General

Pronunciation
KLOE-mi-feen

Trade Name(s)

• Clomid

• Milophene

• Serophene

Pregnancy Category
Category X

Ther. class.
ovulation inducer

Indications

Induces ovulation in anovulatory women who desire pregnancy. Requires intact anterior pituitary, thyroid, and adrenal function

Unlabelled Use(s):
Male infertility due to oligospermia

Action

Stimulates release of pituitary gonadotropins, follicle-stimulating hormone, and luteinizing hormone, resulting in ovulation and the development of the corpus luteum

Therapeutic Effect(s):
Induction of ovulation

Pharmacokinetics

Absorption: Well absorbed following oral administration

Distribution: Unknown

Metabolism and Excretion: Metabolized by the liver, with enterohepatic recirculation. Excreted in feces

Half-life: 5–7 days

TIME/ACTION PROFILE (ovulation)

ROUTE	ONSET	PEAK	DURATION
PO	5–14 days	unknown	unknown

Contraindication/Precautions

Contraindicated in:

• Liver disease or history of liver dysfunction

• Enlargement or development of ovarian cysts (not due to polycystic ovarian syndrome)

• Pregnancy

• Uncontrolled thyroid or adrenal dysfunction

• Pituitary tumor

• Abnormal uterine bleeding of unknown origin

Use Cautiously in:

• Endometriosis

• Fibroids

• Known sensitivity to pituitary gonadotropins (e.g. polycystic ovary syndrome)

Adverse Reactions/Side Effects

CNS: headache.

EENT: blurred vision, floaters, photophobia, scotomata, phosphenes.

CV: hot flashes.

GI: abdominal pain, bloating, distention, nausea, vomiting, liver enzymes.

Endo: ovarian cyst formation, ovarian enlargement, breast discomfort, multiple births, intermenstrual spotting, abnormal menstrual flow.

Metabolic: weight gain.

*CAPITALS indicates life-threatening.
*italic indicates most frequent.

Interactions

Drug-Drug
None significant

Route/Dosage

Ovulatory Failure (Females)

• PO (Adults): 50 mg/day for 5 days (begin on or about 5th day of cycle); if ovulation does not occur, a second course of 100 mg/day for 5 days may be given 30 days after the initial course. A maximum of 3 courses may be administered. Increasing dose above 100 mg/day for 5 days is not recommended.

Male Infertility

• PO (Adults): 25 mg/day for 25 days with 5 days rest or 100 mg every Monday, Wednesday, and Friday.

Availability

• Tablets: 50 mg

Assessment

• Perform a pelvic examination to determine ovarian size and presence of ovarian cysts prior to therapy and before subsequent courses of therapy

• An endometrial biopsy is recommended in older patients prior to clomiphene therapy to rule out the presence of endometrial carcinoma

• Assess patient for abdominal pain throughout therapy. Occurrence requires immediate pelvic examination to determine ovarian enlargement or cyst formation. If these occur, discontinue therapy until ovaries have returned to pretreatment size, usually within a few days to weeks. Dose and duration of next course should be decreased

• If 3 ovulatory responses occur without achievement of pregnancy, further treatment with clomiphene is not recommended

Lab Test Considerations

• Estrogen excretion determinations, histologic studies of the luteal phase endometrium, serum progesterone, and urinary excretion of pregnanediol may be used to determine whether ovulation has occurred following a course of clomiphene

» Liver function tests should be performed prior to course of therapy

» Immunologic assay for human chorionic gonadotropin (HCG) should be used to determine pregnancy if menses do not occur prior each course of treatment with clomiphene

Potential Nursing Diagnoses

• Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

Do not confuse clomiphene with clomipramine

» Clomiphene therapy is usually begun on the 5th day of the menstrual cycle

Patient/Family Teaching

• Instruct patient to take clomiphene exactly as directed at the same time each day. Missed doses should be taken as soon as remembered and the dose doubled if not remembered until the time of the next dose. Notify health care professional if more than one dose is missed

• Advise patient that conception should be attempted with intercourse every other day starting 48 hr prior to ovulation. Ovulation usually occurs 7 days (range 5–10) after last dose of clomiphene

• Instruct patient in the correct method for measuring basal body temperature. A record of the daily basal body temperature should be maintained prior to and throughout course of therapy. Emphasize the importance of compliance with all aspects of therapy

• Prior to therapy, patient should be informed of the potential for multiple births

• Medication may cause visual disturbances or dizziness. Caution patient to avoid driving until the response to the medication is known

• Instruct patient to notify health care professional immediately if pregnancy is suspected; clomiphene should not be taken during pregnancy

• Advise patient that ophthalmologic exams should be performed to evaluate the possibility of ocular toxicity if treatment is continued for more than 1 yr

• Advise patient to notify health care professional promptly if bloating, stomach or pelvic pain, blurred vision, jaundice, persistent hot flashes, breast discomfort, headache, diarrhea, weight gain, or nausea and vomiting occur

• Emphasize the importance of close monitoring by health care professional throughout therapy

Evaluation/Desired Outcomes

Occurrence of ovulation measured by estrogen excretion, biphasic body temperature curve, urinary excretion of pregnanediol at postovulatory levels, and endometrial histologic changes. If conception is not achieved after 3 courses of clomiphene, diagnosis should be re-evaluated

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