mycophenolate mofetil tablet

1 INDICATIONS AND USAGE Mycophenolate mofetil tablets are indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1) ] , heart [see Clinical Studies (14.2) ] or liver transplants [see Clinical Studies (14.3) ] , in combination with other immunosuppressants. Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. ( 1 )

amneal pharmaceuticals ny llc

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] off label use` `[4] nausea` `[5] pain` `[6] diarrhoea` `[7] dyspnoea` `[8] headache` `[9] vomiting` `[10] arthralgia`

2 years ago

OVAL PURPLE E735

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 Handling and Disposal

MYCOPHENOLATE MOFETIL (MMF) has demonstrated teratogenic effects in humans [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] .

MYCOPHENOLATE MOFETIL tablets should not be crushed. Follow applicable special handling and disposal procedures 1 . 16.3

MYCOPHENOLATE MOFETIL Tablets USP, 500 mg

MYCOPHENOLATE MOFETIL Tablets USP, 500 mg, are supplied as peach to purple-colored, oblong, film-coated tablets debossed with “E735” on one side and plain on the other. They are available as follows: Bottles of 100: NDC 60219-2135-1 Bottles of 500: NDC 60219-2135-5 Storage and Dispensing Information: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light resistant container as defined in USP.

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mycophenolate mofetil tablet

FDA Reported Adverse Reactions [1] drug ineffective [2] fatigue [3] off label use [4] nausea [5] pain [6] diarrhoea [7] dyspnoea [8] headache [9] vomiting [10] arthralgia

OVAL PURPLE E735

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FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] off label use` `[4] nausea` `[5] pain` `[6] diarrhoea` `[7] dyspnoea` `[8] headache` `[9] vomiting` `[10] arthralgia`