Angela

Hormone replacement therapy (HRT) for the treatment of:
Climacteric syndrome in postmenopausal women including vasomotor symptoms (such as hot flushes and sweating attacks), sleep disorders, depressed moods, nervousness and atrophic, urogenital conditions caused by deficient endogenous estrogen production due to natural menopause, hypogonadism, castration or primary ovarian failure in women with an intact uterus.
Prevention of postmenopausal osteoporosis.

The most commonly reported adverse drug reactions (ADRs) with Ethinylestradiol & Drospirenone are breast pain, female genital tract bleeding and gastrointestinal and abdominal pains. They occur in >6% of users. Bleeding irregularities usually subside during continued treatment. The frequency of bleeding decreases with the duration of treatment. Serious adverse reactions are arterial and venous thromboembolic events as well as breast cancer

Before initiating therapy, all conditions/risk factors mentioned below should be considered when determining the individual benefit/risk of treatment for the patient. During HRT use, therapy should be discontinued immediately in case a contraindication is discovered, as well as in the following situations:
Migrainous or frequent and unusually severe headaches that occur for the first time or other symptoms that are possible prodromal of cerebrovascular occlusion.
Recurrence of cholestatic jaundice or cholestatic pruritus which occurred first during pregnancy or previous use of sex steroids.
Symptoms of a thrombotic event.
In the event of new onset or deterioration of the following conditions or risk factors, the individual benefit/risk analysis should be re-done, taking into consideration the possible necessity of discontinuing therapy. The potential for an increased synergistic risk of thrombosis should be considered in women who possess a combination of risk factors or exhibit a greater severity of an individual risk factor. This increased risk may be greater than a simple cumulative risk of the factors. HRT should not be prescribed in case of a negative risk benefit assessment.
Venous thromboembolism: Both randomized-controlled and epidemiological studies have suggested an increased relative risk of developing venous thromboembolism (VTE), i.e. deep venous thrombosis or pulmonary embolism. Benefit/Risk should therefore be carefully weighed in consultation with the patient when prescribing HRT to women with a risk factor for VIE. Generally recognized risk factors for VTE include a personal history, a family history (the occurrence of VTE in a direct relative at a relatively early age may indicate genetic disposition) and severe obesity. The risk of VTE also increases with age. There is no consensus about the possible role of varicose veins in VTE. The risk of VTE may be temporarily increased with prolonged immobilization, major elective or post-traumatic surgery, or major trauma. Depending on the nature of the event and the duration of the immobilization, consideration should be given to a temporary discontinuation of HRT.

173-estradiol, which is chemically and biologically identical to endogenous human E2, and the synthetic progestogen, DRSP. 173-estradiol provides hormone replacement during and after the climacteric. The addition of DRSP helps to provide bleeding control and opposes the development of endometrial hyperplasia caused by estrogens.
Effects of estradiol: The loss of the ovarian function, accompanied by a depletion of estrogen and progesterone production, leads to the menopausal syndrome, characterized by vasomotor and organic symptoms. Hormone replacement therapy is indicated to eliminate these complaints. Of all physiological estrogens, E2 is the most potent one with the highest affinity to the estrogen receptor. Estrogen target organs include, in particular, uterus, hypothalamus, pituitary, vagina, breast, bones (osteoclasts).
Other effects of estrogens include reduction of insulin and blood glucose concentrations local vasoactive effects mediated by receptors, and receptor-independent effects on vascular smooth muscle. Estrogen receptors have been identified in the heart and coronary arteries. Oral administration of natural estrogens is advantageous in certain cases of hypercholesterolemia in order to maximize beneficial metabolic liver effects on lipids.