mycophenolate mofetil capsule mycophenolate mofetil tablet
1 INDICATIONS AND USAGE Mycophenolate mofetil (MMF) is 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 )
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OVAL PURPLE AHI 500
AHI 500 OVAL PURPLE
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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 and
MYCOPHENOLATE MOFETIL capsules should not be opened or crushed. Wearing disposable gloves is recommended during reconstitution and when wiping the outer surface of the bottle/cap and the table after reconstitution. Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in
MYCOPHENOLATE MOFETIL capsules. Follow applicable special handling and disposal procedures 1 . 16.2
MYCOPHENOLATE MOFETIL capsules USP 250 mg
MYCOPHENOLATE MOFETIL capsules, USP are available containing 250 mg of
MYCOPHENOLATE MOFETIL, USP. The 250 mg capsules are light blue/ peach, size ‘1’ hard gelatin capsules, printed in black with ‘GC1’ on body containing white to off white powder. NDC Number Size NDC 16729-094-01 Bottle of 100’s count with child-resistant closure NDC 16729-094-29 Bottle of 120’s count with child-resistant closure NDC 16729-094-16 Bottle of 500’s count Storage Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). 16.3
MYCOPHENOLATE MOFETIL Tablets USP 500 mg
MYCOPHENOLATE MOFETIL Tablets, USP are available containing 500 mg of
MYCOPHENOLATE MOFETIL, USP. The 500 mg tablets are purple coloured, capsule shaped, biconvex, film coated tablets debossed ‘AHI’ on one side and ‘500’ on other side. NDC Number Size NDC 16729-019-01 Bottle of 100’s count with child-resistant closure NDC 16729-019-16 Bottle of 500’s count Storage and Dispensing Information 1.Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). 2.Dispense in light-resistant containers, such as the manufacturer's original containers.
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