- Approval Id
- bb6046d187c48190
- Drug Name
- MOFECON-GR 360 GASTRO-RESISTANT TABLETS 360 MG
- Product Name
- MOFECON-GR 360 GASTRO-RESISTANT TABLETS 360 MG
- Approval Number
- SIN16970P
- Approval Date
- 2024-03-08
- Registrant
- GOLDPLUS UNIVERSAL PTE LTD
- Licence Holder
- GOLDPLUS UNIVERSAL PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, ENTERIC COATED
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong><br>
Oral. Mofecon can be taken with or without food. Patients may select either option but must adhere to their selected option.</p>
<p>In order to retain the integrity of the enteric coating, Mofecon tablets should not be crushed. If for any reason the Mofecon tablet is crushed, avoid inhalation of the powder or direct contact of the powder with skin or mucous membrane. If such contact occurs, wash throughly with soap and water; rinse eyes with plain water. This is due to the teratogenic effects of mycophenolate.</p>
<p><strong>Dosage</strong><br>
The recommended dose is 720 mg (four 180 mg or two 360 mg Mofecon gastro-resistant tablets) twice daily (1440 mg daily dose). Mofecon gastro-resistant tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent.</p>
<p><strong>General target population</strong><br>
Treatment with Mofecon should be initiated and maintained by appropriately qualified transplant specialist.</p>
<p>Mofecon should be initiated in de-novo patients within 48 hours following transplantation.</p>
<p>Mofecon can be taken with or without food.</p>
<p><strong>Special population</strong><br>
<u>Renal impairment</u><br>
No dose adjustments are needed in patients experiencing delayed post-operative renal graft function. Patients with severe chronic renal impairment (glomerular filtration rate <25 ml . min<sup>-1</sup> . 1.73 m<sup>-2</sup>) should be carefully monitored.</p>
<p><u>Hepatic impairment</u><br>
No dose adjustments are needed for renal transplant patients with severe hepatic impairment.</p>
<p><u>Paediatric patients (below 18 years)</u><br>
Safety and efficacy in paediatric patients have not been established. Limited pharmacokinetic data are available for paediatric renal transplant patients.</p>
<p><u>Geriatic patients (65 years of age or above)</u><br>
Geriatric patients may generally be at increased risk of adverse drug reactions due to immunosuppression. Geriatric patients receiving MPA as part of a combination immunosuppressive regimen, did not show an increased risk of adverse reactions, compared to younger individuals in the MPA clinical trials. No dose adjustment is required in this patient population.</p>
<p><strong>Treatment during rejection episodes</strong><br>
Renal transplant rejection does not affect mycophenolic acid pharmacokinetics; dosage reduction or interruption of Mofecon is not required.</p>
<p><strong>Method of administration</strong><br>
Mofecon tablets should not be crushed in order to maintain the integrity of the enteric coating.</p>
<p>Note: The information given here is limited. For further information, consult your doctor or pharmacist.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATIONS</strong><br>
Indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in adult patients receiving allogeneic renal transplants.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong></p>
<ul>
<li>Mofecon is contraindicated in patients with hypersensitivity to mycophenolate sodium, mycophenolic acid or mycophenolate mofetil or to any of the excipients.</li>
<li>Mofecon is contraindicated in pregnant women.</li>
</ul>
- Atc Code
- L04AA06
- Atc Item Name
- mycophenolic acid
- Pharma Manufacturer Name
- GOLDPLUS UNIVERSAL PTE LTD
- Company Detail Path
- /organization/goldplus-universal-pte-ltd
