Home / Products

Geston

Geston

Geston

Instructions for use of the drug (for patients)

GESTON-200vaginal or rectal pessaries
GESTON

GESTON-400vaginal and rectal pessaries
GESTON

International non-proprietary name:Progesterone

Composition
Active ingredient:   1 pessary contains 200 or 400 mg of progesterone.
Auxiliary substances:solid fat.

Description
They are white or whitish pessaries with a cylindrical shape.

Pharmacotherapeutic group
Sex hormones and functional modulators of the reproductive system, gestagens.

ATC code:G03DA04.

Pharmacological properties
Pharmacodynamics
Progesterone is a natural steroid synthesized by the ovaries, fallopian tubes and adrenal glands of women.
When estrogen levels are adequate, progesterone causes the proliferative endometrium to transform into a secretory endometrium. Progesterone increases the sensitivity of the endometrium to embryo implantation and helps maintain pregnancy after implantation.
Pharmacokinetics
Absorption
Vaginal use every 12 hours in physiological conditions of the ovarian cycle, such as the luteal phase and early pregnancy, has been shown to be effective for rapid recovery and maintenance of blood progesterone levels.
After repeated administration for 10 days, the average Cmax is 18.4 ng/ml, and Ctrough is 10.5 ng/ml.
Distribution
Mainly 96-99% bound to blood proteins such as albumin, globulin and globulin-binding corticosteroids.
Metabolism
Progesterone is mainly metabolized in the liver, especially through pregnanediols and pregnanolones. Progesterone metabolites that are excreted through the bile are dehydroxylated and undergo further metabolism in the intestines through regeneration dehydroxylation and epimerization.
Exclusion
Progesterone is excreted from the body through the kidneys and bile ducts.

Instructions for use

  • Premenstrual syndrome, including premenstrual tension and depression.
  • postpartum depression;
  • as an aid during the luteal phase in women under assisted reproductive technologies (ART).

Contraindications

  • hypersensitivity to progesterone or any other component of the drug;
  • vaginal bleeding of unknown cause;
  • detected and probable progesterone-sensitive malignant derivatives;
  • porphyria;
  • acute liver failure or any liver diseases;
  • incomplete disruption of pregnancy or detected ectopic pregnancy;
  • active or recent arterial or venous thromboembolism or acute thrombophlebitis.

Special instructions and precautions
Progesterone use is stopped when there is a threat of natural and incomplete disruption of pregnancy (miscarriage).
The drug is not used in the following cases:

  • myocardial infarction,
  • cerebrovascular disorders,
  • venous or arterial thromboembolism (venous thrombosis and pulmonary embolism),
  • thrombophlebitis or retinal thrombosis.

Although the risk of thromboembolism is related to estrogens, it is suspected that it is related to progesterone.
The use of the drug in patients with a personal or family history of acute thromboembolism risk may lead to activation of the risk.
Patients with a history of depression should be monitored and treatment should be discontinued when relevant symptoms are observed.
Since progesterone can cause small amounts of fluid retention, patients should be systematically monitored to avoid risks such as epilepsy, migraine, bronchial asthma, heart or kidney failure.
Reception of combined estrogen-progesterone drugs can cause a decrease in glucose tolerance in some patients. The mechanism of action of this process is not known. Patients receiving treatment for diabetes should be monitored.
Taking into account that Geston pessaries contain progesterone hormone, as well as the significant increase in progesterone concentration in women during pregnancy and the second half of the menstrual cycle, it is important to monitor patients with sensitivity to hormones during the treatment period.
Abrupt discontinuation of treatment may cause anxiety, emotional instability, and seizures.
Use in premenstrual syndrome and postpartum depression:
Geston pessaries are administered rectally when used together with barrier contraceptives.
Geston pessaries are used rectally in patients taking barrier contraceptives, vaginal infections (especially candidiasis), chronic cystitis, and those who have recently given birth.
In cases of constipation or impotence, the preparation is used vaginally.

Interaction with other drugs
Drugs that induce isoenzymes of the cytochrome P4503A (CYP3A4) system (eg, rifampicin, carbamazepine, or phenytoin) increase the rate of excretion of progesterone, which leads to a decrease in the bioavailability of this drug.
Geston pessaries should not be used simultaneously with other vaginal preparations.

Use during pregnancy and lactation
Pregnancy
Geston pessaries are indicated for use within assisted reproductive technologies (ART) only in the I trimester of pregnancy.
There are limited and inconclusive data on the risk of genital abnormalities in newborns, male or female, following intrafetal interactions from both congenital and gestational use in neonates.
Although the data on the incidence of congenital anomalies, spontaneous termination of pregnancy, and ectopic pregnancy observed during clinical research are at a level comparable to the existing data on the incidence of such cases in the general population, they are not sufficient to draw conclusions about the effect levels. It can be used during pregnancy only after assessing the benefit-risk ratio.
Lactation period
Since progesterone passes into breast milk, it should not be used during lactation.

Effects on the ability to drive vehicles and other potentially dangerous mechanisms
There are no data on the effect of the drug on the ability to drive vehicles and other potentially dangerous mechanisms.

Method of use and dosage
Premenstrual syndrome and postpartum depression:
The recommended dose is 200-400 mg vaginally or rectally twice a day.
In the case of premenstrual syndrome, treatment is continued from the 14th day of the menstrual cycle until the onset of menstruation.
In case of ovulation symptoms, the treatment is started from the 12th day of the menstrual cycle.
Lutein phase in assisted reproductive technologies (ART).
During the collection of oocytes, starting from the day of collection, 400 mg is used vaginally 2 times a day. During confirmed pregnancy, Geston is used for 38 days.
Use in a special group of patients:There are no data on its use in patients with liver and kidney failure.
Use in children:not used in children.
Use in elderly patients over 65 years of age:There are no clinical data on its use in elderly patients over 65 years of age.

Side effects
The frequency of occurrence of side effects is classified as follows (MedDRA classification):
very common (≥1/10),
often (≥1/100,