
Asthma:
12 months to 14 years: 4 mg once daily.
15 years and older: 10 mg once daily.
Allergic Rhinitis:
6 months to 14 years: 4 mg once daily.
15 years and older: 10 mg once daily.
Exercise-Induced Bronchoconstriction: 10 mg taken at least 2 hours before exercise. Do not take more than once daily.
Administration: Administer orally. The granules can be swallowed directly or mixed with one teaspoon of room temperature or cold soft food (e.g., applesauce, infant formula, or breast milk). The mixture must be used immediately and not stored.
3. Mechanism of Action
Receptor Antagonism: Montelukast selectively antagonizes cysteinyl leukotriene (CysLT) receptors, specifically CysLT1.
Anti-inflammatory Effects: By blocking the binding of leukotrienes, it inhibits the inflammatory response mediated by these mediators, thereby reducing airway inflammation, bronchoconstriction, and mucus secretion.
4. Safety and Warnings
Neuropsychiatric Events: Antagonists of leukotriene receptors have been associated with neuropsychiatric events, including agitation, aggressive behavior, anxious, depression, sleep disturbances, and suicidal thinking and behavior.
Hypersensitivity: Exacerbations of asthma and hypersensitivity reactions (e.g., urticaria, angioedema) may occur.
Not a Rescue Medication: The drug is not indicated for the treatment of acute asthma symptoms.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Infection, fever, headache, rhinitis, abdominal pain, and cough.
Clinical Research: Clinical trials have demonstrated that montelukast effectively improves asthma control and reduces allergic rhinitis symptoms when used as a prophylactic agent.
6. Drug Interactions
Phenytoin, Phenobarbital, Rifampin: Concomitant use may decrease montelukast plasma concentrations by inducing its metabolism.
Gemfibrozil: May increase montelukast plasma concentrations.
7. Pharmaceutical Information
Active Ingredient: Montelukast Sodium.
Appearance: White to yellowish granules.
Storage: Store in the sealed packet under normal conditions. The packet should be opened immediately before administration, and the dose must be taken immediately.