Endoxan pills 50mg, 50pcs

Composition

1 tablet contains:

Active ingredients:

cyclophosphamide 50 mg.

The blister contains 10 tablets.

In a cardboard box of 5,40,100 or 200 blisters.

Pharmacological action

Pharmacodynamics

Antitumor agent of alkylating action. It has cytostatic and immunosuppressive effects. The antitumor effect is realized directly in tumor cells, where cyclophosphamide is biotransformed under the action of phosphatases to form an active metabolite with an alkylating effect.

Pharmacokinetics

After a single intravenous injection, the concentration of cyclophosphamide and its metabolites in plasma decreases rapidly in the first 24 hours, but can be determined within 72 hours. When taken orally, the concentrations of cyclophosphamide and its metabolites are almost the same as when administered intravenously.

T_1/2 from plasma after intravenous use averages 7 hours in adults and about 4 hours in children. It is excreted in the urine and bile.

Indications

• Ovarian cancer;
• breast cancer;
• lung cancer;
• lymphogranulomatosis;
• non-Hodgkin’s lymphoma;
• lymphosarcoma;
• reticulosarcoma;
• osteogenic sarcoma;
• multiple myeloma;
• chronic lymphocytic leukemia;
• acute lymphoblastic leukemia;
• Wilms tumor;
• Ewing sarcoma;
• testicular seminoma.
• prevention of graft rejection reaction.
• rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, nephrotic syndrome (as an immunosuppressant).

Use during pregnancy and lactation

Cyclophosphamide is contraindicated during pregnancy. If it is necessary to use it during lactation, the question of stopping breastfeeding should be decided.

Women of childbearing age should use reliable methods of contraception during therapy.

Teratogenic and embryotoxic effects of cyclophosphamide have been established in experimental studies.

Contraindications

• Cachexia;
• anemia;
• leukopenia;
• thrombocytopenia;
• heart failure;
• severe liver and/or kidney disease;
• pregnancy.

Side effects

From the digestive system: nausea, vomiting, diarrhea, stomach pain; rarely-toxic hepatitis.

From the hematopoietic system: leukopenia, thrombocytopenia, anemia.

From the respiratory system: with prolonged use of high doses – pneumonitis or interstitial pulmonary fibrosis.

From the cardiovascular system: tachycardia, shortness of breath, acute myopericarditis; in some cases – severe heart failure (associated with hemorrhagic myocarditis and myocardial necrosis).

From the urinary system: aseptic hemorrhagic cystitis, nephropathy (associated with hyperuricemia).

From the reproductive system: menstrual disorders, amenorrhea, azoospermia.

Allergic reactions: skin rash, urticaria, anaphylactic reactions.

Other: alopecia, muscle and bone pain, headache.

Interaction

Concomitant use of cyclophosphamide may increase the effect of hypoglycemic drugs.

Concomitant use with allopurinol may lead to increased myelotoxicity.

When used concomitantly with indirect anticoagulants, anticoagulant activity may change (as a rule, cyclophosphamide reduces the synthesis of clotting factors in the liver and disrupts the process of platelet formation).

When combined with cytarabine, daunorubicin or doxorubicin, it is possible to increase the cardiotoxic effect.

When combined with immunosuppressants, the risk of infections and secondary tumors increases.

Concomitant use of cyclophosphamide with lovastatin increases the risk of acute skeletal muscle necrosis and acute renal failure.

Drugs that are inducers of microsomal enzymes cause an increased formation of active metabolites of cyclophosphamide, which leads to an increase in its action.

How to take, course of use and dosage

Set individually, depending on the indications and stage of the disease, the state of the hematopoietic system, the scheme of antitumor therapy.

Overdose

Treatment: use of supportive measures, including appropriate treatment for infections, myelosuppression and/or cardiotoxicity. There is no specific antidote. Treatment is symptomatic.

Special instructions

It is not recommended for use in patients with chickenpox (including recently transferred or after contact with the sick), with herpes zoster and other acute infectious diseases.

Use with caution in patients with a history of gout or nephrolithiasis, as well as after adrenalectomy (correction of hormone replacement therapy and cyclophosphamide doses is necessary).

Cyclophosphamide is used with caution in patients with bone marrow infiltration by tumor cells, as well as in patients receiving antitumor chemotherapy or radiation therapy.

In the course of treatment, systematic monitoring of the peripheral blood picture is necessary: during the main course,2 times / week; with maintenance treatment,1 time/week. If the number of white blood cells decreases to 2500/µl and platelets to 100,000/µl, treatment should be discontinued.

During therapy, the activity of hepatic transaminases and LDH, the level of bilirubin, uric acid concentrations in blood plasma, diuresis and specific density of urine are monitored, and tests are also performed to detect microhematuria.

When using cyclophosphamide in higher doses to prevent hemorrhagic cystitis, it is advisable to prescribe mesna.

In experimental studies, the carcinogenic and mutagenic effects of cyclophosphamide were established.

Form of production

Sugar-coated tablets.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Cyclophosphamide

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

Children as prescribed by a doctor, Adults as prescribed by a doctor

Indications

Cancer