Prozhestozhel gel naruzhn.prim-I 1% 80g

Description

Composition
Active substance:
Natural Progesterone Micronized – 1 Year
Excipients:
Octyldodecanol – 1 g Carbomer 980 – 0.5 g macrogol glitserilgidroksistearat (polioksilgidrogenizirovannoe castor oil) – 4 g, trolamine (triethanolamine) – 0.5 g of ethanol in terms of absolute ethanol – 47.7 g Purified water – 100 g
Description:
Colorless translucent slightly opalescent gel with odor of alcohol without visible particles.
Product form:
Gel for external application of 1%.
80 g of product in an aluminum tube, sealed with screw cap. The tube is placed in a cardboard box together with the applicator-dispenser and instructions for use.
Contraindications
Nodular fibrocystic breast disease.
Tumors (tumor formation), breast unknown etiology.
Individual hypersensitivity to any component of the drug.
Breast cancer and genital organs (as monotherapy).
Pregnancy (II and III trimester).
Be wary – hepatic impairment; – renal failure; – bronchial asthma; – epilepsy; – migraine; – depression; – hyperlipoproteinemia – ectopic pregnancy; – abortion in progress; – the tendency to thrombosis; – acute forms of phlebitis or thromboembolic disorders; – vaginal bleeding of unknown etiology; – porphyria; – arterial hypertension; – diabetes.
Indications
Mammalgia.
Diffuse fibrocystic breast disease.
Interaction with other drugs
Prozhestozhelya effect can be amplified against the backdrop of contraception with combined hormonal therapy.
Overdose
Due to the low systemic absorption overdose is unlikely.
pharmachologic effect
Pharmacological group:
Progestogen.
Pharmacodynamics:
The action of progesterone on the one hand, by blocking estrogen receptors, resulting in improved absorption of fluids from the tissue decreases compression of milk ducts; on the other – by blocking prolactin receptors in breast tissue, which leads to a reduction laktopoeza. Thus, the local use of the product, creating a high concentration of progesterone in the application zone, does not have systemic action and avoids unwanted side effects.
Prozhestozhelya mechanism of action is based on the increase in the concentration of progesterone in the breast tissue. The active component of the drug is progesterone. 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 (17beta-hydroxysteroid and estronsulfotransferazy) oxidizing estradiol less active estrone, and then tying the last, transforming it into an inactive estronasulfat. Thus, progesterone limits the proliferative effect of estrogens on the breast tissue. Also natriydiureticheskim progesterone has little effect due to inhibition of tubular reabsorption and increased filtration cell, thereby preventing fluid retention during transformation secretory mammary glandular component and, consequently, 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 the permeability of the capillaries and, hence, decreases the degree of swelling of the breast tissue and mastalgia symptoms disappear.
Pharmacokinetics:
When transdermal application method Prozhestozhel reaches mammary tissue without being destroyed in the liver and without exerting adverse systemic effects on the body. Study of serum prolactin concentrations, estradiol and progesterone in the treatment Prozhestozhelem showed that one hour after application of the drug when it is observed maximum absorption in tissue, hormone levels virtually unchanged. Absorption of progesterone in the cutaneous application is about 10% of the dose. Cutaneous applications for breast region allow, on the one hand to reduce the applied dose of the drug, and on the other – to create a high concentration range (10 times higher than in the systemic circulation).
A second drug is metabolized in the liver to form conjugates with glucuronic acid and sulfuric acid. Also involved in the metabolism of the isozyme CYP2C19. Excreted by the kidneys – 50-60%, with bile – more than 10%. Metabolites, kidneys displayed varies depending on the luteal phase.
Pregnancy and breast-feeding
There is insufficient experience with Prozhestozhelya during pregnancy. 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.
Conditions of supply of pharmacies
At temperatures above 25 ° C.
Keep out of the reach of children.
side effects
Very rarely: breast tenderness, “hot” hot flushes, metrorrhagia, decreased libido.
With increased sensitivity to the drug components – erythema at the site of gel application, swelling of the lips and neck, fever, headache, nausea.
special instructions
Prozhestozhel may be administered at mastodynia associated with taking oral contraceptives, puberty, premenopause, premenstrual syndrome.
The preparation should be applied onto breast skin applicator-dispenser, without rubbing or massaging the mammary gland.
Avoid direct sunlight after applying the cream.
Effects on ability to drive and working mechanisms
We have not been conducted to identify the possible impact of the drug on the ability to drive or operating machinery handling ability.
Storage conditions
On prescription.
Dosing and Administration
1 applique (2.5 g gel) containing 0.025 g of progesterone, applied to the skin of breast applicator-dispenser until complete absorption 1-2 times daily or in 2-phase (from 16 to 25 day) menstrual cycle. The course of treatment up to 3 cycles.
Repeated treatment may be appointed only after consultation with your doctor.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist