PROGYNOVA ® is a drug based on Estradiol valerate
THERAPEUTIC GROUP: Natural estrogens
IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects
Indications PROGYNOVA ® - Estradiol
Hormone therapy replacing PROGYNOVA ® is indicated in the treatment of both local and systemic disorders related to menopause.
Mechanism of action PROGYNOVA ® - Estradiol
Hormone replacement therapy was created with the main objective of replacing the physiological proportion of the hormone lost due to physiopathological problems.
In the case of substitution therapy with estradiol, the need takes over with the onset of menopause, a physiological condition characterized by a marked reduction in the production of estrogen, and by the associated associated symptomatology and marked by vasomotor disorders such as spasms and hot flushes, nervous disorders such as anxiety, panic attacks, insomnia and difficulty in falling asleep and chronic and progressive conditions such as osteoporosis.
The efficacy of PROGYNOVA ® is due to the ability of estradiol valerate to be completely absorbed following oral intake and metabolised to the hepatic level in estradiol, allowing the maximum peak to be reached 1 to 3 hours after intake.
The plasma concentrations of this hormone, which remain high for about 24 hours, then tend to decrease following hepatic metabolism and subsequent excretion through the urine.
Studies carried out and clinical efficacy
1. ESTROGENIC THERAPY AND INSOMNIA
The improvement of sleep quality is an important factor, compromised in menopausal women, which significantly affects the quality of life. Studies show that estradiol valerate can improve this characteristic especially when associated with progestins.
2. ESTRADIOLO VALERATO AND VAGINAL ATROPHY
Estradiol valerate therapy in combination with levonorgestrel has proven to be particularly effective in improving vaginal atrophy, thickening the vaginal epithelium, improving cell morphology and controlling pH values.
3. ESTROGENIC THERAPY AND DEPRESSION
The hormone replacement therapy with estradiol proved to be useful, albeit still in experimental animal models, in alleviating the depressive symptoms related to menopause, reducing the demand for antidepressant drugs.
Method of use and dosage
PROGYNOVA ® 2-mg 17 beta-estradiol valerate-coated tablets :
Oral estradiol therapy should be performed at the lowest dosages useful to alleviate the complained symptomatology.
The doctor can choose continuous or cyclical intake protocols depending on the therapeutic needs, remembering that in the case of non-hysterectomised women, the combination with progestins is always necessary, in order to avoid significant insults to the uterine mucosa.
Warnings PROGYNOVA ® - Estradiol
The correct therapeutic procedure should include, before the formulation of the dosage, a careful control visit useful to ascertain the absence of pathological conditions such as endometriosis, history or familiarity for dependent thromboembolic or estrogen diseases, hypertension, hepatopathies, diabetes, migraine and pathologies autoimmune, capable of significantly increasing the risk of side effects of HRT.
Medical supervision is therefore important both during the initial phases of the therapy and during the subsequent maintenance period so that the efficacy of the therapy can be guaranteed and the patient's health is safeguarded.
The doctor should inform the patient of potential side effects with particular care for long-term side effects such as breast and endometrial carcinomas.
PREGNANCY AND BREASTFEEDING
Despite the scientific literature agreeing on the absence of direct side effects of estrogens on the health of the fetus, therapy with PROGYNOVA ® is strictly contraindicated both during pregnancy and in the subsequent period of breastfeeding.
Interactions
The first-pass liver effect that characterizes oral administration of estradiol significantly increases the risk of clinically relevant drug interactions.
More precisely, the enzymes responsible for the metabolism of these hormones, such as the citrochromial enzymes p 450, are easily subjected to the inducing and inhibiting action of different active ingredients such as phenobarbital, phenytoin, carbamazepine, rifampicin, rifabutin, ritonavir and nelfinavir, thus altering the normal pharmacokinetic profile of estradiol and its biological efficacy.
Contraindications PROGYNOVA ® - Estradiol
The use of PROGYNOVA ® is contraindicated during pregnancy and lactation, in patients with estorgeno-dependent carcinomas, breast carcinoma, acute thrombophlebitis, recent embolic thrombus disease, history of thrombus embolism, liver disease, porphyria, untreated endometrial hyperplasia, undiagnosed vaginal discharge and of course in case of hypersensitivity to the active ingredient or to one of its excipients.
Undesirable effects - Side effects
The side effects described in the scientific literature and reported by post-marketing experience following the replacement therapy with estradiol are significant and characterized by both acute and chronic course.
Migraine, dizziness, abdominal pain, nausea and vomiting, diarrhea, alterations of the tension and of the breast volume, palpitations, edema, cramps, weight gain, alterations in appetite, visual disturbances and vaginal bleeding are the most frequent but fortunately lateral side effects acute and transitory.
The possible long-term consequences are, however, more serious, with a significant increase in the risk of breast and endometrial carcinomas.
Note
PROGYNOVA ® is salable only under medical prescription.
