Mastopathy and Cycle disruption / Obstetrics and Gynecology

Prozhestozhel 1% 80g gel (topical application)

Brands: Besins Healthcare (Belgium)

$32.20

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Prozhestozhel 1% 80g gel (topical application) quantity

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44ea0ea6f60e

Brands:: Besins Healthcare (Belgium)

Description

The instruction
for medical use

of Prozhestozhel Torgovoye medicine a name
Prozhestozhel

Mezhdunarodnoye the unlicensed

name Progesterone Dosage Form Gel for external use, 1% 80 g

Structure
of 100 g of gel contain
active agent – progesterone the natural micronized 1 g,
excipients: octyllauryl alcohol, carbomer 980, polioksilgidrogenizirovanny castor oil, trietanolamine, ethanol of 95%, water

the Pharmacotherapeutic group cleaned the Description Colourless translucent slightly opalescent gel with an alcohol smell without visible particles
Sex hormones and modulators of a reproductive system.
Progestogens.
Pregninum derivatives.
Progesterone.
The ATX G03DA04 code

the Pharmacological

Pharmacokinetics At properties a transdermalny route of administration Prozhestozhel reaches tissue of mammary glands, without collapsing in a liver and has no systemic action on an organism. The research of serumal concentration of prolactin, oestradiol and progesterone at treatment by Prozhestozhel showed that in an hour after putting drug when its maximum absorption in tissues of a mammary gland is observed, the level of hormones practically does not change. Absorption
of progesterone at skin use is about 10% of a dose. Skin appliques allow to reduce by area of mammary glands, on the one hand, the applied drug dose, and with another – to create high concentration in an area of coverage (10 times higher, than in a system blood-groove). Drug is again metabolized in a liver with formation of conjugates with glucuronic and sulfuric acids. Also CYP2C19 isoenzyme participates in metabolism. It is removed by kidneys – 50-60%, with bile – more than 10%. The quantity of the metabolites removed by kidneys fluctuates depending on a phase of a yellow body.
A pharmacodynamics
Effect of progesterone, on the one hand, is based on blocking of receptors of estrogen as a result of which absorption of liquid from fabrics improves, compression of lacteal channels, with another – blocking of receptors of prolactin in tissue of a mammary gland decreases that leads to decrease in a laktopoez. Thus, local use of drug, creating high concentration of progesterone in a use zone, has no systemic action and allows to avoid undesirable side effects.
The mechanism of action of Prozhestozhel is based on increase in concentration of progesterone in tissues of a mammary gland. Active component of drug is progesterone. Progesterone reduces an expression of receptors of estrogen in tissues of a mammary gland and also reduces local level of active estrogen by means of stimulation of products of the enzymes (a 17beta-hydroksisteroiddegidrogenaza and an estronsulfotransferaza) oxidizing oestradiol in less active estrone and then, connecting the last, turning it into an inactive estronasulfat. Thus, progesterone limits proliferative effect of estrogen on tissue of a mammary gland. Also progesterone has small natriydiuretichesky effect due to oppression of a canalicular reabsorption and increase in cellular filtration, thereby preventing a liquid delay at secretory transformations of a ferruterous component of mammary glands and, as a result, development of a pain syndrome (mastalgiya or mastodynias). Along with it, the transdermalny method of administration of a gestagen allows to influence also a condition of a ferruterous epithelium and vascular network therefore the permeability of capillaries decreases, and, therefore, degree of hypostasis of tissues of mammary gland decreases and mastalgiya symptoms disappear.

Indications
– a mastodynia
– diffusion fibrous and cystous mastopathy

the Route of administration and doses
1 applique (2.5 g of gel) containing 0.025 g of progesterone is applied to clean skin of mammary glands by the applicator doser before full absorption 1-2 times daily, or in 2 phase (from 16 to 25 day) a menstrual cycle. A course of treatment up to 3 cycles (1 cycle of 28-30 days).
It is not necessary to apply a double dose to completion of the passed dose.
The repeated course of treatment can be appointed only after consultation with the doctor.

Side effects
Extremely seldom
– morbidity of mammary glands
– hot rushes of blood
– a metrorrhagia
– decrease in a libido
– at hypersensitivity on drug components – an erythema in the place of applique of gel, hypostasis of lips and a neck, fever, a headache, nausea.

Contraindications
– individual hypersensitivity to any of
drug components
– nodal forms of fibrous and cystous mastopathy
– a tumor (tumorous formations) of mammary glands of not clear etiology
– a breast cancer and genitals (as monotherapy)
– pregnancy II and III trimester

Medicinal interactions
Prozhestozhel’s Action can amplify against the background of contraception by the combined hormonal drugs

Special instructions
External means, is not intended for intake.
Prozhestozhel can be appointed at the mastodynia connected with reception of oral contraceptives, the pubertal period premenopauzy, a premenstrual syndrome.
Is not a contraceptive.
Drug should be applied to skin of a mammary gland the applicator doser, without rubbing and without massing mammary glands.
To avoid direct sunshine after putting cream.
With care
to Use drug in a liver failure, a renal failure, bronchial asthma, epilepsy, migraine, a depression, a giperlipoproteinemiya, an extrauterine pregnancy, abortion in the course, tendency to fibrinferments, acute forms of phlebitis or thromboembolic diseases, bleeding from a vagina of not clear etiology, a porphyria, arterial hypertension, diabetes.
Pregnancy and the period of a lactation
At pregnancy the use of drug is not shown.
Use of drug during the I trimester of pregnancy and in the period of a lactation perhaps only when the expected advantage for mother exceeds potential risk for a fruit and the child.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
researches on identification of potential impact of drug on ability of driving of the car or on ability of control of working mechanisms were not conducted.

Overdose
Symptoms: approach of periods on 1 – 2 day before term.
Treatment: use of drug from 10 to 25 day of a cycle.

The form of release and packing
On 80 g of drug place in aluminum tubas with the screwing-up cover of white color.
On 1 tuba together with the pallet doser and with the instruction for medical use in the state and Russian languages place in a cardboard pack.

To Store storage conditions at a temperature not above 25 °C.
To store out of children’s reach!

3 years
not to use a period of storage after expiry date.

Prescription status
According to the prescription

the Producer Bezen Manyufekchuring Beldzhium, Belgium

Vladelts of the registration certificate
of BEZEN HELSCARE SA, BELGIUM

the Name and the country
of the Bezen Manyufekchuring organization packer Beldzhium, Belgium

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims on quality of products
123557 Moscow, Russia, Sredny Tishinsky Lane, 28
ph. (495) 980 10 67, fax (495) 98010 68

Additional information