Андрокур®

General characteristics. Structure:

Active agent:
tsiproterona of acetate, micro 20 - 10 mg.
Excipients:
lactoses monohydrate - 63,40 mg, starch corn - 44,00 mg, povidone of 25000 - 1,35 mg, silicon dioxide colloid, micronized - 1,00 mg, magnesium stearate - 0,25 mg.
Description. Round from white till light yellow color of a tablet with risky on one party, on other party the hexagon in which the letter "BW" is engraved.

Pharmacological properties:

Андрокур® represents hormonal anti-androgenic drug. Active ingredient of the drug Androkur® weakens influence of male sex hormones (androgens) which are produced in a small amount as well in a female body. Therefore at women it is possible to treat the drug Androkur® pathological changes which are caused by the strengthened formation of androgens or hypersensitivity to them: pathological growth of hair in the face and other parts of a body at a hirsutism, and also an acne (eels) and seborrhea which are substantially caused by the strengthened function of sebaceous glands depending on androgens.
The drug Androkur® renders also progestagenny and anti-gonadotropic effect, reducing, thus, concentration of testosterone in blood that causes additional therapeutic effect.
At a drug Androkura® combination to Diane®-35 there is an oppression of function of ovaries.
All above-stated changes are reversible after drug withdrawal.

Indications to use:

Manifestations of a moderately severe androgenization at women, such, as:
• hirsutism (pathological growth of hair in the face and body) of moderate severity;
• an androgenic alopecia (the baldness caused by androgens) of moderate severity;
• the severe and medium-weight forms of an acne (an acne disease) which are followed by an inflammation, nodulation or risk of emergence of hems and seborrheas. Drug is used as a part of a combination therapy with the drug Diane®-35
in cases when clinical improvement in response to other treatment is not observed and satisfactory results when using were not achieved only of the drug Diane®-35.

Route of administration and doses:

For ensuring reliable contraception and prevention of irregular bleedings the drug Androkur® is accepted in combination with the drug Diane®-35.
Reception of both drugs is begun in the 1st day of a cycle (=1 day of menstrual bleeding).
As a rule, if it is not appointed in a different way, daily accept on one tablet of the drug Androkur® with 1 - го till the 15th day of a cycle of treatment in addition to
Диане®-35.
Days of a cycle of treatment
1st day 15th day    21st day      28th day

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Bleeding
about 1 tablet Androkur® about 1 tablet Diane®-35
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Bleeding

In packaging each tablet is marked by a day of the week in which it has to be accepted. Accept on one tablet of the drug Androkur® and Диане®-35 at the same time every day, washing down with a small amount of water. Follow in the direction of an arrow until all 15 pill Androkur® are taken. In the next 6 days accept only Diane®-35.
When in 21 days of reception calendar packaging of the drug Diane®-35 ends, the 7-day break in reception of tablets during which menstrualnopodobny bleeding has to begin follows.
After a 7-day break irrespective of whether menstrualnopodobny bleeding stopped or still proceeds, reception of tablets is resumed from the following calendar packagings of the drug Androkur® and Диане®-35.
If during a break menstrualnopodobny bleeding did not come that happens extremely seldom, it is necessary to interrupt treatment and not to resume reception of tablets until pregnancy is excluded.
Duration of treatment is determined by the doctor depending on severity of pathological signs of an androgenization and their dynamics during treatment. Usually drugs need to be accepted within several months. The therapeutic effect at an acne and seborrhea is usually shown quicker, than at a hirsutism and an alopecia.
After achievement of clinical improvement it is necessary to try to continue treatment only by the drug Diane®-35.
If therapeutic action seems to you too strong, or too weak, it is necessary to report about it to the attending physician.
The admission of reception of a tablet If the woman forgot to take a drug Diane®-35 pill in usual time, then it should be made not later, than within the next 12 hours. If since
standard practice of Diane®-35 there passed more than 12 hours, the contraceptive effect in this cycle can be weakened. It is necessary to pay attention to the instructions concerning contraceptive reliability, and also the recommendation about the passed tablets which are included in information on the drug Diane®-35. If after this cycle menstrualnopodobny bleeding is absent, before resuming of reception of tablets it is necessary to exclude pregnancy.
The admission of tablets of the drug Androkur® can lead to decrease in therapeutic effect and cause menstrualnopodobny bleeding. The passed tablets of the drug Androkur® leave not drunk (i.e. it is not necessary to accept a double dose to compensate the passed tablet), and resume administration of drug in usual time together with Diane®-35.
After the end of therapy by the drug Androkur® symptoms concerning which it was appointed by the doctor can appear again.
Children's and teenage age
Studying of efficiency and safety within clinical trials with participation of children or teenagers to 18 years was not carried out. Advanced age
The drug Androkur® is shown only to women of childbearing age. Liver failure
Use of the drug Androkur® is contraindicated to patients with liver diseases (until indicators of a liver are not normalized). Renal failure
There are no data on need to change a dose at this category of patients.
 Pregnancy and lactation
Use of drug at pregnancy and during breastfeeding is contraindicated.

Features of use:

Before an initiation of treatment it is necessary to conduct the general medical and gynecologic examination (including inspection of mammary glands and a cytologic research of a cervical epithelium). It is also necessary to exclude pregnancy. Influence on a liver
During treatment periodic control of function of a liver is necessary.
Against the background of use of the drug Androkur® development of benign and malignant tumors of a liver which can lead to life-threatening intra belly bleedings was noted. At increase in a liver, emergence of severe pain in upper parts of a stomach or a clinical picture of intraperitoneal bleeding it is necessary to consider a possibility of existence at the patient of a tumor of a liver. Diabetes mellitus
At patients with a diabetes mellitus the need for peroral hypoglycemic means or insulin can change. Patients with a diabetes mellitus, during treatment by the drug Androkur® have to be under observation of the doctor. The combined treatment
If at a combination therapy during the 3 weeks period of reception of tablets the smearing bloody allocations are observed, treatment should not be interrupted. However at the persistent or repeating untimely bleedings it is necessary to conduct gynecologic examination for the purpose of an exception of a disease of organic character.
In view of need of additional administration of drug of Diane®-35 it is also necessary to consider all contraindications and all information which is contained in the application instruction Diane®-35.
The drug Androkur® contains 63 mg of lactose in 1 tablet. The patients with rare hereditary diseases of intolerance of milk sugar, a lactose intolerance, a sprue of glucose and a galactose who are on a delactosed diet should not use this drug.
Absence of bleeding of "cancellation"
If during a break or after drug phase-out menstrualnopodobny bleeding did not come within 7 days that happens extremely seldom, it is necessary to interrupt treatment and not to resume reception of tablets until pregnancy is excluded.
Defeat of a meninx
Also more was reported about development of meningiomas (single and multiple) in connection with long (within several years) administration of drug of Androkur® in a dose of 25 mg. In case of diagnosing of a meningioma at the patients accepting Androkur® in a dose of 10 mg treatment by drug should be stopped. Influence on driving of motor transport and control of mechanisms
The researches concerning influence on ability to manage the vehicle and other mechanisms were not conducted.

Side effects:

The most widespread side effects at the patients accepting the mg drug Андрокур® 10 are bloody allocations from a vagina, increase in body weight and decrease in mood.
The most serious side effect of the drug Андрокур® 10 of mg is development of benign and malignant tumors of a liver which can lead to life-threatening intra belly bleedings.
Side effects of the drug Андрокур® 10 of mg proceeding from post-market researches and cumulative experience which frequency cannot be determined are listed in the included below table.

            Bodies and                                                        the Frequency systems it is not defined
Benign and malignant tumors      Benign and malignant tumors of a liver *
Disturbances from immune system                       of Reaction of hypersensitivity
Disturbances from a metabolism                     a body Degrowth, increase in body weight, a hyperglycemia
Mental disturbances                                         Decrease in mood, increase in a libido, decrease in a libido
Disturbances from outside   
digestive tract                                   Intra belly bleedings *
Skin and hypodermic fabrics                                                Pour
Disturbances from reproductive                  Morbidity of mammary glands,
system and mammary glands                                      lack of an ovulation, bloody
                                                                                allocations from a vagina *

* - additional information is provided in the section "Special Instructions".
Against the background of a combination therapy there is a braking of an ovulation therefore there is a state at which conception is impossible.
It is also necessary to consider the side effects specified in the application instruction of the drug Diane®-35.

Interaction with other medicines:

The need for antidiabetic means or insulin can change.
The patient has to report to the attending physician about any drugs which she is going to accept or already accepts during treatment by the drug Androkur®.

Contraindications:

Pregnancy and during breastfeeding, a liver disease, a syndrome the Cudgel Johnson, a syndrome of the Rotor, a liver tumor (including in the anamnesis), idiopathic jaundice or a persistent itch during the previous pregnancy, herpes of pregnant women in the anamnesis, a cachexia, a heavy chronic depression, a meningioma (including in the anamnesis), thromboembolic processes (including in the anamnesis), a severe form of a diabetes mellitus with a diabetic angiopatiya, a sickemia, deficit of lactase, a lactose intolerance, glyukozo-galaktozny malabsorption, hypersensitivity to any of drug Androkur® components, teenage age (before completion of puberty).
It is also necessary to take into account contraindications for use of the drug Diane®-35 which is appointed in a combination with the drug Androkur®.
With care
At patients with a diabetes mellitus.

Overdose:

In researches of acute toxicity after a single dose of drug it was revealed that a tsiproterona acetate, active component of the drug Androkur®, can be considered as almost non-toxic substance. The risk of acute intoxication after single accidental dose of the dose several times exceeding the recommended therapeutic dose is improbable.

Storage conditions:

To store at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity of 5 years. Not to use after a period of validity.

Issue conditions:

According to the recipe

Packaging:

Tablets of 10 mg.
On 15 tablets in the blister PVC Is scarlet/. On 1 blister together with the application instruction place in a cardboard pack.