A1,
A2,
B,
C1,
C2,
D,
E,
F,
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I-K,
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P1,
P2,
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Cellcept Online, Description, Chemistry, Ingredients - Mycophenolate Mofetil
Cellcept Online, Description, Chemistry, Ingredients - Mycophenolate Mofetil
DESCRIPTION
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WARNING: Increased susceptibility to infection and the possible
development of lymphoma may result from immunosuppression. Only
physicians experienced in immunosuppressive therapy and management
of renal or cardiac transplant patients should use CellCept. 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.
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CellCept (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-(l,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate.
It has an empirical formula of C23H31NO7
a molecular weight of 433.50.
Mycophenolate mofetil is a white to off-white crystalline powder. It
is slightly soluble in water (43 µg/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.
CellCept is available for oral administration as capsules containing
250 mg of mycophenolate mofetil, tablets containing 500 mg of mycophenolate
mofetil, and as a powder for oral suspension, which when constituted contains
200 mg/mL mycophenolate mofetil.
Inactive ingredients in CellCept 250 mg capsules include croscannellose
sodium, magnesium stearate, povidone (K-90) and pregelatinized starch.
The capsule shells contain black iron oxide, FD&C blue #2, gelatin, red
iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide,
and yellow iron oxide.
Inactive ingredients in CellCept 500 mg tablets include black iron oxide,
croscannellose sodium, FD&C blue #2 aluminum lake, hydroxypropyl cellulose,
hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose,
polyethylene glycol 400, povidone (K-90), red iron oxide, talc, and titanium
dioxide; may also contain ammonium hydroxide, ethyl alcohol, methyl alcohol,
n-butyl alcohol, propylene glycol, and shellac.
Inactive ingredients in CellCept Oral Suspension include aspartame, citric
acid anhydrous, colloidal silicon dioxide, methylparaben, mixed fruit
flavor, sodium citrate dihydrate, sorbitol, soybean lecithin, and xanthan
gum.
CellCept Intravenous is the hydrochloride salt of mycophenolate mofetil.
The chemical name for the hydrochloride salt of mycophenolate mofetil
is 2-morpholinoethyl (E)-6-(l,3-dihydro-4 hydrochloride. It has an empirical
formula of C23H31NO7 HCl and a molecular
weight of 469.96.
CellCept Intravenous is available as a sterile white to off-white lyophilized
powder in vials containing mycophenolate mofetil hydrochloride for administration
by intravenous infusion only. Each vial of CellCept Intravenous contains
the equivalent of 500 mg mycophenolate mofetil as the hydrochloride salt.
The inactive ingredients are polysorbate 80, 25 mg, and citric acid, 5
mg. Sodium hydroxide may have been used in the manufacture of CellCept
Intravenous to adjust the pH. Reconstitution and dilution with 5% Dextrose
Injection USP yields a slightly yellow solution of mycophenolate mofetil,
6 mg/mL (For detailed method of preparation, see DOSAGE
AND ADMINISTRATION.)
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