Estramon 50, transdermal patch 50 mcg/day, 6pcs — Made in Germany — Free Delivery
(Estramon 50)
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Description Estramon 50, transdermal patch 50 mcg/day, 6pcs — Made in Germany — Free Delivery
Indications
Hormone replacement therapy for pre- and postmenopausal estrogen deficiency in women. prevention of postmenopausal osteoporosis in women who have passed no more than 5 years after the onset of menopause.
Application
Treatment should begin with the lowest effective dose.
It is recommended to apply 1 patch with an interval of 3-4 days (on average 2 times a week). If after 3 months of using the patch the symptoms of estrogen deficiency are not eliminated, the dose can be increased, but the maximum dose should not exceed 100 mcg / day.
Estramon 50 patch can be used at any time, but patients who exit cyclic therapy should start using the preparation the next day after the end of the previous treatment regimen.
For the prevention of postmenopausal osteoporosis in women, the patch is used at a dose of 50 mcg / day (1 patch with an interval of 3-4 days).
Experience with the use of the Estramon 50 patch in women over the age of 65 is limited.
Mode of application:
1. Immediately before use, it is necessary to tear off the protective shell of the bag, cutting it closer to the edge, and remove the patch without damaging it.
2. The patch should be carefully folded up and down along the perforations until most of the protective film has peeled off along the perforated strip from the adhesive surface of the transdermal patch. This part of the protective film is removed by one of the resulting tips.
3. The open adhesive surface of the patch is applied to healthy, cleansed skin of the outer surface of the thigh.
4. Then the convex part of the transdermal patch is slightly lifted so that the rest of the protective film can be removed, and fixed completely.
5. After the patch is completely fixed, it must be pressed by hand for 10 s.
The patch should not be used in the area of the mammary glands. When using each new patch, it is necessary to change the place of application. Immediately before application, the skin area should be degreased, the skin should not be damaged or irritated. The patch should not be attached to areas from which it can move when sitting. After fixing the patch, you should make sure that it is well fixed, especially at the edges. If the patch does not hold, it should be pressed harder to strengthen.
If the patch is attached correctly, the patient can bathe or shower as usual. However, it can peel off the skin when in contact with very hot water or in a sauna. Protect the patch from direct sunlight.
If the patch comes off partially or completely before the appointed time (earlier than 3-4 days), you should stick a new patch. If the next application of the patch was missed, a new patch should be applied as soon as possible.
duration of treatment. The duration and treatment regimens are determined by the doctor individually. The patch is used in the form of mono- or during combination therapy.
With cyclic use after 3 weeks of treatment, a 1-week break should be taken.
For women who have had a hysterectomy or if estrogen deficiency symptoms recur intensely during a treatment break, continuous, non-cyclic treatment may be considered.
Estrogen therapy should be supplemented with regular use of gestagens. Gestagens must be used during the last 12-14 days of each 28-day course of estradiol therapy.
Contraindications
Hypersensitivity to estradiol or other components of the preparation. diagnosed or suspected breast cancer; diagnosed or suspected estrogen-dependent malignant tumor (especially endometrial carcinoma); vaginal bleeding of unknown origin; untreated endometrial hyperplasia; a history of idiopathic jaundice or thromboembolic venous disease (especially deep vein thrombosis, pulmonary embolism); active or thromboembolic arterial disease (especially angina pectoris, myocardial infarction); severe liver diseases (club-Johnson syndromes, rotor syndromes); porphyria; liver tumors in the current period or in history (benign or malignant).
Side effects
Undesirable effects are classified according to the frequency of manifestations: very often (≥1 / 10), often (≥1 / 100, 1/10), sometimes (≥1 / 1000, 1/100), rarely (≥1 / 10,000, 1 / 1000), very rare (1/10,000), unknown (frequency cannot be estimated due to lack of data).
Application site reactions (such as erythema and itching), headache, tightness in the mammary glands and chest pain, as well as pain during menstruation and complaints during the menstrual cycle are the most common side effects when using the preparation.
Immune system disorders: very rarely - urticaria, anaphylactoid reactions, hypersensitivity (including anaphylactic reactions and angioedema).
Metabolic disorders and nutrition: sometimes - hypercholesterolemia, weight gain; very rarely - a change in carbohydrate tolerance.
Mental disorders: often - depression; sometimes - anxiety; very rarely - exacerbation of epilepsy.
From the side of the central nervous system: very often - headache; often - nervousness, drowsiness, insomnia, mood changes, irritability, hot flashes; sometimes - migraine, dizziness; rarely - paresthesia; very rarely - chorea.
On the part of the organ of vision: sometimes - blurred vision, a feeling of dryness in the eyes; very rarely - intolerance to contact lenses.
Cardiovascular disorders: sometimes - hypertension, tachycardia, loss of consciousness; rarely - venous thromboembolism, a feeling of heaviness in the legs.
Gastrointestinal and hepatobiliary system disorders: often - nausea, dyspepsia, flatulence, diarrhea, abdominal pain, increased appetite; sometimes - vomiting, constipation, increased levels of enzymes in the liver; rarely - a change in hepatic functions and a violation of the outflow of bile (the formation of stones in the gallbladder).
On the part of the skin and subcutaneous tissue: very often - reactions at the site of application, including skin irritation, erythema; often - acne, skin rash, dry skin, itching; sometimes - a change in skin color; rarely - alopecia; very rarely - skin necrosis, the appearance of excess hair, erythema multiforme, erythema nodosum and hemorrhagic rash, chloasma or melanosis.
Disorders of the musculoskeletal system and connective tissue: sometimes - arthralgia, muscle spasms; rarely - myasthenia gravis.
Respiratory disorders: sometimes - sore throat.
From the urinary system: sometimes - dysuria, infectious diseases of the urinary system.
Disorders of the reproductive system and mammary glands: very often - a feeling of tension and pain in the mammary glands; sometimes - breast enlargement, uterine spasms, endometrial hyperplasia, vaginal discharge, increased secretion from the cervix, cervical neoplasms, uterine pathology, uterine / vaginal bleeding, including spotting, pelvic pain, endometrial pathology, vulvovaginitis, vaginal candidiasis, dryness vagina, breast cancer, ovarian cyst, fibrocystic disease of the mammary glands, cyst in the mammary glands, abnormal cytological smear, uterine prolapse; rarely - uterine leiomyoma, cyst formation outside the tubes, endocervical polyps, galactorrhea.
General disorders: often - pain, dorsalgia, asthenia, peripheral edema, change in body weight; sometimes - malaise; rarely - a change in libido, allergic reactions.
special instructions
Hormone replacement therapy should only be initiated to treat postmenopausal symptoms that adversely affect quality of life. at least once a year, a careful assessment of the benefit-risk ratio of therapy should be carried out before starting or continuing to use the estramone 50 patch.
Reactions at the site of application. With topical application of the patch, severe anaphylactic reactions and angioedema are very rarely possible. Possible reactions from the skin (urticaria, itching, swelling of the lips, tongue, larynx, face, limbs), respiratory tract (complicated breathing) or gastrointestinal tract (abdominal pain, vomiting). If angioedema occurs, the patch should be discontinued.
Estrogens can increase and exacerbate the symptoms of angioedema, in particular in women with a hereditary tendency to it.
In the presence or exacerbation of any of the following diseases or risk factors, special monitoring of the patient's health is recommended.
Venous thromboembolism. The results of studies using standard doses of estrogen alone or in combination with progestogens suggest an increased risk of developing venous thromboembolism, that is, deep vein thrombosis or pulmonary embolism. As a result, the risk/benefit ratio of treatment must be carefully weighed.
Generally recognized risk factors for the development of venous thromboembolism include: personal history, family history (a case of venous thromboembolism in close relatives at a relatively early age may indicate a genetic predisposition), and severe obesity. The risk of venous thromboembolism also increases with age. The question of the role of varicose veins in the development of venous thromboembolism remains controversial.
The risk of venous thromboembolism may temporarily increase with prolonged immobilization, after major elective or post-traumatic surgery, or after severe trauma. The issue of temporary cessation of the use of the Estramon 50 patch should be decided depending on the nature of the circumstances and the duration of immobilization.
Arterial thromboembolism. The results of clinical studies using a combination of conjugated estrogens and medroxyprogesterone acetate (MPA) in a continuous mode indicate a possible increase in the risk of developing coronary heart disease during the 1st year of their use. With continued treatment, no benefits regarding the cardiovascular system were noted. The results of studies have shown a potential reduction in the incidence of coronary heart disease in women aged 50–59 years treated with estrogen monotherapy, in the absence of an overall benefit in the population. Another negative consequence is an increased risk of stroke by 30–40% with estrogen alone or in combination with MPA. However, the dependence on the method of application has not been established.
endometrial cancer. Long-term monotherapy with standard doses of estrogens increases the risk of endometrial hyperplasia or cancer. When using the Estramon 50 patch, no significant stimulation of the endometrium was detected due to the low dose of estradiol in the preparation. However, clinical monitoring of the health status of women receiving estrogen therapy in the postmenopausal period is necessary (for example, determining the thickness of the endometrium using transvaginal ultrasound once a year). In the presence of undiagnosed persistent or recurrent abnormal vaginal bleeding, adequate diagnostic measures, including endometrial biopsy, should be used to rule out a malignant condition.
Mammary cancer. An increased risk of developing breast cancer has been established in women who have used standard doses of estrogen alone or in combination with progestogens for many years. These facts may be due to earlier diagnosis, a stimulating effect on existing tumors, or a combination of both factors.
The relative risk increases with duration of treatment and may be minimal or unchanged with estrogen monotherapy.
An increased risk of breast cancer detection is noted, for example, with a delay in the onset of natural menopause, alcohol consumption or obesity.
A few years after hormone replacement therapy, the increase in risk is leveled.
It was noted that tumors detected in women who are undergoing or recently treated with hormone replacement therapy are characterized by a higher degree of differentiation than tumors detected in women who did not receive hormone replacement therapy. Data on the spread of the detected tumor beyond the borders of the mammary gland are inconclusive.
Hormone replacement therapy increases the density of images in mammography studies, which can, in some cases, adversely affect the diagnosis of breast cancer.
The effect of the low dose of estrogen contained in the Estramon 50 patch on the risk of developing breast cancer has not been studied.
Ovarian cancer. An increased risk of developing ovarian cancer has been identified in women receiving estrogen replacement therapy for a long period (10 years), while a meta-analysis of studies did not show an increased risk for women receiving estrogen replacement therapy. In view of the foregoing, the effect of replacement therapy on the development of ovarian cancer has not been established.
The effect of the low dose of estrogen contained in the Estramon 50 patch on the risk of developing ovarian cancer has not yet been studied.
Tumor of the liver. After the use of hormonal preparations, including estrogen, in some cases, the development of benign, and even less often, malignant liver tumors was detected. In some cases, these tumors were the cause of intra-abdominal bleeding, which threatened life. With pain in the upper abdomen, an enlarged liver, or signs of intra-abdominal bleeding, the differential diagnosis should take into account the likelihood of a liver tumor.
Cholelithiasis. It is known that estrogens increase the lithogenicity of bile. Some women are prone to gallbladder disease during estrogen treatment.
Dementia. Hormone use has not been proven to increase the risk of developing dementia when treatment is started in women aged ≥65. The risk may be reduced if treatment is started early in the menopause. It has not been established whether these facts apply to other hormone replacement therapy preparations.
Other states
Reasons for immediate discontinuation of therapy: therapy should be discontinued immediately if any of the contraindications are identified, as well as if the following conditions and diseases occur:
- migraine-like, frequent and unusually severe headache that appeared for the first time, or other symptoms that may be prodromal signs of cerebral vascular occlusion;
- recurrence of cholestatic jaundice or cholestatic pruritus, which was first noted during pregnancy or previous use of sex steroids;
- symptoms of thrombotic disorders or suspicion of their occurrence.
If a prolactinoma is suspected, the possibility of such a disease should be excluded before starting treatment.
Leiomyoma and fibroma of the uterus can increase in size under the influence of estrogens. In this case, therapy should be discontinued.
It is recommended to stop treatment if a recurrence of endometriosis is noted during therapy.
Persistent skin irritation (eg, persistent erythema or pruritus) may be seen at the site of application of the patch.
A general relationship between the use of hormone replacement therapy and the development of clinical hypertension has not been established. A slight increase in blood pressure has been reported in women who take standard doses of estrogen alone or in combination with progestogens, clinically significant cases of blood pressure increase were rare.
Sex hormones may be poorly metabolized in patients with impaired liver function. Although no first-pass hepatic effect has been observed with transdermal hormones, estrogens should be used with caution in these patients.
Available information does not indicate an increased risk of diabetes mellitus with the use of estradiol. Transdermal estrogen may be the most beneficial form of administration for women with type II diabetes mellitus (insulin dependent). Prescribe Estramon to 50 patients with type II diabetes mellitus and with additional risk factors (such as smoking, blood clotting disorders) should be used with caution; patients should be regularly examined during its use.
In some cases, chloasma may be noted, especially in women with a history of chloasma of pregnancy. When using the Estramon 50 patch, women who are predisposed to developing chloasma should avoid exposure to the sun or ultraviolet radiation.
It has been established that when using standard doses of estrogens in monotherapy or in combination with progestogens, the following conditions and diseases may occur or worsen. Although it is not certain that these changes are related to therapy, patients with epilepsy, benign breast disease, asthma, migraine, porphyria, otosclerosis, systemic lupus erythematosus, and chorea should be closely monitored.
Medical examination/consultation
Before starting or resuming the use of the preparation Estramon 50, it is necessary to carefully study the patient's history and conduct a physical examination, taking into account contraindications (see CONTRAINDICATIONS) and warnings (see PECULIARITIES OF USE), and periodically repeat such examinations. The frequency and nature of examinations should be based on existing standards of medical practice, taking into account the individual characteristics of each patient. As a rule, the pelvic organs are subject to examination, including a standard cytological examination of the cervix, abdominal cavity, mammary glands, measurement of blood pressure.
Use during pregnancy and lactation. Use of the preparation during pregnancy and lactation is contraindicated.
Children. The preparation is not prescribed to children.
The ability to influence the reaction rate when driving vehicles or working with other mechanisms. Unknown.
Interactions
The level of metabolic conversion of estrogens may increase with the simultaneous use of agents that activate the enzymes of the cytochrome p450 system. such active substances include phenobarbital, phenytoin, carbamazepine, and antibacterial preparations (such as rifampicin, rifabutin, nevirapine, and efavirenz).
Although ritonavir and nelfinavir are strong inhibitors, they acquire the properties of enzyme activators when used simultaneously with steroid hormones.
Herbal remedies containing St. John's wort (Hypericum perforatum) also increase the metabolic conversion of estrogens.
Increased metabolism can lead to a decrease in the effectiveness of the hormone and changes in the characteristics of uterine bleeding.
With transdermal use of estradiol, the effect of the first passage through the liver is eliminated, therefore, the level of the hormone in the body in the presence of enzyme activators changes less significantly than when taken orally.
CYP 3A4 inhibitors such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, and grapefruit juice may increase plasma estrogen levels, which may contribute to side effects.
Estrogens enhance the therapeutic effect and side effects when using imipramine.
With simultaneous use with cyclosporine, an increase in the concentration of cyclosporine, creatinine and transaminases in the blood plasma is possible.
Estrogens can affect glucose tolerance and the therapeutic response to insulin, so dose adjustment of antidiabetic preparations or insulin is necessary.
Estrogens can reduce the effect of antihypertensive preparations and anticoagulants.
Excessive alcohol consumption during the period of hormone replacement therapy can lead to an increase in the level of estradiol in the bloodstream.
The use of sex steroids may affect laboratory results, including biochemical parameters of liver, thyroid, adrenal and kidney function, the level of transport proteins such as globulin that binds corticosteroids and lipid/lipoprotein fractions, parameters of carbohydrate metabolism, as well as parameters of coagulation and fibrinolysis.
Overdose
With this method of application, an overdose of estradiol is unlikely. nausea, vomiting, and, in some cases, withdrawal bleeding may occur.
There is no specific antidote. The patch should be removed. Treatment is symptomatic.
Storage conditions
At temperatures up to 25 °c.
Tags: Estramon
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