$57.33
Manufacturer: Germany
Anjelik contains synthetic 17β-estradiol, which is identical in its chemical and biological properties to estradiol produced in the human body. It compensates for the decrease in estrogen production in menopausal women and relieves postmenopausal symptoms. Estrogens prevent bone loss after menopause or oophorectomy.
Description
Ingredients
active ingredients : estradiol, drospirenone;
1 tablet contains estradiol (as estradiol hemihydrate) 1.0 mg and drospirenone 2.0 mg;
other ingredients : lactose monohydrate, corn starch, pregelatinized starch, povidone 25,000, magnesium stearate, hydroxypropyl methylcellulose, macrogol 6,000, talc, titanium dioxide (E 171), iron oxide red.
Dosage form
Coated tablets.
Basic physical and chemical properties: round, biconvex, moderately red coated tablets, embossed with “DL” in a regular hexagon on one side.
Pharmacotherapeutic group
Sex hormones. Estrogen-gestagenic combinations.
Code ATX G03F A17.
Pharmacodynamics
Estradiol
Anjelik contains synthetic 17β-estradiol, which is identical in its chemical and biological properties to estradiol produced in the human body. It compensates for the decrease in estrogen production in menopausal women and relieves postmenopausal symptoms. Estrogens prevent bone loss after menopause or oophorectomy.
Drospirenone
Drospirenone is a synthetic progestogen.
Because estrogens promote endometrial growth, estrogen monotherapy increases the risk of endometrial hyperplasia and cancer. The use of an additional progestogen reduces, but does not eliminate the risk of estrogen-induced endometrial hyperplasia in women with a preserved uterus.
Drospirenone exhibits antagonistic activity against aldosterone. Therefore, there may be an increase in the excretion of sodium and water and a decrease in the excretion of potassium.
In preclinical studies, drospirenone did not show estrogenic, glucocorticoid, or antiglucocorticoid activity.
Data obtained in the course of clinical studies.
- Reducing symptoms of estrogen deficiency and improving the bleeding profile.
Within the first few weeks of treatment, a reduction in menopausal symptoms was achieved. Amenorrhea was observed in 73% of women within 10-12 months of treatment. Menstrual bleeding and/or spotting occurred in 59% of women in the first three months of therapy and in 27% of women during 10-12 months of treatment.
- Prevention of osteoporosis.
Estrogen deficiency during menopause is associated with an increased rate of bone remodeling and decreased bone mass. The effect of estrogens on bone mineral density is dose dependent. Effective protection is provided during the treatment period. After discontinuation of hormone replacement therapy (HRT), bone loss occurs at the same rate as in untreated women.
The results of the WHI study and data from a meta-analysis of other studies show that the use of HRT, mainly in healthy women, alone or in combination with a progestogen, reduces the risk of fractures of the femoral neck, spine and other fractures associated with osteoporosis. HRT may also prevent fractures in women with low bone density and/or osteoporosis, but data to support this fact is limited.
After 2 years of therapy with Anjelik, the increase in bone mineral density of the thigh was 3.96 ± 3.15% (mean ± standard deviation) in patients with osteoporosis and 2.78 ± 1.89% (mean ± standard deviation) in individuals. not suffering from osteoporosis. The number of women who during treatment noted the preservation or increase in the mineral density of the thigh bones was 94.4% among patients with osteoporosis and 96.4% among patients without osteoporosis.
The influence of the drug Anjelik on the mineral density of the bones of the lumbar spine was established. The increase in density after 2 years of therapy was 5.61 ±
3.34% (mean ± SD) in women with osteoporosis and 4.92 ± 3.02% (mean ± SD) in women without osteoporosis. During treatment, bone mineral density of the lumbar spine was preserved or increased in 100% of women with osteoporosis and 96.4% of women without osteoporosis.
- Antimineralocorticoid activity.
Drospirenone has a competitive antagonistic effect on aldosterone, due to which a decrease in blood pressure can be observed in women with arterial hypertension. During a double-blind, placebo-controlled study in women with postmenopausal hypertension who received Anjelik (n = 123) for 8 weeks, there was a significant decrease in blood systolic / diastolic pressure (office indicators obtained when measured by baseline: -12 / -9 mmHg, including taking into account the placebo effect: -3/-4 mmHg, 24-hour ambulatory BP measurement compared to baseline: -5/-3 mmHg, in including taking into account the placebo effect: -3/-2 mm Hg).
Anjelik is not used to treat hypertension. Women with hypertension should be treated according to protocols for the treatment of hypertension.
Indications
Hormone replacement therapy (HRT) for symptoms of estrogen deficiency in postmenopausal women more than 1 year after menopause.
Prevention of osteoporosis in postmenopausal women who are at increased risk of developing bone fractures and have intolerance to other drugs used to prevent osteoporosis or contraindicated such drugs.
The experience of using the drug in women over 65 years of age is limited.
Contraindications
- Genital bleeding of unknown etiology.
- Breast cancer, suspicion of it, or the presence of a specified pathology in history.
- Estrogen-dependent malignant tumors or suspicion of them (for example, endometrial cancer).
- Untreated endometrial hyperplasia.
- Venous thromboembolism or a history of a specified pathology (deep vein thrombosis, pulmonary embolism).
- Arterial thromboembolism in the acute stage or recently transferred (for example, angina pectoris, myocardial infarction, stroke).
- High risk of venous or arterial thrombosis.
- Acute liver disease or a history of liver disease – until liver function tests return to normal
- Severe liver disease.
- Current or history of liver tumors (benign or malignant).
- Predisposition to the development of thrombosis (for example, protein C deficiency, protein S deficiency or antithrombin).
- Impaired kidney function or AKI.
- Adrenal insufficiency
- Known anaphylactic reactions, Quincke’s edema, hypersensitivity to active substances or to any of the excipients of the drug.
- Porfiry.
- Severe hypertriglyceridemia.
Dosage and administration
If HRT was prescribed for the first time or there is a transition to Anjelik from a combined preparation for continuous HRT, then Anjelik tablets can be started at any time. If there is a transition to Anjelik from a cyclic combination drug for HRT, the current cycle of therapy should be completed before starting the use of Anjelik.
Dosage.
1 tablet per day. Each package is designed for a 28-day course of treatment.
Mode of application.
Take the tablet without chewing with a small amount of liquid. The treatment is carried out continuously, that is, taking the tablets from the next package is started immediately after the end of the pre-package, without any intervals. Tablets should preferably be taken at the same time. If there is a delay in taking the next pill, you should take it as soon as possible. If the next tablet has not been taken for more than 24 hours, you do not need to take an additional tablet. If several tablets were missed, bleeding may begin.
For the treatment of postmenopausal symptoms, the lowest effective dose is used.
To start and continue therapy for postmenopausal symptoms, the lowest effective dose is used as soon as possible.
Additional information about special categories of patients
Elderly patients.
There are no data indicating the need for dose adjustment in elderly patients. When used in women aged 65 years or older.
Patients with liver failure.
In women with mild or moderate hepatic insufficiency, drospirenone is well tolerated (see Pharmacokinetics). The use of the drug Anjelik is contraindicated in women with hepatic insufficiency.
Patients with renal insufficiency.
In women with mild or moderate renal insufficiency, a slightly increased exposure to drospirenone is observed, but this effect is considered to be of no clinical significance. The use of Anjelik is contraindicated in women with severe renal insufficiency.
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