Prozestzhel gel outer 1% 80g
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Active ingredients
Progesterone
Release form
Gel
Composition
Progesterone (progesterone) 800 mg. Excipients: octyldodecanol, carbomer 980, macrogol glycerylhydroxystearate (polyoxylhydrogenated castor oil), trolamine (triethanolamine), ethanol, purified water.
Pharmacological effect
Progestin for external use. The active ingredient of the drug is progesterone.; The action of progesterone is based on the blocking of estrogen receptors, which improves fluid absorption from tissues and decreases the pressure of the milky ducts, as well as blocking prolactin receptors in the breast tissue, which leads to a decrease in lactopoiesis; Local use of the drug , creating a high concentration of progesterone in the area of application, has no systemic effect and avoids undesirable side effects. I Prozhestozhelya based on increasing concentrations of progesterone in breast tissue. Progesterone reduces the expression of estrogen receptors in breast tissue, and also reduces the local level of active estrogens by stimulating the production of enzymes (17-beta-hydroxysteroid dehydrogenase and estrone sulfotransferase), which oxidizes estradiol to less active estrone (by linking the latter, it turns it into inactive estrogen sulfone ; Thus, progesterone limits the proliferative effect of estrogen on the breast tissue.; Also, progesterone has a slight sodium diuretic effect. by inhibiting tubular reabsorption and increasing cell filtration, preventing fluid retention during secretory transformations of the glandular component of the mammary glands and, as a result, the development of pain syndrome (mastalgia or mastodynia) .; In addition, the transdermal method of administering a gestagen allows you to affect the glandular epithelium and vascular network, resulting in reduced capillary permeability, decreases the degree of edema of the breast tissue, mastalgia symptoms disappear.
Pharmacokinetics
For transdermal administration, Progestogel; reaches the breast tissue, not breaking down in the liver and not having adverse systemic effects on the body.; Absorption of progesterone in the skin application is about 10% of the dose.The study of serum concentrations of prolactin, estradiol and progesterone during treatment with Progestogel showed that after 1 h after application of the drug, when maximum absorption in the tissue is observed, the level of hormones practically does not change; (10 times higher than in the systemic circulation) of the drug while reducing the applied dose.; Metabolism; The drug is again metabolized in the liver to form conjugates with glucuron sulfuric acid. Also involved in the metabolism isoenzyme CYP2С19.; Excretion; Excreted by the kidneys - 50-60%, with bile - more than 10%. The number of metabolites excreted by the kidneys varies depending on the phase of the corpus luteum.
Indications
Mammalgia; diffuse fibrocystic mastopathy.
Contraindications
Nodular forms of fibrocystic mastopathy; tumors (tumor-like formations) of the mammary glands of unknown etiology; - monotherapy of breast cancer; monotherapy for genital cancer; II and III trimesters of pregnancy; individual hypersensitivity to the drug.
Use during pregnancy and lactation
There is not enough experience with the drug Progestogel; during pregnancy. Use of the drug during pregnancy and lactation is possible only in the case when the intended benefit to the mother outweighs the potential risk to the fetus and child.
Dosage and administration
It is necessary to apply 1 gel application (2.5 g of gel; contains 0.025 g of progesterone) on the skin of the mammary glands with a dosing applicator until it is completely absorbed 1-2 times / day daily or during the 2nd phase (from the 16th to the 25th day) of menstrual cycle. The course of treatment is up to 3 cycles.; A repeated course of treatment can be prescribed only after consulting a doctor.
Side effects
On the part of the reproductive system: extremely rare - breast tenderness, hot flushes, metrorrhagia, decreased libido.; Allergic reactions: erythema at the site of gel application, swelling of the lips and neck, fever, headache, nausea.
Overdose
Due to low systemic absorption; Overdose; unlikely.
Interaction with other drugs
The effect of the drug may be enhanced when used simultaneously with combined hormonal contraceptives.
special instructions
Prozhestozhel; can be used for mastodynia associated with oral contraceptives, puberty, premenopausal syndrome, premenstrual tension.; Effects on the ability to drive motor vehicles and control mechanisms; Studies to determine the possible effect of the drug on the ability to drive a car or the ability to control mechanisms were not conducted .; The drug should be applied to the skin of the mammary gland with an applicator-dispenser, without rubbing and massaging the mammary glands. amb direct sunlight.