Estrozhel gel for mestn. comment 0.6mg/g fl. 80 g

Pharmacological properties

Estrogenic medicine for external use. pharmacological features are caused by availability of the oestradiol which is follicular hormone. against the background of medicament treatment the expressiveness of manifestations of a menopausal syndrome considerably decreases (including inflows, the increased perspiration, dystrophic changes of a mucous membrane of a vagina, instability of mood). at women during a climacteric the application estrozhelya interferes with demineralization of a bone tissue and development of osteoporosis. prevention of osteoporosis has individual character and is proportional to a dose of available estrogen. at application of 2.5 g of gel a day for 21 of 28 days the effect is provided approximately at 89% of women.

Transdermalny way of introduction allows to apply to treatment the natural estrogen produced by ovaries — 17β-эстрадиол. This way excludes effect of primary passing through a liver, prevents stimulation of synthesis of angiotensinogen, LDL and some factors of coagulation that reduces risk of developing diseases of a cardiovascular system, tromboemboliya and violations of metabolism.

When putting gel alcohol quickly evaporates and 17β-эстрадиол gets through skin, at the same time its most part directly gets to a system blood-groove, and a number is late in hypodermic fatty tissue and comes to a system blood-groove gradually. Metabolism and removal 17β-эстрадиола at Estrozhel's application correspond to biotransformation and removal of natural estrogen. Level 17β-estradiola in blood plasma at women in the period of a menopause at application of 2.5 g of gel a day — 80 pg/ml. It corresponds to a normal ratio estrone/oestradiol at women of childbearing age.

Indication

Elimination of manifestations of the menopausal syndrome connected with deficiency of estrogen at an age and artificial menopause, prevention of post-menopausal osteoporosis.

Use

Estrozhel is appointed cycles — 24–28 days a month. doses and duration of treatment establish individually. one dose (2.5 g of gel) is applied 1 time a day in the morning or in the evening on pure leather of a stomach, lumbar area, hips, shoulders or forearms with a thin layer before full absorption. if necessary after 2–3 cycles the dose can be corrected depending on a clinical picture or deficiency of estrogen. it is necessary to apply gel with a thin layer on the surface of skin (on above-mentioned areas). it is not recommended to massage. it is necessary to prevent hit of gel on mammary glands and mucous membranes. application correct and effective if gel was absorbed in 2–3 min.

Route of administration. Gel is applied with the patient independently. For this purpose it is necessary to open a tuba and to pierce a metal membrane by means of the small punch which is in a stopper. For calculation of a daily dose use the plastic pallet doser. It is necessary to press a tuba over a ruler of the pallet, at the same time 1 dose equals to a column (diameter of a pencil) which length matches deepening on a ruler. Deepening has a hyphen which gives the chance to divide a daily dose in half. One tube is expected 30 doses. It is necessary to apply gel with a thin layer on the surface of skin in the above-stated places. It is not necessary to mass. To prevent hit of gel on mammary glands and mucous membranes. Use is considered correct and effective if gel is completely soaked up less than in 2–3 min.

Contraindication

Thrombembolia of coronary and cerebral vessels, sharp thrombophlebitis, uterine bleedings of not clear etiology, an estrogenzavisimy breast cancer, ovaries or a uterus, a serious illness of a liver, the period of pregnancy and feeding by a breast, hypersensitivity to medicine components.

Majority of following side effects were observed by

at oral administration of artificial estrogen. at application estrozhelya side effects arise seldom, but it is recommended to stop use of medicine at development: cardiovascular insufficiency, tromboembolic episodes, cholestatic jaundice, benign mastopathy or a tumor of a uterus (for example increase in the sizes of a fibromyoma), liver adenomas (development of internal bleeding is possible), a galactorrhoea (it is necessary to exclude hypophysis adenoma).

to

Needs dose adjustment at emergence of signs of a lack of estrogen (inflows, frequent headaches, migraine, dryness mucous vaginas, irritation of eyes at application of contact lenses) and signs of their high content (nausea, vomiting, an abdominal pain, a meteorism, a nagrubaniye of mammary glands, irritability, peripheral hypostases, feeling of weight in legs, strengthening of secretion from a neck of the uterus).

uterine bleedings (it is necessary to define the reason), exacerbation of epilepsy, a hloazm or a melanosis Are possible

.

Special instructions

As at prolonged use of estrogen in the form of monotherapy the risk of developing endometrial cancer increases, it is necessary to take the gestagenny medicament not less than 12 last days of each monthly cycle of treatment estrozhely. before an initiation of treatment it is necessary to perform full clinical and gynecologic examination. periodic examinations have to be performed (including mammography) during therapy by medicine, their frequency and volume are established individually. special attention should be paid to inspection of mammary glands, a uterus, to measurement hell and body weights, to a condition of a cardiovascular system and a metabolism. constant control behind a condition of patients in such cases is necessary: an ischemic stroke at atherosclerosis, a cerebral hemorrhage, occlusion of veins of a retina, obesity (in connection with risk of developing a vein thrombosis), a bed rest and preparation for planned operation (it is desirable to cancel medicament treatment in 1 month prior to operation), increase hell. careful observation is necessary for patients with endometriosis, a uterus fibromyoma, an endometrium hyperplasia, a benign skin tumor, a system lupus erythematosus, a prolaktinsekretiruyushchy tumor of a hypophysis, a porphyria, at a recurrent cholestasia in the anamnesis, a renal failure, epilepsy, asthma, abnormal liver functions, an otospongiosis, existence in the family anamnesis of a breast cancer.

Period of pregnancy and feeding by a breast: use of medicine is not shown. Women who accepted estrogen or estroprogestagena in early pregnancy do not need to carry out abortion.

Interaction

At simultaneous application estrozhelya with the medicines inducing liver enzymes: anticonvulsant medicines (carbamazepine, phenobarbital, fenition, Primidonum), with barbiturates, griseofulvin, rifabutiny, rifampicin, decrease in level of oestradiol in blood plasma is possible. at application together with cyclosporine the decrease in removal of cyclosporine through a liver and increase in level of cyclosporine, creatinine and Transaminases in blood plasma is possible.

Overdose

symptoms specified in the section side effects, disappearing at medicament withdrawal or a dose decline Develop.

Storage conditions

At a temperature up to 25 °C.