clomiphene citrate
Clomid, Milophene, Serophene

Pharmacologic classification: chlorotrianisene derivative
Therapeutic classification: ovulation stimulant
Pregnancy risk category X


Available forms
Available by prescription only
Tablets: 50 mg

Indications and dosages
 To induce ovulation. Adults: 50 mg P.O. daily for 5 days, starting any time in women who have had no recent uterine bleeding; or 50 mg P.O. daily starting on day 5 of menstrual cycle (first day of menstrual flow is day 1). Dose may be increased to 100 mg if ovulation doesn’t occur. Repeat the 5-day course each ovulatory cycle until conception occurs or until three courses of therapy are completed.
 Male infertility ◇. Adults: 50 to 400 mg P.O. daily for 2 to 12 months.

Pharmacodynamics
Ovulation stimulant action: Mechanism of action for inducing ovulation in anovulatory women is unknown. Drug may stimulate release of pituitary gonadotropin, follicle-stimulating hormone (FSH), and luteinizing hormone (LH), which results in development and maturation of the ovarian follicle, ovulation, and subsequent development and function of corpus luteum.

Pharmacokinetics
Absorption: Absorbed readily from the GI tract.
Distribution: May undergo enterohepatic recirculation or may be stored in body fat.
Metabolism: Metabolized by the liver.
Excretion: Half-life is about 5 days. Drug is excreted principally in feces via biliary elimination.

Route Onset Peak Duration
P.O. Unknown Unknown Unknown


Contraindications and precautions
Contraindicated during pregnancy and in patients with undiagnosed abnormal genital bleeding, ovarian cyst not caused by polycystic ovarian syndrome, hepatic disease or dysfunction, uncontrolled thyroid or adrenal dysfunction, or presence of organic intracranial lesion (such as a pituitary tumor).

Interactions
None reported.

Adverse reactions
CNS: headache.
EENT: blurred vision, diplopia, scotoma, photophobia.
GI: nausea, vomiting, bloating, distention.
GU: abnormal uterine bleeding; ovarian enlargement and cyst formation, which regress spontaneously when drug is stopped; ovarian hyperstimulation syndrome.
Respiratory: cough, dyspnea.
Other: hot flashes; reversible breast discomfort.

Effects on lab test results
None reported.

Overdose and treatment
No information available.

Special considerations
• Advise patient to stop drug and call immediately if abdominal symptoms or pain occur; these may indicate ovarian enlargement or ovarian cyst. Also tell patient to immediately report visual disturbances.
• Human chorionic gonadotropin (5,000 to 10,000 units) may be administered 5 to 7 days after the last dose of drug to stimulate ovulation.
Pregnant patients
• Drug is contraindicated during pregnancy because of teratogenic possibilities. Advise patient to discontinue drug and call if she suspects she’s pregnant.

Patient education
• Advise patient of possibility of multiple births, which increases with higher doses.
• Patient should take basal body temperature every morning (starting on day 1 of menstrual period) and chart on a graph to detect ovulation.
• Inform patient of importance of properly timed coitus.
• Warn patient to avoid hazardous tasks until response to drug is known because dizziness or visual disturbances may occur.

Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE THREATENING.
◆ Canada only
◇ Unlabeled clinical use