Mycophenolate Mofetil-TL, 250 mg capsules, 100 pcs.

Mycophenolate Mofetil-TL – Immunosuppressive agent; morpholinoethyl ester of mycophenolic acid produced by Penicillium stoloniferum.

Disrupts guanosine nucleotide synthesis by inhibiting inosine monophosphate dehydrogenase. Inhibits the proliferation of T- and B-lymphocytes and the production of antibodies.

Indications

Prevention of acute organ rejection and treatment of treatment-refractory organ rejection in patients after allogeneic kidney transplantation.
Prevention of acute organ rejection and to improve graft survival and patient survival after allogeneic heart transplantation.
Prevention of acute organ rejection in patients after allogeneic liver transplantation.

Pharmacological effect

Mycophenolate Mofetil-TL – Immunosuppressive drug; morpholinoethyl ester of mycophenolic acid produced by Penicillium stoloniferum.

It disrupts the synthesis of guanosine nucleotides by inhibiting inosine monophosphate dehydrogenase. Inhibits the proliferation of T- and B-lymphocytes, as well as the production of antibodies.

Special instructions

It is necessary to take into account the possibility of an increased risk of developing lymphoproliferative processes, regularly monitor the composition of peripheral blood; if the number of neutrophils decreases, dose reduction or a break in treatment (and appropriate therapy) is indicated.

If the glomerular filtration rate decreases below, use more than 2 times a day is not recommended.

For more detailed information, see the instructions for medical use of the drug.

Active ingredient

Mycophenolate mofetil

Composition

Active ingredients:

mycophenolate mofetil250 mg

Excipients:

microcrystalline cellulose 0.065 g,

povidone K90 0.014 g,

croscarmellose sodium 0.0175 g,

magnesium stearate 0.0035 g.

Composition of the capsule body:

iron oxide dye black 0.0224%, iron oxide red dye – 0.0224%, iron oxide dye yellow 0.4343%, titanium dioxide 0.5265%, gelatin up to 100%.

Composition of the capsule cap:

iron dye black oxide 0.7%, iron dye red oxide – 0.07%, iron dye yellow oxide 0.5%, titanium dioxide 0.667%, gelatin up to 100%

Contraindications

Hypersensitivity to mycophenolate mofetil.

Side Effects

Nausea, vomiting, diarrhea, constipation, leukopenia or leukocytosis, anemia, thrombocytopenia, increased incidence of infectious and septic complications; headaches, insomnia, tremor, fever, asthenia, lumbago, hypertension, cough, pharyngitis, shortness of breath, peripheral edema, oropharyngeal candidiasis, hematuria, tubular necrosis, impotence, acne, hyper- or hypokalemia, hyperglycemia, hypophosphatemia, hypercholesterolemia, allergic reactions, rash, skin itching

Interaction

Probenecid and other drugs that affect tubular secretion increase the plasma concentration of mycophenolic acid. Antacids containing magnesium and aluminum hydroxides reduce absorption. Drugs that change the flora of the gastrointestinal tract can disrupt the enterohepatic circulation.

Reduces the effectiveness of oral contraception. Azathioprine increases the risk of developing lymphomas, especially of the skin.

Overdose

Symptoms: increased frequency of gastrointestinal and hematological (in particular neutropenia) side effects.

Treatment: dose reduction or drug withdrawal.

To speed up excretion, it is possible to prescribe bile acid sequestrants.

Small amounts of glucuronide can be removed by hemodialysis (mycophenolic acid is not dialysable).

Storage conditions

In a dry place, protected from light, at a temperature not exceeding 30 °C.
Keep out of the reach of children.

Shelf life

2 years

Manufacturer

Drug technology, Russia