Product Name: Clomiphene
Active Ingredient:
Clomiphene Citrate
Description:
Clomiphene is a selective estrogen receptor modulator (SERM) commonly used in the treatment of infertility, particularly in women with anovulatory cycles or polycystic ovary syndrome (PCOS). By blocking estrogen receptors in the hypothalamus, clomiphene stimulates the release of gonadotropins, which in turn promote ovarian follicle development and ovulation. It is often used as a first-line treatment for female infertility. Clomiphene may also be used in the treatment of male infertility, specifically in cases of secondary hypogonadism.
Quantitative and Qualitative Composition:
- Active Substance: Each tablet contains 50 mg of clomiphene citrate.
- Excipients: Lactose, cellulose, magnesium stearate, and other excipients.
Pharmaceutical Form:
White, circular tablets for oral administration.
Packaging:
40 tablets per container.
Pharmacotherapeutic Classification:
Selective estrogen receptor modulators (SERM) (ATC Code: G03GB02)
Therapeutic Indications:
- Female Infertility: Clomiphene is indicated for the treatment of ovulatory dysfunction in women with infertility, including those with polycystic ovary syndrome (PCOS) or unexplained infertility. It is used to induce ovulation and increase the chances of conception.
- Male Infertility: Clomiphene is used off-label to treat male infertility, particularly in cases of secondary hypogonadism, by increasing the release of gonadotropins (LH and FSH) and stimulating endogenous testosterone production.
- Treatment of Amenorrhea: Clomiphene may also be prescribed for women with amenorrhea (absence of menstruation) due to anovulation.
Dosage and Administration:
The dosage of clomiphene varies based on the individual’s condition and response to treatment:
- For female infertility: The typical starting dose is 50 mg daily for 5 days, beginning on the 5th day of the menstrual cycle. If ovulation does not occur, the dose may be increased up to 100 mg or 150 mg for subsequent cycles.
- For male infertility: The usual dosage is 25–50 mg daily, often for several months, depending on the clinical response.
- Monitoring: Patients should be monitored for ovulation using serum progesterone levels and ultrasound, as overuse or misuse of clomiphene can lead to multiple pregnancies.
Storage Conditions:
Store below 25°C. Protect from moisture and light. Keep out of reach of children.
Regulatory Status:
Prescription-only medication (Rx).
Manufactured in accordance with current Good Manufacturing Practice (cGMP) standards.