- Approval Id
- f10bcc10fa43f878
- Drug Name
- MONTAS-10 FILM COATED TABLET 10 MG
- Product Name
- MONTAS-10 FILM COATED TABLET 10 MG
- Approval Number
- SIN16364P
- Approval Date
- 2021-11-05
- Registrant
- ACCORD HEALTHCARE PRIVATE LIMITED
- Licence Holder
- ACCORD HEALTHCARE PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- **4.2 Posology and method of administration\***
Montelukast Tablet should be taken once daily. For asthma, the dose should be taken in the evening. For allergic rhinitis, the time of administration may be individualized to suit patient needs.
Patients with both asthma and allergic rhinitis should take only one tablet daily in the evening.
_Adults 15 Years of Age and Older with Asthma and/or Allergic rhinitis_
The dosage for adults 15 years of age and older is one 10-mg tablet daily.
_Pediatric Patients 6 to 14 Years of Age with Asthma and/or Allergic rhinitis_
The dosage for pediatric patients 6 to 14 years of age is one 5-mg chewable tablet daily.
_Pediatric Patients 2 to 5 Years of Age with Asthma and/or Allergic rhinitis_
The dosage for pediatric patients 2 to 5 years of age is one 4-mg chewable tablet daily or one packet of 4-mg oral granules daily.
_Pediatric Patients 1 to 2 Years of Age with Asthma_
The dosage for pediatric patients 1 to 2 years of age is one packet of 4-mg oral granules daily to be taken in the evening.
_Pediatric Patients 1 Year to 2 Years of Age with Perennial Allergic Rhinitis_
The dosage for pediatric patients 1 year to 2 years of age is one packet of 4-mg oral granules daily.
_General Recommendations_
The therapeutic effect of Montelukast Tablet on parameters of asthma control occurs within one day. Montelukast Tablet tablets and chewable tablets can be taken with or without food. Patients should be advised to continue taking Montelukast Tablet while their asthma is controlled, as well as during periods of worsening asthma.
No dosage adjustment is necessary for pediatric patients, the elderly, for patients with renal insufficiency, or mild-to-moderate hepatic impairment, or for patients of either gender.
_Therapy with Montelukast in Relation to Other Treatments for Asthma_
Montelukast can be added to a patient's existing treatment regimen. Reduction in Concomitant Therapy:
_Bronchodilator Treatments:_ Montelukast can be added to the treatment regimen of patients who are not adequately controlled on bronchodilator alone. When a clinical response is evident (usually after the first dose), the patient's bronchodilator therapy can be reduced as tolerated.
_Inhaled Corticosteroids:_ Treatment with Montelukast provides additional clinical benefit to patients treated with inhaled corticosteroids. A reduction in the corticosteroid dose can be made as tolerated. The dose should be reduced gradually with medical supervision. In some patients, the dose of inhaled corticosteroids can be tapered off completely. Montelukast should not be abruptly substituted for inhaled corticosteroids.
\*Kindly note that not all presentations are marketed locally.
- Route Of Administration
- ORAL
- Indication Info
- **4.1 Therapeutic indications**
Montelukast is indicated in adult and pediatric patients 1 year of age and older for the prophylaxis and chronic treatment of asthma, including the prevention of day- and nighttime symptoms, the treatment of aspirin-sensitive asthmatic patients, and the prevention of exercise-induced bronchoconstriction.
Montelukast is indicated for the relief of daytime and nighttime symptoms of allergic rhinitis (seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older, and perennial allergic rhinitis in adults and pediatric patients 1 year of age and older). Because the benefits of Montelukast may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis, reserve use for patients who have an inadequate response or intolerance to alternative therapies.
- Contraindications
- **4.3 Contraindications**
Hypersensitivity to any component of this product.
- Atc Code
- R03DC03
- Atc Item Name
- montelukast
- Pharma Manufacturer Name
- ACCORD HEALTHCARE PRIVATE LIMITED
- Company Detail Path
- /organization/7b2062edde9ff0f1/accord-healthcare-private-limited
