FARLUTAL ® - Medroxyprogesterone

FARLUTAL ® is a drug based on Medroxyprogesterone acetate

THERAPEUTIC GROUP: Progestogens

Indications FARLUTAL ® - Medroxyprogesterone

FARLUTAL ® is a progestin used in the treatment of some female gynecological disorders such as secondary amenorrhea and functional menometrorrhagia.
Furthermore, experimental data have tested its efficacy, also obtaining good successes, in hormone-dependent tumors and in cases of advanced cachexia.
As a progestin it is also combined with hormone therapy replaced with estrogen, to reduce the risk of endometrial carcinomas.

Mechanism of action FARLUTAL ® - Medroxyprogesterone

FARLUTAL ® is a drug based on medroxyprogesterone, a progestin derivative characterized by a different pharmacokinetic profile and a selective biological activity.
From a pharmacokinetic point of view, this active ingredient is distinguished from other progestogens and from endogenous progesterone for its long duration of action, estimated between 20 and 30 hours, at the end of which, after hepatic metabolism, it is excreted mainly via the urine. .
Like endogenous progesterone, medroxyprogesterone is able to interact mainly with endometrial cells by reprogramming gene expression and mediating the transition from the proliferative to the secretory structure, necessary in nature to adequately accommodate the newly formed embryo, facilitating its nesting .
This active principle also maintains the androgenic activity, fundamental in the treatment of cachectic states, while it lacks estrogenic activity and modulatory activity on the hypothalamus-pituitary axis when taken orally in a single dose.
In the latter case, therefore, taking FARLUTAL ® does not inhibit either folliculogenesis or oogenesis.

Studies carried out and clinical efficacy

1. FARLUTAL AND ENDOMETRIAL HYPERPLASIA: the molecular structure

Contraception. 2011 Aug; 84: 122-7. Epub 2010 Dec 24.

Long-term assessment of forearm bone mineral density in postmenopausal former users of depotmedroxyprogesterone acetate.

Viola AS, Castro S, Marchi NM, Bahamondes MV, Viola CF, Bahamondes L.

Although medroxyprogesterone therapy did not prove particularly useful in improving bone health during the work, good results were instead observed following the arrival of menopause, guaranteeing a significant increase in bone density in former users.

2. ANAPHYLAXIS FROM MEDROXYPROGESTERONE

Obstet Gynecol. 2011 Aug; 118 (2 Pt 2): 443-5.

Anaphylaxis from depot medroxyprogesterone acetate in an adolescent girl.

Lestishock L, Pariseau C, Rooholamini S, Ammerman S.

Important case report denouncing the onset of anaphylactic reactions in a young 16-year-old girl undergoing treatment with medroxyprogesterone. These reactions, present even in the absence of a previous clinical history, underline the importance of continuous medical supervision.

3. MEDROXYPROGESTERONE AND CELL TRANSFORMATION

J Low Genit Tract Dis. 2011 Jul; 15: 219-23.

Differences in cervical cytologic and histologic findings between women using depot-medroxyprogesterone acetate and oral contraceptives.

Clark MK, Stockdale CK, Railsback L, Nichols S.

Study conducted on over 1500 women, which evaluates the presence of side effects related to the histological health of the uterine cervix monitored through colposcopy, following prolonged administration of medroxyprogesterone. The results show, even in the absence of a frank transformation, an increase in atypical glandular cells for which continuous medical monitoring becomes useful.

Method of use and dosage

FARLUTAL ® 10 - 20 mg film-coated tablets of medroxyprogesterone:
the dosage of FARLUTAL ® must necessarily be established by the doctor after a "careful evaluation of the patient's clinical picture and relative therapeutic objectives.
In fact, the very wide range of application leaves the doctor an excellent possibility of therapeutic modulation, in order to optimize its effectiveness while reducing the potential side effects.
Usually, therapy with FARLUTAL ® follows cyclical protocols with blood loss occurring approximately 3 days after discontinuation of therapy.

Warnings FARLUTAL ® - Medroxyprogesterone

Therapy with FARLUTAL ® must necessarily be preceded by a careful check-up to clarify the need for therapy, the therapeutic objectives and the possible presence of predisposing factors for the development of potential side effects.
In the latter case, in fact, patients suffering from impaired liver function, renal insufficiency, asthma, diabetes, lupus, psychiatric pathologies, porphyria and cholestasis should be followed scrupulously by their doctor in order to avoid the onset of unpleasant adverse reactions.
At the onset of the first side effects such as: vision disturbances, migraines and vaginal discharge, the patient should be subjected to careful checks to eventually opt for the suspension of the therapy.
Given the potential side effects, the patient must be informed by his doctor of both the possible advantages and the potential adverse reactions, in order to carefully evaluate the cost / benefit ratio.
If FARLUTAL ® were administered in combination with estrogen therapy, it would also become necessary to evaluate the interactions, contraindications, warnings and side effects of estrogen-based hormone replacement therapy.
FARLUTAL ® contains lactose, so its intake could lead to the onset of more or less serious side effects in patients with lactase enzyme deficiency, glucose / galactose malabsorption and lactose intolerance.

PREGNANCY AND BREASTFEEDING

The administration of progestogens during pregnancy should be limited to cases of real need and only under strict medical supervision.
The ability of these hormones to easily cross the hematoplacental barrier could expose the fetus to cardiac risks and structural malformations of the urethra.
FARLUTAL ®, on the other hand, is contraindicated during the lactation period due to the ability of medroxyprogesterone to pass through the breast filter and be secreted into breast milk.

Interactions

It is necessary to remember, even in the absence of clinically relevant drug interactions, that the concomitant intake of active ingredients capable of altering the activity of hepatic enzymes responsible for the metabolism of medroxyprogesterone could determine a significant variation in the blood concentrations of the aforementioned active ingredient and in the relative biological efficacy.

Contraindications FARLUTAL ® - Medroxyprogesterone

FARLUTAL ® is contraindicated in case of hypersensitivity to the active substance or to one of its excipients, in case of vaginal haemorrhages of unknown origin, breast cancer or estrogen-progestogen dependent tumors, impaired liver function and current or previous thromboembolic processes.

Undesirable Effects - Side Effects

The assumption of FARLUTAL ® like that of other progestogens, can expose the patient to clinically relevant side effects affecting different organs and systems.
Among the most affected are:

• the gastro-enteric system with diarrhea, nausea, vomiting and abdominal cramps;
• The nervous system with depression, migraine, headache and other neurological symptoms;
• the genitourinary system, with lesions affecting the uterine and vaginal mucosa, increased secretions and cervical erosions;
• the breast, with increased breast tenderness;
• the integumentary system subject to skin eruptions, rash and urticaria.

Clinically more important were the long-term side effects of estrogen-progestin therapy with a significant increase in the incidence of breast cancer, progestin-dependent neoplasms, venous thrombosis and myocardial infarction.

Note

FARLUTAL ® can only be sold under medical prescription.
The use of FARLUTAL ® without medical necessity before or during a sporting competition constitutes the DOPING offense.

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