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Cyproterone

Bayer Pharma AG
20 Items
2019-09-19
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$100.69
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Clinical Pharmacology

Androcur - antiandrogenic, gestagennoe.

Pharmacodynamics

Oral anti-androgenic drug. Inhibits the effects of male sex hormones (androgens), in small amounts also produced by the woman’s body. It has a gestagenic, antiandrogenic and antigonadotropic action.

In men, while taking the drug, there is a weakening of sexual desire and potency, as well as a decrease in the function of the testes. These changes disappear after cessation of treatment. The drug reduces or completely eliminates the effect of androgens on the target organs (including the prostate gland).

In women, while taking Androcur, both pathologically excessive hair growth on the face and body, and hair loss caused by androgens, is reduced. In addition, the increased function of the sebaceous glands is reduced and ovarian function is inhibited during the treatment period.

Pharmacokinetics

Suction

After taking the drug inside cyproterone acetate is completely absorbed from the gastrointestinal tract. After taking 10 mg Cmax is reached in 1.5 hours and is 75 ng / ml, after taking 50 mg - 140 mg / ml. After taking the pill 100 mg Cmax reaches an average of 2.8 ± 1.1 hours. Bioavailability is 88%.

Distribution and metabolism

Plasma protein binding is about 96%. Biotransformed in the liver by hydroxylation and conjugation, the main metabolite, as determined in human plasma, is a 15β-hydroxyl derivative.

Removal

T1/2 for pills of 10 mg and 50 mg, it is equal to 43.9 ± 12.8 hours; for 100 mg, it is 42.8 ± 9.7 hours. It is excreted in bile and urine mainly as metabolites in the ratio 3: 7.

Indications

Manifestations of moderate androgenization in women, such as:

  • moderate hirsutism (pathological body hair of the face and body of moderate severity);
  • moderate androgenic alopecia (moderately severe baldness due to androgens);
  • severe and moderate forms of acne (acne), accompanied by inflammation, nodulation or the risk of scarring, and seborrhea.

Composition

1 tablet contains:

Active substances: cyproterone acetate, micro 20 - 10 mg;

Excipients: lactose monohydrate - 63.4 mg, corn starch - 44 mg, povidone 25 000 - 1.35 mg, colloidal micronized silicon dioxide - 1 mg, magnesium stearate - 0.25 mg.

Cyproterone is marketed under different brands and generic names, and comes in different dosage forms:

Brand nameManufacturerCountryDosage form
Androcur Bayer Pharma AG Germany pills
Cyproterone-Teva Teva Israel pills

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Cyproterone

Dosage and Administration

Antiandrogenic therapy for inoperable prostate cancer: At 200-300 mg / day (1 tablet 2-3 times a day, for a long time).

If you improve or achieve remission, you should not interrupt treatment or reduce the dosage.

To reduce the initial increase in androgen levels in GnRH agonist therapy:First, 200 mg per day (1 tablet 2 times a day) as monotherapy for 5–7 days, then 200 mg per day for 3–4 weeks in combination with a GnRH agonist in the dosage recommended by the manufacturer.

For the treatment of hot flashes during therapy with GnRH analogues or after orchiectomy: At 50-100 mg / day (0.5-1.5 pills per day), if necessary, followed by increasing the dose to 300 mg per day (1 tablet 3 times a day).

Adverse reactions

From the hemopoietic system: frequency unknown - anemia.

On the part of the immune system: rarely, hypersensitivity reactions.

Mental Disorders: often - depression, depressed mood, anxiety (temporarily).

From the side of the vessels: frequency unknown - thrombosis and thromboembolism.

Carefully: if patients with inoperable prostate cancer have a thrombosis and thromboembolism in history, severe diabetes mellitus with angiopathy, sickle cell anemia® appointed only after assessing the individual balance of benefit and risk in each case.

Drug interactions

The antigonadotropic effect of cyproterone acetate is enhanced by its combined use with gonadotropin-releasing hormone agonists.

Under the action of cyproterone acetate, the initial increase in testosterone production caused by gonadotropin-releasing hormone agonists is reduced.

Pregnancy and Lactation

Contraindicated in pregnancy and during breastfeeding.

Special instructions

Treatment with Androcur should be carried out under the control of the liver, adrenal cortex and peripheral blood.

If there is evidence of hepatotoxicity, the drug should be discontinued.

In patients with diabetes mellitus, dosage adjustment of insulin or other hypoglycemic drugs may be required (glucose monitoring should be performed more often than usual).

The negative impact of Androcur on fertility after cessation of treatment is not marked.

Impact on the ability to drive vehicles and other mechanisms that require high concentration of attention

During the period of treatment it is necessary to refrain from activities requiring increased attention.

Overdosage

Cyproterone is practically non-toxic.

In case of an unintended single dose in a dose that is many times higher than the therapeutic one, one should not expect acute intoxication.

Studies and clinical trials of Cyproterone (Click to expand)
  1. Cleavage of poly(ADP-ribose) transferase during p53-independent apoptosis in rat liver after treatent with N-nitrosomorpholine and cyproterone acetate
  2. Cyproterone acetate in advanced male breast cancer
  3. Cyproterone acetate in the treatment of metastatic cancer of the male breast
  4. Combined treatment with buserelin and cyproterone acetate in metastatic male breast cancer
  5. Luteinizing hormone-releasing hormone agonists in prostate cancer. Elimination of flare reaction by pretreatment with cyproterone acetate and low-dose diethylstilbestrol
  6. Cyproterone acetate–-mechanism of action and clinical effectiveness in prostate cancer treatment
  7. A further analysis of european organization for research and treatment of cancer protocol 30805. Orchidectomy versus orchidectomy plus cyproterone acetate versus low-dose diethylstilbestrol
  8. Short-term versus long-term addition of cyproterone acetate to buserelin therapy in comparison with orchidectomy in the treatment of metastatic prostate cancer
  9. Effects of neonatal cyproterone acetate administration on isolation-induced fighting behavior and mounting behavior in male and female TO strain albino mice
  10. Effects of neonatal treatment with cyproterone acetate on aggressive behavior induced by footshock in adult male rats
  11. Fine structure of the testis and epididymis of rats treated with cyproterone acetate
  12. Direct action upon avian target organs by the antiandrogen cyproterone acetate
  13. Alterations in the fine structure of the prostate and seminal vesicle of rats treated with cyproterone acetate
  14. Effect of cyproterone acetate on structure and function of rhesus monkey reproductive organs
  15. Effect of Prolactin and Bromocriptine on the Population of Prostate Neuroendocrine Cells from Intact and Cyproterone Acetate-Treated Rats: Stereological and Immunohistochemical Study
  16. Effect of Prolactin on the Population of Epithelial Cells From Ventral Prostate of Intact and Cyproterone Acetate-Treated Peripubertal Rats: Stereological and Immunohistochemical Study
  17. Hormonal modulation in systemic lupus erythematosus. Preliminary clinical and hormonal results with cyproterone acetate
  18. Efficient Synthesis of 16α-Methyl Cyproterone Acetate.
  19. The First Syntheses of 16β-Chloro- and 16β-Bromo-cyproterone Acetate.
  20. Effect of cyproterone acetate and conjugated estrogens on the human insulin receptor
  21. Normalization of sexual behaviour in a female with dementia after treatment with cyproterone
  22. The antiandrogen cyproterone acetate induces synthesis of transforming growth factor β1 in the parenchymal cells of the liver accompanied by an enhanced sensitivity to undergo apoptosis and necrosis without inflammation
  23. Liver cell proliferation induced by nafenopin and cyproterone acetate is not associated with increases in activation of transcription factors NF-κB and AP-1 or with expression of tumor necrosis factor α
  24. Effect of antiandrogen cyproterone acetate on the development of the antler cycle in Southern pudu (Pudu puda)

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