ATC code:G AGENTS AFFECTING THE GENITORY SYSTEM AND SEX HORMONES; G03 SEX GLAND HORMONES AND PREPARATIONS USED IN PATHOLOGY OF THE SEXUAL SPHERE; G03C ESTROGENS; G03C A Simple preparations of natural and semi-synthetic estrogens; G03C A03 Estradiol
Country of manufacture:Belgium
Diabetics:Can
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Estrogel gel for topical use 0.6 mg/g bottle with dosing device 80 g
717.33 грн.
Description
Instructions for use Estrogel gel for topical use 0.6 mg/g bottle with dosing device 80 g
Composition
active ingredient: estradiol;
1 g of gel contains 0.6 mg of estradiol (as estradiol hemihydrate);
1 press on the bottle corresponds to 1.25 g of gel or 0.75 mg of estradiol.
Dosage form
Gel for topical use.
Main physicochemical properties: colorless transparent gel with an alcohol odor.
Pharmacotherapeutic group
Hormones of the sex glands and drugs used in pathologies of the genital area. Estrogens. Simple preparations of natural and semi-synthetic estrogens.
ATX code G03C A03.
Pharmacological properties
Pharmacodynamics.
Estrogel belongs to the group of natural physiological estrogens. The active substance is chemically and biologically identical to endogenous human estradiol. Systematic use of 17β-estradiol is possible by application to intact skin. Estrogel corrects the deficiency of estrogen production in women in menopause or after oophorectomy and alleviates the symptoms of menopause. Estrogen prevents bone loss caused by menopause or oophorectomy.
When interacting with a specific receptor, estrogen forms a complex that mainly stimulates the synthesis of DNA and proteins at the intracellular level and has metabolic effects at the level of "target" organs. The most active estrogen at the receptor level is estradiol, which is mainly synthesized in ovarian follicles during the period, starting with menarche and ending with menopause. Estrogel also has an estrogenic effect on the main "target" organs, acting not only on the ovaries, endometrium and mammary glands, but also on the hypothalamus, pituitary gland, vagina, uterus and liver. In this case, an effect similar to that which usually occurs in the follicular phase of the cycle is observed.
Transdermal administration of Estrogel avoids the so-called first-pass effect through the liver, which is the cause of increased synthesis of angiotensinogen, LDL lipoproteins (triglycerides), and some blood clotting factors.
Information obtained from clinical studies
Relieving menopause symptoms:
relief of menopausal symptoms is observed from the first weeks of treatment;
The nature of withdrawal bleeding or amenorrhea depends on the individually selected dosage regimen of estrogen and progestogens.
Osteoporosis prevention:
Estrogen deficiency in menopause is associated with increased bone turnover and bone loss. The effect of estrogen on bone mineral density is dose-dependent. The protective effect persists until the end of treatment. When hormone replacement therapy (HRT) is discontinued, bone loss occurs at the same rate as in untreated women.
Data from the Women's Health Initiative (WHI) trial and meta-analysis suggest that the use of HRT in the form of estrogen monotherapy or in combination with progestogens in otherwise healthy women reduces the risk of hip, spine, and other fractures due to osteoporosis. HRT may also reduce the risk of fractures in women with low bone density and/or a diagnosis of osteoporosis, but data on this issue are limited.
Pharmacokinetics.
During the first few hours after gel application (2–12 hours), estradiol levels reach values directly proportional to the dose and surface area of gel application.
Serum estradiol concentrations measured under experimental conditions 24 hours after daily application of 2.5 g and 5 g of gel to a skin surface area of 750 cm2 averaged 75 pg/ml and 98 pg/ml, respectively (individual differences ranged from a minimum of 42 pg/ml to a maximum of 122 pg/ml for 2.5 g of gel and from a minimum of 67 pg/ml to a maximum of 160 pg/ml for 5 g of gel). On average, these levels remained stable and comparable for 72 hours after daily application of the gel, even with six consecutive treatment cycles according to other experimental studies.
Blood estradiol levels remain constant in the same patient, even after an interval of several months (individual differences are approximately 11%). Transdermal administration of estradiol avoids the first-pass effect through the liver: compared with physiological levels, circulating E2 and E1 levels range from 0.78 to 0.97, thus similar to the levels maintained and comparable to those observed before menopause. After cessation of therapy, serum hormone levels return to baseline levels after approximately 76 hours, as does the concentration of conjugated estradiol excreted in the urine.
Estradiol
With transdermal application, approximately 10% of the applied dose of estradiol penetrates through the skin.
The half-life of estradiol from plasma is approximately 1 hour. The plasma clearance of these metabolites ranges from 650 to 900 liters/day/m2.
Estradiol is mainly metabolized in the liver to form estrone and conjugates (glucuronides, sulfates); they are much less active and are mainly excreted from the body in the form of glucuronides and sulfates. The metabolites also participate in enterohepatic circulation.
Indication
Hormone replacement therapy (HRT) to correct estrogen deficiency and symptoms of estrogen deficiency, especially in age-related or artificial menopause: vasomotor disorders (hot flashes, night sweats), trophic disorders of the genitourinary tract (atrophic vulvovaginitis, dyspareunia, urinary incontinence) and mental disorders (sleep disorders, asthenia).
Prevention of postmenopausal osteoporosis in women at high risk of fractures, women who cannot tolerate other drugs approved for the prevention of osteoporosis, or for whom these drugs are contraindicated.
Experience with this therapy in women aged 65 years and older is limited.
Contraindication
Hypersensitivity to the active substance or to any of the excipients.
Breast cancer (diagnosed, suspected or history).
Diagnosed or suspected estrogen-dependent malignant tumors (e.g. endometrial cancer).
Vaginal bleeding of unknown etiology.
Untreated endometrial hyperplasia.
Current or history of idiopathic thromboembolic venous diseases (e.g. deep vein thrombosis (DVT), pulmonary embolism).
Increased blood clotting has been detected (for example, protein C, protein S, or antithrombin deficiency).
Acute arterial thromboembolism, current or recent (e.g. angina pectoris, myocardial infarction).
Acute liver diseases, present or in history (until normalization of laboratory liver function tests).
There is a history of severe liver damage or liver dysfunction with residual elevated levels of liver function tests.
Porphyria.
Interaction with other medicinal products and other types of interactions
Estrogel does not stimulate excessive synthesis of liver proteins when used in normal doses: it does not have any adverse effect on lipid metabolism, blood clotting factors (fibrinogen, antithrombin II activity), on the level of circulating renin substrate, on sex hormone binding proteins; thus, it does not contribute to the development of hypertriglyceridemia, diabetes mellitus and arterial hypertension.
At the same time, estrogen metabolism may be enhanced by concomitant use of enzyme inducers, particularly cytochrome P450 enzymes, such as anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine, meprobamate and phenylbutazone) or antimicrobials (e.g. rifampicin, rifabutin, nevirapine, efavirenz).
CYP3A4 inhibitors, such as erythromycin, clarithromycin, ketoconazole, itraconazole and grapefruit juice, may increase plasma estrogen concentrations and cause adverse reactions.
When used together with cyclosporine, a decrease in the hepatic excretion of cyclosporine and an increase in the levels of cyclosporine, creatinine and transaminases in the blood plasma are possible.
Ritonavir and nelfinavir, although known as potent enzyme inhibitors, act as inducers when used concomitantly with steroid hormones.
Herbal preparations containing St. John's wort (Hypericum perforatum) may enhance the metabolism of estrogens and progestogens.
When used transdermally, the drug bypasses the "first pass" effect through the liver, therefore, transdermally applied estrogens and progestogens are less exposed to enzyme inducers than hormones administered internally.
Clinically increased metabolism of estrogens and progestogens may lead to a decrease in the effect and a change in the pattern of vaginal bleeding.
Application features
In the treatment of postmenopausal symptoms, HRT should only be used if these symptoms affect the quality of life. In any case, a careful risk-benefit analysis should be carried out at least once a year. HRT should only be continued if the benefits outweigh the possible risks.
Data on the risks associated with HRT in the treatment of premature menopause are limited. However, due to the low absolute risk in younger women, the benefit-risk balance may be more favourable in these women than in older women.
Clinical examination and observation
Before starting or re-prescribing HRT, the doctor should collect a complete personal and family history of the patient, conduct a medical examination (including pelvic organs and mammary glands) to identify possible contraindications and exercise due caution when prescribing the drug. During treatment, it is also recommended to perform regular medical examinations, the frequency and type of which should be selected individually for each patient.
Women should be informed about changes in their breasts, which they should report to their doctor or nurse (see the section “Breast cancer” below). Regular examinations, including mammography, should be performed during treatment. The frequency and type of methods included in this are determined for each patient individually, in accordance with current practical recommendations.
Examinations, including mammography, should be performed in accordance with accepted standards and adapted to the individual clinical needs of each patient.
If any of the following conditions are present, have occurred previously and/or have been aggravated during pregnancy or previous hormonal therapy, the patient should be under constant medical supervision. These conditions, in some cases, may recur or be aggravated during treatment with Estrogel, in particular uterine leiomyoma (fibroid) or endometriosis, previous or existing risk factors for thromboembolic complications (see above), risk factors for estrogen-dependent tumors (e.g., first-degree hereditary breast cancer), arterial hypertension, impaired liver function (e.g., hepatic adenoma), diabetes mellitus with or without vascular involvement, cholelithiasis, migraine or severe headaches, systemic lupus erythematosus, a history of endometrial hyperplasia, epilepsy, bronchial asthma, otosclerosis, hereditary angioedema.
When simultaneously prescribing progestogens, contraindications to their use should be taken into account: pregnancy - for progestogens with androgenic activity, breast, ovarian or endometrial cancer - for progestogens with estrogenic activity.
Caution should be exercised in the presence of risk factors for cardiovascular complications, coronary and/or cerebrovascular complications, the likelihood of which increases in the presence of arterial hypertension and/or in patients who smoke.
In case of changes detected during palpation of the mammary glands, an additional gynecological examination of the appropriate volume is required at any stage of treatment. It is also necessary to consult a doctor if irregular vaginal bleeding occurs (except for menstrual-like reactions that occur after discontinuation of the drug), headache or visual disturbances, painful swelling of the lower extremities or abdominal pain.
Reasons requiring immediate discontinuation of treatment
Therapy should be discontinued immediately if contraindications to its administration are identified or in the presence of the following conditions: jaundice or severe liver dysfunction, significant increase in blood pressure, new episodes of migraine-like headache, pregnancy or suspected pregnancy.
Endometrial hyperplasia and carcinoma
In women with an intact uterus, the risk of endometrial hyperplasia and carcinoma is increased when estrogens are used alone for long periods. In patients taking estrogens alone, the risk of developing endometrial cancer has been observed to be 2-12 times higher than in women not taking this drug, depending on the duration of treatment and the dose of estrogen (see section "Adverse reactions"). After stopping treatment, the risk may remain elevated for at least 10 years.
Therefore, in patients with an intact uterus, the use of Estrogel should be accompanied by cyclical administration of progestogens. Simultaneous administration of progestogens for at least 12 days per month/28-day cycle or continuous treatment with a combination of estrogen and progestogen in women without prior hysterectomy prevents the excess risk associated with estrogen-only HRT.
Breakthrough bleeding or spotting may occur during the first months of treatment. If they appear after some time on treatment and persist after discontinuation of therapy, it is necessary to search for the cause of their occurrence, which may require an endometrial biopsy to exclude a malignant etiology of the above symptoms.
Estrogen monotherapy may lead to premalignant processes and malignant transformation of residual endometriosis. Currently, in women after hysterectomy for endometriosis, the addition of progestogen to estrogen replacement therapy should be considered, as it is known that endometriosis may persist.
Breast cancer
The general evidence suggests an increased risk of breast cancer in women taking combined estrogen and progestogen, and possibly also in women taking estrogen-only HRT, depending on the duration of HRT use.
Treatment with a combination of estrogen and progestogen
The Women's Health Initiative randomised placebo-controlled trial, as well as epidemiological studies including the Million Women Study, have shown an increased risk of breast cancer in women taking combined oestrogen-progestagen therapy after approximately 3 years (see section 4.8).
Estrogen-only treatment
At the same time, the WHI trial did not show an increased risk of breast cancer in women who had undergone hysterectomy and who used estrogen-only HRT. Observational studies have shown mainly a small increased risk of breast cancer, which was significantly lower than in women who received combinations of estrogen and progestogen (see section "Adverse reactions").
When using HRT, particularly when combined with estrogen and progestogen, there is an increase in breast density on mammography, which may negatively affect the accuracy of breast cancer diagnosis using radiation methods.
Venous thromboembolic complications
HRT use is associated with a 1.3- to 3-fold increased relative risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism. This is more likely to occur during the first year of HRT use than later (see section 4.8).
Patients with known thrombophilia are at increased risk of VTE, and HRT may further increase this risk. Therefore, HRT is contraindicated in these patients (see Contraindications).
Generally recognized risk factors for VTE include a personal or family history of VTE, severe obesity (BMI > 30 kg/m2), systemic lupus erythematosus (SLE), estrogen use, older age, major surgery, prolonged immobilization, pregnancy/postpartum period, and cancer. There is no consensus regarding the role of varicose veins in the development of venous thrombosis.
Patients with a history of VTE and patients with thrombophilia are at high risk for VTE. The use of HRT may increase this risk. Patients with a personal or family history of severe VTE or a history of recurrent spontaneous abortion should be evaluated for thrombophilia. If the patient has no history of venous thromboembolism but has close relatives who have had thromboembolism at a young age, screening may be offered, provided that the restrictions are carefully reviewed (screening only detects a subset of thrombophilic disorders). If a thrombophilic disorder is known to be associated with thrombosis in a family member, or if the disorder is severe (e.g., antithrombin, protein S, or protein C deficiency, or a combination of disorders), HRT is contraindicated.
Until a thorough evaluation of thrombophilic factors has been performed and anticoagulant therapy has been initiated, HRT is considered contraindicated in this group of patients. Women already receiving anticoagulants require special attention and an assessment of the risk-benefit ratio of HRT.
The risk of VTE may be temporarily increased by prolonged immobilisation, severe trauma or major surgery. As in all patients, special attention should be paid to the prevention of VTE in the postoperative period. Since prolonged immobilisation is a consequence of elective surgery, especially abdominal or orthopaedic surgery of the lower extremities, temporary discontinuation of HRT for 4–6 weeks prior to surgery should be considered as a preventive measure. HRT should not be resumed until the patient is fully ambulatory.
If VTE develops after initiation of treatment, treatment should be discontinued. Patients should be advised to seek immediate medical attention if they experience possible symptoms of thromboembolism (e.g. painful swelling of the legs, sudden chest pain or shortness of breath).
Coronary heart disease
Controlled randomized trials have not shown any preventive effect on myocardial infarction in women with or without coronary heart disease who received combined estrogen and progestogen or estrogen alone HRT.
Treatment with a combination of estrogen and progestogen
The relative risk of developing coronary heart disease is slightly increased with the use of combined estrogen-progestogen HRT. Since the baseline absolute risk of developing coronary heart disease is largely age-dependent, the number of additional cases of coronary heart disease due to the use of estrogen-progestogen is very small in healthy women approaching menopause, but increases in older women.
Estrogen-only treatment
Randomized controlled trials have not shown an increased risk of coronary heart disease in women after hysterectomy who received estrogen-only treatment.
Cerebral vascular complications (ischemic stroke)
Treatment with a combination of estrogen and progestogen and treatment with estrogen alone increases the risk of ischemic stroke by a factor of 1.5 or less. The relative risk does not depend on age or time since menopause. However, since the baseline risk of stroke is strongly age-dependent, the overall risk of stroke in women taking HRT will increase with age (see section 4.8).
Ovarian cancer
Ovarian cancer is much less common than breast cancer. Epidemiological studies in a large meta-analysis suggest a small increased risk in women taking estrogen-only or combined estrogen-progestogen HRT, which becomes apparent within 5 years of treatment and gradually decreases after stopping treatment.
Other studies, including the WHI study, suggest a similar or slightly lower risk with combined HRT (see section 4.8).
Estrogens can cause fluid retention in the body, so patients with impaired cardiac and renal function should be under special supervision. Patients with end-stage renal failure require particularly careful monitoring, as an increase in the level of the active substances of Estrogel in the blood should be expected.
Changes in glucose tolerance have been observed in some patients taking estrogen/progestogen preparations. Estrogel may increase insulin sensitivity and accelerate its elimination. In patients with diabetes mellitus, blood glucose levels should be carefully monitored during the first months of HRT.
There is an increased risk of surgically confirmed gallstone disease in postmenopausal women taking estrogens.
The use of estrogens may change the results of some endocrinological tests and liver function tests.
Patients with hypertriglyceridemia who use estrogen monotherapy or hormone replacement therapy should be carefully monitored, given the described isolated cases of pronounced increases in plasma triglyceride levels, which may lead to the development of pancreatitis.
Estrogens increase thyroid-binding globulin (TBG), which leads to increased circulating thyroid hormone levels as measured by protein-bound iodine, T4 (column or radioimmunoassay), or TS (radioimmunoassay). The increase in TS is reduced, reflecting the increased TSH; free T4 and TS concentrations are unchanged. Serum concentrations of other binding proteins may be increased, such as corticoid-binding globulin (CBG), sex hormone-binding globulin (SHBG), leading to increased circulating corticosteroids and sex steroid concentrations, respectively. Free or biologically active hormone concentrations remain unchanged. Other plasma proteins may be increased (angiotensin/renin substrate, alpha-1-antitrypsin, ceruloplasmin).
Chloasma may occasionally occur, especially in women with a history of chloasma during pregnancy. Women with a predisposition to chloasma should minimize exposure to sunlight or ultraviolet radiation during HRT.
There is no convincing evidence that HRT improves cognitive function. The WHI trial showed a trend towards a possible increased risk of dementia in women on long-term HRT who started combined therapy based on conjugated estrogens and medroxyprogesterone acetate after the age of 65. It remains unknown whether these observations apply to younger postmenopausal women or to other types of HRT.
Careful monitoring of the patient's condition is necessary in the following cases:
ischemic stroke due to atherosclerosis, cerebral hemorrhage, retinal vein occlusion, obesity due to the risk of venous thrombosis, bed rest and preparation for elective surgery (it is advisable to cancel treatment 1 month before surgery). Close supervision is required for patients with a benign skin tumor, prolactin-secreting pituitary tumor, otospongiosis or a history of pruritus.
Use during pregnancy or breastfeeding
Do not use during pregnancy or breastfeeding. Treatment with Estrogel should be discontinued immediately if pregnancy is confirmed or suspected. Threatened abortion and suppression of lactation are not indications for estrogen therapy. Epidemiological studies have not confirmed an additional risk of congenital malformations of the fetus due to the use of estrogen in early pregnancy in case of late diagnosis. However, it should be noted that artificial termination of pregnancy in women who took estrogens or estroprogestogens in early pregnancy in case of late diagnosis is not necessary. To date, no evidence of teratogenic effect or fetotoxic effect has been identified according to epidemiological studies in pregnant women with accidental use of therapeutic doses of estrogen.
Ability to influence reaction speed when driving vehicles or other mechanisms
There are no data, but the possibility of developing reactions from the nervous system - dizziness, drowsiness - should be taken into account.
Method of administration and doses
The drug should be applied transdermally.
Dosage should be selected depending on individual needs.
For women with an intact uterus, long-term treatment with estrogen without progestogen is not recommended due to the possible risk of developing adverse effects on the endometrium (glandular cystic hyperplasia, dysplasia, which increases the risk of endometrial cancer); treatment should be carried out for at least 3 consecutive weeks, then a break of 1 week should be taken, simultaneously with oral progestogens for 12-14 days per month/28-day cycle. Treatment can be carried out from the 1st to the 25th day of the month simultaneously with oral progestogen, if necessary. During the week-long break, bleeding may occur due to a decrease in hormone levels. It is recommended to use only those progestogens that are allowed to be taken simultaneously with estrogen.
At the same time, long-term estrogen therapy may be indicated in women after hysterectomy or when severe symptoms of estrogen deficiency appear after discontinuation of treatment. In the latter case, progesterone can be prescribed for the first 12–14 days of each month. Only in cases of a known diagnosis of endometriosis is the simultaneous administration of progestogen in women after hysterectomy not recommended.
The dosage can be adjusted if necessary after 2–3 cycles of treatment depending on clinical symptoms, namely:
If symptoms of hyperestrogenia appear, such as a feeling of tension in the mammary glands, a feeling of fullness in the abdomen and pelvis, anxiety, nervousness, aggressiveness, the dose should be reduced;
If symptoms of hypoestrogenism occur, such as persistent hot flashes, vaginal dryness, headaches and sleep disturbances, asthenia, and a tendency to depression, the dose should be increased.
If a dose is missed, do not take a double dose the next day. If the next dose is due in less than 12 hours, wait until the next dose is due. If the next dose is due in more than 12 hours, take the missed dose immediately and take the next dose at the usual time. Skipping doses increases the risk of spotting and bleeding.
Method of application
It is recommended to apply the dose to the largest areas of skin, preferably the forearm, shoulder and/or upper arm or to a large surface of intact skin. Application to the skin of the mammary gland and the mucous membranes of the vulvovaginal area should be avoided.
The gel should be applied by patients themselves, in the evening or in the morning, preferably after the evening or morning toilet procedures, at the same time every day. To do this, remove the cap from the bottle and press firmly on the pump-dispenser, using the other hand to collect the gel. With 1 press on the pump-dispenser, 1.25 g of gel is released, which is half the daily dose. The dose released with the first press may be inaccurate. It is recommended to throw it away. The bottle is designed for 64 presses. After 64 presses, the amount of gel released with one press may be less than required. Therefore, it is not recommended to use the bottle after 64 presses on the pump-dispenser.
The gel should be applied in a thin layer to the skin surface in the above-mentioned areas. If the skin remains oily for more than 3 minutes after application, this means that the surface area covered with the gel was too small. You should try to apply the gel to a larger surface area of the body the next time you use it.
After applying the gel, wash your hands thoroughly.
Children
The drug should not be used in pediatric practice.
Overdose
In case of overdose, headache, nervousness, breast tenderness and vaginal bleeding may occur, as well as the symptoms mentioned in the section "Adverse reactions" (signs of excessive estrogen). These symptoms usually disappear when treatment is discontinued or the dose is reduced.
Side effects
All possible side effects are listed below, especially those that occur in a maximum of 10% of patients.
The frequency of adverse reactions was assessed using the following criteria: > 1/100, < 1/10 – common; > 1/1000, < 1/100 – uncommon.
Mental disorders: often - nervousness, depressive disorders.
From the nervous system: often - headache; infrequently - migraine, dizziness, drowsiness.
Cardiovascular system: infrequently - deep or superficial vein thrombosis, thrombophlebitis.
Gastrointestinal: often - abdominal pain, gastric colic, bloating, nausea, vomiting.
On the part of the hepatobiliary system: infrequently - deviations from the norm of liver function tests, liver adenoma, cholelithiasis.
From the reproductive system and mammary glands: often - dysmenorrhea, menorrhagia, bleeding (bloody discharge), menstrual disorders, leukorrhea; infrequently - benign breast tumors, endometrial polyps, increased size of uterine leiomyomas, endometriosis, mastodynia, progression of estrogen-dependent tumors.
Musculoskeletal and connective tissue disorders: common: muscle cramps, pain in the extremities; uncommon: arthralgia.
General disorders and administration site conditions: uncommon - peripheral edema, sodium retention, feeling of edema, weight changes.
Adverse reactions observed in clinical trials.
Nervous system: restlessness.
Cardiovascular system: palpitations.
Hepatobiliary system: diarrhea.
Reproductive system: breast pain, metrorrhagia, vaginitis, vaginal bleeding, endometrial disorders, changes in the Papanicolaou test.
General disorders: infections, back pain, pain, influenza-like illness, asthenia.
Adverse reactions obtained during clinical trials and in the post-marketing period.
Benign, malignant and unspecified neoplasms (including cysts and polyps): myoma.
On the part of the immune system: exacerbation of hereditary angioedema.
Metabolism and nutrition disorders: increased appetite, hypercholesterolemia.
Mental disorders: changes in libido and mood, anxiety, insomnia, apathy, emotional lability, impaired concentration, euphoria, excitement.
Nervous system: paresthesia, tremor.
On the part of the organs of vision: visual impairment, dry eyes.
From the cardiovascular system: increased heartbeat, increased blood pressure, impaired cerebral circulation, superficial phlebitis, purpura.
Respiratory, thoracic and mediastinal disorders: shortness of breath, rhinitis.
Hepatobiliary system: impaired liver function and bile outflow, cholestatic jaundice.
Skin and subcutaneous tissue disorders: acne, alopecia, dry skin, contact dermatitis, eczema, nail plate changes, nodular skin changes, hirsutism.
Musculoskeletal and connective tissue disorders: joint symptoms.
Renal and urinary disorders: increased frequency and urgency of urination, urinary incontinence, cystitis, urine discoloration, hematuria.
Reproductive system: breast tenderness/pain/tension, vaginal discharge, vulvar/vaginal symptoms, breast enlargement, endometrial hyperplasia, uterine symptoms.
General disorders and administration site reactions: irritation, pain, hyperhidrosis, fatigue, laboratory abnormalities, asthenia, hyperthermia, flu-like symptoms, malaise.
Other adverse reactions that have occurred with combined estrogen-progestogen therapy.
Gallbladder dysfunction, hemorrhagic rash.
Risk of developing ovarian cancer.
Long-term use of estrogen-only and estrogen-progestogen-only HRT is associated with a small increased risk of ovarian cancer (see section 4.4). A meta-analysis of 52 epidemiological studies has shown an increased risk of ovarian cancer in women currently using HRT compared with women who have never used HRT (relative risk (RR) 1.43, 95% confidence interval (CI): 1.31-1.56). Among women aged 50 to 54 years, 5 years of HRT use causes one extra case in 2000 women. Among women aged 50 to 54 years who do not use HRT, 2 in 2000 women will develop ovarian cancer over a 5-year period.
Risk of developing venous thromboembolism.
HRT is associated with a 1.3- to 3-fold increased risk of venous thromboembolism, such as deep vein thrombosis or pulmonary embolism. The risk of developing the disease is highest in the first year of HRT use (see section 4.4). The results of the WHI trials are presented in Table 1.
Table 1
WHI study: additional risk of venous thromboembolism over 5 years of use
Age range
(years)
Incidence rate per 1000 women in the placebo group over 5 years
Specifications
Characteristics
Active ingredient
Estradiol 17-beta
Adults
Can
ATC code
G AGENTS AFFECTING THE GENITORY SYSTEM AND SEX HORMONES; G03 SEX GLAND HORMONES AND PREPARATIONS USED IN PATHOLOGY OF THE SEXUAL SPHERE; G03C ESTROGENS; G03C A Simple preparations of natural and semi-synthetic estrogens; G03C A03 Estradiol
Country of manufacture
Belgium
Diabetics
Can
Dosage
0.6 mg/g
Drivers
With caution, dizziness and drowsiness are possible.
For allergies
With caution
For children
It is impossible.
Form
Gel
Method of application
Other system
Nursing
It is impossible.
Pregnant
It is impossible.
Producer
Besins Healthcare
Quantity per package
80 г
Trade name
Estrogel
Vacation conditions
By prescription
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