DEA Class; Rx

Common Brand Names; Clomid, Serophene

Indicated for treatment of Treatment of Ovulatory Failure

Pregnancy

Liver disease or history of liver disease

Undiagnosed abnormal uterine bleeding

Uncontrolled thyroid or adrenal dysfunction

Endometrial cancer

Ovarian cysts not due to PCOS

Presence of organic intracranial lesion, including pituitary tumor

Ovarian enlargement (14%)

Vasomotor flushing (10%)

Abdominal discomfort (6%)

Blurred vision (1.5%)

Breast discomfort (2%)

Nausea/vomiting (2%)

Body as a whole: Fever, tinnitus, weakness

Cardiovascular: Arrhythmia, chest pain, edema, hypertension, palpitation, phlebitis, pulmonary embolism, shortness of breath, tachycardia, thrombophlebitis

Central nervous system: Migraine headache, paresthesia, seizure, stroke, syncope

Dermatologic: Acne, allergic reaction, erythema, erythema multiforme, erythema nodosum, hypertrichosis, pruritus, urticaria

Genitourinary: Endometriosis, ovarian cyst (ovarian enlargement or cysts could, as such, be complicated by adnexal torsion), ovarian hemorrhage, tubal pregnancy, uterine hemorrhage; reduced endometrial thickness

Hepatic: Transaminases increased, hepatitis, pancreatitis

Musculoskeletal: Arthralgia, back pain, myalgia

Careful attention should be given to selection of candidates for therapy; pelvic examination is necessary prior to treatment and before each subsequent course

Uterine fibroids, pituitary or ovarian failure may occur

Potential for multiple births, especially at 100 mg dosage

Use should be supervised by a practitioner with training and thoroughly familiar with infertility problems and their management

Risk of visual disturbance (like scotoma & photopsia); patients should be warned that visual symptoms may render activities such as driving a car or operating machinery more hazardous than usual, particularly under conditions of variable lighting; while etiology of visual symptoms is not yet understood, patients with any visual symptoms should discontinue treatment and have complete ophthalmological evaluation carried out promptly

Cases of hypertriglyceridemia reported; preexisting or family history of hyperlipidemia and use of higher than recommended dose and/or longer duration of treatment are associated with risk of hypertriglyceridemia; periodic monitoring of plasma triglycerides is recommended in patients with preexisting or family history of hyperlipidemia; pretreatment screening of triglyceride levels is recommended in patients initiating therapy

Cases of pancreatitis reported

Prolonged use of clomiphene citrate tablets USP may increase risk of a borderline or invasive ovarian tumor

Presence of organic intracranial lesion, including pituitary tumor

Use in pregnant women is contraindicated, as treatment does not offer benefit in this population; to avoid inadvertent administration during early pregnancy, appropriate tests should be utilized during each treatment cycle to determine whether ovulation and/or pregnancy occurs; patients should be evaluated carefully to exclude ovarian enlargement or ovarian cyst formation between each treatment cycle; the next course of therapy should be delayed until these conditions have been excluded

It is not known whether drug is excreted in human milk; because many drugs are excreted in human milk, caution should be exercised if drug is administered to a nursing woman; in some patients, therapy may reduce lactation