Provera pill 500mg №30

PROVERA

Composition

1 pill contains:

Active substance: medroxyprogesterone (in the form of acetate) 500 mg.

Excipients: corn starch; Magnesium stearate; MCC; gelatin; polyethylene glycol 400; sodium starch; docusate sodium (85%) with sodium benzoate (15%).

Release form

Pills.

Mechanism of action

Pharmacodynamics

Progestin Does not possess androgenic and estrogenic activity. Inhibits the secretion of gonadotropic hormones (especially LH). In small doses, inhibits ovulation. It has an inhibitory effect on the changes necessary for the preparation of the endometrium for implantation of a fertilized egg and increases the viscosity of the mucus of the cervix.

In higher doses, it has an antitumor effect in hormone-sensitive malignant neoplasms. This effect is due, apparently, to the action on the receptors of steroid hormones and on the pituitary-gonadal system.

Pharmacokinetics

Plasma protein binding is 90-95%. It penetrates the BBB, is excreted in breast milk. Metabolized in the liver.

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

Indications

For use in gynecology:

• contraception;
• endometriosis.

For use in oncology:

• additional and palliative treatment for recurrent and metastatic endometrial cancer or kidney cancer;
• palliative treatment for hormone-dependent forms of recurrent breast cancer in postmenopausal women;
• prostate carcinoma, some forms of prostate adenoma;
• cancer cachexia with advanced tumors of various localization.

Contraindications

• Pregnancy;
• hypersensitivity to medroxyprogesterone.

Use during pregnancy and lactation

Contraindicated in pregnancy.

Does not affect lactation. It is excreted in breast milk in small quantities, while there are no negative events in the development of children receiving this milk.

Special notes

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

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

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

When conducting histopathological studies of certain organs and tissues, it is necessary to warn the histologist about the previous treatment with progestogens. Against the background of the use of medroxyprogesterone, changes in the results of the following studies are possible: determination of the level of gonadotropins; determining the level of Progesterone, cortisol, testosterone (in men),estrogen (in women) in the blood plasma; determination of the level of pregnandiol in the urine; carrying out test with sugar loading; Conducting a test with a metapiron.

Dosage and administration

Set individually, depending on the evidence, the stage of the disease, treatment regimens.

Side effects

From the side of the central nervous system: headache, irritability, sleep disturbances, drowsiness, fatigue, depression, dizziness.

Gastrointestinal: nausea.

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

Hemic and lymphatic: thromboembolic disorders.

On the part of the endocrine system: hypersensitivity 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.

Drug interaction

With simultaneous use with aminoglutetimid may reduce the concentration of medroxyprogesterone in the blood plasma.

With simultaneous use with drugs that induce the induction of liver microsomal enzymes, it is possible to reduce the contraceptive effect of medroxyprogesterone when administered parenterally.

Carbamazepine, Griseofulvin, phenobarbital, phenytoin, rifampicin can increase the clearance of gestagens (progestogens).

Progestogens (progestogens) can alter the effectiveness of hypoglycemic drugs.

Progestogens (progestogens) can inhibit the metabolism of cyclosporine, which leads to an increase in its concentration in the blood plasma and increase the risk of toxicity.

Storage conditions

Store at 15-30 ° C.