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
Contraindicated (1)
- ospemifene
ospemifene, clomiphene. Either increases effects of the other by pharmacodynamic synergism. Contraindicated.
Serious - Use Alternative (0)
Monitor Closely (1)
- benazepril
clomiphene, benazepril. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Increases risk of hypotension.
Minor (0)
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Serophene oral - | 50 mg tablet |  | |
| clomiphene citrate oral - | 50 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
clomiphene citrate oral
CLOMIPHENE - ORAL
(KLOE-mi-feen)
COMMON BRAND NAME(S): Clomid, Serophene
USES: This medication is used to treat infertility in women. It works by stimulating an increase in the amount of hormones that support the growth and release of a mature egg (ovulation). This medication is not recommended for women whose ovaries no longer make eggs properly (primary pituitary or ovarian failure).
HOW TO USE: Clomiphene must be taken by mouth exactly as directed by your doctor in order to be most effective. It is important to follow your dosing schedule carefully.Your dosage is based on your medical condition and response to therapy. Do not take it more often or for a longer time than prescribed by your doctor. Long-term treatment with this medication is not recommended and should not be more than 6 cycles.You may be directed to record your body temperature, perform ovulation tests, and properly time sexual intercourse for best results. Ask your doctor if you have any questions.
SIDE EFFECTS: Stomach upset, bloating, abdominal/pelvic fullness, flushing ("hot flashes"), breast tenderness, headache, or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: abnormal vaginal bleeding, mental/mood changes.Vision changes (e.g., blurred vision, seeing spots or flashes) may sometimes occur during clomiphene treatment, especially if you are exposed to bright light. These side effects usually go away a few days or weeks after treatment is stopped. However, in rare cases, vision changes may be permanent. Get medical help right away if any of the following occur: vision problems/changes, eye pain.This medication may cause a condition known as ovarian hyperstimulation syndrome (OHSS). Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. This may occur during therapy or after treatment has been stopped. Get medical help right away if you develop any of the following side effects: severe pain/swelling in the lower abdomen (pelvic) area, sudden/rapid weight gain, nausea/vomiting, diarrhea, shortness of breath, decreased urination, pain/redness/swelling of the legs, chest pain, fast/irregular heartbeat.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking clomiphene, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: ovarian cysts or enlarged ovaries (not due to polycystic ovary syndrome), abnormal vaginal bleeding, liver disease, uterus problems (e.g., uterine fibroids, endometriosis), thyroid/adrenal gland problems, tumor in the brain (pituitary tumor), high levels of fats/triglycerides in the blood.Use of clomiphene may result in multiple births (e.g., twins, triplets). Consult your doctor for more details.This drug may make you dizzy or cause vision changes. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Stop using this medication when you become pregnant. This medication must not be used during pregnancy. If you think you may be pregnant, tell your doctor right away.It is not known whether this drug passes into breast milk. This drug may reduce milk production. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: gonadorelin.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: vomiting, abdominal/pelvic pain, vision problems.
NOTES: Do not share this medication with others.Laboratory and/or medical tests (e.g., hormone levels, pelvic examination/ultrasound) should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, contact your doctor promptly for further instructions. Do not double the dose to catch up unless your doctor directs you to do so.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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