Compound
1 tablet of Androkur 50 contains:
Cyproterone acetate – 50 mg;
Additional substances, including lactose monohydrate.
pharmachologic effect
Androcur 50 is an antiandrogenic drug containing cyproterone acetate. The active substance of the drug Androkur 50 competitively inhibits the effect of androgenic hormones on target organs, in particular, it protects the prostate gland from the influence of androgens, which are formed in the adrenal cortex or testicles. Cyproterone acetate has a central effect, the antigonadotropic effect helps to reduce testosterone synthesis, as a result of which the level of the latter decreases in plasma.
In men, the use of cyproterone acetate leads to a decrease in libido and potency, as well as inhibition of the activity of the gonads. These effects disappear after discontinuation of Androkur 50.
In women, cyproterone acetate helps to reduce the severity of androgen-dependent conditions, including pathological hair growth, androgenetic alopecia and increased activity of the sebaceous glands, which results in seborrhea and acne. In combination therapy with Androkur 50 and Diane-35, ovarian function is inhibited.
The antigonadotropic effect of Androkur 50 is manifested when combined with gonadotropin-releasing hormone agonists (increased testosterone production, characteristic of the start of therapy with these drugs, is reduced by cyproterone acetate).
When using high doses of cyproterone acetate, there is a slight increase in prolactin levels.
Toxicity studies of Androkur 50 did not show any specific risks to humans with repeated use.
Cyproterone acetate does not have an embryotoxic effect, however, when used during the period of hormone-sensitive differentiation of the genital organs of the fetus, the use of cyproterone acetate can lead to feminization of male fetuses.
Androkur 50 somewhat inhibits spermatogenesis, but does not damage spermatozoa and does not pose risks to offspring.
The association of cyproterone acetate with the risk of developing liver tumors has not been proven, however, it should be borne in mind that steroid drugs in general increase such risks.
When taking high doses of cyproterone acetate, a corticoid-like effect on the adrenal cortex was noted in rats and dogs; for humans, the potential effect of cyproterone acetate on the adrenal cortex is possible when taking doses above 300 mg per day.
When administered orally, cyproterone acetate is well absorbed and reaches peak plasma concentrations within 3 hours (when taking 50 mg of cyproterone acetate, the maximum plasma level is 140 ng / ml). The level of the active substance in plasma decreases within 24-120 hours, the final elimination half-life reaches 43.9 ± 12.8 hours.
Cyproterone acetate is converted mainly in the liver with the participation of the CYP3 A4 enzyme, the derivatives do not have pharmacological activity.
A small part of cyproterone acetate is excreted unchanged in the bile, the rest is excreted in the form of derivatives by the kidneys and liver.
About 3-4% of the accepted dose in plasma is in free form, the rest is bound to plasma proteins.
When taken orally, the absolute bioavailability of cyproterone acetate reaches 88%.
Indications for use
For men, Androcur 50 is prescribed as a palliative therapy for locally progressive or metastatic inoperable prostate cancer, including in the case when gonadotropin-releasing hormone (GnRH) agonist therapy and / or surgery are contraindicated or do not give the desired effect, as well as in the case when if oral therapy is preferred.
Androkur 50 is prescribed to men with inoperable prostate cancer to prevent complications and secondary events caused by an increase in testosterone levels at the beginning of therapy with gonadotropin-releasing hormone agonists, as well as for the treatment of conditions (hot flashes) that develop after orchiectomy or during treatment with GnRH agonists.
Androkur 50 can be prescribed to men to reduce sexual desire against the background of hypersexuality and sexual deviations.
For women, Androkur 50 can be prescribed for the treatment of severe androgenization phenomena, including severe forms of hirsutism and androgenetic alopecia, including when these phenomena are combined with severe acne and seborrhea. The drug Androkur 50 should be prescribed to women only if other hormonal drugs and lower doses of cyproterone acetate are ineffective (before starting therapy, it is mandatory to exclude pregnancy in women).
Mode of application
Androkur 50 tablets are taken orally. To achieve the maximum effect, Androkur 50 should be taken after meals with a small amount of liquid. The duration of treatment with cyproterone acetate and the dose of Androkur 50 is determined by the doctor.
Prescribing Androcur to 50 men:
To reduce sexual desire in sexual pathologies, cyproterone acetate is usually prescribed at an initial dose of 50 mg twice a day. The time of onset of a therapeutic effect can vary significantly – from several weeks to several months. Depending on the patient’s response and tolerability of Androcur 50, the dose of cyproterone acetate can be increased to 100 mg twice daily.
Short-term therapy with maximum doses of cyproterone acetate is allowed – 2 Androkur 50 tablets three times a day. After improvement is achieved, the dose of cyproterone acetate should be gradually reduced to the minimum effective dose, which is taken as a maintenance dose.
The average maintenance dose of cyproterone acetate is 25 mg (1/2 tablet Androkur 50) twice a day.
Cancellation of the drug Androkur 50, as well as the transition to a maintenance dose, should be carried out gradually (reducing the current dose by 25-50 mg every few weeks).
To achieve a stable effect, Androkur 50 is taken for a long time.
The maximum daily dose of cyproterone acetate is 300 mg.
For men with inoperable prostate cancer, cyproterone acetate 100 mg twice or thrice daily is usually given as palliative therapy for locally advanced or metastatic cancer (without GnRH agonist treatment and orchiectomy). After improvement of the condition and achievement of remission, it is not recommended to stop treatment or change the dose of cyproterone acetate.
In men with inoperable prostate cancer, treatment with cyproterone acetate monotherapy at a dose of 100 mg twice a day is initiated to prevent adverse events that accompany the initiation of GnRH therapy. After 5-7 days, an additional GnGH agonist is prescribed and cyproterone acetate therapy is continued at a dose of 100 mg twice a day. It is necessary to take into account the features of the GnRH agonist indicated in its annotation.
For men with inoperable prostate cancer, cyproterone acetate 50 mg 1 to 3 times a day is prescribed for the treatment of hot flushes during GnRH agonist therapy or after orchiectomy. If necessary, the dose of cyproterone acetate is increased to 100 mg three times a day.
Before starting Androcur 50, women should exclude pregnancy and choose a reliable contraceptive (if necessary, combined treatment with estrogens / progestogens, an appropriate combined oral contraceptive drug should be selected). In addition, before the start of therapy, an examination is carried out (including a gynecological examination, examination of the mammary glands and determination of the level of sex hormones).
Androkur 50 should be started on the first day of the menstrual cycle (first day of menstruation). Women with amenorrhea can start taking Androcur at any time (immediately after the appointment), in which case the day of taking the first tablet of Androcur 50 should be considered the first day of the cycle.
From the first to the 10th day of the menstrual cycle, 100 mg of cyproterone acetate per day should be taken in combination with low-dose estrogen preparations or a combination of estrogens and gestagens. An oral contraceptive is taken from the first to the 21st day of the cycle (or according to the recommendations of the instructions for the corresponding drug).
It is recommended to take the drugs at the same time of day.
After taking 21 tablets of an oral contraceptive, a break of 7 days is taken (during which menstrual-like bleeding develops) and Androcur is taken again (from the first to the 10th day of the cycle) and an oral contraceptive (from the first to the 21st day of the cycle). A new cycle should be started regardless of whether the bleeding has stopped or not.
In the absence of menstrual bleeding during the seven-day break, pregnancy must be excluded before taking the tablets from the new calendar packs.
When the condition improves, the dose of cyproterone acetate is reduced to 25-50 mg per day (from the first to the 10th day of the cycle).
In some cases, after improvement in the condition, it is sufficient to take only a combination of a progestogen / estrogen with an antiandrogenic effect to maintain the effect.
It should be borne in mind that skipping the intake of hormonal contraceptives increases the risk of pregnancy (if more than 12 hours have passed since the planned intake, in case of skipping a tablet, follow the instructions attached to oral contraceptives).
If you miss taking a tablet of Androkur 50 for more than 12 hours, the dose should not be doubled (the missed tablet is not taken, and the next one is taken at the usual time). If you skip taking Androkur 50 tablets, the risk of developing intermenstrual bleeding increases.
For postmenopausal women and women who have undergone a hysterectomy, Androkur 50 can be prescribed as monotherapy. In this case, cyproterone acetate is prescribed at a dose of 25-50 mg per day for 21 days. After that, they take a break for 7 days and start taking Androkur 50 again. Reception is cyclical, each cycle begins on the same day of the week (exactly 4 weeks after the start of the previous one).
It is necessary to monitor the function of the liver and adrenal glands, as well as the blood picture during the entire period of therapy with Androkur 50.
Side effects
The most serious side effects of Androkur 50 are hepatotoxicity, benign and non-malignant liver tumors (which can lead to the development of intra-abdominal bleeding), as well as thromboembolic events.
In men, when taking Androkur 50, erectile dysfunction, decreased libido and reversible inhibition of spermatogenesis may develop.
In addition, during clinical and post-marketing studies of Androkur 50, patients noted the development of such an undesirable effect of cyproterone acetate:
On the reproductive system: intermenstrual bleeding, gynecomastia, increased sensitivity of the nipples in men, inhibition of ovulation, amenorrhea, as well as enlargement, tension and soreness of the mammary glands.
On the hepatobiliary system: jaundice, increased activity of hepatic transaminases, hepatitis, liver failure.
On the blood system: anemia (mainly in men).
On the nervous system: depression, fatigue, hot flashes, changes in libido, depressed mood, causeless anxiety, headache.
Allergic reactions: itching, skin rash, angioedema, skin peeling, urticaria.
Other side effects: change in body weight, increase in prolactin levels, decrease in cortisol levels, shortness of breath, shortness of breath, osteoporosis. In addition, it is possible to develop increased sweating, nausea and vomiting.
Patients with diabetes may develop hyperglycemia while taking Androkur 50.
It was reported about the development of multiple meningiomas in patients receiving the drug Androkur 50 (with an increase in the dose, the risk of developing multiple meningiomas increases).
At the beginning of treatment with Androkur 50, nitrogen imbalances may develop, which disappear with further therapy.
Contraindications
Androkur 50 is not prescribed to patients with intolerance to cyproterone acetate or additional tablet components (including patients with rare forms of lactose intolerance).
Androkur 50 is not prescribed to adolescents until the end of puberty.
Contraindications of the drug Androkur 50 depend on the gender of the patient and the condition in which cyproterone acetate therapy is necessary, in particular:
For men who need cyproterone acetate therapy to reduce sexual desire in pathologies of the genital area, Androkur 50 is not prescribed for:
– Dubin-Johnson syndrome, liver disease or liver tumor (including history), Rotor syndrome, meningioma (including history), as well as severe chronic depression;
– Thromboembolic conditions (including a history), severe diabetes with angiopathy, malignant diseases (including suspected malignant disease), as well as sickle cell anemia.
For men who need treatment of inoperable prostate cancer with cyproterone acetate, Androkur 50 is not prescribed for:
– Diseases and tumors of the liver (which are not caused by metastases of prostate cancer), including a history;
– Rotor syndrome, Dubin-Johnson syndrome, meningioma (including history), as well as malignant diseases, excluding progressive prostate cancer (including if this pathology is suspected);
– Severe chronic depression, sickle cell anemia, thromboembolic conditions and severe forms of diabetes with angiopathy.
Women Androkur 50 is contraindicated in:
– Pregnancy and lactation;
– The presence of vaginal bleeding of unknown origin and liver diseases, including a liver tumor (including when a history of a liver tumor is indicated);
– Rotor syndrome and Dubin-Johnson syndrome;
– Indication of the development of jaundice, itching and herpes during a previous pregnancy;
– Meningioma (including when indicating a history of meningioma), sickle cell anemia, thromboembolic conditions and angiopathy against a background of severe diabetes mellitus;
– Chronic severe form of depression and malignant diseases (including if this pathology is suspected).
When prescribing complex therapy with Androkur 50 and an estrogen or combined estrogen / progestogen drug, women should take into account contraindications to the use of the latter.
The use of the drug Androkur 50 for the treatment of children under 18 years of age is prohibited.
Caution should be exercised when prescribing Androcur to 50 patients with a high risk of developing thromboembolic events (including patients with cerebrovascular disorders, deep vein thrombosis, myocardial infarction and a history of pulmonary embolism).
It is necessary to prescribe cyproterone acetate with caution in patients with diabetes mellitus (the use of Androkur 50 is allowed only with regular monitoring of glucose levels).
It is necessary, if possible, to exclude activities that require increased concentration of attention during treatment with Androkur 50 (taking into account the possibility of developing increased fatigue and dizziness during treatment with cyproterone acetate).
Pregnancy
The use of Androkur 50 during pregnancy is contraindicated. It is necessary to exclude pregnancy before starting Androkur 50. During the entire period of taking antiandrogenic drugs, reliable contraception should be used.
Cyproterone acetate passes into breast milk in low doses, you should not breast-feed a child during therapy with Androkur 50. If cyproterone acetate therapy is avoided during lactation, the issue of interrupting breastfeeding should not be resolved.
drug interaction
Ethyl alcohol can neutralize the effect of Androkur 50 on sexual desire (in patients with increased sexual desire on the background of sexual pathologies, ethyl alcohol neutralizes the effects of cyproterone acetate).
Ketoconazole, itraconazole, ritonavir and clotrimazole, as well as other strong inhibitors of CYP3 A4, when used in combination with Androkur 50, can increase the level of cyproterone acetate by inhibiting its metabolism.
CYP3 A4 inducers, including phenytoin, rifampicin and St. John’s wort, when combined with Androkur 50, can reduce plasma concentrations of cyproterone acetate by accelerating its metabolism.
When taking high doses of cyproterone acetate, it is possible to inhibit the activity of enzymes of the cytochrome P450 system, in particular CYP2 C9, CYP2 C8, CYP2 C19, CYP2 D6 and CYP3 A4.
It is possible to increase the risk of developing rhabdomyolysis and myopathy caused by statins with the combined use of Androkur 50 and HMGCoA inhibitors (statins).
Overdose
Cyproterone acetate does not cause acute intoxication with a single use of high doses.
Release form
Androkur 50 tablets, packaged in blister packs of 10 pieces, in a carton pack of 20 (2×10) or 50 (5×10) tablets.
Storage conditions
Androkur 50 must be stored out of the reach of children, where the temperature is not higher than 25 degrees Celsius.
The shelf life of Androkur tablets is 50 – 5 years.
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