Mifortik (mycophenolate sodium) enteric tablets 180 mg. №120

Description

Mifortik composition
Main active ingredient: mycophenolate mofetila.
Excipients included in the preparation: lactose, starch, povidone, sodium croscarmellose, talc, magnesium stearate, titanium dioxide, etc.

Release form
It is produced in the form of tablets, in dosages of 180 mg of mycophenolate mofetil.

Pharmacological properties
Mifortik belongs to the group of selective immunosuppressive drugs used for complex therapy in the period after transplantation of internal organs.
The drug owes its therapeutic effect to its main active ingredient – mycophenolate mofetil. This substance is two-morpholinoethyl ether (abbreviated – IFC).
This substance has the properties of a potent selective non-competitive, but at the same time reversible inhibitor of inoside nucleoside (IMPDH). The latter has the property of suppressing the synthesis of nucleotides-guanosines “de novo”, without being included in DNA.
IFC produces a more pronounced cytostatic effect, acting on the lymphocytic cells of the immune system than on other cells.
Quickly has the expected effects when taken orally.

Indications
Mifortik is used in complex therapy for organ transplant procedures (in transplantology).
It is effective as an immunosuppressant in the prevention of probable acute rejection of a transplanted organ and in the treatment of organ rejection refractory to therapy in patients who have undergone allogeneic transplantation:

• kidneys;
• hearts;
• liver.

This drug is prescribed as part of a combination therapy with cyclosporine and corticosteroids.

Contraindications
The drug in question is contraindicated for use in cases where the patient has severe hypersensitivity (allergy) to the main or to one of the auxiliary components.
Use is contraindicated in neutropenia.
It should be used with caution in conjunction with medications that affect the hepatic-intestinal circulation, as they can reduce the effectiveness of mycophenolate mofetil.

Children
Not recommended for use in children under 2 years of age.

Application during pregnancy and lactation
This drug is contraindicated in the treatment of pregnant women.
If it is necessary to take the drug during breastfeeding, lactation is suspended.

Method of administration and dosage
Mifortik is administered orally. Do not crush the capsules.
The recommended dosage is 1 gram of mycophenolate mofetil twice a day (2 grams per day; at the beginning of treatment, a dosage of 3 grams per day is permissible).
Reception should begin no later than 72 hours after the organ transplant operation.
The dosage may vary depending on the age and body surface area of ​​the patient, from 600 mg per square meter of body surface area to no more than 2 grams per day (maximum dosage).
The exact dosage is determined by the attending physician, calculating it from the individual indicators of patients.
The drug is often given concurrently with standard cyclosporine and corticosteroid therapy
No dose adjustment is required for renal or hepatic insufficiency, including after transplantation.
Rejection of a renal transplant does not lead to a change in the pharmacokinetics of mycophenolate mofetil. In such cases, discontinuation of mycophenolate mofetil treatment or dose reduction is not required.

Overdose
In case of an overdose, the side effects described in the corresponding section may increase, possibly excessive suppression of the immune system.
Hemodialysis is ineffective.
In case of such an overdose – apply treatment of symptoms, rinse the stomach, induce vomiting, take enterosorbents.

Side effects
Possible side effects:

• diarrhea, leukopenia, anemia, thrombocytopenia;
• sepsis, vomiting, infections of the genitourinary system, respiratory organs – pneumonia, pharyngitis, sinusitis;
• increased risk of lymphoma, melanoma formation;
• susceptibility to infection by viruses, incl. herpes, bacteria, fungi;
• acidosis, anorexia, hyperuricemia, dehydration, hypovolemia, hypoxia, hypoglycemia;
• agitation, convulsions, depression, anxiety;
• violations of the cardiovascular system – angina pectoris, heart rhythm disturbances;
• arterial hypotension, thrombosis;
• acne, hyperhidrosis, alopecia, dermatitis;
• peritonitis, gastritis, stomatitis, constipation, dyspepsia;
• cholangitis, hepatitis, jaundice, pancreatitis;
• arthralgia, osteoporosis;
• impaired renal function;
• changes in blood quality;
• diabetes mellitus, hypothyroidism;
• hypersensitivity reactions.

Storage conditions and periods
The shelf life is 3 years.
Do not exceed storage temperature of 30 ° C.