- Approval Id
- 3a3d4a8eadcf2ff3
- Drug Name
- MUREST-DR 180 DELAYED-RELEASE TABLETS 180MG
- Product Name
- MUREST-DR 180 DELAYED-RELEASE TABLETS 180MG
- Approval Number
- SIN16638P
- Approval Date
- 2022-11-09
- Registrant
- DKSH SINGAPORE PTE. LTD.
- Licence Holder
- DKSH SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, DELAYED RELEASE
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong></p>
<p><u><strong>Dosage regimen</strong></u><br>
The recommended dose is 720 mg (four 180 mg or two 360 mg Murest-DR tablets administered twice daily (1440 mg daily dose). Murest-DR 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><u><strong>General target population</strong></u></p>
<p><strong>Transplant patient</strong><br>
Treatment with Murest-DR tablets should be initiated and maintained by appropriately qualified transplant specialists.</p>
<p>Murest-DR tablets should be initiated in de-novo patients within 48 hours following transplantation. Murest-DR tablets can be taken with or without food.</p>
<p><strong>Lupus nephritis patients</strong><br>
Adequate dose finding studies have not been performed. The prescriber should adjust the dose based on clinical response. The dose may be tapered for maintenance purposes following a complete or partial response (see Clinical Studies section – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Induction treatment with Murest-DR tablets is usually initially administered in combination with corticosteroids.</p>
<p><u><strong>Special populations</strong></u></p>
<p><strong>Renal impairment</strong><br>
No dose adjustments are needed in patients experiencing delayed renal graft function post-operatively (see section CLINICAL PHARMACOLOGY – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). Patients with severe chronic renal impairment (glomerular filtration rate 25 mL.min-1.1.73 m-2) should be carefully monitored.</p>
<p><strong>Hepatic impairment</strong><br>
No dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease.</p>
<p><strong>Pediatric patients (below 18 years old)</strong><br>
Safety and efficacy in pediatric patients have not been established. Limited pharmacokinetic data are available for pediatric renal transplant patients (see section CLINICAL PHARMACOLOGY – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Geriatric patients (65 years of age or above)</strong><br>
No dose adjustment is required in this patient population.</p>
<p><strong>Treatment during rejection episodes</strong><br>
Renal transplant rejection does not lead to changes in mycophenolic acid pharmacokinetics; dosage reduction or interruption of Murest-DR is not required.</p>
<p><strong>Method of administration</strong><br>
Murest-DR should not be crushed in order to maintain the integrity of the enteric coating (see sections CLINICAL PHARMACOLOGY and PHARMACEUTICAL INFORMATION – <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>INDICATIONS</strong></p>
<p>Murest-DR tablets are indicated in combination with ciclosporin for microemulsion and corticosteroids for the prophylaxis of acute transplant rejection in adult patients receiving allogeneic renal transplants.</p>
<p>Murest-DR tablets are indicated for induction and maintenance treatment of adult patients with ISN/RPS Class III, IV or V lupus nephritis.</p>
<p>The evidence for efficacy was based on surrogate endpoints in studies where the majority of patients with lupus nephritis were ISN/RPS (2003) Class IV (see Clinical Studies section – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong></p>
<p>Murest-DR tablets are contraindicated in patients with a hypersensitivity to mycophenolate sodium, mycophenolic acid or mycophenolate mofetil or to any of the excipients, and in pregnant women. (see section DESCRIPTION AND COMPOSITION – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- L04AA06
- Atc Item Name
- mycophenolic acid
- Pharma Manufacturer Name
- DKSH SINGAPORE PTE. LTD.
