Androcur, pills 10 mg, 15 pcs.

Composition

Active ingredients:

ciproterone acetate, micro 20-10 mg.

Auxiliary substances:

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

. Pharmacological action

Pharmacodynamics

Oral antiandrogenic drug. Inhibits the effect of male sex hormones (androgens), which are also produced in small amounts by the female body. It has progestogenic, antiandrogenic and antigonadotropic effects.

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

In women, taking Androcur reduces both pathologically excessive hair growth on the face and body, and androgen-induced hair loss on the head. In addition, the increased function of the sebaceous glands decreases and the function of the ovaries is inhibited during the treatment period.

Pharmacokinetics

Suction

After oral administration, ciproterone 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 a 100 mg tablet_{, cmax} is reached on average in 2.8±1.1 hours. Bioavailability is 88%.

Distribution and metabolism

Binding to plasma proteins is about 96%. Biotransformed in the liver by hydroxylation and conjugation, the main metabolite detected in human blood plasma is the 15b-hydroxyl derivative.

Elimination

T_1/2 for tablets of 10 mg and 50 mg is 43.9±12.8 h, for 100 mg-42.8±9.7 h. It is excreted in bile and urine mainly in the form of metabolites in a ratio of 3: 7.

Indications

For women:

• androgen-induced severe head hair loss to baldness (moderate androgenetic alopecia); moderate
• hirsutism;
• severe to moderate acne and/or seborrhea.

Contraindications

• liver Disease;
• jaundice;
• constant itching or herpes during pregnancy in history;
• syndrome Dubin-Johnson,
• Rotor syndrome;
• existing or previously migrated liver tumors (in carcinoma of the prostate only in cases if the tumor is not due to metastases);
• cachexia (with the exception of patients with carcinoma of the prostate);
• severe chronic depression;
• existing or previous thromboembolic processes;
• severe diabetes with vascular complications;
• sickle cell anemia;
• pregnancy;
• lactation (breastfeeding);
• hypersensitivity to the drug.

Side effects

Musculoskeletal disorders: men rarely have osteoporosis.

From the endocrine system: taking Androcur for several weeks in men leads to a decrease in the ability to fertilize (suppression of spermatogenesis, reversible decrease in libido and potency), which is fully restored in 3-4 months after discontinuation of the drug; in isolated cases – gynecomastia, sometimes in combination with increased tactile sensitivity of the nipples of the mammary glands. Women sometimes have a feeling of tension in the mammary glands, a change in body weight.

Combination therapy with Androcurine suppresses ovulation and prevents conception.

From the central nervous system: in women, in isolated cases, there is a decrease in mood and depressive states, a feeling of internal anxiety, a violation of the ability to concentrate; when using 100 mg tablets at the beginning of therapy, increased fatigue, apathy, anxiety, and a decrease in the ability to concentrate are possible.

From the digestive system: when using 100 mg tablets at the beginning of therapy, nausea and abdominal pain are possible; in isolated cases, liver function disorders are possible.

Other: when using tablets of 100 mg at the beginning of therapy, dry skin may occur; in isolated cases, when used in high doses, a feeling of lack of air.

Interaction

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

The antiandrogenic effect of ciproterone acetate is enhanced when combined with GnRH agonists, while the initial increase in testosterone production by GnRH agonists decreases under the action of ciproterone acetate.

How to take, course of administration and dosage

Use in women

In cases of moderate androgenization, the drug is taken in the form of tablets of 10 mg daily from the 1st to the 15th day of the menstrual cycle at a dose of 10 mg 1 time / day. Androcur in the form of tablets of 10 mg is taken together with the drug Diana-35 to obtain the necessary contraceptive effect and exclude intermenstrual bleeding.

To stabilize the cycle and for the purpose of reliable contraception, patients with androgenization phenomena additionally take the drug Diana-35 from the 1st to the 21st days of the cycle,1 tablet/day at the same hours. Both medications should be started on day 1 of the cycle (the first day of bleeding). After stopping taking Androcur (the 10th or 15th day of the cycle), the remaining tablets from the calendar package of the drug Diana-35 are taken during the next days of the cycle (a total of 21 days). Then there is a break of 7 days, during which bleeding should occur. After a 7-day break, the intake is continued from the following calendar packages of Androcur and Diane-35 preparations, regardless of whether the bleeding has ended or is still ongoing. If there is no bleeding after the end of taking the pills, treatment should be stopped and an examination should be performed.

The duration of treatment is determined by the doctor and depends on the type, as well as the severity of the pathological phenomena of androgenization and the results of treatment. Acne and seborrhea are usually cured earlier than alopecia.

Androcur tablets are taken orally after a meal, washed down with a small amount of liquid.

Overdose

Studies of the acute toxicity of Androcurum have shown that ciproterone acetate can be attributed to substances with very low toxicity.

In case of accidental ingestion of several Androcur tablets, the development of intoxication should not be expected.

Special instructions

In patients with prostate cancer and the presence of severe diabetes with vascular changes, sickle cell anemia or previous thromboembolic events, when deciding whether to prescribe Androcur, it is necessary to individually weigh the possible benefits and risk of negative consequences of treatment.

Before starting Androcur therapy, patients should undergo a general medical examination, and patients should additionally undergo a gynecological examination to exclude pregnancy.

When taking Androcur and Diane-35 at the same time, the patient should be informed that if you miss taking Androcur and / or Diane-35 pills at the usual time, you should take the drug no later than the next 12 hours. If the above time is exceeded, the contraceptive effect for this cycle is not provided. Taking Androcur tablets or pills Diana-35 should be continued on time from the started packages, skipping forgotten tablets and / or pills, in order to prevent premature bleeding in this cycle. Additionally, until the end of this cycle, it is necessary to use other, non-hormonal methods of preventing conception. If this cycle does not end with bleeding, you should stop therapy and conduct an examination.

With the simultaneous use of alcohol that has a disinhibiting effect, patients with pathologically increased sexual desire may experience a decrease in the effect of Androcur therapy.

Monitoring of laboratory parameters

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

Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention

Patients whose activities require increased attention should take into account that when taking Androcur, increased fatigue, lethargy, and decreased ability to concentrate may occur.

Form of production

Tablets

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

5 years

Active ingredient

Ciproterone

Conditions of release from pharmacies

By prescription

Dosage form

of the tablet

Purpose

For women, For adults as prescribed by a doctor

Indications

Acne, Seborrhea, Alopecia, Hirsutism

Weight

Weight: 11 gr.