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Indications/Uses
Montelukast (Montela) is indicated for: The prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older.
It is indicated for the prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older.
It is also indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older.
It is indicated for the prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older.
It is also indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older.
Dosage/Direction for Use
Montelukast (Montela) should be taken once daily in the evening. Following doses are recommended: Asthma: 15 years & older: 10 mg once daily.
6 to 14 years of age: 5 mg once daily.
2 to 5 years of age: 4 mg once daily.
Allergic rhinitis: For allergic rhinitis and perennial rhinitis, Montelukast (Montela) should be taken once daily.
Following doses for seasonal allergic rhinitis are recommended: 15 years & older: 10 mg once daily.
6 to 14 years of age: 5 mg once daily.
2 to 5 years of age: 4 mg once daily.
In case of EIB, a single 10 mg dose of Montelukast (Montela) should be taken at least 2 hours before exercise.
6 to 14 years of age: 5 mg once daily.
2 to 5 years of age: 4 mg once daily.
Allergic rhinitis: For allergic rhinitis and perennial rhinitis, Montelukast (Montela) should be taken once daily.
Following doses for seasonal allergic rhinitis are recommended: 15 years & older: 10 mg once daily.
6 to 14 years of age: 5 mg once daily.
2 to 5 years of age: 4 mg once daily.
In case of EIB, a single 10 mg dose of Montelukast (Montela) should be taken at least 2 hours before exercise.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to any component of this product.
Special Precautions
Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks. Patients with known Aspirin sensitivity should continue avoidance of Aspirin or other NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) while taking Montelukast. Neuropsychiatric events such as agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, dream abnormalities, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thinking and behavior (including suicide) and tremor have been reported in adult, adolescent and pediatric patients taking Montelukast. Systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, has been reported. These events usually, but not always, have been associated with the reduction of oral corticosteroid therapy.
Use In Pregnancy & Lactation
Pregnancy Category B: there are no adequate and well-controlled studies in pregnant women. Montelukast (Montela) should be used during pregnancy only if clearly needed.
Studies in rats have shown that Montelukast is excreted in milk. It is not known if Montelukast is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Montelukast (Montela) is given to a nursing mother.
Studies in rats have shown that Montelukast is excreted in milk. It is not known if Montelukast is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Montelukast (Montela) is given to a nursing mother.
Adverse Reactions
Most common adverse reactions are upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis and otitis.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: Montelukast (Montela) is an orally active compound that binds with high affinity and selectivity to the CysLT1 receptor. Montelukast inhibits physiologic actions of LTD4 at the CysLT1 receptor without any agonist activity. Montelukast (Montela) is rapidly absorbed following oral administration. After administration of the 10 mg film-coated tablet, 5 mg tablet and 4 mg tablet, the mean peak Montelukast plasma concentrations (Cmax) are achieved respectively in 3 to 4 hours, 2 to 2.5 hours, and within 2 hours. Montelukast is more than 99% bound to plasma proteins and is extensively metabolized. Montelukast (Montela) and its metabolites are excreted almost exclusively via the bile.
MedsGo Class
Antiasthmatic & COPD Preparations
Features
Brand
Montela 5
Full Details
Dosage Strength
5 mg
Drug Ingredients
- Montelukast
Drug Packaging
Chewable Tablet 20's
Generic Name
Montelukast Sodium
Dosage Form
Chewable Tablet
Registration Number
DR-XY44579
Drug Classification
Prescription Drug (RX)