menopause

ETINILESTRADIOLO Amsa ® - Ethinyl estradiol

ETINILESTRADIOLO Amsa ® is a drug based on Ethinylestradiol

THERAPEUTIC GROUP: Non-associated semi-synthetic estrogens

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Directions ETINILESTRADIOLO Amsa ® - Ethinyl estradiol

ETINILESTRADIOLO Amsa ® is used in the management of estrogen deficiency symptoms typical of menopause, in the prevention of postmenopausal osteoporosis, in the prevention of milk supply and in men in the treatment of prostatic disorders.

Mechanism of action ETINILESTRADIOLO Amsa ® - Ethinyl estradiol

Ethinylestradiol, the active ingredient of ETINILESTRADIOLO Amsa ® is a semi-synthetic estrogen, which shares the same biological activities with estradiol, distinguishing itself instead by the different pharmacokinetic characteristics.

Taken orally, it is rapidly and almost completely absorbed at the intestinal level, and bound to plasma proteins, mainly to albumin, is distributed to the various tissues and subsequently metabolized to the liver level.

Its metabolites are eliminated both biliary and urinary with a ratio of 6: 4 after a half-life of about 3- 24 hours.

Its biological action, carried out through interaction with nuclear receptors and the modulation of gene expression, takes the form of the reduction of post-climacteric symptoms such as: vasomotor disorders and nervous disorders, associated with the typical estrogen deficiency of menopause.

The therapy with estrogens and analogues has proved to be particularly effective also in the prevention of chronic and degenerative diseases such as osteoporosis, preserving bone health through the balancing of resorption - osteodeposition processes.

Studies carried out and clinical efficacy

1. ETINILESTRADIOLO E PSA

Treatment with oral ethinyl estradiol was useful in reducing blood PSA concentrations by over 50% in 70% of treated patients. However, among the side effects anorexia, liver damage and heart failure were observed.

2.ETINIL ESTRADIOL AND ARGININE

The addition of arginine to oral ethinyl estradiol therapy reduced the incidence of cardiovascular side effects measured through the evaluation of biochemical and functional parameters, such as ecodoppler blood pressure monitoring and evaluation of vascular flow.

3. ETINILESTRADIOLO AND FITOESTROGENI

As is known, soy is rich in phytoestrogens and is often recommended in the postclimaterial period. In this study it was observed that the addition of this legume to ethinyl estradiol estrogen therapy can significantly improve the activation status of estrogenic receptors, increasing the therapeutic effect of hormone replacement therapy.

Method of use and dosage

ETINILESTRADIOLO Amsa ® tablets of 10, 50 and 100 mcg of ethinyl estradiol:

The dosages of ethinyl estradiol to be used in the treatment of post-climacteric symptoms vary from patient to patient based on the clinical condition.

The dosage, defined by the doctor after a careful clinical-medical examination, may be subject to variations in the course of work to maximize the therapeutic effects avoiding the appearance of side effects.

Therapy with ETINILESTRADIOLO Amsa ® generally set according to cyclic protocols must generally be followed by the progestogen according to medical indications.

Warnings ETINILESTRADIOLO Amsa ® - Ethinyl estradiol

The biological complexity of estrogen hormone replacement therapy requires a particularly thorough medical examination before undertaking the therapeutic procedure.

Medical supervision throughout the treatment is necessary to minimize the possible occurrence of side effects while maintaining high therapeutic efficacy.

Endometriosis, thromboembolic or estrogenic diseases dependent on leiomyoma, hypertension, liver disease, diabetes, migraine, cardiovascular pathologies, liver and kidney pathologies, bronchial asthma and allergic pathologies represent only some of the conditions for which particular care must be given, during therapy with estrogens and analogs.

The correct doctor / patient relationship is the basis of therapeutic success and is useful to better understand the potential risks and benefits of therapy, being able to help the patient to recognize early the first side effects by making useful and effective remedies.

PREGNANCY AND BREASTFEEDING

Although the literature has observed the absence of side effects on fetuses accidentally exposed to estrogens, the absence of a correct evaluation of the safety profile of these active ingredients does not allow their free use during pregnancy and lactation.

Interactions

The activity of the cytochromial p450 enzymes, responsible for the metabolism of ethinyl estradiol, is subject to modulation by inhibitory and inducing active principles, such as antibiotics, phenobarbital and anticonvulsants.

The aforementioned variations may be responsible for significant pharmacokinetic variations that can alter the therapeutic properties of ethinylestradiol by varying the efficacy and risk of side effects.

Contraindications ETINILESTRADIOLO Amsa ® - Ethinyl estradiol

ETINILESTRADIOLO Amsa ® is contraindicated in cases of untreated endometrial hyperplasia, venous thromboembolism, hepatopathy, porphyria, estrogen-dependent tumors, vaginal bleeding, breast cancer and related predisposing conditions, pregnancy and lactation and hypersensitivity to the active ingredient or one of its excipients .

Undesirable effects - Side effects

Estrogen-replacing hormone therapy exposes the patient to numerous potential side effects with both acute and chronic course.

Taking for prolonged periods of time or at high doses could favor the appearance of nausea, vomiting, diarrhea, abdominal cramps, diffuse edema, increased volume and breast tension, neuro-psychiatric disorders, endometrial bleeding spots and gynecomastia in man.

Osteoporosis, increased risk of mammary and endometrial carcinomas, cardiovascular affections are the most clinically relevant chronic course of disease.

The risk of developing endometrial carcinomas is significantly greater in the absence of a combined progestin therapy.

Note

ETINILESTRADIOLO Amsa ® is salable only under medical prescription.