No

Ovulation Stimulator

Treatment of ovulatory failure in patients desiring pregnancy

X

Hypersensitivity or allergy to clomiphene citrate or any of its components; liver disease, abnormal uterine bleeding, suspected pregnancy, enlargement or development of ovarian cyst, uncontrolled thyroid or adrenal dysfunction in the presence of an organic intracranial lesion such as pituitary tumor

Patients unusually sensitive to pituitary gonadotropins (eg, polycystic ovary disease); multiple pregnancies, blurring or other visual symptoms can occur, ovarian hyperstimulation syndrome, and abdominal pain

>10%: Endocrine & metabolic: Hot flashes, ovarian enlargement

1% to 10%:

Cardiovascular: Thromboembolism

Central nervous system: Mental depression, headache

Endocrine & metabolic: Breast enlargement (males), breast discomfort (females), abnormal menstrual flow

Gastrointestinal: Distention, bloating, nausea, vomiting, hepatotoxicity

Ocular: Blurring of vision, diplopia, floaters, after-images, phosphenes, photophobia

<1%: Insomnia, fatigue, alopecia (reversible), weight gain, polyuria

Decreased response when used with danazol; decreased estradiol response when used with clomiphene

Protect from light

Induces ovulation by stimulating the release of pituitary gonadotropins

Half-life: 5-7 days

Elimination: Enterohepatically circulated; excreted primarily in feces with small amounts appearing in urine

Adults: Oral:

Female (ovulatory failure): 50 mg/day for 5 days (first course); start the regimen on or about the fifth day of cycle. The dose should be increased only in those patients who do not ovulate in response to cyclic 50 mg Clomid®. A low dosage or duration of treatment course is particularly recommended if unusual sensitivity to pituitary gonadotropin is suspected, such as in patients with polycystic ovary syndrome.

If ovulation does not appear to occur after the first course of therapy, a second course of 100 mg/day (two 50 mg tablets given as a single daily dose) for 5 days should be given. This course may be started as early as 30 days after the previous one after precautions are taken to exclude the presence of pregnancy. Increasing the dosage or duration of therapy beyond 100 mg/day for 5 days is not recommended. The majority of patients who are going to ovulate will do so after the first course of therapy. If ovulation does not occur after 3 courses of therapy, further treatment is not recommended and the patient should be re-evaluated. If 3 ovulatory responses occur, but pregnancy has not been achieved, further treatment is not recommended. If menses does not occur after an ovulatory response, the patient should be re-evaluated. Long-term cyclic therapy is not recommended beyond a total of about 6 cycles.

FSH and LH are expected to peak 5-9 days after completing clomiphene; ovulation assessed by basal body temperature or serum progesterone 2 weeks after last clomiphene dose

Clomiphene may increase levels of serum thyroxine and thyroxine-binding globulin (TBG)

May cause insomnia, fatigue, or depression

None reported

No information available to require special precautions

No effects or complications reported

Follow recommended schedule of dosing. You may experience hot flashes (cool clothes and cool environment may help). Report acute sudden headache; difficulty breathing; warmth, pain, redness, or swelling in calves; breast enlargement (male) or breast discomfort (female); abnormal menstrual bleeding; vision changes (blurring, diplopia, photophobia, floaters); acute abdominal discomfort; or fever. Breast-feeding precautions: Do not breast-feed.

May cause visual disturbances, dizziness, lightheadedness; if possibility of pregnancy, stop the drug and consult your physician

Tablet, as citrate: 50 mg

Purvin VA, "Visual Disturbance Secondary to Clomiphene Citrate," Arch Ophthalmol, 1995, 113(4):482-4.

Sokol RZ, "Prevention and Management of Complications Occurring During Treatment With Clomiphene," Drug Saf, 1990, 5(5):313-6.

Walker AB, Eldridge PR, and MacFarlane IA, "Clomiphene-Induced Pituitary Apoplexy in a Patient With Acromegaly," J Endocrinol, 1995, 144:29.