Prover® (Provera® )

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceMedroxyprogesteroneMedroxyprogesterone
Similar drugsTo uncover
  • Veraplex
    pills inwards 
    Teva Pharmaceutical Enterprises Co., Ltd.     Israel
  • Depo-Provera
    suspension w / m 
    Pfizer IFG Belgium N.V.     Belgium
  • Depo-Provera®
    suspension w / m 
    Pfizer IFG Belgium N.V.     Belgium
  • Medroxyprogesterone-LENS
    suspension w / m 
    LENS-PHARM, LLC     Russia
  • Prover®
    pills inwards 
    Pfizer H.C. Corporation     USA
    • Dosage form: & nbsppills.
    Composition:1 tablet contains:
    active substance: medroxyprogesterone acetate 500 mg;
    Excipients: cellulose microcrystalline 222.0 mg, corn starch 90.0 mg, gelatin hydrolyzed (Biko C) 47.5 mg, sodium starch glycolate (type A) 46.3 mg, polyethylene glycol (macrogol 400) 10.0 mg, sodium docusate 85%) with sodium benzoate (15%) 4.63 mg, magnesium stearate 4.63 mg.

    Description:White oblong biconvex tablets with the product code "Upjohn 717" on one side (without a notch).
    Pharmacotherapeutic group:progestogen.
    ATX: & nbsp

    L.02.A.B.02   Medroxyprogesterone

    L.02.A.B   Progestogens

    Pharmacodynamics:Medroxyprogesterone acetate (MPA), a synthetic derivative of progesterone, refers to progestins that do not possess estrogenic activity and has the following pharmacological effect on the endocrine system:
    - inhibits the secretion of pituitary gonadotropins (inflammatory hormone (LH) and follicle-stimulating (FSH));
    - reduces the concentration of adrenocorticotropic hormone (ACTH) and hydrocortisone in the blood plasma;
    - Suppresses the function of Leydig cells in men and reduces the concentration of testosterone in the blood plasma;
    - reduces the concentration of estrogens in the blood plasma (by inhibiting the secretion of FSH, as well as the enzymatic induction of hepatic reductase, which leads to an increase in testosterone clearance and the subsequent decrease in the conversion of androgens to estrogens).
    The antitumor effect of the drug in therapeutic doses in the treatment of hormone-dependent malignant neoplasms may be due to its effect on the hypothalamic-pituitary-gonadal system, the receptors of progestins and estrogens, and the metabolism of steroids at the cellular level. IPA, as well as progesterone, has a pyrogenic effect. At very high doses, used for the therapy of certain cancers (500 mg per day or more), it is possible to develop the Itenko-Cushing syndrome.
    Pharmacokinetics:After oral administration MPA is quickly absorbed from the gastrointestinal tract, the maximum concentration in the blood plasma is observed after about 2-4 hours. The half-life of MPA is from 12 to 17 hours.
    With simultaneous intake of food, the bioavailability of the drug increases, while the half-life does not change.
    More than 90% of MPA is in the blood in a protein-related condition (predominantly with albumin). IPA does not bind to a specific globulin that binds sex hormones. Unbound IPA also has pharmacological activity.
    MPA is largely metabolized with the participation of cytochrome P450 3A4 in liver microsomes by hydroxylation followed by conjugation. At present, not less than 16 metabolites of MPA are known. Most of the metabolites are excreted in the urine in the form of glucuronides and only a small part - in the form of sulfates.
    MPA penetrates the blood-brain barrier and into breast milk.
    Indications:Additional and palliative treatment: cancer of the kidney (recurrent and metastatic), breast cancer (hormone-dependent, recurrent, in the postmenopausal period), endometrial cancer (including metastatic), prostate cancer, cancerous cachexia in advanced tumors of various locations.

    Contraindications:- Hypersensitivity to MPA or any other component of the drug.
    - Vaginal bleeding.
    - Expressed liver function abnormalities.
    - Pregnancy and the period of breastfeeding.
    - Thrombophlebitis.
    - Thromboembolic disorders.
    - Hemorrhages in the brain.
    - The initial stages of breast cancer.
    - Children under 18 years.

    Carefully:Hepatic insufficiency, hypercalcemia, epilepsy, migraine, bronchial asthma, cardiac or renal insufficiency, diabetes mellitus, depressive states. Care should be taken when treating patients whose condition may be adversely affected by fluid retention in the body.
    Pregnancy and lactation:MPA is contraindicated in pregnancy.
    There are reports that under certain conditions, there is a correlation between the intrauterine exposure of progestogens during the first trimester of pregnancy and the developmental disorders of the genitals in the fetus.
    Newborns, in the case of an unplanned pregnancy occurring within 1-2 months after the injection of MPA, have a greater risk of developing hypotrophy, which in turn increases the risk of intrapartum and neonatal mortality. The risk of developing such complications is relatively low, since pregnancy is rare when using MPA.
    In the event that pregnancy has developed against the background of the use of MPA, the patient should be warned about the possible risk to the fetus.
    MPA is excreted in breast milk. There is no evidence that this may cause any harm to the newborn breastfed. However, the use of MPA in the first six weeks of the postpartum period is not recommended.
    Dosing and Administration:Inside. Tablets should be taken, not liquid, squeezed with water.
    - Breast cancer: 400-1500 mg / day.
    - Endometrial cancer and kidney cancer: 100-600 mg / day.
    - Metastatic prostate cancer: 100-500 mg / day.
    - Syndrome of anorexia and cachexia: 1000 mg / day.
    Treatment is continued until there is a positive response to therapy.
    Side effects:On the part of the hematopoiesis system: an increase in the number of leukocytes and platelets in the blood plasma.
    On the part of the endocrine system: the Itzenko-Kunshng syndrome (obesity, lunar face, osteoporosis, menstrual cycle disorder, different color streaks, hirsutism, swelling of the lower extremities, decreased sexual function, hyperpigmentation of the skin in places of friction, hypokalemia), decompensation of diabetes mellitus, glucosuria. galactorrhea, a decrease in glucose tolerance, a change in body weight.
    With the genitourinary system: changes in libido, dysfunctional uterine bleeding (irregular, copious, scanty), amenorrhea, changes in vaginal discharge, cervical erosion, prolonged anovulation, mammalgia. soreness of the breast or mammary glands, abdominal pain, vaginitis, hypersensitivity of the nipples of the breast or mammary glands, erectile dysfunction.
    From the nervous system: confusion, euphoria, insomnia, drowsiness, depression, dizziness, headache, decreased ability to concentrate, irritability, fatigue, reaction, like adrenergic (such as tremor, sweating, leg cramps but at night), tonic or clinical cramps.
    From the cardiovascular system: stroke, myocardial infarction, chronic heart failure, palpitations. tachycardia, thromboembolism of the pulmonary artery, thromboembolic disorders, thrombophlebitis, increased blood pressure, sensation of "hot flashes".
    From the side of the organ of vision: diabetic cataract, visual disturbances, thrombosis of retinal vessels.
    On the part of the digestive system: constipation, diarrhea, dryness of the oral mucosa, nausea, vomiting, impaired liver function, jaundice, changes in appetite, pain and discomfort in the abdomen, flatulence.
    From the skin and skin appendages: acne, alopecia, hirsutism, itching, rash, urticaria.
    On the part of the immune system: hypersensitivity reactions (anaphylaxis and anaphylactoid reactions, angioedema).
    Other: reactions at the injection site (compaction at the injection site, skin discoloration at the injection site, sterile abscess), swelling / fluid retention, malaise, hyperthermia, hypercalcemia. pain in the back and joints.
    When using the drug after its registration, rare cases of osteoporosis, including osteoporotic fractures of bones, were recorded.
    Overdose:The use of very high doses of the drug can cause a number of symptoms, including an increase in body weight (with some fluid retention), increased fatigue, and also in some cases the effects inherent in corticosteroids.
    In cases of overdose, discontinue use of the drug. Specific treatment is not required.Oral doses up to 3 g / day were well tolerated.
    Treatment of an overdose includes symptomatic and supportive interventions.
    Interaction:When combined aminoglutethimide can significantly reduce the bioavailability of the Provera® preparation and thereby reduce its effectiveness.
    MPA in vitro is metabolized predominantly by hydroxylation via the CYP3A4 isoenzyme. Special studies of the effect of inhibitors or inducers of the isoenzyme CYP3A4 on the pharmacokinetics of MPA have not been conducted. In connection with the high probability of such interaction, it is theoretically possible to assume the effect on the efficiency of MPA. However, the clinical effects of simultaneous application of inhibitors or inducers of the isoenzyme CYP3A4 and MPA are unknown.

    Special instructions:The drug is used strictly for the purpose and under the supervision of a doctor
    - In the event of dysfunctional uterine bleeding, the patient should be examined to determine the etiology.
    - In the treatment of patients, the condition of which may be adversely affected by fluid retention in the body, caution should be exercised.
    - During the period of treatment with Provera®, you should carefully monitor the condition of patients who were previously treated for depression.
    - When treating patients with diabetes mellitus, the ability of MPA to reduce glucose tolerance should be considered.
    - If necessary, cytological and histological examination of endometrial or cervical pathology report should be warned about drug therapy Provera®.
    - In laboratory studies should take into account that the use of the IPA is to change the concentration of the following endocrine biomarkers:
    a) Steroids in blood plasma and urine (cortisol, estrogens, pregnanediol, progesterone, testosterone);
    b) gonadotropins in blood plasma and urine (LH and FSH);
    c) a specific globulin that binds the sex hormones.
    - In some patients taking MPA revealed suppression of adrenocortical function (decrease ACTH and hydrocortisone in the blood plasma).
    - When metapironovogo test should be considered that high doses of MPA used in oncology, can cause partial adrenal insufficiency (decrease in response of the pituitary-adrenal axis),so before the introduction of the metapyron, it is necessary to check the ability of the adrenal cortex to respond to AK GG.
    - It is necessary to interrupt the use of the drug and to conduct a test with sudden partial or complete loss of vision, or with the development of exophthalmos, double vision, migraine attacks. When revealing damage to the vessels of the retina or edema of the optic nerve, treatment with Provera® should be discontinued.
    - Despite the fact that there was no causal relationship between the use of MPA and the development of thromboembolic complications, the use of Provera® is not recommended in patients with these complications in the history or when they occur against the background of treatment.
    - The effect of using the drug in high doses on the density of bone tissue (PCT) has not been studied. The decrease in the concentration of estrogens in blood plasma, caused by the use of the drug, leads to a decrease in PCT in women before menopause and may increase the risk of osteoporosis in subsequent years of life. All patients who use Provera ® are recommended to take calcium and vitamin D preparations (in the absence of contraindications), and with prolonged use - periodically measure PBC.
    Effect on the ability to drive transp. cf. and fur:The effect of the drug on the ability to drive vehicles and mechanisms has not been studied, but it must be taken into account that Provera® can cause dizziness and visual impairment, therefore, when taking the drug, care should be taken when performing the above actions.
    Form release / dosage:Tablets 500 mg in blisters from PVC / alum. foil of 10 tablets; 3 blisters together with instructions for use in a cardboard bundle.
    Storage conditions:At a temperature not higher than 25 ° C, out of the reach of children.
    Shelf life:5 years.
    Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N011853 / 01
    Date of registration:10.08.2010
    The owner of the registration certificate:Pfizer H.C. CorporationPfizer H.C. Corporation USA
    Information update date: & nbsp30.07.2015
    Illustrated instructions
      Instructions
      Up