- Approval Id
- d6b1645d629f4842
- Drug Name
- MONTELUKAST-TEVA FC TABLET 10 MG
- Product Name
- MONTELUKAST-TEVA FC TABLET 10 MG
- Approval Number
- SIN16431P
- Approval Date
- 2022-02-25
- Registrant
- TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
- Licence Holder
- TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong><br>
MONTELUKAST-TEVA 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.</p>
<p>Patients with both asthma and allergic rhinitis should take only one tablet daily in the evening.</p>
<p><em><strong>Adults 15 Years of Age and Older with Asthma and/or Allergic rhinitis</strong></em><br>
The dosage for adults 15 years of age and older is one 10-mg tablet daily.</p>
<p><em>General Recommendations</em><br>
The therapeutic effect of Montelukast on parameters of asthma control occurs within one day. Montelukast tablets can be taken with or without food. Patients should be advised to continue taking Montelukast tablets while their asthma is controlled, as well as during periods of worsening asthma.</p>
<p>No dosage adjustment is necessary for the elderly, for patients with renal insufficiency, or mild-to-moderate hepatic impairment, or for patients of either gender.</p>
<p><em>Therapy with Montelukast in Relation to Other Treatments for Asthma</em><br>
Montelukast can be added to a patient’s existing treatment regimen.</p>
<p><u>Reduction in Concomitant Therapy:</u><br>
<em>Bronchodilator Treatments:</em> 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.</p>
<p><em>Inhaled Corticosteroids:</em> 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.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATIONS</strong><br>
MONTELUKAST-TEVA is indicated in adults 15 years 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.</p>
<p>MONTELUKAST-TEVA is indicated for the relief of daytime and nighttime symptoms of allergic rhinitis (seasonal allergic rhinitis and perennial allergic rhinitis in adults 15 years of age and older).<br>
Because the benefits of MONTELUKAST-TEVA 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.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong><br>
Hypersensitivity to any component of this product</p>
- Atc Code
- R03DC03
- Atc Item Name
- montelukast
- Pharma Manufacturer Name
- TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
