Expiration date: 01/2026

Release form and composition:

Gel for external application of 1%, colorless, translucent, slightly opalescent without visible particles, with the smell of alcohol.

Natural progesterone is micronized: 1 dose - 25 mg, 1 tube - 800 mg.

Excipients: octyldodecanol, carbomer 980, macrogol glitserilgidroksistearat (castor oil polioksilgidrogenizirovannoe) trolamine (triethanolamine), ethanol, distilled water.

80 g (32 doses of 2.5 g of gel) - tubas aluminum complete with a dosing applicator - packs cardboard.

Pharmachologic effect:

Progestogen for outdoor use. The active component of the drug is progesterone.

Progesterone action by blocking estrogen receptors, resulting in improved absorption of fluids and tissue compression decreases ducts, and on blocking prolactin receptors in breast tissue, which leads to a reduction laktopoeza.

Local drug use, creating a high concentration of progesterone in the application zone, does not have systemic action and avoids unwanted side effects.

Progestogel action mechanism is based on increasing concentrations of progesterone in the tissues of the breast. 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 estronsulfotransferazy) oxidizing estradiol less active estrone (linking the latter, enzymes convert it into an inactive estrone sulfate).

Thus, progesterone limits the proliferative effect of estrogens on the breast tissue.

Progesterone also has a slight natriuretic effect due to inhibition of tubular reabsorption and increase cell filtration, preventing fluid retention at secretory transformations of the glandular component of the breast and, as a consequence, the development of pain (mastalgia or mastodynia).

Along with this, the transdermal route of administration of progestogen can also affect the condition of the glandular epithelium and vasculature, thereby reducing capillary permeability decreases the degree of swelling of the breast tissue, the symptoms disappear mastalgia.

Pharmacokinetics:

Suction

When transdermal application Progestogel reaches breast tissue, without being destroyed by the liver and without exerting adverse systemic effects on the body.

Absorption of progesterone in cutaneous application is approximately 10% of the dose. Study of serum prolactin concentrations, estradiol and progesterone in the treatment Progestogel showed that after 1 h after drug application, when there is a maximum absorption in tissue levels of hormones virtually unchanged.

Distribution

Cutaneous applications for breast region allow to create a high concentration range (10-fold higher than the systemic circulation) of the drug by reducing the applied doses.

Metabolism

A second drug is metabolized in the liver to form conjugates with glucuronic acid and sulfuric acid. Also participates in the metabolism of CYP2C19 isozyme.

breeding

Return with urine - 50-60%, with bile - more than 10%. Number of metabolites in the urine output varies depending on the phase of the corpus luteum.

Testimony:

• mammalgia
  
• Diffuse fibrocystic breast disease.
  

Dosage and administration:

It should be applied 1 applique gel (2.5 g of gel contains 0.025 g progesterone) to the skin of breast applicator-dispenser until complete absorption 1-2 times / day on a daily basis or during the 2nd phase (from the 16th to 25th day) of the menstrual cycle . The course of treatment - up to 3 cycles.

Repeated treatment may be appointed only after consultation with your doctor.

Side effects:

From the reproductive system: very rarely - 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.

Contraindications:

• Nodular fibrocystic breast
  
• Tumors (tumor formation) of the mammary glands of unknown etiology
  
• Breast cancer monotherapy
  
• Monotherapy genital cancers
  
• II and III trimesters of pregnancy
  
• Hypersensitivity to the drug.
  

With care use in patients with hepatic insufficiency, renal failure, asthma, epilepsy, migraine, depression, hyperlipoproteinemia, ectopic pregnancy, abortion in the course, tendency to thrombosis, acute forms of phlebitis or thromboembolic disorders, bleeding of unknown etiology of vaginal porphyria, arterial hypertension, diabetes mellitus.

Pregnancy and lactation:

There is insufficient experience with the drug during pregnancy Progestogel.

Use of the drug during pregnancy and lactation is possible only when the intended benefits to the mother outweighs the potential risk to the fetus and child.

Special instructions:

Progestogel can be used in mastodynia associated with taking oral contraceptives, puberty, premenopausal syndrome premenstrual tension.

The preparation should be applied onto breast skin applicator-dispenser without rubbing or massaging the mammary gland.

After applying the cream to avoid direct sunlight.

Effects on ability to drive vehicles and management mechanisms

Studies to identify the possible impact of the drug on the ability to drive a car or the ability to management mechanisms have not been conducted.

Overdose:

Due to the low systemic absorption overdose unlikely.

Drug Interactions:

The drug may be increased by the simultaneous use of combined hormonal contraceptives.

Conditions and terms:

The drug should be stored out of reach of children at or above 25 ° C. Shelf life - 2 years.