CellCept (mycophenolic acid) capsules 250 mg. №100

Description

CellCept (mycophenolic acid) capsules 250 mg. №100

Composition

active substance: mycophenolic acid;

1 capsule contains mycophenolate mofetil 250 mg;

excipients: pregelatinized starch; croscarmellose sodium; povidone (K90); magnesium stearate; capsule shell: titanium dioxide (E 171); iron oxide yellow (E 172); iron oxide red (E 172); indigo carmine FD and C blue 2 (E 132); gelatin; printing ink.

Medicinal form

Capsules.

Main physical and chemical properties: hard gelatin capsules, body – opaque, brown, cap – opaque, blue; black labeling: “CellCept 250” on the cap and “Roche” on the body; the contents of the capsules are a fine granular powder, partially agglomerated, from white to almost white in color.

Pharmacotherapeutic group

Selective immunosuppressive drugs. Mycophenolic acid.
ATX code L04A A06.

Pharmacological properties

Mycophenolate mofetil is a 2-morpholinoethyl ester of mycophenolic acid (MFC). 2-morpholinoethyl ester of mycophenolic acid is a powerful selective non-competitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), which inhibits de novo synthesis of guanosine nucleotides without incorporation into DNA. 2-morpholinoethyl ester of mycophenolic acid exerts a more pronounced cytostatic effect on lymphocytes than on other cells, since the proliferation of T- and B-lymphocytes is highly dependent on de novo purine synthesis, while other types of cells can switch to bypassing metabolic pathways.

Indications

CellCept is used in combination therapy with cyclosporins and corticosteroids for:

• prevention of acute rejection after kidney transplantation or treatment of organ rejection refractory to therapy in patients who have undergone allogeneic transplantation;
• improving the quality of survival and prevention of acute transplant rejection and survival of patients after a homogeneous heart transplant;
• prevention of acute organ rejection in patients who have undergone homogeneous liver transplantation.

Contraindications

Cellsept is not prescribed for patients who suffer from mycophenolate mofetil intolerance and a hereditary deficiency of hypoxanthine-guanine phosphoribosyl transferase.
It is not prescribed for children with a body area of ​​less than 1.5 square meters and for patients who have not reached the age of 14, since there is no information on the safety of using the drug in therapy after heart, kidney or liver transplantation in patients of this age group.
Care should be taken to prescribe CellCept to patients suffering from chronic diseases of the digestive system.
The drug is not prescribed in conjunction with azathioprine and is used with caution as part of a complex treatment together with tacrolimus, sirolimus and drugs that affect the hepatic-intestinal circulation.

Application during pregnancy and lactation

CellCept is categorically contraindicated in pregnant and lactating women. The drug can be used in the treatment of women of fertile age only when using reliable methods of contraception.

Method of administration and dosage

CellCept capsules and tablets are used only for oral administration. To prevent the development of kidney rejection, treatment begins in the first 72 hours after organ transplantation. Adult patients and children take 1 g of the drug 2 times a day.
To prevent the occurrence of rejection of a homogeneous heart or liver, treatment begins in the first five days after transplantation. The drug is taken 1.5 g 2 times per knock.
If, in the process of taking CellCept, the patient develops neutropenia, then his reception is temporarily stopped until the laboratory parameters are normalized.
Patients with severe renal failure are prohibited from taking Cellsept more than 3 g per day.

Overdose

When Cellsept is taken in high doses, there is an increased development of side symptoms.

Side effects

Taking CellCept with corticosteroids or cyclosporins may cause vomiting, diarrhea, leukopenia, anemia, sepsis, and an increased risk of opportunistic infections.
When taking CellCept, some patients experience asthenia, peritonitis, abdominal pain, edema of the extremities, fever, ascites, impaired wound healing, leukocytosis, headaches, arrhythmias, heart failure, acidosis, pleural or pericardial effusion, weight gain, anorexia, herpes , acne, drowsiness, facial swelling and hair loss.