Composition: Clomiphene Citrate 50mg
Clomiphene citrate (Clomifene citrate) is a selective estrogen receptor modulator. Clomiphene citrate has been the most widely used treatment for fertility enhancement for the past 40 years. Clomiphene was a revolutionary advance in reproductive medicine and quickly became popular for induction of ovulation because of its ease of administration and minimal side effects.
Clomiphene is used to treat absent or irregular menstrual cycles (ovulation induction), to address a condition called luteal phase defect by increasing progesterone secretion during the second half of the cycle and to make menstrual cycle lengths more predictable, thus improving the timing of intercourse or artificial insemination. Clomiphene may also be used to enhance ovulation in women who are already ovulating (ovulation augmentation).
Mechanism of Action
Clomiphene is a nonsteroidal triphenylethylene derivative distantly related to diethylstilbestrol. It acts as a selective estrogen receptor modulator (SERM). The commercially available form of clomiphene is the dihydrogen citrate salt (clomiphene citrate). It contains two stereoisomers: zu-clomiphene (38 percent) and en-clomiphene (62 percent), which were originally called the cis-isomer and trans-isomer, respectively. En-clomiphene is cleared rapidly, while zu-clomiphene has a long half-life. The two clomiphene isomers have mixed estrogenic and antiestrogenic effects that vary among species. En-clomiphene is the more potent isomer with greater antiestrogenic activity and the one primarily responsible for inducing follicular development
Working of Clomiphene
Clomiphene triggers the brain’s pituitary gland to secrete an increased amount of follicle stimulating hormone (FSH) and LH (luteinizing hormone). This action stimulates the growth of the ovarian follicle and thus initiates ovulation.
During a normal menstrual cycle only one egg is ovulated. The use of clomiphene often causes the ovaries to produce two or three eggs per cycle. Clomiphene is taken orally for 5 days and is active only during the month it is taken.
Fertix50 is indicated only in patients with demonstrated ovulatory dysfunction who meet the conditions described below:
- Patients who are not pregnant.
- Patients without ovarian cysts. Fertix50 should not be used in patients with ovarian enlargement except those with polycystic ovary syndrome. Pelvic examination is necessary prior to the first and each subsequent course of Fertix50
- Patients without abnormal vaginal bleeding. If abnormal vaginal bleeding is present, the patient should be carefully evaluated to ensure that neoplastic lesions are not present.
- Patients with normal liver function.
Treatment of the selected patient should begin with a low dose, 50 mg daily (1 tablet) for 5 days. The dose should be increased only in those patients who do not ovulate in response to cyclic 50 mg Fertix50. A low dosage or duration of treatment course is particularly recommended if unusual sensitivity to pituitary gonadotropin is suspected, such as in patients with polycystic ovary syndrome. The patient should be evaluated carefully to exclude pregnancy, ovarian enlargement, or ovarian cyst formation between each treatment cycle.
Storage and Handling
Keep the container tightly closed. Store tablets at controlled room temperature 59-86°F (15-30°C).