Dosing & Uses
Dosage Forms & Strengths
tablet
- 50mg
Treatment of Ovulatory Failure
50 mg PO qDay initially for 5 days
If no ovulation, treatment can be repeated as early as 30 days after previous therapy; exclude presence of pregnancy; use the lowest effective dose
Dosage can be increased to 100 mg only in patients who do not respond to first course; lower doses of 12.5-25 mg qDay may be administered in women sensitive to the drug or who consistently develop large ovarian cysts
Monitor
Reassess diagnosis after 3 courses if ovulation has not occurred or if menses does not occur following ovulatory response
Not used in children
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Adverse Effects
>10%
Ovarian enlargement (14%)
Vasomotor flushing (10%)
1-10%
Abdominal discomfort (6%)
Blurred vision (1.5%)
Breast discomfort (2%)
Nausea/vomiting (2%)
Postmarketing Reports
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
Neoplasms: Liver (hepatic hemangiosarcoma, liver cell adenoma, hepatocellular carcinoma); breast (fibrocystic disease, breast carcinoma); endometrium (endometrial carcinoma); nervous system (astrocytoma, pituitary tumor, prolactinoma, neurofibromatosis, glioblastoma multiforme, brain abscess); ovary (luteoma of pregnancy, dermoid cyst of the ovary, ovarian carcinoma); trophoblastic (hydatiform mole, choriocarcinoma); miscellaneous (melanoma, myeloma, perianal cysts, renal cell carcinoma, Hodgkin’s lymphoma, tongue carcinoma, bladder carcinoma)
Psychiatric: Anxiety, irritability, mood changes, psychosis
Visual disorders: Abnormal accommodation, cataract, eye pain, macular edema, optic neuritis, photopsia, posterior vitreous detachment, retinal hemorrhage, retinal thrombosis, retinal vascular spasm, temporary or prolonged loss of vision, possibly irreversible
Metabolism disorders: Hypertriglyceridemia
Other: Leukocytosis, thyroid disorder
Fetal/neonatal anomalies
- Abnormal bone development: skeletal malformations of the skull, face, nasal passages, jaw, hand, limb (ectromelia including amelia, hemimelia, and phocomelia), foot (clubfoot), spine, and joints
- Cardiac abnormalities: septal heart defects, muscular ventricular septal defect, patent ductus arteriosus, tetralogy of Fallot, and coarctation of the aorta
- Chromosomal disorders: Downs syndrome
- Ear abnormalities and deafness
- Gastrointestinal tract abnormalities: cleft lip and palate, imperforate anus, tracheoesophageal fistula, diaphragmatic hernia, omphalocele
- Genitalia abnormalities: hypospadias, cloacal exstrophy
- Lung tissue malformations
- Malformations of the eye and lens (cataract)
- Neoplasms: neuroectodermal tumor, thyroid tumor, hepatoblastoma, lymphocytic leukemia
- Nervous system abnormalities: neural tube defects (anencephaly, meningomyelocele), microcephaly, and hydrocephalus
- Renal abnormalities: renal agenesis and renal dysgenesis
- Others: dwarfism, mental retardation
Warnings
Contraindications
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
Cautions
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
Ovarian enlargement may be accompanied by abdominal distention or abdominal pain and generally regresses without treatment within days or weeks of discontinuing therapy; withhold therapy if ovaries are abnormally enlarged until size returns to pretreatment size; reduce dose and duration of future cycles
Ovarian hyperstimulation syndrome
- Ovarian hyperstimulation syndrome is a rare exaggerated response to ovulation induction therapy
- May begin within 24 hours of treatment but may become severe 7 to 10 days after therapy
- Symptoms may include abdominal distention discomfort, nausea, diarrhea, vomiting
- Severe symptoms may include severe abdominal pain ascites, hypotension, anuria/oliguria
- Treatment is primarily symptomatic, including analgesics, fluid and electrolyte management, and prevention of thromboembolic complications
Pregnancy & Lactation
Pregnancy
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
Available human data from epidemiologic studies do not show apparent cause and effect relationship between clomiphene citrate periconceptual exposure and an increased risk of overall birth defects, or any specific anomaly
Lactation
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
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Binds to estrogen receptors, induces ovulation by increase output of pituitary gonadotropins
Pharmacokinetics
Half-Life elimination: 5-7 days
Onset: Within 5-10 days
Peak plasma time 6.5 hours
Bioavailability: Readily absorbed from GI tract
Metabolism: Enterohepatically circulated
Excretion: feces 37-51%; small amount in urine
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Formulary
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