Progestogel gel is produced on the basis of progesterone. This is a hormone that can block estrogen receptors.
The gel form is intended for local use only. It is applied to the mammary gland. In this case, a locally high concentration of progesterone is created in the application area.
It practically does not penetrate into the general bloodstream, which allows one to avoid severe side effects such as an increased tendency to form blood clots, fluid retention, and increased skin greasiness.
Release form and composition
The drug is available only in gel form. When the gel is applied cutaneously, a high concentration of progesterone is created only in the tissues of the mammary gland itself, and the hormone does not have a systemic effect and therefore does not cause unwanted side effects.
- The main active ingredient of the drug is progesterone. Its content in one dose is 25 mg (800 mg of progesterone in a tube).
The gel also contains auxiliary components, which include:
- Ethanol.
- Carbomer 980.
- Trolamine.
- Macrogol.
- Octyldodecanol.
- Purified water.
The gel is contained in an aluminum tube in the amount of 80 g. A cardboard pack contains one tube, a special dispenser applicator and instructions for using the drug.
Cream "Mastofit"
Cream for the treatment of mastopathy "Mastofit" refers to dietary supplements and cannot be used as an alternative treatment, but only in combination with the main therapy. The drug consists of soybean oil, glycerin, lard and seaweed extract.
Judging by the reviews, Mastofit cream for mastopathy effectively moisturizes the skin and eliminates swelling of the mammary glands.
Women who have problems with the thyroid gland should use Mastofit cream with caution, since the drug has a high concentration of iodine.
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Pharmacological effect
A medicine with an active gestagenic effect is intended for application to the skin of the mammary glands. After treating problem areas, progesterone penetrates the tissue, suppresses the sensitivity of estrogen receptors, which has a positive effect on the condition of the breast. After application, the concentration of the female hormone progesterone increases in the mammary glands.
The influence of the main substance causes positive changes in the tissues of the mammary glands:
- activation of fluid absorption;
- transformation of estradiol into a less active type of estrogen - estrone;
- blocking the influence of prolactin receptors;
- reducing compression of the milk ducts;
- decreased lactopoiesis;
- a sharp decrease in the proliferative effect of estrogens on the milk ducts and glandular tissue of the breast;
- reduction of negative manifestations in patients with premenstrual syndrome;
- disappearance of swelling and swelling of the breast before monthly bleeding and in other phases of the cycle (with the progression of fibrocystic mastosis).
The gel is absorbed only 10% of the applied dose. It does not penetrate the systemic bloodstream, which means it does not undergo metabolism in the liver. Therefore, the side effects of Progestogel gel can only appear in the form of local reactions. Studies have shown that when applied cutaneously, maximum absorption of progesterone occurs within an hour. The level of the hormone in the blood remains unchanged. And the concentration in breast tissue increases 10 times.
Side effects
Local remedy Progestogel 1% does not have a systemic effect on the body: absorption of the active substance is up to 10%. The low absorption of progesterone into the blood explains the good tolerability of the drug and the low likelihood of adverse reactions.
Reviews about the negative effect of Progestogel ointment on the condition of the mammary glands and other parts of the body are rare:
- in isolated cases, women note a decrease in libido, increased discomfort in the chest, and a feeling of heat;
- in case of an individual reaction to a progesterone-containing agent, erythema appears in the treatment area, the neck and lips swell, nausea and headache occur.
Cases of overdose have not been described during treatment with a drug based on micronized progesterone.
On what day of the cycle should a mammogram be done and what do the results of the study show? We have the answer!
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Contraindications
The use of Progestogel is contraindicated for:
- Tumors (tumor-like formations) of the mammary glands of unknown etiology;
- Nodular forms of fibrocystic mastopathy;
- Monotherapy for breast and genital cancer;
- Individual hypersensitivity to the components included in the drug.
Progestogel is not prescribed to women in the 2-3 trimesters of pregnancy. The question of the possibility of using the product by nursing women is decided individually by a doctor based on the indications after assessing the risk-benefit ratio for the health of the mother and child.
The drug should be used with caution in patients with:
- Abortion is in progress;
- Ectopic pregnancy;
- Acute forms of phlebitis or thromboembolic diseases;
- Tendency to thrombosis;
- Porphyria;
- Bronchial asthma;
- Hepatic renal failure;
- Migraine;
- Epilepsy;
- Hyperlipoproteinemia;
- Depression;
- Bleeding of unknown etiology from the vagina;
- Diabetes mellitus;
- Arterial hypertension.
Indications for use of the gel
An ointment product is prescribed to eliminate benign pathological phenomena in the mammary glands that develop against the background of general or local progesterone deficiency:
Diseases | What helps remove and prevent |
Mastodynia (mastalgia) of the essential type, due to progesterone deficiency. | Chest pain. Unpleasant sensations in the breast. Swelling and swelling of breast tissue. Increased sensitivity of the bust. |
Fibrocystic mastopathy | Proliferation of cysts and fibrous compactions. Constant pain discomfort. |
Dosage and method of administration
The instructions for use indicate that 1 application of Progestogel gel (2.5 g of gel; contains 0.025 g of progesterone) should be applied to the skin of the mammary glands with a dispenser applicator until complete absorption 1-2 times a day daily or in the 2nd phase (from the 16th to the 25th day) of the menstrual cycle. The course of treatment is up to 3 cycles.
During the course of therapy, you need to ensure that the sun's rays do not fall on the treatment area: visiting the beach and solarium is prohibited. In the summer, a woman should wear light clothing that covers the décolleté, shoulders, and armpits to prevent exposure to the sun.
During treatment, the mammary glands should not be massaged. There is also no need to rub Progestogel gel into painful areas: the movements are light, without pressure.
A repeated course of treatment can be prescribed only after consultation with a doctor.
Progestogel
Registration number:
P No. 013765/01
Trade name:
Progestogel
INN:
progesterone
Dosage form:
gel for external use
Composition per 100 g
Active ingredient:
natural micronized progesterone - 1.0 g.
Excipients:
octyldodecanol - 1.0 g, carbomer 980 - 0.5 g, macrogol glyceryl hydroxystearate (polyoxyl hydrogenated castor oil) - 4.0 g, trolamine (triethanolamine) - 0.5 g, ethanol in terms of absolute ethanol - 47.7 g, purified water - up to 100 g.
Description
Colorless translucent slightly opalescent gel with the odor of alcohol without visible particles. Pharmacotherapeutic group:
gestagen
ATX code:
G03DA04
Pharmacological properties
Pharmacodynamics
The action of progesterone, on the one hand, is based on blocking estrogen receptors, as a result of which the absorption of fluids from tissues improves and compression of the milk ducts decreases; on the other hand, by blocking prolactin receptors in breast tissue, which leads to a decrease in lactopoiesis. Thus, local use of the drug, creating a high concentration of progesterone in the area of application, does not have a systemic effect and avoids unwanted side effects. The mechanism of action of Progestogel is based on increasing the concentration of progesterone in 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 dehydrogenase and estrone sulfotransferase) that oxidize estradiol into less active estrone, and then bind the latter, converting it into inactive estrone sulfate. Thus, progesterone limits the proliferative effect of estrogens on breast tissue. Progesterone also has a slight natriuretic effect due to inhibition of tubular reabsorption and increased cellular filtration, thereby preventing fluid retention during secretory transformations of the glandular component of the mammary glands and, as a consequence, the development of pain syndrome (mastalgia or mastodynia). Along with this, the transdermal method of administering gestagen also makes it possible to influence the condition of the glandular epithelium and vascular network, as a result of which capillary permeability decreases, and, consequently, the degree of swelling of the mammary gland tissue decreases and the symptoms of mastalgia disappear.
Pharmacokinetics
When administered transdermally, Progestogel reaches the mammary gland tissue without being destroyed in the liver and without causing adverse systemic effects on the body. A study of the serum concentrations of prolactin, estradiol and progesterone during treatment with Progestogel showed that an hour after application of the drug, when its maximum absorption into the tissue is observed, the level of hormones remains virtually unchanged. Absorption of progesterone when applied cutaneously is about 10% of the dose. Cutaneous applications to the area of the mammary glands allow, on the one hand, to reduce the dose of the drug used, and on the other, to create a high concentration in the area of action (10 times higher than in the systemic circulation). The drug is secondarily metabolized in the liver to form conjugates with glucuronic and sulfuric acids. The CYP2C19 isoenzyme is also involved in metabolism. Excreted by the kidneys - 50-60%, with bile - more than 10%. The amount of metabolites excreted by the kidneys varies depending on the phase of the corpus luteum.
Indications for use
- Mammalgia.
- Diffuse fibrocystic mastopathy.
Contraindications
- Nodular forms of fibrocystic mastopathy.
- Tumors (tumor-like formations) of the mammary glands of unknown etiology.
- Individual hypersensitivity to any of the components of the drug.
- Breast and genital cancer (as monotherapy).
- Pregnancy (II and III trimesters).
Carefully
- liver failure; - renal failure; - bronchial asthma; - epilepsy; - migraine; - depression; - hyperlipoproteinemia, - ectopic pregnancy; - abortion is in progress; - tendency to thrombosis; - acute forms of phlebitis or thromboembolic diseases; - bleeding from the vagina of unknown etiology; - porphyria; - arterial hypertension; - diabetes.
Pregnancy and breastfeeding
There is not enough experience with the use of Progestogel during pregnancy. The use of the drug during pregnancy and lactation is possible only if the expected benefit to the mother outweighs the potential risk to the fetus and child.
Directions for use and doses
1 application (2.5 g of gel) containing 0.025 g of progesterone is applied to the skin of the mammary glands with a dispenser applicator until complete absorption 1-2 times daily, or in the 2nd phase (from 16 to 25 days) of the menstrual cycle. The course of treatment is up to 3 cycles. A repeated course of treatment can be prescribed only after consultation with a doctor.
Side effect
Extremely rare: breast tenderness, hot flushes, metrorrhagia, decreased libido. In case of hypersensitivity to the components of the drug - erythema at the site of gel application, swelling of the lips and neck, fever, headache, nausea.
Overdose
Due to low systemic absorption, overdose is unlikely.
Interaction with other drugs
The effect of Progestogel may be enhanced by contraception with combined hormonal drugs.
special instructions
Progestogel can be prescribed for mastodynia associated with taking oral contraceptives, puberty, premenopause, and premenstrual syndrome. The drug should be applied to the skin of the mammary gland using a dispenser applicator, without rubbing or massaging the mammary glands. Avoid direct sunlight after applying the cream.
Impact on the ability to drive a car and operate machinery
No studies have been conducted to determine the possible effect of the drug on the ability to drive a car or the ability to control working mechanisms.
Release form
Gel for external use 1%. 80 g of the drug in an aluminum tube, sealed with a screw cap. The tube is placed in a cardboard box along with a dispenser applicator and instructions for use.
Best before date
3 years. Do not use after expiration date.
Storage conditions
At a temperature not exceeding 25° C. Keep out of the reach of children.
Conditions for dispensing from pharmacies
On prescription.
Produced
Name and address of the legal entity in whose name the registration certificate is issued:
Bezen Healthcare SA Avenue Louise 287, 1050 Brussels, Belgium Name and address of the manufacturer: Bezen Manufacturing Belgium SA Groot - Bijgaardenstraat 128, 1620 Drogenbosch, Belgium
or Laboratories Bezen International SAS 13, Rue Perrier, 92122 Montrouge, France
Consumer complaints should be sent to:
Bezen Healthcare RUS LLC 123022, Moscow, st. Sergeya Makeeva, 13 Tel; Fax
Reviews
We have selected some reviews from women who have used Progestogel gel:
- Anna. Six months ago, a cyst was found in my right breast and I was diagnosed with fibrocystic mastopathy. I immediately wanted a stronger remedy, but was afraid of getting stomach problems in addition to mastopathy. The doctor said that Progestogel would be enough. I was prescribed a three-month course, followed by a control ultrasound. On ultrasound, the cyst had almost halved in size, but was still there. I continued taking it for another 3 months. The result is that everything is clear on the ultrasound. I won’t say that it’s very easy to use; at the beginning I struggled with this ruler. But most importantly, I got the result I wanted.
- Nastya. The doctor prescribed Progestogel for the treatment of fibrocystic mastopathy. Regarding the application, I don’t agree with the above! It is applied very easily with the spatula that comes with the gel. Absorbs instantly... while I'm smearing the second breast, the first one is already drying out! I don’t see the result yet, because... I've only been using it for a week, but I'm hoping for the best.
- Olya. Progestogel was prescribed to me by both a gynecologist and an oncologist. A diagnosis of mastopathy was made. My mother also used this gel. It helped her too. My chest hurt very badly, even my bra was very bothersome. I started applying it and it became much easier. I didn't notice any unpleasant smell. It is easy to apply (there is a spatula, but I just applied it with my hand). The only “but” is the cost. When you use the drug for more than one month, the amount comes out to be quite large. But if it helps, you should take it. The pain went away, no side effects were found.
Expert opinion
Lyudmila Sheveleva, pharmacist Progestogel is one of the most effective drugs used in the treatment of diffuse fibrocystic mastopathy. It copes well with engorgement and discomfort characteristic of mastodynia. The drug is used simultaneously for both etiotropic and symptomatic monotherapy. This allows you to reduce the pharmacological load on a woman’s body.
But Progestogel should be used to eliminate pain in the mammary glands only as prescribed by a doctor. Cancer of the genital organs and breasts exhibits similar signs. In such cases, the use of antitumor agents is required.
Analogs
When treating mastodynia and eliminating the manifestations of diffuse mastopathy (fibrocystic form), doctors prescribe other drugs containing progesterone. Pharmacies receive several types of medicines whose ATC code and active substance are the same as Progestogel gel. Analogues have different dosage forms: injection solution, capsules, gel, vaginal tablets. It is important to consider the restrictions for use, including the form of mastopathy.
Effective analogues of Progestogel gel:
- Ginprogest.
- Endometrin.
- Ingesta.
- Krinon vaginal gel.
- Luteina.
- Progesterone.
- Progestin CR gel.
- Progynorm.
- Protelux.
- Utrozhestan.
Before using analogues, consult your doctor.