Description

Clomiphene citrate (clostilbegyt) tablets 50 mg, #10

Product Overview

Clomiphene citrate is a non-steroidal antiestrogenic medication. Its mechanism of action is due to its specific binding to estrogen receptors in the ovaries and pituitary gland. At low estrogen levels in the body, it exhibits a moderate estrogenic effect; at high estrogen levels, it exerts an antiestrogenic action. In low doses, it enhances the secretion of gonadotropins (prolactin, FSH, and LH) and stimulates ovulation; in high doses, it suppresses the secretion of gonadotropins. It does not possess progestogenic or androgenic activity.

Indications

• Anovulatory infertility (induction of ovulation).
• Amenorrhea (hypogonadotropic form).
• Secondary amenorrhea.
• Post-contraceptive amenorrhea.
• Stein-Leventhal syndrome (polycystic ovary syndrome).
• Oligomenorrhea.
• Galactorrhea (associated with pituitary tumor).
• Chiari-Frommel syndrome (prolonged postpartum amenorrhea-galactorrhea syndrome).
• Androgen deficiency.
• In men: oligospermia.

Interaction

Compatible with gonadotropin hormone preparations.

Dosage and Administration

In cases of infertility, the dosage and duration of treatment depend on the sensitivity (response to the medication) of the ovaries. Patients with regular menstrual cycles are recommended to start treatment on the 5th day of the cycle (or on the 3rd day in cases of early ovulation or a follicular phase duration of less than 12 days). For amenorrhea, treatment can be initiated on any day.

Regimen I: 50 mg/day for 5 days with simultaneous monitoring of ovarian response through clinical and laboratory examinations. Ovulation usually occurs between days 11 and 15 of the cycle. If this regimen doesn’t induce ovulation, then Regimen II should be used.

Regimen II: Starting on the 5th day of the next cycle, administer 100 mg/day for 5 days. If ovulation is not observed during this time, repeat the same regimen (100 mg/day). If anovulation persists, discontinue the medication for 3 months and then repeat the treatment for another 3 months. If the second course is ineffective, subsequent treatment with the medication is also not effective. The maximum total dose taken during each course is 750 mg.

For polycystic ovary syndrome, due to a tendency for hyperstimulation, the initial dose is 50 mg/day. For post-contraceptive amenorrhea, administer 50 mg/day daily. Typically, a successful outcome is achieved with a five-day course using Regimen I. In men, as indicated, the medication can be administered at 50 mg 1-2 times/day for 6 weeks under systematic spermogram monitoring.

Formulation

Tablets

Storage Conditions

Store at a temperature of 15-25°C.

---

Safety of clomiphene citrate: a literature review