MYCOPHENOLATE MOFETIL capsule MYCOPHENOLATE MOFETIL tablet, film coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

MYCOPHENOLATE MOFETIL (UNII: 9242ECW6R0) (MYCOPHENOLIC ACID - UNII:HU9DX48N0T)

Tersedia dari:

Mylan Pharmaceuticals Inc.

INN (Nama Internasional):

MYCOPHENOLATE MOFETIL

Komposisi:

MYCOPHENOLATE MOFETIL 250 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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. 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.   There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing mycophenolate mofetil treatment. To report a pregnancy or obtain information about the registry, visit www.mycophenolateREMS.com or call 1-800-617-8191. Use of mycophenolate mofetil (MMF) during pregnancy is associated with an increased risk of first trimester pr

Ringkasan produk:

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 [see Dosage and Administration (2) ] . Follow applicable special handling and disposal procedures1 . Mycophenolate Mofetil Capsules, USP are available containing 250 mg of mycophenolate mofetil, USP. The 250 mg capsules are hard-shell gelatin capsules with a caramel opaque cap and a lavender opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over 2250 in black ink on both the cap and body. They are available as follows: NDC 0378-2250-01 bottles of 100 capsules NDC 0378-2250-05 bottles of 500 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mycophenolate Mofetil Tablets, USP are available containing 500 mg of mycophenolate mofetil, USP. The 500 mg tablets are light pink, film-coated, oval, unscored tablets debossed with MYLAN on one side of the tablet and 472 on the other side. They are available as follows: NDC 0378-4472-01 bottles of 100 tablets NDC 0378-4472-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET, FILM COATED
Mylan Pharmaceuticals Inc.
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MEDICATION GUIDE
Mycophenolate Mofetil Capsules, USP
and
Mycophenolate Mofetil Tablets, USP
(mye'' koe fen' oh late moe' fe til)
Read the Medication Guide that comes with mycophenolate mofetil 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?
Mycophenolate mofetil 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 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, 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 mycophenolate mofetil you must also use another form
of birth control. Talk to
your doctor about other birth control methods t

Karakteristik produk

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL CAPSULE
MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MYCOPHENOLATE
MOFETIL CAPSULES AND MYCOPHENOLATE MOFETIL TABLETS SAFELY AND
EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR MYCOPHENOLATE MOFETIL CAPSULES AND
MYCOPHENOLATE
MOFETIL TABLETS.
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_
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RECENT MAJOR CHANGES
Indications and Usage, Pediatric Heart or Liver Transplants (1) 6/2022
Dosage and Administration, Dosage Recommendations for Heart Transplant
Patients (2.3) 6/2022
Dosage and Administration, Dosage Recommendations for Liver Transplant
Patients (2.4) 6/2022
Warnings and Precautions, Serious Infections (5.3) 10/2021
Warnings and Precautions, Acute Inflammatory Syndrome Associated with
Mycophenolate Products
(5.7) 10/2021
INDICATIONS AND USAGE
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)
DOSAGE AND ADMINISTRATION
ADULTS
DOSAGE
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)
Heart Transplant
600 mg/m orally twice daily (starting dose) up to a
maximum of 900 mg/m twice daily (3 g or 15 mL of
oral suspension) (2.3)
Liver Transplant
600 mg/m orally twice daily (starting dose) up to a
maximum of 900 mg/m twice daily (3 g or 15 mL of
oral suspension) (2.4)
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DOSAGE FORMS AND STRENGTHS
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CON