SEROFENE ® - Clomiphene citrate

SEROFENE ® is a drug based on Clomiphene citrate

THERAPEUTIC GROUP: Antiestrogens - gonadotropins and other ovulation stimulants

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

Indications SEROFENE ® - Clomiphene citrate

SEROFENE ® is used in the treatment of anovularia associated with alterations of the luteinic phase or due to oligomenorrhea, secondary amenorrhea and polycystic ovary.

Mechanism of action SEROFENE ® - Clomiphene citrate

The therapeutic efficacy of clomiphene citratro contained in SEROFENE ® is to be associated with its dual activity, both weakly estrogenic and anti-estrogenic.

This particular biological characteristic allows the aforementioned active principle to bind to estrogen receptors present at the hypothalamic and pituitary level with high affinity, inhibiting the negative feedback normally exerted by estrogens.

In this way the GnRH axis - Gonadotropins (FSH and LH) - estrogens, remains active, guaranteeing follicular maturation and subsequent ovulation, thus facilitating the establishment of a pregnancy.

The important efficacy of this treatment also lies in the advantageous pharmacokinetic properties of clomiphene citrate, which allow the patient to take the tablet orally, and the active principle to be easily absorbed at the intestinal level, and thus distributed in the circulation, to be eliminated afterwards a half-life of about 5 days mainly with faeces.

Studies carried out and clinical efficacy

1. CLOMIFENE CITRATE AS AN OPTION OF FIRST CHOICE

The induction of ovulation with clomiphene citrate and the time ratio is as effective as intrauterine insemination to achieve pregnancy in polycystic ovary syndrome, thus representing the initial therapeutic option.

2. CITRATE-RESISTANT CLOMIFENE SYNDROMES

Study that supports the need for surgical practices in the event of failure to ovulate in women suffering from polycystic ovary syndrome and not responsive to medical therapy with clomiphene citrate.

3. CLOMIFENE CITRATE AND L-CARNITINE IN THE TREATMENT OF MALE INFERTILITY

Treatment with clomiphene citrate and L-carnitine proved to be a safe and effective step in the treatment of idiopathic male infertility, increasing sperm count and motility.

Method of use and dosage

SEROFENE ®

Tablets containing 50 mg of clomiphene citrate:

ovarian stimulation cycles should last 5 days, with the daily intake of one tablet.

In the event of ovulatory failure, the same cycle could be repeated 2 more times with higher dosages and under strict medical supervision.

Each phase of the therapy, from the definition of the dosage to the end of the cycle, should be supervised by your doctor.

Warnings SEROFENE ® - Clomiphene citrate

Before undertaking ovarian stimulation processes with clomiphene citrate, it is appropriate to characterize the reason for anovulation in physio-pathological terms and verify that the causes are compatible with the therapeutic indications provided for SEROFENE ®

For this reason it is essential to supervise a specialist doctor in defining the treatment and throughout the therapeutic process.

Moreover, the intake of clomiphene citrate, even if indirectly, could determine a volumetric increase of ovarian and cyst ovaries as well as an ovarian hyperstimulation syndrome, such as to require the rapid suspension of therapy.

Statistical data describe how the incidence of twin pregnancies is more frequent in women undergoing ovarian stimulation.

SEROFENE ® contains lactose therefore it is contraindicated in patients with galactose intolerance, lactase enzyme deficiency or glucose-galactose malabsorption.

The appearance of side effects on the visual apparatus, fogginess and opacification, could make the driving of vehicles or the use of machinery dangerous.

PREGNANCY AND BREASTFEEDING

The scientific literature reports numerous studies carried out on experimental animal models, in which the intake of clomiphene citrate has contributed to the appearance in the fetus of evident malformations, concentrated above all on the genital, gastrointestinal and nervous apparatus, such as to compromise the survival of the fetus.

It is also useful to remember how the intake of this active ingredient during lactation could inhibit milk production.

Interactions

At the moment, given also the short periods of treatment, active ingredients are not known, whose intake, together with that of clomiphene citrate, could determine the onset of clinically relevant interactions.

Contraindications SEROFENE ® - Clomiphene citrate

The use of SEROFENE ® is contraindicated in women with menometrorrhagia, changes in liver function, pregnancy and lactation or in case of hypersensitivity to the active substance or one of its excipients.

Undesirable effects - Side effects

Despite the short duration of the treatment can significantly reduce the risk of side effects related to the use of clomiphene citrate it is possible that the therapy with SEROFENE ® may be associated with the appearance of: nausea, vomiting, nervousness, fatigue, headache, visual changes, increase in volume of ovaries and ovarian cysts, abdominal tension, abdominal pain, vasomotor disorders and increased breast tension with tenderness.

Fortunately, the aforementioned symptoms tend to return easily once the therapy is suspended.