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Androcur® (Androcur®)

To ensure reliable contraception and prevent irregular bleeding, Androcur® is taken in combination with Diane®-35.

Both drugs are started on the 1st day of the cycle (that is, on the 1st day of menstrual bleeding).

As a rule, take one Androcur® tablet daily from the 1st to the 15th day of the treatment cycle in addition to Diana®-35.

In the package, each tablet is marked with the day of the week on which it should be taken. You should take one tablet of Androcur® and Diane®-35 at the same time every day with a small amount of water. Follow the direction of the arrow until all 15 Androcur® tablets have been taken. In the next 6 days, only Diane®-35 is taken.

When, after 21 days of taking the calendar pack of Diane®-35, the drug runs out, there should be a 7-day break in taking the pills, during which menstrual-like bleeding should begin.

After a 7-day break, regardless of whether the menstrual bleeding has stopped or is still ongoing, taking the tablets is resumed from the following calendar packs of Androcur® and Diane®-35.

If menstrual bleeding does not occur during the break, which is extremely rare, treatment should be interrupted and do not resume taking the pills until pregnancy has been ruled out.

Taking missed pills

If the patient forgot to take Diane®-35 tablet at the usual time, this should be done no later than within the next 12 hours. If more than 12 hours have passed since the usual intake of Diane®-35, the contraceptive effect in this cycle may be weakened. It is necessary to pay attention to special notes regarding contraceptive reliability, as well as recommendations for missed pills, which are included in the information about the drug Diane®-35. If there is no menstrual-like bleeding after this cycle, pregnancy should be ruled out before resuming taking the pills.

Skipping Androcur® tablets may lead to a decrease in the therapeutic effect and cause menstrual-like bleeding. The missed tablet of the drug is not taken (i.e., you should not take a double dose to compensate for the missed tablet) and the drug is resumed at the usual time along with the drug Diane®-35.

The duration of treatment is determined by the doctor depending on the severity of the pathological signs of androgenization and their dynamics during treatment. The drugs must be taken for several months. The therapeutic effect for acne and seborrhea usually manifests itself faster than for hirsutism and alopecia.

After achieving clinical improvement, you should try to continue treatment with Diane®-35 only.

Use in certain categories of patients

Childhood and adolescence

Efficacy and safety have not been studied in clinical trials in children or adolescents under 18 years of age.

Elderly age

The drug Androkur® is indicated only for women of reproductive age.

Liver failure

The use of Androcur® is contraindicated in patients with liver disease.

Kidney failure

There is no data on the need to change the dose in this category of patients.

Androcur 100 mg tablet. No. 30 - Instructions

Dosage form

Tablets, 30 pieces per pack.

Compound

1 tablet of Androcur 100 contains:

Cyproterone acetate – 100 mg
Additional ingredients including lactose monohydrate

pharmachologic effect

Androcur is an antiandrogenic hormonal drug containing cyproterone acetate. Androcur competitively inhibits the effect of androgens on target organs, which leads to a decrease in the severity of androgen-dependent conditions, including pathological hair growth (hirsutism), androgenic alopecia and pathologically increased activity of the sebaceous glands (including in patients with acne and seborrhea). The decrease in androgen levels, which is noted due to the antigonadotropic effect of cyproterone acetate, contributes to an additional therapeutic effect. The effect of Androcur is reversible, the effects disappear after discontinuation of cyproterone acetate.

When combined with Diane-35, suppression of ovarian function is also observed.

Repeated use of cyproterone acetate did not lead to the development of specific toxicity in clinical studies. When using the drug Androcur during pregnancy in the period before organogenesis, it did not lead to the development of a teratogenic effect, however, the use of cyproterone during the formation of genital organs in the fetus can lead to the development of feminization in male embryos. There were no signs of feminization in newborns, but cyproterone should not be used during pregnancy.

In a study of cyproterone acetate in rats, a slight increase in the risk of developing liver tumors was noted, but this effect was not confirmed in human studies (it should be borne in mind that steroid hormones in general can induce the growth of some hormone-dependent tissues and tumors).

Pharmacokinetics

When taken orally, cyproterone has an absolute bioavailability of 88%.

After taking 10 mg of cyproterone acetate, peak plasma concentrations were reached after 1.5 hours and amounted to 75 ng/ml.

The half-life is characterized by two phases: 0.8 hours – the first phase and 2.3 days – the second phase. Cyproterone acetate is almost completely bound to plasma proteins (the free fraction is no more than 4%).

Cyproterone is metabolized with the participation of CYP3 A4, the derivatives do not have pharmacological activity.

Some of the cyproterone is excreted unchanged in the bile; most of the dose taken is excreted by the kidneys and liver in the form of derivatives.

Given the long half-life of cyproterone acetate, when taking Androcur daily, some accumulation of the active component in the body is possible.

Indications for use

Androkur is used to treat women with signs of moderate androgenization, including hirsutism, acne (with severe inflammatory processes, risk of scarring and nodule formation), androgenetic alopecia and seborrhea. In combination with the drug Diane-35, Androcur is prescribed to women if other treatment (including monotherapy with Diane-35) does not bring the desired result.

For men, Androkur is prescribed as palliative therapy for locally progressive or metastatic inoperable prostate cancer, including in cases where therapy with gonadotropin-releasing hormone (GnRH) agonists and/or surgery is contraindicated or does not provide the required effect, as well as in cases where oral therapy is preferable.

Androcur is prescribed to men with inoperable prostate cancer to prevent complications and secondary effects 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 can be prescribed to men to reduce libido against the background of hypersexuality and sexual deviations.

Androcur is also used to treat patients with inoperable prostate cancer.

Directions for use and doses

Androcur is taken orally. It is advisable to take Androcur tablets with a small amount of liquid after meals.

The duration of administration and dose of cyproterone acetate is determined by the doctor.

Men with inoperable prostate cancer are usually prescribed 200-300 mg of cyproterone acetate per day (1 Androcur tablet twice or thrice daily).

After the patient's condition improves or after the onset of remission, you should not stop taking cyproterone acetate or change the dose of Androcur.

To reduce the level of sex hormones at the beginning of treatment with gonadotropin-releasing hormone agonists, take 1 Androcur tablet twice a day (200 mg of cyproterone acetate per day) for 5-7 days, after which they begin taking gonadotropin-releasing hormone agonists without stopping taking cyproterone acetate. For 3-4 weeks, 200 mg of cyproterone acetate per day is taken in combination with gonadotropin-releasing hormone agonists.

To reduce the severity of hot flashes during therapy with gonadotropin-releasing hormone agonists or after orchiectomy, 50-150 mg of cyproterone acetate per day is usually prescribed. If necessary, the daily dose can be increased to 300 mg of cyproterone acetate (1 tablet Androcur 100 three times a day).

During therapy with Androcur, the function of the liver and adrenal glands, as well as the blood count, should be carefully monitored.

Side effects

When taking Androcur, decreased libido, impotence and reversible suppression of spermatogenesis are possible; hepatotoxicity, the development of benign and malignant liver tumors, which can lead to intraperitoneal bleeding and the development of thromboembolic processes; depression, depressed mood, anxiety.

Contraindications

Androkur is contraindicated in liver diseases; jaundice; history of constant itching or herpes during pregnancy; Dubin-Johnson syndrome; Rotor syndrome; liver tumors; cachexia; severe chronic depression; thromboembolic processes; severe diabetes with vascular complications; sickle cell anemia; pregnancy and lactation; hypersensitivity to the drug.

Overdose

No cases of overdose were observed.

Use during pregnancy and breastfeeding

Androcur is contraindicated for use during pregnancy. If it is necessary to prescribe the drug during lactation, the issue of stopping breastfeeding should be decided.

Special Warnings

Before starting therapy with Androcur, patients must undergo a general medical examination, and patients must undergo an additional gynecological examination to exclude pregnancy.

Treatment with Androcur is not recommended until the end of puberty, since the possibility of an adverse effect on growth and on the endocrine system, which is not yet stabilized, cannot be excluded.

During treatment with the drug, careful monitoring of liver function and peripheral blood patterns is necessary.

When used simultaneously with Androcur, the effectiveness of hypoglycemic drugs and insulin may change.

With simultaneous consumption of alcohol in patients with pathologically increased sexual desire, a decrease in the effect of Androcur therapy may be observed.

When taking Androcur, you may experience increased fatigue, lethargy, and decreased ability to concentrate.

Storage conditions

There are no special requirements for storage conditions.

Best before date

5 years.

Vacation category

On prescription.