MYCOPHENOLATE MOFETIL capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Avera McKennan Hospital

INN (International Name):

MYCOPHENOLATE MOFETIL

Composition:

MYCOPHENOLATE MOFETIL 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mycophenolate Mofetil Capsules USP and Mycophenolate Mofetil Tablets USP are indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. Mycophenolate Mofetil Capsules USP and Mycophenolate Mofetil Tablets USP should be used concomitantly with cyclosporine and corticosteroids. Allergic reactions to Mycophenolate Mofetil Capsules USP and Mycophenolate Mofetil Tablets USP have been observed; therefore, Mycophenolate Mofetil Capsules USP and Mycophenolate Mofetil Tablets USP are contraindicated in patients with a hypersensitivity to mycophenolate mofetil USP, mycophenolic acid or any component of the drug product.

Product summary:

Mycophenolate Mofetil Capsules USP, 250 mg are supplied as caramel opaque/blue opaque capsules with "54 848" printed in black ink on the capsule and body, containing a white to an off-white powder. Mycophenolate Mofetil Tablets USP, 500 mg are supplied as white, modified oval tablets debossed with product identification "54 135" on one side and plain on the other side. 0054-0163-25 250 mg, caramel opaque/blue opaque capsules, bottle of 100 0054-0163-29 250 mg, caramel opaque/blue opaque capsules, bottle of 500 0054-0166-25 500 mg, white tablets, bottle of 100 0054-0166-29  500 mg, white tablets, bottle of 500 NDC 69189-0164-1 single dose pack with one capsule as repackaged by Avera McKennan Hospital NDC 69189-0164-2 single dose pack with two capsules as repackaged by Avera McKennan Hospital NDC 69189-0164-3 single dose pack with three capsules as repackaged by Avera McKennan Hospital Storage Store at 25°C (77°F). See USP Controlled Room Temperature; excursions permitted to 15° to 30°C (59° to 86°F). Dispense in light-resistant containers, such as the manufacturer's original containers.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL CAPSULE
Avera McKennan Hospital
----------
MEDICATION GUIDE
MYCOPHENOLATE MOFETIL
Capsules USP and Tablets USP
Read the Medication Guide that comes with Mycophenolate Mofetil
Capsules USP and Tablets USP
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
your 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:
•
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 one 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 therapy 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

Summary of Product characteristics

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL CAPSULE
AVERA MCKENNAN HOSPITAL
----------
WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES, AND SERIOUS
INFECTIONS
Use during pregnancy is associated with increased risks of first
trimester pregnancy loss and
congenital malformations. Females of reproductive potential (FRP) must
be counseled regarding
pregnancy prevention and planning (see WARNINGS andPRECAUTIONS).
Immunosuppression may lead to increased susceptibility to infection
and possible development of
lymphoma. Only physicians experienced in immunosuppressive therapy and
management of renal,
cardiac or hepatic transplant patients should prescribe Mycophenolate
Mofetil USP. Patients
receiving the drug should be managed in facilities equipped and
staffed with adequate laboratory
and supportive medical resources. The physician responsible for
maintenance therapy should
have complete information requisite for the follow-up of the patient
(see WARNINGS
andPRECAUTIONS).
DESCRIPTION
Mycophenolate mofetil is the 2 morpholinoethyl ester of mycophenolic
acid (MPA), an
immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH)
inhibitor.
The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl
(E) 6 (1,3 dihydro 4 hydroxy 6 methoxy 7 methyl
3 oxo 5 isobenzofuranyl) 4 methyl
4 hexenoate. It
has a molecular formula of C
H NO , a molecular weight of 433.50, and the following structural
formula:
Mycophenolate mofetil is a white to off white crystalline powder. It
is slightly soluble in water (43
mcg/mL at pH 7.4); the solubility increases in acidic medium (4.27
mg/mL at pH 3.6). It is freely soluble
in acetone, soluble in methanol, and sparingly soluble in ethanol. The
apparent partition coefficient in
1 octanol/water (pH 7.4) buffer solution is 238. The pKa values for
mycophenolate mofetil are 5.6 for
the morpholino group and 8.5 for the phenolic group.
Mycophenolate mofetil hydrochloride has a solubility of 65.8 mg/mL in
5% Dextrose Injection USP
(D5W). The pH of the reconstituted solution is 2.4 to 4.1.