- Approval Id
- 898e1d8abbe13cfb
- Drug Name
- MEZAVANT XL GASTRO-RESISTANT PROLONGED RELEASE TABLET 1200MG
- Product Name
- MEZAVANT XL GASTRO-RESISTANT PROLONGED RELEASE TABLET 1200MG
- Approval Number
- SIN14999P
- Approval Date
- 2016-05-03
- Registrant
- TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
- Licence Holder
- TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, DELAYED RELEASE
- Dosage
- <p><strong>4.2 Posology and method of administration</strong><br>
Mezavant XL is intended for once daily, oral administration. The tablets must not be crushed or chewed and should be taken with food.</p>
<p><u>Adults, including the elderly (>65 years)</u><br>
For induction of remission: 2.4 to 4.8 g (two to four tablets) should be taken once daily. The highest dose of 4.8 g/day is recommended for patients not responding to lower doses of mesalazine. When using the highest dose (4.8 g/day), the effect of the treatment should be evaluated at 8 weeks.<br>
For maintenance of remission: 2.4 g (two tablets) should be taken once daily.</p>
<p><u>Children and adolescents</u><br>
Mezavant XL is not recommended for use in children below the age of 18 years due to a lack of data on safety and efficacy.</p>
<p>Specific studies have not been performed to investigate Mezavant XL in patients with hepatic or renal impairment (see sections 4.3 and 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong><br>
For the induction of clinical and endoscopic remission in patients with mild to moderate, active ulcerative colitis. For maintenance of remission.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong><br>
History of hypersensitivity to salicylates (including mesalazine) or any of the excipients of Mezavant XL.<br>
Severe renal impairment (GFR <30 ml/min/1.73m<sup>2</sup>) and/or severe hepatic impairment.</p>
- Atc Code
- A07EC02
- Atc Item Name
- mesalazine
- Pharma Manufacturer Name
- TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
