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Generic Name
Montelukast Sodium

Therapeutic Class: Leukotriene receptor antagonists

Indications :

Montelukast Sodium is indicated for:

• Prophylaxis and chronic treatment of asthma
• Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
• Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis

Presentation:
4 Chewable Tablet: Each tablet contains Montelukast Sodium INN equivalent to Montelukast 4 mg.
5 Chewable Tablet: Each tablet contains Montelukast Sodium INN equivalent to Montelukast 5 mg.
10 Tablet: Each tablet contains Montelukast Sodium INN equivalent to Montelukast 10 mg.
4 ODT: Each orodispersible tablet contains Montelukast Sodium BP equivalent to Montelukast 4 mg.
5 ODT: Each orodispersible tablet contains Montelukast Sodium BP equivalent to Montelukast 5 mg.

Description:
Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma ( such as, airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contributes to the signs and symptoms of asthma).

Dosage & Administration :

Adults & adolescents (15 years & older)-

• Asthma & Allergic Rhinitis: 10 mg/day
• Exercise-Induced Bronchoconstriction: 10 mg/day

Pediatric patients (6 to 14 years)-

• Asthma & Allergic Rhinitis: 5 mg/day
• Exercise-Induced Bronchoconstriction: 5 mg/day

Pediatric patients (6 months to 5 years)-

• Asthma & Allergic Rhinitis: 4 mg/day
• Exercise-Induced Bronchoconstriction: Not recommended

Patients with both asthma and allergic rhinitis should take only one dose daily in the evening. For prevention of Acute prevention of Exercise-Induced Bronchoconstriction, a single dose should be taken at least 2 hours before exercise.

Route of administration: Oral. Montelukast may be taken with or without food or as directed by the physician.

Interaction :

Montelukast could also be administered with other therapies routinely utilized in the prophylaxis and chronic treatment of asthma In drug-interactions studies, the recommended clinical dose of montelukast didn't have clinically important effects on the subsequent medicinal products: theophylline, prednisone, prednisolone, oral contraceptives, terfenadine, digoxin, and warfarin. Caution should be exercised, particularly in children, when montelukast is coadministered with phenytoin, phenobarbital, and rifampicin.

Contraindications :

Hypersensitivity to any element of this product.

Side Effects :

Montelukast appears to be tolerated. The foremost common adverse effect reported in clinical trials was a headache, occurring in approximately 18% of patients. Rash, dyspepsia, dizziness, and abdominal pain were all reported in but 2% of patients. Elevated liver transaminases are reported with montelukast use, but not at a greater incidence than with placebo. a little percentage of pediatric patients have experienced diarrhea, sinusitis, and otitis during montelukast clinical trials.

Pregnancy & Lactation :

Montelukast is assessed as maternity class B. The drug has been shown to cross the placenta of pregnant rats and rabbits, however, there are no reports of its use in pregnant girls. Montelukast is additionally best-known to be excreted into breast milk, however solely restricted data is obtainable on the importance of this finding. Caution ought to be used before initiating montelukast medical aid in nursing mothers.

Precautions & Warnings :

Montelukast isn't indicated to be used within the reversal of spasm in acute respiratory illness attacks and bronchial asthma. Patients ought to be suggested to possess applicable rescue medication offered.

Storage :

Store below 25° C at a cool and dry place, aloof from lightweight and wet. keep of reach of children.