API

Clomiphene (100mg)

Drug classification

Selective estrogen receptor modulator (SERM); ovulation stimulant.

Dosage form

Oral tablet containing 100 mg of clomiphene citrate.

API strength per dosage

Dose

Clomiphene is typically initiated at 50 mg daily for 5 days, starting on day 2–5 of the menstrual cycle; may increase to 100 mg daily in subsequent cycles if ovulation does not occur. Not recommended in pediatric patients. Use with caution in hepatic impairment; contraindicated in active liver disease. No specific renal dosing adjustments established.

Mechanism of action

Clomiphene acts as a selective estrogen receptor modulator (SERM), antagonizing estrogen receptors in the hypothalamus. This blocks negative feedback, increasing gonadotropin-releasing hormone (GnRH) secretion, which stimulates pituitary release of follicle-stimulating hormone (FSH) and luteinizing hormone (LH), promoting ovarian follicular development and ovulation.

Indications

Treatment of Female infertility

Side effects

Nausea Vomiting Bloating Headache Enlarged ovary Hot flashes Metrorrhagia menstrual bleeding at irregular intervals Breast discomfort

Pregnancy category

Clomiphene should be avoided in pregnancy; use is contraindicated as it may cause fetal harm. Confirm absence of pregnancy before initiating treatment.

Precautions

Ovarian enlargement risk, monitor for ovarian hyperstimulation syndrome, assess for visual disturbances, contraindicated in liver disease, monitor for multiple pregnancy, use caution in polycystic ovary syndrome, discontinue if pregnancy suspected, monitor for abdominal pain, avoid prolonged use, regular pelvic examination recommended.

Contraindications

Liver disease, abnormal uterine bleeding of unknown origin, ovarian cysts not due to polycystic ovary syndrome, uncontrolled thyroid or adrenal dysfunction, pregnancy, hypersensitivity to clomiphene or any component of the formulation.