- Approval Id
- 48f4cdb4a458f2c2
- Drug Name
- CORTIMENT PROLONGED RELEASE TABLETS 9 MG
- Product Name
- CORTIMENT PROLONGED RELEASE TABLETS 9 MG
- Approval Number
- SIN15311P
- Approval Date
- 2017-08-04
- Registrant
- FERRING PHARMACEUTICALS PRIVATE LIMITED
- Licence Holder
- FERRING PHARMACEUTICALS PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED, EXTENDED RELEASE
- Dosage
- <p><strong>POSOLOGY AND METHOD OF ADMINISTRATION<br>
Posology</strong><br>
<u>Adults</u><br>
The recommended daily dose for induction of remission is one 9 mg tablet in the morning, for up to 8 weeks.</p>
<p>When treatment is discontinued, it may be useful to gradually reduce the dose (for more details on treatment discontinuation, see section SPECIAL WARNINGS AND PRECAUTIONS FOR USE – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><u>Paediatric population</u><br>
The safety and efficacy of Budesonide (CORTIMENT) tablets in children aged 0–18 years have not yet been established. No data are available, therefore the use in paediatric population is not recommended until further data become available.</p>
<p><u>Elderly</u><br>
No special dose adjustment is recommended. However, experience of the use of Budesonide (CORTIMENT) in the elderly is limited.</p>
<p><u>Hepatic and renal impairment population</u><br>
Budesonide (CORTIMENT) 9 mg was not studied in patients with hepatic and renal impairment, therefore caution should be exercised in the administration and monitoring of the product in these patients (see section SPECIAL WARNINGS AND PRECAUTIONS FOR USE – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Method of administration</strong><br>
One tablet of Budesonide (CORTIMENT) 9 mg is taken orally in the morning, with or without food. The tablet should be swallowed with a glass of water and must not be broken, crushed or chewed as the film coating is intended to ensure a prolonged release.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>THERAPEUTIC INDICATIONS</strong><br>
Budesonide (CORTIMENT) is indicated in adults for induction of remission in patients with mild to moderate active ulcerative colitis (UC) where 5-ASA treatment is not sufficient.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong><br>
Hypersensitivity to the active substance, lecithin (derived from soya oil, peanut oil) or any of the excipients listed in section LIST OF EXCIPIENTS – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Atc Code
- A07EA06
- Atc Item Name
- budesonide
- Pharma Manufacturer Name
- FERRING PHARMACEUTICALS PRIVATE LIMITED
