Instruction for use: Androcur Depot

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Active substance: Cyproterone

ATX code G03HA01 Cyproterone

Pharmacological group

Antiandrogen [Androgens, antiandrogens]

Antiandrogen [Antitumor hormonal and hormone antagonists]

Nosological classification (ICD-10)

C61 Malignant neoplasm of prostate

Adenocarcinoma of the prostate, Hormone-dependent prostate cancer, Hormone-Resistant Prostate Cancer, Malignant tumor of prostate, Malignant neoplasm of prostate, Carcinoma of the prostate, Locally-distributed non-metastatic prostate cancer, Locally advanced prostate cancer, Locally spread prostate cancer, Metastatic prostatic carcinoma, Metastatic prostate cancer, Metastatic hormone-resistant prostate cancer, Non-metastatic prostate cancer, Incompatible prostate cancer, Prostate Cancer, Prostate cancer, Common prostate cancer, Testosterone-Depot Prostate Cancer

C79.8 Secondary malignant neoplasm of other specified locations

Metastatic carcinoid tumors, Metastasis of breast tumors, Metastatic hormone-resistant prostate cancer, Metastatic Testicular Carcinoma, Metastatic choriocarcinoma of the testes, Metastatic squamous cell carcinoma of the head, Metastatic squamous cell carcinoma of the neck, Metastatic malignant testicular tumor, Metastatic squamous cell carcinoma of the head and neck, Metastatic Breast Cancer, Metastatic Testicular Cancer, Metastatic breast cancer, Metastases in the pericardium, Metastases in the heart

E28.1 Excess androgen

Androgen-dependent diseases in women, Androgen-dependent conditions in women, Androgenation in women, Diseases androgen-dependent in women, Excess androgen in women

F52.7 Increased libido

Sexual dysfunction, Hypersexuality, Male hypersexuality, Hypersexuality with deviant sexual behavior, Increased sexual desire for sexual deviations

Z100 * CLASS XXII Surgical practice

Abdominal surgery, adenomectomy, Amputation, Coronary angioplasty, Angioplasty of the carotid arteries, Antiseptic skin treatment for wounds, Antiseptic Hand, Appendectomy, atherectomy, Balloon coronary angioplasty, Vaginal hysterectomy, The coronary bypass, Interventions in the vagina and cervix, Interventions on the bladder, Intervention in the mouth, Restoration and reconstructive surgery, Hand hygiene of medical personnel, Gynecologic surgery, Gynecological intervention, Gynecological surgery, Hypovolemic shock during operations, Disinfection of purulent wounds, Disinfection of wounds edges, Diagnostic intervention, Diagnostic procedures, Cervical Diathermocoagulation, Long-surgery, Replacing the fistula catheters, Infection in orthopedic surgery, Artificial heart valve, cystectomy, Short-term outpatient surgery, Short-term operation, Short surgical procedures, Krikotireotomiya, Blood loss during surgery, Bleeding during surgery and in the postoperative period, Kuldotsentez, laser photocoagulation, laser coagulation, retinal laser coagulation, Laparoscopy, Laparoscopy in Gynecology, CSF fistula, Small gynecological operations, Small surgical procedures, Mastectomy and subsequent plastic, mediastinotomy, Microsurgical operations on the ear, Mukogingivalnye operation, suturing, Minor surgery, neurosurgical operation, Immobilization of the eyeball in ophthalmic surgery, testectomy, pancreatectomy, Perikardektomiya, The period of rehabilitation after surgery, The period of, convalescence after surgery, Percutaneous transluminal coronary angioplasty, Pleural thoracentesis, Pneumonia postoperative and posttraumatic, Preparation for surgical procedures, Preparation for surgery, Preparation of the surgeon's hands before surgery, Preparation of the colon for surgical procedures, Postoperative aspiration pneumonia in neurosurgical and thoracic surgery, Postoperative nausea, Postoperative bleeding, postoperative granuloma, postoperative shock, The early postoperative period, myocardial revascularization, Radiectomy, gastric Resection, bowel resection, uterine Resection, liver Resection, enterectomy, Resection of part of the stomach, Reocclusion of the operated vessel, Bonding tissues during surgical procedures, Removal of sutures, Condition after eye surgery, Condition after surgery, Condition after surgery in the nasal cavity, Condition after gastrectomy, Status after resection of the small intestine, Condition after tonsillectomy, Condition after removal of the duodenum, Condition after phlebectomy, Vascular surgery, Splenectomy, Sterilization of surgical instruments, Sterilization of surgical instruments, sternotomy, Dental surgery, Dental intervention in periodontal tissues, strumectomy, Tonsillectomy, Thoracic surgery, total gastrectomy, Transdermal intravascular coronary angioplasty, Transurethral resection, Turbinektomiya, Removal of a tooth, cataract surgery, Removal of cysts, tonsillectomy, Removal of fibroids, Removing the mobile primary teeth, Removing polyps, Removing broken tooth, Removal of the uterus body, Removal of sutures, Urethrotomy, Fistula likvoroprovodyaschih ways, Frontoetmoidogaymorotomiya, Surgical infection, Surgical treatment of chronic limb ulcersm, Surgery, The surgery in the anal area, The surgery on the colon, Surgical practice, The surgical procedure, Surgical interventions, Surgery on the gastrointestinal tract, Surgical procedures on the urinary tract, Surgical procedures on the urinary system, Surgical intervention of the genitourinary system, Surgical procedures on the heart, Surgical manipulation, surgery, Surgery on the veins, Surgical intervention, Vascular surgery, Surgical treatment of thrombosis, cholecystectomy, Partial gastric resection, transabdominal hysterectomy, Percutaneous transluminal coronary angioplasty, Percutaneous transluminal angioplasty, Coronary artery bypass, tooth Extirpation, Extirpation of milk teeth, pulpectomy, pulsative cardiopulmonary bypass, tooth Extraction, teeth Extraction, cataract extraction, Electrocoagulation, endourological intervention, episiotomy, Etmoidotomiya, Complications after tooth extraction

Composition

Tablets 10 mg 1 table.

active substance:

Cyproterone acetate, micro 20 10 mg

Auxiliary substances: lactose monohydrate - 64.1 mg; Corn starch - 44 mg; Polyvidone 25,000 - 1,35 mg; Magnesium stearate 0.25 mg; Silicon dioxide colloidal micronized - 1 mg

Tablets 50 mg 1 table.

active substance:

Cyproterone acetate, micro 20 50 mg

Auxiliary substances: lactose monohydrate - 110.5 mg; Corn starch - 59.5 mg; Polyvidone 25000 - 2.5 mg; Magnesium stearate - 0.5 mg; Silica colloidal anhydrous - 2 mg

Tablets 100 mg 1 table.

active substance:

Cyproterone acetate, micro 20 100 mg

Excipients: lactose monohydrate - 193 mg, corn starch - 100 mg, povidone 25,000 - 4 mg, magnesium stearate - 3 mg

Androkur® Depot

Solution for intramuscular administration oily 100 mg / ml 1 ml

active substance:

Cyproterone acetate 100 mg

Auxiliary substances: castor oil - 353.4 mg; Benzyl benzoate 618, 6 mg

Description of dosage form

Androkur® (10 mg): round from white to light yellow colored tablets, with a risk on one side and engraving in the form of a hexagon, inside which the letters "BW" - on the other.

Androcour® (50 mg): round white or slightly yellowish tablets, with a risk on one side and an engraving in the form of a hexagon, inside which the letters "BV" - on the other.

Androcour® (100 mg): capsular, from white to light yellow colored tablets. On both sides, the risks are squeezed out "LA", on the reverse side - a hexagon.

Androkur® Depot: transparent, colorless to yellowish, liquid.

pharmachologic effect

The pharmacological action is gestagenic, antiandrogenic.

To the beginning ^

Pharmacodynamics

Androkur®, 10 mg

Androkur® is a hormonal antiandrogenic drug.

Competitive displacement of androgens in target organs leads to relief of symptoms in androgen-dependent conditions, such as pathological hair growth in hirsutism, androgenic alopecia and increased function of sebaceous glands in acne and seborrhea. The decrease in androgen concentration, caused by the antigonadotropic action of cyproterone, provides an additional therapeutic effect. These changes are reversible after drug withdrawal. When combined with Diane-35, ovarian function is suppressed.

Systemic Toxicity

Existing results of preclinical toxicity studies with repeated use of the drug do not imply any specific risk for a person.

Embryotoxicity / teratogenicity

Studies of embryotoxicity showed the absence of a teratogenic effect after application of the drug in the period of organogenesis to the development of external genital organs. The intake of high-dose cyproterone during the hormonal-sensitive phase of genital differentiation led to the appearance of feminization signs in male fetuses. A survey of newborn boys, whose mothers received cyproterone during pregnancy, revealed no signs of feminization. The use of Androkur® during pregnancy is contraindicated.

Genotoxicity and carcinogenicity

In the first series of preclinical studies of the genotoxicity of cyproterone, negative results were obtained. However, the ability of cyproterone to form compounds with DNA, incl. Increase the activity of DNA repair in liver cells in different animal species and in a freshly prepared culture of human hepatocytes.

Consequences of in vivo treatment with cyproterone in female rats were more frequent occurrence of focal, possibly premalignant, foci in the liver with altered enzyme composition of cells and an increase in the mutation rate in the transgenic in the bacterial gene of rats.

Clinical experience and carefully conducted epidemiological studies do not confirm an increase in the incidence of liver tumors in humans. Studies on rodents also do not give any indication of the specific oncogenic potential of cyproterone. However, it must be borne in mind that sex hormones can induce the growth of certain hormone-dependent tissues and tumors.

Androcour®, 50 and 100 mg

Androkur® Depot

The drug Androkur® is an antiandrogenic hormone drug.

Ciproterone but the competitive mechanism inhibits the action of androgens on their target organs, for example, protects the prostate gland from the action of androgens of the sex glands and / or the adrenal cortex. Cyproterone has a central antigonadotropic effect, leading to a decrease in the synthesis of testosterone in the testicles and its content in the blood serum. As a result, androgenic stimulation of prostate tissue is suppressed.

In men with the use of Androkur®, depression of sexual desire, potency and function of the testicles is observed. These effects are completely reversible and pass after discontinuation of treatment.

The antigonadotropic effect of cyproterone also manifests itself in combination with GnRH agonists. The temporary increase in serum testosterone concentration, observed at the initial stage of GnRH agonist therapy, decreases with the intake of cyproterone.

Sometimes, when taking high doses of cyproterone, there was an increase in the concentration of prolactin.

Systemic Toxicity

According to standard preclinical studies, toxicity with repeated long-term administration does not exist any specific risk to humans.

Pharmacokinetics

Androkur®, 10 mg

Absorption. Ciproterone is completely absorbed after ingestion. Absolute bioavailability of cyproterone is about 88%.

Distribution. Cmax of cyproterone in blood plasma after taking a dose of 10 mg reaches 75 ng / ml on average after 1.5 hours. T1 / 2 cyproterone biphasic: the first phase - 0.8 h, the second - 2.3 days. The total clearance of cyproterone from plasma is 3.6 ml / min / kg.

Ciproterone almost completely binds to albumin plasma. About 3.5-4% of cyproterone remains unbound. Since the association with plasma proteins is non-specific, a change in the content of globulin binding the sex hormones does not affect the pharmacokinetics of cyproterone.

Metabolism / biotransformation. Ciproterone is metabolized by hydroxylation and conjugation. The main metabolite in the blood plasma is a 15β-hydroxy derivative.

Excretion. Subjected to biotransformation in the liver, is derived mainly in the form of metabolites with bile and kidneys (T1 / 2 - 1.9 days) in a ratio of 3: 7, part is displayed unchanged with bile. Metabolism in the blood plasma occurs at the same rate (T1 / 2 1.7 days).

Ciproterone has a long T1 / 2, which during daily admission during the cycle leads to its cumulation and increase in plasma concentration by 2-2.5 times.

Androkur®, 50 mg

Absorption. Ciproterone is completely absorbed after ingestion. Absolute bioavailability of cyproterone is about 88%.

Distribution. Cmax of cyproterone in the blood serum after taking a dose of 50 mg reaches 140 ng / ml on average after 3 hours. The decrease in the concentration of cyproterone is biphasic and occurs within 24-120 h with a final T1 / 2 (43.9 ± 12.8) H. The total clearance of ciproterone from serum is (3.5 ± 1.5) ml / min / kg.

Ciproterone almost completely binds to albumin plasma. About 3.5-4% of cyproterone remains unbound. Since the association with proteins is non-specific, a change in the content of globulin binding the sex hormones does not affect the pharmacokinetics of cyproterone

Due to the long period of elimination in the final phase of elimination from plasma as well as daily intake, ciproteron cumulation in serum is likely to be 3 times higher when repeated doses are used per one treatment cycle.

Metabolism / biotransformation. Ciproterone is metabolized by hydroxylation and conjugation. The main metabolite in the blood plasma is a 15β-hydroxy derivative. The first phase of metabolism is mainly catalyzed by the cytochrome P450 isoenzyme CYP3A4.

Androcour®, 100 mg

Absorption. Ciproterone is completely absorbed after ingestion. Absolute bioavailability of cyproterone is about 88%.

Distribution. Cmax of cyproterone in the blood serum after taking a dose of 100 mg reaches (239.2 ± 114.2) ng / ml on average (2.8 ± 1.1) h. Reduction of serum ciproterone concentration is biphasic and occurs within 24-120 h with a final T1 / 2 (42.8 ± 9.7) h. The total clearance of ciproterone from the serum is (3.8 ± 2.2) ml / Min / kg. Ciproterone almost completely binds to albumin plasma. About 3.5-4% of cyproterone remains unbound. Since the association with proteins is non-specific, a change in the content of globulin binding the sex hormones does not affect the pharmacokinetics of cyproterone. Due to the long period of elimination in the final phase of elimination from plasma, as well as daily intake, it is probable that ciproteron cumulation in serum is 3 times higher when repeated doses are used per one treatment cycle.

Androkur® Depot

After the / m introduction of cyproterone, acetate is slowly and completely released. Absolute bioavailability of cyproterone after the / m administration is considered complete. Cmax - (180 ± 54) ng / ml, is achieved after 2-3 days. After that, the concentration of the drug in the plasma decreases from T1 / 2 - (4 ± 1,1) days. The total clearance of ciproterone from serum is (2.8 ± 1.4) ml / min / kg. Ciproterone almost completely binds to plasma albumins. Only 3.5-4% are in the blood in a free form. Since the association with plasma proteins is nonspecific, changes in the level of SHBG (globulin binding sex hormones) do not affect the pharmacokinetics of cyproterone.

Given prolonged T1 / 2 from plasma in the final distribution phase and the dose taken, ciproteron cumulation can be expected with repeated doses. Css is reached after about 5 weeks of the drug.

Excretion. Small amounts are output with bile in an unchanged form. Most of the administered dose is excreted as metabolites with bile and kidney.

Indication

Androkur®, 10 mg

Manifestations of androgenization of moderate severity in women, such as:

Hirsutism of moderate severity (pathological hairiness of the face and body of moderate severity);

Androgenic alopecia of moderate severity (androgen-induced baldness of moderate severity);

Severe and moderately severe forms of acne (acne), accompanied by inflammation, the formation of nodules or the risk of scarring, and seborrhea.

The drug is used as part of a combination therapy with Diane-35 in cases where there is no clinical improvement in response to other treatments and satisfactory results were achieved with only Diane-35.

Androkur®, 50 mg

Common inoperable or metastatic prostate cancer when it is necessary to suppress the action of testosterone.

- antiandrogen therapy for inoperable prostate cancer;

- a decrease in the severity of hyperandrogenism observed at the beginning of therapy with gonadotropin-releasing hormone agonists (GnRH);

- relief of "hot flashes" in patients with prostate cancer receiving therapy with GnRH agonists, or in patients undergoing orchiectomy;

Increased sexual desire for sexual deviations.

Ancodrour®, 100 mg

Common inoperable or metastatic prostate cancer when it is necessary to suppress the action of testosterone:

- antiandrogen therapy for inoperable prostate cancer;

- decrease in the severity of hyperandrogenism observed at the beginning of therapy with GnRH agonists;

- relief of hot flashes in patients with prostate cancer receiving therapy with GnRH agonists, or in patients undergoing orchiectomy.

Androkur® Depot

Increased sexual desire for sexual deviations;

Antiandrogen therapy with inoperable carcinoma of the prostate.

Contraindications

Androkur®, 10 mg

pregnancy;

breast-feeding;

Liver diseases (including Dubin-Johnson syndrome, Rotor syndrome, liver tumors, including in the anamnesis);

Idiopathic jaundice or persistent itching during a previous pregnancy;

Herpes of pregnant women in the anamnesis;

Cachexia;

Severe chronic depression;

Meningioma (including in the anamnesis);

Thrombosis (arterial and venous) and thromboembolism at present or in the anamnesis (including thrombosis, deep vein thrombophlebitis, pulmonary embolism, myocardial infarction, stroke, cerebrovascular disorders);

Severe diabetes mellitus with diabetic angiopathy;

Sickle-cell anemia;

Deficiency of lactase, lactose intolerance, glucose-galactose malabsorption;

Hypersensitivity to any of the components of the drug;

Adolescence (until the end of puberty).

Contraindications for the use of the Diane-35 preparation, which is prescribed in combination with the Androkur® preparation, should also be taken into account.

With caution: Patients with diabetes mellitus; Diseases / conditions requiring compliance with the precautionary measures when using the drug Diane-35.

Androcour®, 50 and 100 mg

Androkur® Deepo

Hypersensitivity to cyproterone or other components of the drug;

Liver diseases (including Dubin-Johnson syndrome, Rotor syndrome);

Liver tumors in the anamnesis or at present (with the exception of metastases of prostate cancer in the liver);

Cachexia (with the exception of cachexia in prostate cancer);

Severe chronic depression;

Thrombosis and thromboembolism at the present time;

The presence of a meningioma at present or in an anamnesis;

Children and adolescents under 18 years.

With caution: in the presence of patients with inoperable prostate cancer, thrombosis and thromboembolism in history, severe diabetes mellitus with angiopathy, sickle cell anemia androkur® is prescribed only after assessing the individual benefit-risk ratio in each case.

Patients with rare hereditary diseases of milk sugar intolerance, lactase deficiency, glucose malabsorption syndrome and galactose should apply this medication with caution.

In the treatment of increased sexual desire in sexual disorders in men Androkur® 50 mg, Androkur®Depo are contraindicated in the following conditions and diseases (in addition to the diseases and conditions listed above):

Liver disease, accompanied by a violation of its function;

Cachexia;

Severe diabetes mellitus with angiopathy;

Sickle-cell anemia.

pregnancy and lactation

Androkur®, 10 mg

Contraindicated in pregnancy and during breastfeeding.

Side effects

Androkur®, 10 mg

The most common side effects in women taking Androcour® 10 mg are spotting from the vagina, weight gain and mood reduction.

The most serious side effect of the drug Androkur® 10 mg is the development of benign and malignant liver tumors that can lead to life-threatening intraabdominal bleeding.

The side effects of Androcour® 10 mg are listed below, based on postmarketing studies and cumulative experience, the frequency of which can not be determined.

Benign, malignant and unspecified neoplasms (including cysts and polyps): benign and malignant liver tumors (see "Special instructions").

From the immune system: hypersensitivity reactions.

From the side of metabolism and nutrition: weight loss, weight gain, hyperglycemia.

Disorders of the psyche: depression, increased libido, decreased libido.

From the gastrointestinal tract: intra-abdominal hemorrhage (see "Special instructions").

From the liver and bile ducts: violations of the liver, jaundice, hepatitis.

From the skin and subcutaneous tissues: rash.

On the part of the genitals and mammary glands: tension, tenderness of the mammary glands, absence of ovulation, acyclic bleeding or absence of menstrual bleeding, spotting from the vagina (see "Special instructions").

Against the background of combined therapy, the inhibition of ovulation occurs, so there is a condition in which conception is impossible.

Side effects as specified in the Diane-35 preparation instructions should also be considered.

Androkur®, 50, 100 mg, Androkur® Depot

The most frequently observed side effects are: decreased libido, impotence and reversible suppression of spermatogenesis.

The most serious side effects are hepatotoxicity, the development of benign and malignant liver tumors that can lead to intraperitoneal bleeding and the development of thromboembolic processes.

The adverse events reported in the use of Androkur® are listed below. The frequency is defined as: very often (≥1 / 10); Often (from ≥1 / 100 to <1/10); Infrequently (from ≥1 / 1000 to <1/100); Rarely (from ≥1 / 10000 to <1/1000); Very rarely (<1/10000). For undesirable effects, revealed only in the process of postmarketing observations and for which it is not possible to estimate the frequency, "frequency is unknown" is indicated.

From the hematopoietic system: the frequency is unknown - anemia **.

From the immune system: rarely - hypersensitivity reactions.

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

From the vessels: the frequency is unknown - thrombosis and thromboembolism * **

For Androkur® Depot more

From the side of the vessels: the frequency is unknown - the oil pulmonary microembolia *, vasovagal reactions *

On the part of the respiratory system: often - shortness of breath *.

From the gastrointestinal tract: the frequency is unknown - intraperitoneal bleeding.

From the liver and biliary tract: often - jaundice, hepatitis, liver failure *.

From the skin and subcutaneous tissues: infrequent - rash.

From the side of the musculoskeletal system: the frequency is unknown - osteoporosis.

From the genitals and mammary glands: very often - reversible suppression of spermatogenesis, decreased libido, erectile dysfunction; Often - gynecomastia.

Other: often - increase or decrease in body weight, increased fatigue, hot flashes, excessive sweating; Very rarely - the development of benign or malignant liver tumors *; Frequency unknown - development of meningioma ***

* Adverse events, for which you can find more detailed information in the section "Special instructions".

** Adverse events for which a causal relationship with the administration of Androcur® has not been established.

*** Refer to the "Contraindications" section.

To indicate a specific adverse reaction, the most appropriate term from MedDRA, the medical vocabulary for regulatory activities (version 8.0), is given. Synonyms or related terms are not listed, but they should also be taken into account.

At men on a background of treatment Androkurom® sexual desire and a potency decrease, in addition the function of sexual glands is suppressed. These changes are reversible and pass after the withdrawal of therapy.

Within a few weeks, as a result of anti-androgenic and antigonadotropic actions of Androkur®, suppression of spermatogenesis occurs, which gradually recovers several months after the abolition of therapy. In men, Androkura® can lead to the development of gynecomastia (which is sometimes accompanied by increased tactile sensitivity and soreness of the nipples), which usually occurs after the drug is withdrawn or the dose is reduced. As with the use of other antiandrogen drugs, the long-term androgen deficiency caused by Androkur® can lead to the development of osteoporosis.

There was reported the development of benign cerebral meningiomas due to the long-term (for several years) Androkur® administration in a dose of 25 mg or more (see "Contraindications" and "Special instructions").

Interaction

Androkur®, 10 mg

But the background of taking Androkur® can change the need for oral hypoglycemic agents or insulin.

Studies related to drug interactions were not conducted, but Androkur® is metabolized by the CYP3A4 isoenzyme, it is expected that ketoconazole, itraconazole, clotrimazole, ritonavir, and other potent inhibitors of the CYP3A4 isoenzyme will inhibit cyproterone metabolism. And accordingly, inducers of the isoenzyme CYP3A4, such as rifampicin, phenytoin, and preparations containing St. John's wort, can reduce the concentration of cyproterone in the blood plasma.

In chronic alcoholism, the background of the use of high doses of the drug may reduce (weakening) the effect of therapy in the treatment of increased sexual desire in men. There is no data suggesting a decrease in the therapeutic effect of Androkur® with moderate alcohol use.

Androkur®, 50, 100 mg

Androkur® Depot

Despite the lack of clinical studies of interactions, ketoconazole, itraconazole, clotrimazole, ritonavir and other strong inhibitors of CYP3A4 can be expected to suppress the metabolism of cyproterone acetate, which is metabolized by the CYP3A4 isoenzyme. On the other hand, inducers of CYP3A4, such as rifampicin, phenytoin and preparations containing St. John's Wort, can reduce the concentration of cyproterone acetate.

Based on the results of in vitro studies, at high therapeutic doses of cyproterone acetate (100 mg 3 times daily), it is possible to inhibit the isoenzymes of the cytochrome P450 system, such as CYP2C8, 2C9, 2C19, 3A4 and 2D6. However, in in vivo studies, interaction with CYP2C8 substrates (eg pioglitazone, rosiglitazone) has not been studied and not documented.

When the high doses of cyproterone are combined with HMG-CoA reductase inhibitors (statins), which are also metabolized predominantly by the CYP3A4 isoenzyme, the risk of myopathy and rhabdomyolysis associated with taking statins may increase.

Patients with diabetes require careful medical attention, as the need for oral hypoglycemic agents or insulin may change.

Dosing and Administration

Androkur®

Inside, washing down (if necessary) with a small amount of liquid. If signs of disease progression appear, the drug should be discontinued.

Androkur®, 10 mg

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

The intake of both drugs is started on the 1st day of the cycle (i.e., on the 1st day of menstrual bleeding).

As a rule, one tablet of Androkur® is taken on a daily basis from the 1st to the 15th day of the treatment cycle in addition to Diane-35.

In the package, each tablet is marked with the day of the week in which it should be taken. Take one tablet of Androcur® and Diane®-35 at the same time each day, with a small amount of water. It is necessary to follow the direction of the arrow until all 15 tab. Androkur® will not be accepted. In the next 6 days only Diana®-35 is taken.

When after 21 days of admission, the Diana®-35 calendar pack will end, followed by a 7-day break in taking the tablets, during which menstrual bleeding should begin.

After a 7-day break, regardless of whether menstrual bleeding has stopped or is still ongoing, the pill 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, discontinue treatment and do not resume taking the pills until pregnancy is ruled out.

Acceptance of missed tablets

If the patient has forgotten to take the Diane-35 tablet at the usual time, then this should be done no later than within the next 12 hours. If more than 12 hours have elapsed since the usual Diane-35 treatment, the contraceptive effect in this cycle may be weakened. It is necessary to pay attention to special comments regarding contraceptive reliability, as well as recommendations for missed tablets, which are included in the information on the Diane-35 preparation. If after this cycle, menstrual bleeding is absent, pregnancy should be excluded before resumption of pills.

Passing AndroCur® tablets may lead to a decrease in the therapeutic effect and cause menstrual bleeding. The missed Androkur® tablet is not taken (i.e., do not take a double dose to compensate for the missed tablet) and resume the drug at the usual time together with the Diane-35 preparation.

The duration of treatment depends on the severity of the pathological signs of androgenization and their dynamics during treatment. Drugs should be taken within a few months. The therapeutic effect of acne and seborrhea usually manifests itself more rapidly than with hirsutism and alopecia.

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

Application in certain categories of patients

Children and adolescence. The study of efficacy and safety in clinical trials involving children or adolescents under the age of 18 years has not been conducted.

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.

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

Androcour®, 50 and 100 mg

Antiandrogen therapy for inoperable prostate cancer: 200-300 mg / day (2 tablets Androkura® 50 mg or 1 table Androkura® 100 mg 2-3 times a day, long-term).

If the condition improves or remission is achieved, treatment should not be discontinued or the dosage should be reduced.

To reduce the initial increase in the level of androgens in the treatment of GnRH agonists: First - 200 mg per day (2 tablets Androkura® 50 mg or 1 table Androkura® 100 mg 2 times a day) as monotherapy for 5-7 days , Then - 200 mg per day for 3-4 weeks in combination with the GnRH agonist at the manufacturer's recommended dosage.

For the treatment of hot flashes on the background of therapy with GnRH analogues or after an orchiectomy: 50-100 mg / day (for 1 and 3 tablets Androkura® 50 mg or 0.5-1.5 tablets Androkura® 100 mg per day), If necessary with a subsequent increase in the dose to 300 mg per day (2 tablets Androkura® 50 mg or 1 table Androkura® 100 mg 3 times a day).

Androkur®, 50 mg

With increased sexual desire for sexual disorders. As a rule, treatment begins with 1 table. Androkur® 50 mg twice daily. If necessary, the dose can be increased to 200-300 mg per day (2 tablets 2-3 times a day) for a short period. If a satisfactory result is achieved, try to reduce the dose to a minimum effective dose. In most cases, it is enough to take 50 mg / day (1/2 table 2 times a day). When selecting a maintenance dose or canceling therapy, the dose should be reduced gradually. For this purpose, the daily dose should be reduced by 1 table, or better by 0.5 table, with an interval of several weeks. In order to achieve a sustainable therapeutic effect, Androcour® should be taken for a long time, if possible with simultaneous psychotherapy.

Application in certain categories of patients

Children and adolescence

Androkur® is not recommended for use in children and adolescents under 18 due to insufficient information on efficacy and safety in this category of patients.

Elderly age. There is no data on the need to change the dose of the drug in elderly patients.

Liver failure. The use of the drug Androkur® is contraindicated in patients with liver disease (as long as the liver function is not normalized).

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

Androkur® Depot

In / m, slowly, deep into the muscle.

Like all oil solutions Androkur® Depot is injected only in / m and very slowly. In some cases, pulmonary microembolia with an oily solution can cause the appearance of such signs and symptoms as cough, shortness of breath and chest pain. There may be other signs and symptoms, incl. Vasovagal reactions (eg malaise, increased sweating, dizziness, paresthesia or fainting). These reactions can occur during or immediately after injection and are reversible. In such cases, supportive therapy is usually used (for example, inhalation with oxygen). Avoid intravascular drug administration.

Antiandrogen therapy with inoperable carcinoma of the prostate: 300 mg IM every 7 days.

If the condition improves or remission is achieved, treatment should not be discontinued or the dosage should be reduced.

Reduced sexual desire for sexual deviations: Usually 300 mg (1 amp.) IM every 10-14 days. In exceptional cases, when this dose is not enough, you can inject 600 mg (2 amp) every 10-14 days (preferably 3 ml in the right and left buttocks). When achieving a satisfactory result of treatment, try to reduce the dose, gradually increasing the intervals between injections.

To achieve a sustainable therapeutic effect, Androkur® Depot should be taken for a long time, if possible with simultaneous psychotherapy.

Application in certain categories of patients

Children and adolescence

Androkuro® Depot is not recommended for use in children and adolescents under 18 due to insufficient information on efficacy and safety in this category of patients.

Elderly age. There is no data on the need to change the dose of the drug in elderly patients.

Liver failure. The use of the drug Androkur® Depot is contraindicated in patients with liver disease (until the liver is normalized).

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

Overdose

Androkur®, 10 mg

In studies of acute toxicity after a single dose, it was found that cyproterone acetate, the active ingredient in the Androkur® preparation, can be considered to be practically non-toxic. The risk of acute intoxication after a single random dose, several times higher than the recommended therapeutic dose, is unlikely.

Androcour®, 50 and 100 mg

Androkur® Depot

Studies of acute toxicity after a single application of the drug have shown that cyproterone acetate can be considered a practically non-toxic substance. Also, the risk of acute intoxication after a single random dose, several times higher than the recommended therapeutic dose, is unlikely.

special instructions

Androkur®, 10 mg

Before starting treatment, a general medical and gynecological examination (including breast examination and cytological examination of the cervical epithelium) should be performed. It is also necessary to exclude pregnancy.

Influence on the liver. During the treatment periodical control of liver function is necessary.

Before the start of treatment, periodically during treatment and when there are any symptoms or signs of hepatotoxicity, it is necessary to perform liver function tests. With confirmed hepatotoxicity, therapy with Androkur® is recommended to be canceled.

Against the background of the use of Androkur®, the development of benign and malignant liver tumors was noted, which can lead to life-threatening intraabdominal bleeding. With the increase in the liver, the appearance of severe pain in the upper abdomen or a clinical picture of intra-abdominal bleeding, it is necessary to take into account the possibility of the patient having a liver tumor.

Diabetes. Patients with diabetes may need a dose adjustment for oral hypoglycemic agents or insulin. Patients with diabetes mellitus during treatment with Androkur® should be supervised by a doctor.

Combined treatment. If the combination therapy during the 3-week period of taking the tablets spotting spotting, treatment should not be interrupted. However, with persistent or repeated untimely bleeding it is necessary to perform a gynecological examination in order to eliminate the organic disease.

In view of the need for additional administration of Diane-35, all contraindications and all information contained in the instructions for use of Diane-35 should also be considered.

The drug Androkur® contains 63 mg of lactose in 1 table. Patients with rare hereditary lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome should not use this drug.

No bleeding cancellation. If menstruation-like bleeding does not occur within 7 days during a break or after discontinuation of the drug, which is extremely rare, discontinue treatment and do not resume taking the pills until pregnancy is ruled out.

Meningiomas. The development of meningiomas (single and multiple) has been reported in connection with the long-term (for several years) administration of Androkur® in a dose of 25 mg or more. In the case of diagnosing meningioma in patients taking Androcur® at a dose of 10 mg, treatment with the drug should be discontinued.

Impact on the ability to drive vehicles and mechanisms. Studies concerning the impact on the ability to drive a vehicle and other mechanisms have not been carried out.

Androkur®, 50 and 100 mg, Androkur® Depot

There are reports of a direct dose-dependent toxic effect of Androkur® on the liver (development of jaundice, hepatitis and liver failure). In addition, when the drug was used at a dose of 100 mg or more, fatal cases were reported. Most of the fatal cases were observed in men at the late stage of prostate cancer. Toxicity depends on the dose and usually develops a few months after the initiation of therapy. Before the start of treatment, periodically during treatment and when there are any symptoms or signs of hepatotoxicity, it is necessary to perform liver function tests. With confirmed hepatotoxicity, therapy with Androkur® should be discontinued unless hepatotoxicity is caused by other causes, such as a metastatic process. In the latter case, treatment should be continued only if the expected positive effect exceeds the risk.

In very rare cases, after taking Androkur®, there were benign and, even more rarely, malignant liver tumors that could lead to life-threatening intra-abdominal bleeding. In cases of complaints of acute pain in the upper abdomen, liver enlargement or in the presence of signs of acute intra-abdominal bleeding, a differential diagnosis should be made taking into account a possible liver tumor.

The development of meningiomas (single and multiple) has been reported in connection with the long-term (for several years) administration of Androkur® in a dose of 25 mg or more. In the case of detection of meningioma in a patient receiving treatment with Androkur®, the drug should be discontinued.

There have been reports of thromboembolic complications in patients taking Androkur®, although there was no causal relationship. In patients with previous thrombotic / thromboembolic diseases of the arteries or veins (for example, deep vein thrombosis, pulmonary embolism, myocardial infarction), with a history of cerebral circulation or in advanced stages of malignant diseases, the risk of thromboembolic complications is increased.

During treatment with Androkur®, the development of anemia was reported. Therefore, during treatment with Androkur®, regular peripheral blood testing should be performed.

In patients with diabetes mellitus, the need for oral hypoglycemic agents or insulin may change. Patients with diabetes mellitus during treatment with Androkur® should be supervised by a doctor.

The use of Androcur® in high doses can sometimes be accompanied by shortness of breath. In such cases, differential diagnosis should take into account the known stimulating effect of progesterone and synthetic gestagens on respiration, accompanied by hypocapnia and compensatory respiratory alkalosis. Special treatment with this symptom complex is not required.

During treatment with Androkur®, the function of the cortical layer of the adrenal glands should be checked regularly, because, based on preclinical data, possible suppression of the adrenal function is suggested in connection with the corticoid-like effect of Androkur® in high doses.

When treating Androkur® with patients with an increased sexual desire for sexual disorders, drinking alcohol can lead to a decrease in the effect of the drug.

The drug Androkur®, 50 mg contains 110.5 mg of lactose in 1 tablet, Androkur®, 100 mg - 193 mg. Patients with rare hereditary diseases of milk sugar intolerance, lactase deficiency, glucose malabsorption syndrome and galactose should apply this medication with caution.

The drug Androkur® Depot, like all other oily solutions, should be administered strictly in / m and very slowly. In some cases, pulmonary artery microembolism with oil solution can cause the appearance of such signs and symptoms as coughing, shortness of breath and chest pain. Perhaps the emergence of other signs and symptoms - including. Vasovagal reactions (eg malaise, increased sweating, dizziness, paresthesia or fainting). These reactions can occur during or immediately after injection and are reversible. In such cases, supportive therapy is usually used (for example, inhalation with oxygen)

Influence on driving of motor transport and management of mechanisms. During the treatment with Androkur®, caution should be exercised when driving a car and engaging in other potentially hazardous activities requiring increased concentration of attention, Taking the drug can lead to the development of fatigue, a decrease in vitality and a weakening of the ability to concentrate.

Form of issue

Tablets, 10 mg. For 15 tables. In an aluminum / PVC blister. 1 blister is placed in a cardboard box.

Tablets, 50 mg. For 10 tab. In an aluminum / PVC blister. For 2 or 5 blisters are placed in a cardboard box.

Tablets, 100 mg. For 10 tab. In a blister of PVC and aluminum foil. 6 blisters are placed

Terms of leave from pharmacies

On prescription.

storage Conditions

At a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf Life

5 years.

Do not use after the expiry date printed on the package.

Instructions

Instruction for use: Androcur Depot

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