Additional Information

Description

Clomiphene Citrate Tablets, USP contain clomiphene citrate, a nonsteroidal ovulatory stimulant. Clomiphene citrate is chemically designated as 2-[p-(2-chloro-1,2-diphenylvinyl)phenoxy] triethylamine citrate (1:1). Its molecular formula is C26H28ClNO·C6H8O7 with a molecular weight of 598.09 g/mol. Each white, film-coated, round tablet contains 50 mg of clomiphene citrate for oral administration.

Clomiphene citrate acts as a selective estrogen receptor modulator (SERM). It binds to estrogen receptors in the hypothalamus, blocking endogenous estrogen feedback. This increases gonadotropin-releasing hormone (GnRH) secretion, stimulating follicle-stimulating hormone (FSH) and luteinizing hormone (LH) release from the pituitary gland, thereby promoting follicular development and ovulation.

Important Safety Information

Contraindications

Pregnancy (Category X; may cause fetal harm).
Ovarian cysts (not due to polycystic ovary syndrome).
Liver disease or history of liver dysfunction.
Abnormal uterine bleeding of undetermined origin.
Hypersensitivity to clomiphene citrate or any tablet component.

Warnings and Precautions:

Ovarian Hyperstimulation Syndrome (OHSS): Risk increases with prolonged use or high doses. Discontinue if abdominal pain or ovarian enlargement occurs.

Multiple Pregnancies:

5-8% incidence (mostly twins).
Visual Disturbances:  Blurred vision, photophobia, or scotomata reported. Discontinue if symptoms occur; may be irreversible.
Tumor Risk:  Long-term safety (>6 cycles) not established.
Endometrial Changes:  Abnormal endometrial thickening reported.

Adverse Reactions:
>10%: Hot flashes (10.4%), ovarian enlargement (13.6%)
1-10%: Abdominal discomfort, nausea, vomiting, breast tenderness.
<1%: Visual disturbances, headache, abnormal uterine bleeding.

Drug Interactions:
Estrogen-containing medications may reduce efficacy.
GnRH analogs may increase the risk of OHSS.

Dosage and Administration:
Initial Dose: 50 mg once daily for 5 days, starting on day 5 of the menstrual cycle.
Dose Adjustment: May increase to 100 mg daily for 5 days in subsequent cycles if ovulation does not occur.
Maximum Dose: 100 mg/day; maximum duration per cycle: 5 days.
Monitoring: Perform a pelvic examination before each treatment cycle. Confirm ovulation via basal body temperature or progesterone levels.

Patient Counseling Information

Advise patients to discontinue use and contact the provider immediately if pregnancy is suspected (perform a pregnancy test).
Visual symptoms or severe abdominal pain develop.
Emphasize risk of multiple pregnancies and fetal abnormalities.
Use barrier contraception during treatment due to teratogenic risk.