ANDROCUR ® - Cyproterone

ANDROCUR ® is a drug based on Cyproterone acetate

THERAPEUTIC GROUP: Non-associated antiandrogens

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications ANDROCUR ® - Cyproterone

ANDROCUR ® is used in the pharmacological treatment of adult pathological sexual deviations such as hypersexuality and in the medical treatment of inoperable prostate cancer.

Mechanism of action ANDROCUR ® - Cyproterone

The Cyproterone acetate contained in ANDROCUR ® is a hormone with anti-androgenic activity, able to inhibit the androgenizing effects of testosterone, and in particular of its active metabolite dihydrotestosterone.

Orally, in fact, the cyproterone acetate is absorbed at the intestinal level and released into the circulation mainly bound to albumin, with which it reaches the various target tissues carrying out a competitive action at the receptor level.

More precisely, the antiandrogenic action is carried out through a competitive mechanism useful for example in:

Inhibit androgen-induced prostatic hypertrophy;
reduce hirsutism and accentuation of male secondary sexual characteristics;
Reduce sexual libido and hyperstimulation;
Inhibit spermatogenesis, producing reversible male infertility;
Inhibit the hypothalamic-pituitary-gonadal axis, reducing testosterone secretion, hence its peripheral and central effects.

After a long half-life of more than 36 hours, the hydroxy and conjugated derivatives of cyproterone are eliminated mainly through the faeces and in small part with the urine.

Studies carried out and clinical efficacy

1. THE EFFECTIVENESS OF ANDROCUR IN THE TREATMENT OF INOPTABLE PROSTATIC CARCINOMA

It is known as one of the predisposing and aggravating conditions for prostate cancer and long-term androgenic stimulation of the prostate. In patients with inoperable prostate cancer, ANDROCUR ® therapy has been shown to be effective in reducing pain, prostate size, density and PSA blood concentrations.

2. THE QUALITY OF LIFE OF PATIENTS WITH PROSTATIC DISEASE

Broad spectrum study conducted with the participation of over 30 urologists, who demonstrated how the administration of cyproterone can significantly improve the quality of life of patients with prostate cancer with few side effects.

3. STRIANT IN THE HYPOGONADISM

Interesting work that shows how the combination of cyproterone with psychotherapy has resulted in delinquents with sexual crimes, a reduction in the frequency of criminal episodes and a sexual and relational stabilization. In all, however, long-term therapy with Androcur, 3 to 5 years, was required.

Method of use and dosage

ANDROCUR ®

Tablets of 50 - 100 mg of cyproterone acetate;

Solution for injection of 100 mg / ml of cyproterone acetate:

the dosages used in the medical field vary according to the medical needs of the patient and the severity of the clinical picture.

More precisely :

in the treatment of deviation of the sexual instinct the therapeutic range fluctuates between 100 and 300 mg daily, divided into several administrations, and modulated based on the therapeutic efficacy supported by psychotherapy;
In the treatment of inoperable prostate cancer the dosages range between 200 - 300 mg daily, according to the indications of your doctor.

Warnings ANDROCUR ® - Cyproterone

The particular biological complexity of antiandrogen therapy and the clinical condition in which the patient finds himself, requires careful medical supervision both in the initial phases of the therapy and during the whole therapeutic process.

Before administering ANDROCUR ®, the doctor must carefully investigate the patient's liver function, given the high hepatic toxicity that cyproterone presents, often the cause of death in terminally ill patients.

Furthermore conditions such as the presence or familiarity for embolic thrombus events, anemia, diabetes, dyspnoea are general contraindications to treatment, given the ability of the drug in question to significantly worsen the clinical course of these pathological manifestations.

In patients in whom cyproterone therapy is indicated for the treatment of disorders of the sexual sphere, the simultaneous intervention of a psychotherapist would be necessary.

This drug contains lactose therefore patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take it.

PREGNANCY AND BREASTFEEDING

ANDROCUR ® is indicated for the exclusive treatment of male pathology.

Interactions

Although at the moment there are no pharmacokinetic studies able to characterize possible pharmacologically relevant interactions, the hepatic metabolism to which cyproterone is subject would expose the patient to potential side effects, related to an increase in the biological effect of the drug, due to the simultaneous intake of enzyme inducers of CYP3A4.

On the contrary, a reduction in the therapeutic efficacy of ANDROCUR ® could be observed following the concomitant administration of inducers such as rifampicin, phenytoin and herbal products containing St. John's wort.

Furthermore, cyproterone could enhance the side effects of statin therapy, such as rhabdomyolysis.

Contraindications ANDROCUR ® - Cyproterone

Taking ANDROCUR ® is contraindicated in cases of liver disease, Dubin-Johonson and Rotor syndrome, debilitating diseases, chronic depression, existing or previous thromboembolic pathologies, diabetes with vascular involvement, anemia, meningioma and in case of hypersensitivity to active ingredient or one of its excipients.

Undesirable effects - Side effects

Clinical trials and careful post-marketing monitoring have defined the main side effects of antiandrogen therapy with cyproterone, which are clearly associated with the biological role of this active ingredient.

In fact the decrease in libido, erectile dysfunction and reversible inhibition of spermatogenesis, are conditions always associated with the intake of ANDROCUR ® but fortunately limited to the therapeutic time interval.

Toxicity and liver disease, depressive states, weight gain, gynecomastia, fatigue, hot flushes, anemia, increased incidence of embolic thrombus and osteoporotic events represent the other side effects associated with the therapy, whose course may be clinically relevant.