MUREST-DR 180 DELAYED-RELEASE TABLETS 180MG

Țară: Singapore

Limbă: engleză

Sursă: HSA (Health Sciences Authority)

Ingredient activ:

Mycophenolate Sodium eqv Mycophenolic acid

Disponibil de la:

DKSH SINGAPORE PTE. LTD.

Codul ATC:

L04AA06

Forma farmaceutică:

TABLET, DELAYED RELEASE

Compoziție:

Mycophenolate Sodium eqv Mycophenolic acid 180.00mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

Prescription Only

Produs de:

Biocon Pharma Limited

Statutul autorizaţiei:

ACTIVE

Data de autorizare:

2022-11-09

Caracteristicilor produsului

NAME OF THE MEDICINAL PRODUCT
PRODUCT NAME
MUREST-DR 180
MUREST-DR 360
GENERIC NAME
Mycophenolic Acid Delayed-Release Tablets USP 180mg
Mycophenolic Acid Delayed-Release Tablets USP 360mg
THERAPEUTIC CATEGORY
Immunosuppressant
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Delayed-Release Tablets
ACTIVE SUBSTANCE
180MG:
Each
Delayed-Release
tablet
contains
180mg
of
Mycophenolic
Acid
as
Mycophenolate sodium USP.
360MG:
Each
Delayed-Release
tablet
contains
360mg
of
Mycophenolic
Acid
as
Mycophenolate sodium USP.
ACTIVE MOIETY
Mycophenolate sodium is the sodium salt of the active moiety,
Mycophenolic acid.
EXCIPIENTS
Anhydrous lactose, Colloidal silicon dioxide, Crospovidone, Povidone
K30, Maize starch B
Magnesium stearate.
The delayed release coating of Murest-DR consists of Hypromellose
Phthalate, Titanium
dioxide, Ferric Oxide Red (in 360mg), FD & C Blue 2 AL Lake (in 180mg)
and Ferric Oxide
Yellow.
DESCRIPTION
180MG:
Lime green colored, round shaped, beveled edged coated tablets free
from physical
defects, debossed with “B 180” on one side and plain on other.
360MG:
Pale orange-red, oval shaped biconvex coated tablets free from
physical defects,
debossed with “B360” on one side and plain on other side.
INDICATIONS
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.
Murest-DR tablets are indicated for induction and maintenance
treatment of adult patients
with ISN/RPS Class III, IV or V lupus nephritis.
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).
DOSAGE AND ADMINISTRATION
DOSAGE REGIMEN
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
p