Buy Proginova dragee 2 mg, 21 pcs
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Estradiol

Bayer Pharma AG
1510 Items
2019-09-19
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$98.25
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Clinical Pharmacology

Progynova - estrogen.

Fills the lack of endogenous estrogen, lowers LDL cholesterol in the blood. Suppresses somatic, mental and other climacteric symptoms during periods of pre- and postmenopause, or after oophorectomy; prevents bone loss and osteoporosis.

Indications

Estrogen deficiency (postmenopausal period, oophorectomy, radiation castration), accompanied by vasomotor symptoms: hot flashes, sweating, sleep disturbances, depressive states, irritability, headache, dizziness, hyperesthesia of the bladder, degenerative changes of the skin and mucous membranes; prevention of osteoporosis.

Composition

1 tablet contains:

Active substance: estradiol valerat2 mg;

Excipients: lactose monohydrate 46-250 mg; corn starch 26 to 200 mg; Povidone 25,000 - 3 mg; talc - 2.4 mg; magnesium stearate - 0.15 mg; crystalline sucrose 33 - 540 mg; Povidone 700000 - 0.323 mg; macrogol 6000 - 3,719 mg; calcium carbonate precipitated 14 - 572 mg; talc - 7,104 mg; glycerol 85% (w / w) - 0.205 mg; titanium dioxide (E171, C.1.77891) - 0.411 mg; Indigo Carmine (E132, C.1.73015) - 0.051 mg; montaglycol wax - 0.075 mg.

Estradiol is marketed under different brands and generic names, and comes in different dosage forms:

Brand nameManufacturerCountryDosage form
Proginova Bayer Pharma AG Germany dragee
Climara® (Bayer Pharma AG Bayer Pharma AG Germany transdermal therapeutic system
Divigel Orion Corporation Finland gel

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Estradiol

Dosage and Administration

Divigel prescribed for long-term and cyclic therapy. The initial dose, as a rule, is 1 g of gel (which corresponds to 1 mg of estradiol) per day, but is determined by the severity of symptoms. Depending on the clinical picture, the dose can be changed after 2-3 cycles individually from 500 mg to 1.5 g of gel per day (which corresponds to from 500 μg to 1.5 mg of estradiol per day).

Patients with an intact (unoperated) uterus during treatment with Divigel are recommended to administer progestogen (for example, medroxyprogesterone acetate, norethisterone, norethisterone acetate, or dihydrogesterone) for 10–12 days in each cycle. After the course application of progestogen, menstrual bleeding should occur. With extraordinary or prolonged uterine bleeding should definitely determine the cause of their occurrence.

In postmenopausal patients, the cycle duration can be extended to 3 months.

The gel is applied 1 time / day on the clean skin of the lower part of the anterior abdominal wall, lumbar region, shoulders, forearms, or alternately on the right or left buttocks, alternating daily the application sites. The area of ​​application should be equal in size to 1-2 palms. After applying the drug should wait a few minutes until the gel dries (2-3 minutes).

The place of application of the gel should not be rinsed for 1 hour. Divigel should not be accidentally hit in the eyes. Hands should be washed immediately after applying the gel.

In the case of skipping the next application of the gel should be done as soon as possible, but no later than within 12 hours from the moment of application of the drug according to the scheme. If more than 12 hours have passed, Divigel's application should be postponed until the next time. With the occasional use of the drug (missed doses), menstrual-like uterine breakthrough bleeding may occur.

Adverse reactions

From the side of the central nervous system and peripheral nervous system: headache, migraine, dizziness, depression, chorea.

Since the cardiovascular system: increased blood pressure, thrombophlebitis.

From the digestive system: nausea, vomiting, stomach cramps, flatulence, epigastric pain, cholestatic jaundice, cholelithiasis.

Allergic reactions: in the place of application - rash, skin irritation, skin flushing, contact dermatitis.

From the reproductive system: metrorrhagia, scant bleeding, increased size of uterine leiomyoma, endometrial hyperplasia (when administered without combination with progesterone), endometrial carcinoma (in women with an intact uterus after menopause), ovarian sclerosis with prolonged use, changes in libido.

On the part of the endocrine system: engorgement (tension and / or increase) of the mammary glands, increase in body weight, decrease in tolerance to carbohydrates.

Metabolism: retention of sodium, calcium and water (edema) with prolonged use; bouts of porphyria.

Other: visual impairment (change in corneal curvature), chloasma, melasma, vaginal candidiasis.

WITHcaution: bronchial asthma, migraine, epilepsy, arterial hypertension, heart failure, ischemic heart disease, hepatic and / or renal failure, edematous syndrome, endometriosis, fibrocystic mastopathy, porphyria. Experience with women over 65 is limited.

Contraindications

Divigel should not be applied to the mammary glands, face, genital area, as well as to irritated skin.

Drug interactions

Estradiol increases the effectiveness of lipid-lowering drugs; weakens the effect of preparations of male sex hormones; hypoglycemic, diuretic, antihypertensive drugs and anticoagulants; reduces glucose tolerance (dose adjustment hypoglycemic drugs).

Estradiol metabolism is accelerated when taken simultaneously with barbiturates, tranquilizers (anxiolytics), opioid analgesics, anesthetics, some antiepileptic drugs (carbamazepine, phenytoin), inducers of liver microsomal enzymes; herbal preparations containing herb St. John's wort (St. John's grass).

The concentration of estradiol in the blood also decreases with the simultaneous use of phenylbutazone and some antibiotics (ampicillin, rifampicin, rifabutin) and antiviral drugs (nevirapine, efavirenz), which is associated with changes in the intestinal microflora.

The effect of estradiol increases in patients receiving folic acid and thyroid preparations.

Pregnancy and Lactation

Divigel is contraindicated for use during pregnancy and lactation.

Special instructions

Before starting or reappointment of hormone replacement therapy, complete personal and family history should be collected. A medical examination should be conducted to identify possible contraindications and to observe necessary precautions when using the drug (including the pelvic organs and the mammary glands).

In the course of treatment, it is recommended to conduct periodic examinations, the frequency and set of methods included in it are determined for each specific case individually. Studies, including mammography, should be conducted in accordance with accepted norms and taking into account individual clinical features in each individual case.

During HRT, all the benefits and risks of therapy should be carefully evaluated.

The patient should be under the constant supervision of a physician in case of any of the following diseases or conditions that were observed earlier and / or exacerbated during pregnancy or previous hormonal therapy: leiomyoma (uterine fibroids), endometriosis; history of thromboembolic diseases or risk factors for their occurrence; risk factors for estrogen-dependent tumors (1st degree of heredity of breast cancer); arterial hypertension; abnormal liver function (adenoma); diabetes mellitus with or without vascular lesions; cholelithiasis; migraine and / or (severe) headache; systemic lupus erythematosus; endometrial hyperplasia in history; epilepsy; bronchial asthma; otosclerosis. It should be borne in mind that during treatment with Divigel in rare cases, a relapse or exacerbation of these diseases is possible.

Therapy should be discontinued immediately if contraindications are found and / or in the following situations: jaundice or impairment of liver function; pronounced increase in blood pressure; new bouts of migraine headache; pregnancy.

When taking estrogen for a long time increases the risk of endometrial hyperplasia and carcinoma. To reduce the risk, it is necessary to combine estrogen therapy in women with an un-operated uterus with progesterones for at least 12 days during the treatment cycle.

In the event of breakthrough bleeding and / or scant bleeding after several months of administration of Divigel, studies should be conducted to identify the causes of their occurrence. Studies may include endometrial biopsy (to rule out endometrial malignancy).

Women with a remote uterus due to endometriosis (especially in cases of residual endometriosis) are recommended to add progesterone to estrogen-dependent therapy, due to premalignant or malignant transformation of foci of endometriosis with estrogenic stimulation.

With prolonged use of HRT increases the risk of developing breast cancer. According to epidemiological studies of women aged 50 to 70 years in 45 cases out of 1000 diagnosed with breast cancer. It has been established that among women taking or recently taking HRT, the total number of additional breast cancer cases in the relevant period is 1-3 (an average of 2) additional cases per 1000 people receiving HRT within 5 years; 3-9 (on average - 6) cases per 1000 people receiving HRT for 10 years and 5-20 (average - 12) cases per 1000 women receiving HRT for 15 years.An increase in this risk was found mainly in women of thin or normal stature. In women, full physique (high predisposition to breast cancer) HRT does not further increase the risk of developing breast cancer.

An additional risk of developing breast cancer appears with an increase in the duration of HRT and returns to baseline approximately 5 years after discontinuation of treatment.

Combined estrogen-progestogen HRT causes a similar or higher risk compared with estrogen therapy.

In women receiving HRT, the risk of thromboembolic disease of the veins (deep vein thrombosis of the lower extremities and pulmonary veins) is increased by 2-3 times compared with women who did not receive HRT. The probability is higher in the first year of HRT than in subsequent years.

The main risk factors for thromboembolic complications are: individual or family history, severe obesity (body mass index more than 30 kg / m2), systemic lupus erythematosus.

Patients with a history of thromboembolism or recent spontaneous miscarriages should be further investigated in order to exclude susceptibility to thrombophlebitis. The use of HRT in this case should be initiated after a complete assessment of the risk factors for thrombophlebitis and the start of anticoagulant therapy. The risk increases with prolonged immobilization, extensive injuries or extensive surgical interventions. HRT should be stopped 4-6 weeks before planned surgeries on the abdominal organs or orthopedic operations on the lower limbs. Treatment can be resumed after full recovery of motor ability. With the development of thromboembolic symptoms (sudden pain in the chest, dyspnea), it may be necessary to cancel HRT.

Estrogens cause fluid retention in the body. Patients with impaired renal function should be under the constant supervision of a physician due to increased levels of estradiol and its metabolites in the blood.

Estrogens increase insulin sensitivity and increase its excretion. Patients with diabetes mellitus in the first months of HRT are shown to continuously monitor blood glucose levels.

Acceptance of estrogen increases the risk of surgically confirmed cholelithiasis.

In rare cases, a sharp increase in the level of triglycerides in the blood while taking estrogens may develop pancreatitis.

Estrogens increase the level of thyroid-binding globulin, increasing the level of the total amount of circulating thyroid hormones.

Avoid contact with the gel on the mammary glands and mucous membranes of the vulva and vagina.

Influence on ability to drive motor transport and control mechanisms

Divigel therapy does not affect the ability to engage in potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Overdosage

Symptoms: pains in the mammary glands or in the pelvic region, abdominal distention, anxiety, irritability, nausea, vomiting, in some cases metrorrhagia.

Treatment: conducting symptomatic therapy.

Symptoms disappear when the dose is reduced or when the drug is withdrawn.

  • Brand name: Divigel
  • Active ingredient: Estradiol
  • Manufacturer: Orion
  • Country of Origin: Finland

Studies and clinical trials of Estradiol (Click to expand)

  1. Investigation of the alteration of the composition of various essential oils used in aroma lamp applications
  2. Composition of the Essential Oils of Commercial Samples of Salvia officinalis L. and S. fruticosa Miller: A Comparison of Oils Obtained by Extraction and Steam Distillation
  3. Chemical composition of essential oils from some Salvia species
  4. Composition of the essential oils from leaves and fruits of three Hedyosmum species from Costa Rica
  5. Thrombotic thrombocytopenic purpura and 17β-estradiol transdermal skin patch
  6. Potentiation of antitumor activity of mitomycin C by estradiol: Studies of human breast carcinoma xenografts serially transplanted into nude mice
  7. Estradiol increases the frequency of multiple synapse boutons in the hippocampal CA1 region of the adult female rat
  8. Reflection contrast microscopy for high resolution detection of3H-estradiol in ultrathin sections of human stratum corneum
  9. Human prostatic smooth muscle cells in culture: Estradiol enhances expression of smooth muscle cell-specific markers
  10. Effect of combined testosterone and estradiol-17β treatment on the metabolism of E2 in the prostate and liver of noble rats
  11. Pretreatment plasma testosterone and estradiol levels in patients with locally advanced or metastasized prostatic cancer
  12. Estradiol-17β stimulates aromatase activity and reversible sex change in protandrous black porgy,Acanthopagrus schlegeli
  13. Response of diencephalon but not the gonad to female-promoting temperature with elevated estradiol levels in the sea turtleLepidochelys olivacea
  14. Changes in body weight, ovarian growth, and circulating plasma estradiol level in response to programmed photoperiods in blackheaded bunting,Emberiza melanocephala
  15. Evidence of a progesterone receptor in the liver of the green frogRana esculenta and its down-regulation by 17? estradiol and progesterone
  16. Ultrastructure of the uterus in an ovariectomized gecko (Hemidactylus turcicus) after administration of exogenous estradiol
  17. Monte Carlo-minimized energy profile of estradiol in the ligand-binding tunnel of 17β-hydroxysteroid dehydrogenase: Atomic mechanisms of steroid recognition
  18. Neonatal exposure of male rats to estradiol benzoate causes rete testis dilation and backflow impairment of spermatogenesis
  19. A 67 kDa non-hormone binding estradiol receptor is present in human mammary cancers
  20. Modulation of lymphokine-activated killer cell-mediated cytotoxicity by estradiol and tamoxifen
  21. Antagonism between estradiol and progestin on Bcl-2 expression in breast-cancer cells
  22. Concentrations of estrone, estradiol and their sulfates, and evaluation of sulfatase and aromatase activities in patients with breast fibroadenoma
  23. Estradiol and fibulin-1 inhibit motility of human ovarian- and breast-cancer cells induced by fibronectin
  24. Laminin and estradiol regulation of the plasminogen-activator system in MCF-7 breast-carcinoma cells

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