Genet

Ginette is an anti-androgenic drug, combined with estrogens.

Indications Ginette

It is used in androgen-dependent pathologies in women:

• Acne (especially in a pronounced degree), against which there are seborrhea and inflammatory symptoms, accompanied by the formation of nodes;
• alopecia are androgenic;
• hirsutism to an easy degree.

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

[1]

Release form

The release is made in tablets, in an amount of 28 pieces (21 of them - yellow, and 7 - white) inside the blister pack. In a pack - 1 such a package.

Pharmacodynamics

Ginette is a complex monophasic oral contraceptive that has a progestational effect (due to the activity of cyproterone acetate) and an antiandrogenic effect, as well as containing estrogen-ethinyl estradiol. Contraceptive effect of drugs is provided by suppression of ovulatory release of pituitary gonadotropins, as a result of which the process of ovulation is inhibited. Strengthening contraceptive effects also occurs by changing the degree of viscosity of the cervical mucus.

The development of antiandrogenic effect of the drug is provided by the process of suppression of the steroidogenesis occurring in the ovaries. As a result, the degree of binding of internal testosterone is reduced (high indicators of this phenomenon are noted with hyperandrogenia of ovarian nature), and with it the ability to competitively synthesize with androgen endings within target organs.

[2], [3], [4]

Pharmacokinetics

Drug use leads to a full-fledged and rather rapid absorption of medicamentous components inside the digestive tract. The peak values of cyproterone acetate, as well as ethinyl estradiol within the blood plasma, are recorded after approximately 1.6-1.7 hours.

Further, a two-stage reduction in the performance of both active elements is carried out. The half-life of cyproterone acetate is 1 hour and 2 days, and ethinyl estradiol - 1-2 hours and 1 day. Ciproterone acetate can accumulate inside fatty tissues, due to which, with prolonged use of drugs, its plasma level acquires a stable index and becomes less dependent on a single portion of Ginet.

Values of bioavailability of cyproterone acetate are approximately 88%, and ethinyl estradiol is approximately 45%.

Both active elements are excreted mainly in the form of decay products. About 30% of the acetate of cyproterone and its metabolites is excreted through the kidneys, and up to 70% - together with bile. Approximately 40% of ethinyl estradiol with its decay products are excreted in the urine, and another 60% - along with bile.

The acetate of cyproterone with ethinyl estradiol is almost completely synthesized with blood plasma albumins, and about 2-4% of the portion remains in the free form. Because the synthesis with proteins has a nonspecific form, the change in the indices of the globulin, which is involved in the synthesis of sex steroids, does not affect the pharmacokinetic parameters of cyproterone acetate.

With prolonged use of the drug, ethinyl estradiol increases the hepatic binding of globulins, which synthesize GCS and sex steroids. During therapy, the level of these globulins within the blood serum increases to 300, as well as 95 μg / ml, respectively.

[5], [6], [7], [8],

Dosing and administration

The drug is taken orally on the first pill (yellow) per day. You need to start on the 1st day of the menstrual cycle. It is necessary to take tablets every day, in turn, observing the direction of the arrows put on the foil of the blister pack. The medication is always consumed at the same time of day. The tablet should be swallowed without chewing, and washed down with plain water. The duration of use of active (yellow) tablets is 21 days, and for the first week should be taken on the 1st placebo tablet (white, it does not contain active elements).

The duration of the therapeutic cycle is determined by the form and degree of intensity of the signs of the disease. Elimination of symptoms of androgenation usually lasts a long time - it takes a month of treatment. After reducing the intensity of the signs of the disease, it is necessary to perform an additional 3-4 treatment cycles.

If you miss the use of drugs, the tablet should be taken as quickly as possible in a period of 12 hours. A new tablet should be used at the usual time. If more than 12 hours have elapsed after the medication was missed (thus, the interval from the moment of the extreme use of the yellow tablet lasts more than 36 hours), the degree of the contraceptive reliability of the drug decreases. At the same time, it should be borne in mind that the gap between drug use should be less than 7 days.

If you are late for using drugs that are more than 12 hours (the interval from the time of the extreme use of the active tablet is more than 36 hours), it is required to use the drug as quickly as possible, even if you have to immediately take 2 tablets. It is recommended to additionally use barrier contraception for the next 7 days.

[11]

Use Ginette during pregnancy

Use Jinet during pregnancy or suspected of it is prohibited.

Contraindications

Among the contraindications:

• presence now or in anamnesis of thromboembolism or thrombosis (PE, deep vein thrombosis, cerebrovascular disorders and myocardial infarction);
• increased indicators of blood pressure and coronary artery disease in severe degree;
• Diabetes mellitus with the presence of microangiopathy on its background;
• presence of many or severe factors of the appearance of thrombosis, which has arterial or venous form;
• diseases or severe forms of disorders in the work of the liver;
• hepatic tumors (also their presence in the anamnesis);
• malignant forms of neoplasms that have a hormone-dependent nature (this includes tumors in the genital or chest zone);
• bleeding from the uterus, having an indeterminate nature;
• pancreatitis (also the presence of the disease in the anamnesis), which is aggravated by hypertriglyceridemia in the severe stage;
• migraine, against which neurological signs of a focal character are noted;
• the period of breastfeeding;
• The presence of intolerance in relation to medicamentous elements.

[9],

Side effects Ginette

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

• disorders affecting the endocrine system: there are isolated discharges and pains in the area of the mammary glands or their enlargement occurs, and in addition weight changes;
• disorders in the sexual system: there is a single reduction in libido and the appearance of bleeding in the intermenstrual period;
• problems in the work of the central nervous system: occasionally there is lability of mood or headache;
• disorders of the digestive function: one appears vomiting or nausea;
• other symptoms: sporadic spots on the face skin or signs of allergy occur sporadically.

[10]

Overdose

The combined use of several yellow tablets can provoke vomiting with nausea and bleeding from the uterus, which has a moderate degree of intensity.

Ginet has no antidote, so only symptomatic procedures are performed.

[12]

Interactions with other drugs

When combining the drug with substances that induce microsomal liver enzymes (such as barbiturates, and in addition rifampicin and hydantoin with carbamazepine), the clearance of ciproterone with ethinyl estradiol increases, resulting in bleeding from the uterus and a decrease in the contraceptive safety of drugs.

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

[13], [14], [15]

Storage conditions

Ginette should be kept out of the reach of children and penetration of moisture place. Temperature values are a maximum of 25 ° C.

[16]

Shelf life

Ginette is allowed to take within 24 months after the release of the therapeutic drug.

Analogues

Analogues of the drug are the means of Diana, as well as Chloe.

[17], [18],