MYCOKEM 500 Film-coated tablet Ref.[50464] Active ingredients: Mycophenolate mofetil

Source: Pharmaceutical Benefits Scheme (AU)  Revision Year: 2021  Publisher: Pharmacor Pty Ltd., Suite 803, Level 8, Tower A, The Zenith, 821 Pacific Highway, Chatswood, NSW 2067, Australia www.pharmacor.com.au Website: www.pharmacor.com.au Phone: 1300 138 805

Product name and form

Mycokem 500 – Mycophenolate mofetil.

Pharmaceutical Form

Mycokem 500 are purple coloured, capsule shaped, biconvex, film coated tablets debossed ‘AHI’ on one side and ‘500’ on other side.

Qualitative and quantitative composition

Mycokem 500 contains mycophenolate mofetil 500 mg.

For the full list of excipients, see Section 6.1 List of excipients.

Chemical structure

Mycophenolate mofetil is the 2-morpholinoethyl ester of mycophenolic acid. The chemical name for mycophenolate mofetil is 2-Morpholinoethyl(E)6(1,3-dihydro-4- hydroxy-6- methoxy-7-methyl-3-oxo-5- isobenzofuranyl)-4-methyl-4-hexenoate. It has a molecular formula of C23H31NO7 and a molecular weight of 433.50.

Mycophenolate mofetil is a white to off-white crystalline powder. It is freely soluble in dimethyl sulfoxide, tetrahydrofuran, acetone, acetonitrile, dichloromethane, and ethyl acetate; soluble in methanol and propylene carbonate; sparingly soluble in anhydrous ethanol; slightly soluble in 2-propanol, diethyl ether, and very slightly soluble in hexane. It is practically insoluble in water (43 μg/mL at pH 7.4); the solubility increases in acidic media (4.27 mg/mL at pH 3.6).

Active Ingredient Description
Mycophenolate mofetil

Mycophenolate mofetil is the 2-morpholinoethyl ester of mycophenolic acid (MPA). MPA is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase, and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA.

List of Excipients

Mycokem 500 contains the following excipients: Microcrystalline cellulose, povidone, hydroxypropylcellulose, croscarmellose sodium, purified talc, magnesium stearate and opadry complete film coating system 03B50110 purple (PI number: 12853) includes hypromellose, titanium dioxide (CI No. 77891), macrogol 400, iron oxide red (CI77491), indigo carmine (CI73015) and iron oxide black (CI77499).

Pack sizes and marketing

Mycokem 500 (AUST R No. 164418) are available in blister packs of 150 Tablets.

Marketing authorization holder

Pharmacor Pty Ltd., Suite 803, Level 8, Tower A, The Zenith, 821 Pacific Highway, Chatswood, NSW 2067, Australia
www.pharmacor.com.au
Website: www.pharmacor.com.au
Phone: 1300 138 805

Marketing authorization dates and numbers

2 February 2011

Drugs

Drug Countries
MYCOKEM Hong Kong, South Africa

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.