mycophenolate mofetil 500 MG Oral 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 )
west-ward pharmaceuticals corp
OVAL WHITE 54 135
54 135 OVAL WHITE
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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. 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 250 mg 250 mg capsules are supplied as caramel opaque/blue opaque capsules with product identification “54 848” printed in black ink on the cap and body, containing a white to off-white powder. NDC 0054-0163-25: Bottle of 100 capsules NDC 0054-0163-29: Bottle of 500 capsules Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant, child-resistant container as defined in the USP/NF. 16.3
MYCOPHENOLATE MOFETIL Tablets 500 mg 500 mg tablets are supplied as white film coated modified oval biconvex tablets debossed with product identification “54 135” on one side and plain on the other side. NDC 0054-0166-25: Bottle of 100 Tablets NDC 0054-0166-29: Bottle of 500 Tablets Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant, child-resistant container as defined in the USP/NF.
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