Provera, tablets 500 mg 30 pcs

Pharmacodynamics

Gestagen. Does not have androgenic and estrogenic activity. Inhibits the secretion of gonadotropic hormones (especially LH). In small doses it suppresses ovulation. It has an inhibitory effect on changes necessary for the preparation of the endometrium for implantation of the fertilized egg and increases the viscosity of cervical mucus.

In higher doses it has antitumor effects in hormone-sensitive malignancies. This effect appears to be due to an effect on steroid hormone receptors and on the pituitary-gonadal system.

Pharmacokinetics

The binding to plasma proteins is 90-95%. It penetrates through the BBB and is excreted with breast milk. It is metabolized in the liver.

T_1/2 is about 30 hours. It is excreted with the bile and urine as metabolites and unchanged.

Indications

For use in gynecology:

contraception;
endometriosis.

For use in oncology:

adjunctive and palliative treatment of recurrent and metastatic endometrial or renal cancer;
palliative treatment for hormone-dependent forms of recurrent breast cancer in postmenopausal women;
prostate carcinoma, some forms of prostate adenoma;
cancer cachexia in advanced tumors of various locations.

Pharmacological effect

Pharmacodynamics

Gestagen. Does not have androgenic and estrogenic activity. Inhibits the secretion of gonadotropic hormones (especially LH). In small doses it suppresses ovulation. It has an inhibitory effect on the changes necessary to prepare the endometrium for implantation of a fertilized egg and increases the viscosity of cervical mucus.

In higher doses it has an antitumor effect in hormone-sensitive malignancies. This effect is apparently due to the effect on steroid hormone receptors and on the pituitary-gonadal system.

Pharmacokinetics

Plasma protein binding is 90-95%. Penetrates through the blood-brain barrier and is excreted in breast milk. Metabolized in the liver.

T1/2 is about 30 hours. It is excreted in bile and urine in the form of metabolites and unchanged.

Special instructions

It is necessary to strictly observe the compliance of the dosage form of the drug used with the indications for use.

Medroxyprogesterone should be used with extreme caution in patients with thrombophlebitis, thromboembolic complications, severe liver dysfunction, and hypercalcemia.

Before using medroxyprogesterone for the treatment of gynecological diseases and contraception, it is necessary to exclude the presence of a tumor of the genital organs or mammary glands in the patient.

When conducting pathohistological examination of certain organs and tissues, it is necessary to warn the histologist about previous treatment with progestogens. During the use of medroxyprogesterone, changes in the results of the following studies are possible: determination of the level of gonadotropins; determination of the level of progesterone, cortisol, testosterone (in men), estrogens (in women) in blood plasma; determination of the level of pregnanediol in urine; carrying out a test with a sugar load; carrying out a test with metapyrone.

Active ingredient

Medroxyprogesterone

Composition

1 tablet contains:

Active ingredient:

medroxyprogesterone (in acetate form) 500 mg.

Excipients:

cornstarch;

magnesium stearate;

MCC;

gelatin;

polyethylene glycol 400;

sodium starch salt;

sodium docusate (85%) with sodium benzoate (15%).

There are 10 tablets in a blister.

There are 3 blisters in the package.

Pregnancy

Contraindicated during pregnancy.

Does not affect lactation. It is excreted in breast milk in small quantities, and no negative effects are observed in the development of children receiving this milk.

Contraindications

Pregnancy;
hypersensitivity to medroxyprogesterone.

Side Effects

From the central nervous system: headache, irritability, sleep disturbances, drowsiness, feeling tired, depression, dizziness.

From the digestive system: nausea.

Allergic reactions: urticaria, itching, rash, anaphylactoid reactions.

From the hematopoietic system: thromboembolic disorders.

From the endocrine system: increased sensitivity of the mammary gland, galactorrhea, erosion and changes in cervical secretion. When used at a dose of 500 mg/day or more, acne, hirsutism, weight gain, and a “moon-shaped” face are possible.

Other: hyperthermia.

Interaction

When used simultaneously with aminoglutethimide, a decrease in the concentration of medroxyprogesterone in the blood plasma is possible.

When used simultaneously with drugs that cause the induction of microsomal liver enzymes, the contraceptive effect of medroxyprogesterone when administered parenterally may be reduced.

Carbamazepine, griseofulvin, phenobarbital, phenytoin, rifampicin may increase the clearance of gestagens (progestogens).

Gestagens (progestogens) can change the effectiveness of hypoglycemic drugs.

Progestogens (progestogens) may inhibit the metabolism of cyclosporine, resulting in increased plasma concentrations and an increased risk of toxicity.

Storage conditions

At 15–30 °C

Shelf life

5 years