Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
MYCOPHENOLATE MOFETIL (UNII: 9242ECW6R0) (MYCOPHENOLIC ACID - UNII:HU9DX48N0T)
Bryant Ranch Prepack
ORAL
PRESCRIPTION DRUG
Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in recipients 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. Allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed
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. 16.3 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: 63629-9582-1: 120 TABLETs in a BOTTLE Storage and Dispensing Information Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Dispense in light-resistant containers, such as the manufacturer's original containers.
Abbreviated New Drug Application
Bryant Ranch Prepack ---------- Dispense with Medication Guide available at www.accordhealthcare.us/medication-guides MEDICATION GUIDE Mycophenolate Mofetil Capsules 250 mg Mycophenolate Mofetil Tablets 500 mg (MYE koe FEN oh late MOE fe til) Read the Medication Guide that comes with mycophenolate mofetil capsules and tablets before you start taking it and each time you refill your prescription. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. What is the most important information I should know about mycophenolate mofetil capsules and tablets? Mycophenolate mofetil capsules and tablets can cause serious side effects, including: Increased risk of loss of a pregnancy (miscarriage) and higher risk of birth defects. Females who take mycophenolate mofetil during pregnancy have a higher risk of miscarriage during the first 3 months (first trimester), and a higher risk that their baby will be born with birth defects. • If you are a female who can become pregnant, your doctor must talk with you about acceptable birth control methods (contraceptive counseling) to use while taking mycophenolate mofetil. You should have 1 pregnancy test immediately before starting mycophenolate mofetil capsules and tablets and another pregnancy test 8 to 10 days later. Pregnancy tests should be repeated during routine follow-up visits with your doctor. Talk to your doctor about the results of all of your pregnancy tests. You must use acceptable birth control during your entire mycophenolate mofetil treatment and for 6 weeks after stopping mycophenolate mofetil capsules and tablets, unless at any time you choose to avoid sexual intercourse (abstinence) with a man completely. Mycophenolate mofetil decreases blood levels of the hormones in birth control pills that you take by mouth. Birth control pills may not work as well while you take mycophenolate mofetil, and you could become pregnant. If you take birth control pills while using mycophenol Przeczytaj cały dokument
MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET BRYANT RANCH PREPACK ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MYCOPHENOLATE MOFETIL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL CAPSULES, FOR ORAL USE MYCOPHENOLATE MOFETIL TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1995 WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES AND SERIOUS INFECTIONS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ USE DURING PREGNANCY IS ASSOCIATED WITH INCREASED RISKS OF FIRST TRIMESTER PREGNANCY LOSS AND CONGENITAL MALFORMATIONS. AVOID IF SAFER TREATMENT OPTIONS ARE AVAILABLE. FEMALES OF REPRODUCTIVE POTENTIAL MUST BE COUNSELED REGARDING PREGNANCY PREVENTION AND PLANNING _[SEE WARNINGS AND PRECAUTIONS (5.1)]._ INCREASED RISK OF DEVELOPMENT OF LYMPHOMA AND OTHER MALIGNANCIES, PARTICULARLY OF THE SKIN _[SEE WARNINGS AND PRECAUTIONS (5.2)] _. INCREASED SUSCEPTIBILITY TO INFECTIONS, INCLUDING OPPORTUNISTIC INFECTIONS AND SEVERE INFECTIONS WITH FATAL OUTCOMES _[SEE WARNINGS AND PRECAUTIONS (5.3)]._ INDICATIONS AND USAGE Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, and should be used in combination with other immunosuppressants. ( 1) DOSAGE AND ADMINISTRATION ADULTS DOSING Kidney Transplant 1 g twice daily, orally ( 2.2) Heart Transplant 1.5 g twice daily orally ( 2.3) Liver Transplant 1.5 g twice daily orally ( 2.4) PEDIATRICS Kidney Transplant 600 mg/m orally twice daily, up to maximum of 2 g daily ( 2.2) Reduce or interrupt dosing in the event of neutropenia. ( 2.5) See full prescribing information (FPI) for: adjustments for renal impairment and neutropenia ( 2.5) DOSAGE FORMS AND STRENGTHS Capsules: 250 mg Tablets: 500 mg CONTRAINDICATIONS Hypersensitivity to mycophenolate mofetil, MPA acid or any component of the drug product ( 4) WARNINGS AND PRECAUTIONS Blood Dysc Przeczytaj cały dokument