Active substanceMedroxyprogesteroneMedroxyprogesterone
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  • Dosage form: & nbsppills
    Composition:1 tablet contains:

    active substance: medroxyprogesterone acetate 100.00 mg, 250.00 mg or 500.00 mg;

    Excipients: lactose monohydrate 61.895 mg / 154.737 mg / 309.475 mg, povidone 7.380 mg / 18.450 mg / 36.900 mg; crospovidone 15.225 mg / 38.063 mg / 76.125 mg; potato starch 14,000 mg / 35,000 mg / 70.0 mg; magnesium stearate 1,000 mg / 2,500 mg / 5.0 mg; Silica colloidal dioxide 0,500 mg / 1,250 mg / 2,500 mg.

    Description:Tablets of 100 mg - white, round, biconcave with the inscription "MRA 100" on one side and level with the other.

    250 mg tablets - white, round, biconcave with a risk on one side and the inscription "MRA" over the risk and "250" at risk and even on the other.

    Tablets of 500 mg - white, oblong, biconcave with a risk on one side with the inscription "MRA" and "500" on the sides of the risks and even on the other.

    Pharmacotherapeutic group:Progestogen
    ATX: & nbsp

    L.02.A.B.02   Medroxyprogesterone

    L.02.A.B   Progestogens

    Pharmacodynamics:Synthetic steroid with progestagenic activity. Does not have androgenic and estrogenic activity.Oppresses the secretion of gonadotropic hormones (especially luteinizing). In small doses suppresses ovulation. It has a retarding effect on the processes necessary for the preparation of the endometrium to implant a fertilized egg and increases the viscosity of the cervical mucus. Reduces vasomotor symptoms during menopause.

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

    Pharmacokinetics:Binding to plasma proteins is 90-95%. Penetrates through the blood-brain barrier, excreted in breast milk. Metabolised in the liver. The half-life is about 30 hours. It is excreted in bile and urine in the form of metabolites and unchanged.
    Indications:Recurrent and / or metastatic endometrial cancer, kidney cancer, hormone-dependent forms of breast cancer in postmenopausal women.
    Contraindications:Hypersensitivity to medroxyprogesterone or other components of the drug; pregnancy; the period of breastfeeding; acute and chronic cardiacinsufficiency in the stage of decompensation; thrombophlebitis and other thromboembolic complications, including in the anamnesis; severe liver disease, incl. Cholestatic jaundice, hepatitis, liver tumors, Rotor syndrome, Dubin-Johnson syndrome; porphyria; bleeding from the vagina and urinary tract, unspecified etiology; lactose intolerance; deficiency of lactase; glucose-galactose malabsorption.
    Carefully:Acute disorders of cerebral circulation (increased risk of developing or in anamnesis), hypercalcemia, epilepsy, migraine, bronchial asthma, renal insufficiency, arterial hypertension, diabetes mellitus, depressive disorders in the anamnesis.
    Pregnancy and lactation:Contraindicated in pregnancy and lactation.
    Dosing and Administration:The dose of Veraplex is determined individually and depends on the indications and the treatment regimen used.

    With endometrial cancer and kidney cancer, the drug is taken at 200-600 mg per day, with breast cancer - 400-1200 mg per day. The daily dose is divided into 2-3 doses. Treatment continues until signs of progression of the tumor process appear.

    Side effects:The frequency of side effects is classified according to the recommendations of the World Health Organization: very often - not less than 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0,1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely (including isolated cases) - less than 0.01%.

    From the immune system: infrequently - anaphylactic reaction, skin rash, itchy skin; rarely - hives, erythema.

    From the nervous system: frequent-headache, increased excitability, irritability, sleep disturbances, drowsiness, fatigue, depression, dizziness.

    From the cardiovascular system: infrequent increase in blood pressure; rarely thromboembolic disorders.

    From the side of the organ of vision: rare-acute visual disorders, diplopia, exophthalmos.

    From the respiratory system, chest and mediastinum: rarely - thromboembolism of the pulmonary artery.

    From the skin and subcutaneous tissues: infrequently, acne, chloasma (hyperpigmentation of the facial skin in the form of yellowish-brown spots), alopecia.

    From the gastrointestinal tract: often - nausea, rarely - cholestatic jaundice.

    From the reproductive system and the breast: often - increased sensitivity of the nipples of the breast and mammary glands, tenderness of the mammary glands; infrequently - galactorrhea, menstrual irregularity, erosion and changes in vaginal discharge, amenorrhea.

    Other: infrequently, weight gain, fatigue, symptomatic complex of Itenko-Cushing (obesity, lunar face, striae of different color, swelling of the lower limbs, decreased libido, hyperpigmentation of the skin in places of friction, decreased glucose tolerance and increased blood pressure), hyperthermia, a violation of the liver, rarely - hirsutism, cramps in the calf muscles.

    Overdose:The specific antidote is not known. Treatment is symptomatic.
    Interaction:When used simultaneously with aminoglutethimide, the bioavailability of medroxyprogesterone is reduced. Medroxyprogesterone can enhance the effect of indirect anticoagulants.

    With simultaneous use with anticonvulsants (carbamazepine, phenytoin, phenobarbital), antibacterial drugs (rifampicin, rifabutin, efavirenz) and other inducers of the cytochrome P450 isoenzyme system, the activity of metabolic processes increases.

    Special instructions:With the development of acute visual disorders, up to complete or partial loss of vision, diplopia, migraine attacks and exophthalmos, the drug Veraplex should be stopped immediately. In these cases, a thorough ophthalmological examination is necessary to detect edema of the nipple of the optic nerve or vascular injury of the retina.

    With the development of thrombosis and thromboembolic complications (thrombophlebitis, pulmonary embolism, cerebral circulation disorder, retinal vein thrombosis) therapy with drug Vrapeplex should be discontinued.

    When prescribing high doses of the drug Veraplex (500 mg or more), oppression of the adrenal gland function is possible. After the withdrawal of the drug Veraplex may develop adrenal insufficiency. The drug Vrapeplex can cause fluid retention, so there may be a worsening of the course of epilepsy, migraine, bronchial asthma, heart disease or kidney disease.

    Patients with depressive disorders in the history who receive the drug Veraplex should be under medical supervision.When symptoms of depression appear, therapy with Veraplex should be discontinued.

    The preparation of Veraplex can reduce glucose tolerance, so patients with diabetes who receive the drug Veraplex, need regular monitoring of blood glucose.

    Patients receiving long-term therapy with the drug Veraplex, it is necessary to periodically monitor the function of the liver and endocrine organs.

    When carrying out a cytological or histological examination of the endometrium or cervix, it is necessary to warn the pathologist about the therapy with the drug Veraplex.

    Against the background of the use of the drug Vireplex, changes in the results of the following studies are possible: determination of the concentration of gonadotropins; determination of the concentration of progesterone, cortisol, testosterone (in men), estrogens (in women) in blood plasma; determination of the concentration of pregnanediol in urine; carrying out a sample with sugar loading; conducting a test with metapyron.

    Effect on the ability to drive transp. cf. and fur:When developing unwanted reactions from the central nervous system, patients should be careful when performing actions,requiring increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:Tablets of 100 mg, 250 mg or 500 mg.
    Packaging:10 tablets per blister of PVC / al. foil. For 3 or 10 blisters together with instructions for use in cardboard packaging.
    Storage conditions:Store at temperatures from + 15 ° C to +25 ° C in a dry place inaccessible to children!
    Shelf life:5 years.

    The drug should not be used after the expiry date indicated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N014093 / 01
    Date of registration:25.04.2008 / 15.02.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel
    Manufacturer: & nbsp
    Representation: & nbspTeva Teva Israel
    Information update date: & nbsp29.01.2017
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