PROVERA ® - Medroxyprogesterone

PROVERA G ® is a drug based on Medroxyprogesterone acetate

THERAPEUTIC GROUP: Progestinic

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

Indications PROVERA ® - Medroxyprogesterone

PROVERA G ® is indicated in the treatment of disorders of the female genital sphere such as less functional metrorrhagia and secondary amenorrhea.

The intake of progestogens such as PROVERA G ® is also useful during estrogen hormone replacement therapy to reduce the proliferative stimulus on the endometrium and the related increased risk of endometrial carcinomas.

Mechanism of action PROVERA ® - Medroxyprogesterone

The medroxyprogesterone contained in PROVERA G ® is a progestogen derivative known for its peculiar pharmacokinetic characteristics.

In fact, this hormone is characterized by a long half-life that allows the maintenance of blood progestin concentrations for 20-30 hours, significantly lengthening the administration time with respect to progesterone and at the same time reducing the doses used.

From the pharmacodynamic point of view, on the contrary, medroxyprogesterone, besides acting on the endometrium, promoting cellular reprogramming, useful to guarantee the passage from the proliferative to the secretive phase, necessary to accept and nourish the embryo, presents a slight androgenic activity responsible for the positivity andi-dopping test.

The peculiarities of this hormone are not limited exclusively to the pharmacokinetic aspect but also continue from the point of view of action selectivity, sparing the pituitary gland from the negative feedback control typical of progesterone, thus maintaining unchanged the concentrations of gonodatropins and the processes of folliculogenesis and ovogensis.

Studies carried out and clinical efficacy

1. MEDROSSIPROGESTERONE AND CARDIOVASCULAR DISEASES

Interesting study that demonstrates how the administration of medroxyprogesterone acetate for over 2 years can contribute to altering cholesterolemia and lipid profile, significantly increasing cardiovascular risk.

2. MEDROSSIPROGESTERONE AND BONE HEALTH

A particularly controversial study that demonstrates how the administration of medroxyprogesterone in women between the ages of 25 and 40 can determine a reduction in bone mineral density, fortunately reversible once the therapy has been suspended.

3. MEDROSSIPROGESTERONE AND CELL TRANSFORMATION

Although among the side effects of medroxyprogesterone and progesterone are generally mentioned those affecting the nervous system such as depression, studies show that the administration of this hormone immediately after pregnancy does not seem to predispose to the development of postpartum depression.

Method of use and dosage

PROVERA G ® 5 -10 mg film-coated tablets of medroxyprogesterone:

usually the administration of 5 - 10 mg of medroxyprogesterone per day, during the lutein phase of the menstrual cycle, is effective both for the treatment of functional menometrorrhages and secondary amenorrhea.

In any case the therapeutic scheme and the correct dosage must necessarily be defined by the doctor after a careful clinical-medical evaluation.

Warnings PROVERA ® - Medroxyprogesterone

As with all progestogens, taking PROVERA G ® must also be preceded by a careful medical examination to assess the real therapeutic need and the possible presence of conditions incompatible with the administration of medroxyprogesterone.

More specifically, patients with liver function abnormalities, renal insufficiency, asthma, diabetes, lupus, psychiatric disorders, porphyria and cholestasis should be closely followed by their doctor in order to avoid the onset of unpleasant adverse reactions.

Continuous medical supervision is therefore important both to minimize the risk of side effects and to maintain high therapeutic efficacy; in this regard it is therefore important for the doctor to inform the patient of potential adverse reactions, especially long-term ones, in order to be able to recognize the first signs in a timely manner and, in collaboration with his doctor, to decide whether to suspend therapy.

In the case of PROVERA G ® which is used in combination with estrogen therapy, it would also be necessary to evaluate the interactions, contraindications, warnings and side effects of estrogen-based replacement therapy.

PROVERA G ® contains lactose, so its intake could lead to the appearance of more or less serious side effects in patients with lactase enzyme deficiency, diglucose / galactose malabsorption and lactose intolerance.

PREGNANCY AND BREASTFEEDING

The use of oral medroxyprogesterone during pregnancy is not recommended given the presence in the literature of data showing side effects of the fetus.

PROVERA G ® is also contraindicated during breastfeeding due to the ability of the active ingredient to pass the breast filter and concentrate in breast milk.

Interactions

Although medroxyprogesterone differs significantly from the pharmacokinetic point of view from progesterone, it is also metabolized by the cytochrome p450 liver enzymes.

For this reason it is appropriate to consider that the concomitant intake of active ingredients capable of modulating the activity of the aforementioned enzymes could determine significant pharmacokinetic variations against medroxyprogesterone, rendering its therapeutic efficacy unpredictable.

Contraindications PROVERA ® - Medroxyprogesterone

PROVERA G ® is contraindicated in case of hypersensitivity to the active ingredient or to one of its excipients, in the case of vaginal bleeding of unknown origin, breast cancer or estrogen-progestin dependent tumors, changes in liver function and existing or previous thromboembolic processes.

Undesirable effects - Side effects

Progesterone and its derivatives are often associated with more or less serious side effects.

From the scientific literature and post-marketing monitoring, adverse reactions emerge: thromboembolic diseases, nervousness, insomnia, drowsiness, headache, migraine, nausea, increased breast tension and volume, cholestasis, skin rash, hives, changes in menstrual flow and spotting hemorrhagic.

Among the long-term, clinically relevant side effects, there have been described: thromboembolic pathologies and mammary carcinomas.