PRONTOGEST ® - Progesterone

PRONTOGEST ® is a Progesterone based drug

THERAPEUTIC GROUP: Progestinic

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

Indications PRONTOGEST ® - Progesterone

PRONTOGEST ® is used in the treatment of various gynecological disorders such as hypermenorrhea, polymenorrhea, metrorrhagia, amenorrhea and the symptoms associated with menopause (associated with estrogen replacement therapy).

The administration of progesterone can also be useful in preventing spontaneous abortions and in supporting the lutein phase of the menstrual cycle.

Mechanism of action PRONTOGEST ® - Progesterone

PRONTOGEST ® is a progesterone-based drug that optimizes the pharmacokinetic properties of the active ingredient through intramuscular administration.

Pharmacokinetic studies have indeed shown how the intramuscular intake of this hormone can significantly increase the bioavailability of progesterone, compared to oral administration, without making any kind of variation on hepatic metabolism and on its elimination via the kidney.

The progesterone thus taken, bound to the plasma proteins is distributed to the various tissues, guaranteeing at the endometrial level a reduction of the estrogen-dependent proliferative activity and an increase in the glandular secretion, at the mammary level the proliferation of the glandular acini and at the nervous level an increase in the drowsiness, lung ventilation and temperature.

From the therapeutic point of view PRONTOGEST ® is therefore recommended above all for the endometrial effects useful to facilitate the nesting and growth of the embryo and to avoid carcinomatous transformations of the same cells during estrogen replacement therapy.

Studies carried out and clinical efficacy

1. EFFECTIVENESS OF THE PROGESTERONE INTRAMUSCOLARAE

Italian study that demonstrates how the intramuscular administration of progesterone can guarantee a higher rate of pregnancies and parts than the oral or vaginal administration of the same hormone. The differences are obviously due to the different pharmacokinetic profile.

2. INTRAMUSCULAR PROGESTERONE AND IN VITRO FERTILIZATION

The intramuscular administration of progesterone, as soon as the oocyte is taken, is able to guarantee a significant increase in the endometrial thickness useful for receiving the embryo, while reducing the myometrial contractions.

3. INTRAUMUSCULAR OR VAGINAL PROGESTERONE?

The vaginal intake of progesterone has proved not only easier to implement than the intramuscular one, but above all more effective, guaranteeing a significantly higher percentage of embryonic implants.

Method of use and dosage

PRONTOGEST ® solution for injection for intramuscular use from 50 - 100 mg of progesterone per ml of solution:

the dosage of intramuscular progesterone and the relative intake scheme varies considerably from patient to patient based on the physiopathological conditions and the relative clinical picture.

Although the application range seems to be between 50 and 200 mg daily, the timing of intake varies depending on the therapeutic indication.

For this reason it is important that the doctor formulates and defines the correct therapeutic procedure only after a careful medical examination.

PRONTOGEST ® warnings - Progesterone

Before starting progestin therapy with PRONTOGEST ®, undergo a careful medical and gynecological examination to clarify the need for treatment and to ascertain the absence of conditions incompatible with the treatment.

More precisely thrombo-embolic affections, alterations in cardiovascular function, recurrent cholestasis, reduced hepatic and renal function, epilepsy and neuro-psychiatric disorders, breast lumps or pathologies, diabetes mellitus, lupus and autoimmune diseases are the most common conditions for which it becomes necessary continuous medical monitoring.

The patient should also be adequately informed about the potential side effects of the therapy, especially on long-term ones.

Taking PRONTOGEST ® could make the use of machinery and driving vehicles dangerous.

PREGNANCY AND BREASTFEEDING

As it is known, progesterone is commonly used in pregnancy to compensate for the endogenous deficiency of this hormone, responsible for a bad nesting and a reduced growth of the embryo that often results in spontaneous abortion.

In this regard PRONTOGEST ® can be taken in cases of risky pregnancy under strict medical supervision.

On the contrary, this drug is contraindicated during the breastfeeding period due to its ability to permeate the breast filter and concentrate in breast milk.

Interactions

Although the intramuscular administration of progesterone significantly reduces first-pass metabolism, the simultaneous administration of active ingredients capable of modulating the activity of cytochromial enzymes, responsible for the metabolism of this hormone, could determine significant pharmacokinetic variations, altering the normal therapeutic profile of PRONTOGEST ®

Contraindications PRONTOGEST ® - Progesterone

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

Undesirable effects - Side effects

Numerous clinical trials and an expected post-marketing monitoring have characterized the side effects of progestin therapy, identifying among the most frequent: drowsiness, migraine, depression, changes in menstrual flow, amenorrhea, metrorrhagia, weight changes, increase in volume and tension mammary, hirsutism, alopecia, rash and local irritation.

The administration of progesterone for prolonged periods especially if associated with the replacement estrogen therapy could determine an increase in cardiovascular risk and in the development of mammary carcinomas.