Ginette

Ginet is an antiandrogen agent combined with estrogens.

Indications Gineta

It is used for androgen-dependent pathologies in women:

• acne (especially in a severe form), against the background of which seborrhea and inflammatory symptoms are observed, accompanied by the formation of nodules;
• androgenic alopecia;
• mild hirsutism.

It is also used as an oral contraceptive for women who have signs of androgenization. It can be prescribed for Stein-Leventhal syndrome (to prevent the development of hyperplastic processes within the endometrium).

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Release form

The product is produced in tablets, in the amount of 28 pieces (21 of them are yellow, and 7 are white) inside a blister pack. There is 1 such pack in a pack.

Pharmacodynamics

Ginet is a complex monophasic contraceptive for oral administration, which has a gestagenic effect (due to the activity of cyproterone acetate) and an antiandrogenic effect, and also contains the estrogen ethinyl estradiol. The contraceptive effect of the drug is provided by suppression of the ovulatory release of pituitary gonadotropins, as a result of which the ovulation process is inhibited. The contraceptive effect is also enhanced by changing the viscosity of cervical mucus.

The development of the antiandrogenic effect of the drug is ensured by the process of suppression of steroidogenesis occurring in the ovaries. As a result, the degree of binding of internal testosterone decreases (high rates of this phenomenon are observed in ovarian hyperandrogenism), and along with this, the ability for competitive synthesis with androgenic endings inside target organs.

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Pharmacokinetics

The use of drugs leads to complete and fairly rapid absorption of medicinal components in the gastrointestinal tract. Peak values of cyproterone acetate, as well as ethinyl estradiol in the blood plasma are recorded after approximately 1.6-1.7 hours.

Then a two-stage reduction of the indicators of both active elements is carried out. The half-life of cyproterone acetate is 1 hour and 2 days, and ethinyl estradiol is 1-2 hours and 1 day. Cyproterone acetate can accumulate inside fatty tissues, due to which, with prolonged use of the drug, its plasma level acquires a stable indicator and becomes less dependent on a single dose of Gineta.

The bioavailability values for cyproterone acetate are approximately 88%, and for ethinyl estradiol, approximately 45%.

Both active substances are excreted mainly in the form of breakdown products. About 30% of cyproterone acetate and its metabolic products are excreted via the kidneys, and up to 70% in the bile. Approximately 40% of ethinylestradiol and its breakdown products are excreted in the urine, and another 60% in the bile.

Cyproterone acetate with ethinyl estradiol is almost completely synthesized with blood plasma albumins, and about 2-4% of the portion is in a free form. Since synthesis with proteins has a non-specific form, changes in the globulin indices involved in the synthesis of sex steroids do not affect the pharmacokinetic parameters of cyproterone acetate.

With prolonged use of the drug, ethinyl estradiol increases the hepatic binding of globulins that synthesize GCS and sex steroids. During therapy, the level of these globulins in the blood serum increases to 300 and 95 mcg/ml, respectively.

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Dosing and administration

The medicine is taken orally, 1 tablet (yellow) per day. You need to start on the 1st day of the menstrual cycle. It is necessary to take the tablets every day, one after the other, following the direction of the arrows on the foil of the blister pack. The medicine is always taken at the same time of day. The tablet should be swallowed without chewing and washed down with plain water. The duration of taking the active (yellow) tablets is 21 days, and during the 1st week you should take 1 placebo tablet (white; it does not contain active elements).

The duration of the therapeutic cycle is determined by the form and intensity of the disease symptoms. Elimination of androgenization symptoms usually takes a long time – it requires months of treatment. After the intensity of the disease symptoms has decreased, it is necessary to additionally perform 3-4 more therapeutic cycles.

If you miss taking a pill, take the pill as soon as possible within 12 hours. Take the new pill at your usual time. If more than 12 hours have passed since you missed taking the pill (the interval since the last yellow pill was taken is more than 36 hours), the contraceptive reliability of the drug is reduced. At the same time, it should be taken into account that the interval between taking the pill should be less than 7 days.

If you are more than 12 hours late in taking the medicine (the interval from the last use of the active tablet is more than 36 hours), you must take the medicine as quickly as possible, even if you have to take 2 tablets at once. It is also recommended to use barrier contraception for the next 7 days.

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Use Gineta during pregnancy

It is prohibited to use Ginet if you are pregnant or suspected of being pregnant.

Contraindications

Among the contraindications:

• current or history of thromboembolism or thrombosis (pulmonary embolism, deep vein thrombosis, cerebrovascular disorders and myocardial infarction);
• elevated blood pressure and severe coronary heart disease;
• diabetes mellitus with the presence of microangiopathy against its background;
• the presence of multiple or severe factors for the occurrence of thrombosis, which has an arterial or venous form;
• diseases or severe forms of disorders in the functioning of the liver;
• liver tumors (also their presence in the anamnesis);
• malignant forms of neoplasms that are hormone-dependent (this includes tumors in the genital area or breasts);
• uterine bleeding of uncertain origin;
• pancreatitis (also the presence of the disease in the anamnesis), which is aggravated by hypertriglyceridemia in a severe stage;
• migraine, against the background of which focal neurological signs are observed;
• breastfeeding period;
• the presence of intolerance to medicinal elements.

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Side effects Gineta

The use of the drug may lead to the occurrence of certain side effects:

• disorders affecting the endocrine system: occasional discharge and pain in the mammary glands or their enlargement, and in addition, weight changes;
• disorders in the reproductive system: occasionally, a weakening of libido and the appearance of bleeding in the intermenstrual period are observed;
• problems with the central nervous system: mood swings or headaches occasionally occur;
• digestive disorders: vomiting or nausea occurs occasionally;
• other symptoms: occasional pigment spots on the skin of the face or signs of allergy.

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Overdose

The combined use of several yellow tablets can provoke vomiting with nausea and uterine bleeding of moderate intensity.

There is no antidote for Jinnet, so only symptomatic treatments are performed.

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Interactions with other drugs

When combining the drug with substances that induce liver microsomal enzymes (such as barbiturates, as well as rifampicin and hydantoin with carbamazepine), the clearance rates of cyproterone with ethinyl estradiol increase, resulting in uterine bleeding and a decrease in the contraceptive reliability of the drug.

Concomitant use of the drug with tetracyclines or ampicillin weakens its contraceptive properties.

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Storage conditions

Dzhinet should be kept in a place closed to children and moisture penetration. Temperature values are maximum 25°C.

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Shelf life

Ginet is allowed to be taken within 24 months from the date of release of the therapeutic drug.

Analogues

The medicine's analogues are Diane and Chloe.

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