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Ovulatory stimulant




Treatment of ovulatory dysfunction in women desiring pregnancy.


Ovulatory Dysfunction

Initial: 50mg qd for 5 days
If progestin-induced bleeding is planned, or if spontaneous uterine bleeding occurs prior to therapy, start on 5th day of cycle; may start at any time if w/o recent uterine bleeding
Titrate: Increase to 100mg qd for 5 days only in patients who do not ovulate in response to cyclic 50mg after the 1st course of therapy; may start as early as 30 days after 1st course
Max: 100mg/day for 5 days
Long-term cyclic therapy beyond a total of 6 cycles is not recommended

If ovulation does not occur after 3 courses of therapy or if 3 ovulatory responses occur but pregnancy is not achieved, further treatment is not recommended

If menses does not occur after an ovulatory response, reevaluate patient


Other Important Considerations
Polycystic Ovary Syndrome (PCOS)/Unusual Pituitary Gonadotropin Sensitivity:
Use lowest recommended dose and shortest treatment duration for the 1st course of therapy


Oral route


Tab: 50mg* *scored


Pregnancy, liver disease or history of liver dysfunction, abnormal uterine bleeding of undetermined origin, ovarian cysts or enlargement not due to PCOS, uncontrolled thyroid or adrenal dysfunction or in the presence of an organic intracranial lesion (eg, pituitary tumor).


Workup and treatment should be supervised by physician experienced in management of gynecologic or endocrine disorders. Visual symptoms (eg, blurring, spots, flashes), some occurring after discontinuation of therapy, reported; d/c treatment and perform complete ophthalmological evaluation promptly if visual symptoms develop. Visual disturbances may be irreversible, especially w/ increased dosage or duration of therapy. Ovarian hyperstimulation syndrome (OHSS), which may progress rapidly (w/in 24 hrs to several days) reported; monitor for abdominal pain/distention, N/V, diarrhea, weight gain, and for other warning signs. If conception results, rapid progression to severe form of the syndrome may occur. Use lowest effective dose consistent w/ expected clinical results to minimize the hazard of abnormal ovarian enlargement. If ovarian enlargement occurs, do not give additional therapy until the ovaries have returned to pretreatment size, and reduce the dosage or duration of the next course. Ovarian enlargement and cyst formation usually regresses spontaneously w/in a few days or weeks after discontinuing treatment; manage cystic enlargement conservatively unless surgical indication for laparotomy exists. Perform a thorough evaluation to rule out ovarian neoplasia if ovarian cysts do not regress spontaneously. Prolonged use may increase risk of borderline/invasive ovarian tumor. Perform pelvic exam prior to initiating therapy and before each subsequent course. Carefully evaluate to exclude pregnancy, ovarian enlargement, or ovarian cyst formation between each treatment cycle. Caution w/ uterine fibroids; potential for further enlargement.


Ovarian enlargement, vasomotor flushes, abdominal-pelvic discomfort/distention/bloating.


Category X, caution in nursing.


Ovulatory stimulant; may compete w/ estrogen for estrogen-receptor-binding sites and may delay replenishment of intracellular estrogen receptors. Increases release of pituitary gonadotropins, thereby initiating steroidogenesis and folliculogenesis, resulting in ovarian follicle growth and increased circulating estradiol levels.


Absorption: Readily absorbed. Elimination: Feces (42%), urine (8%).


Assess for hypersensitivity to drug, ovarian cysts/enlargement, abnormal vaginal/uterine bleeding, presence of organic intracranial lesion, primary pituitary/ovarian failure, endometriosis/endometrial carcinoma, liver disease or history of liver dysfunction, impediments to pregnancy (eg, thyroid/adrenal disorders, hyperprolactinemia, male factor infertility), uterine fibroids, preexisting or family history of hyperlipidemia, and pregnancy/nursing status. Perform pelvic exam prior to treatment. Assess estrogen levels.


Monitor for signs/symptoms of visual symptoms (eg, blurring, spots, flashes), OHSS, ovarian neoplasia, and other adverse reactions. Monitor plasma TG levels periodically in patients w/ preexisting or family history of hyperlipidemia. Exclude pregnancy, ovarian enlargement, or ovarian cyst formation between each treatment cycle. Perform pelvic exam before each subsequent course.


Advise that blurring or other visual symptoms may occur during or shortly after therapy and inform that in some instances, visual disturbances may be prolonged, and possibly irreversible, especially w/ increased dosage or duration of therapy. Advise that visual symptoms may render such activities as driving a car or operating machinery more hazardous than usual, particularly under conditions of variable lighting. Instruct to inform physician whenever any unusual visual symptoms occur and to d/c therapy. Advise that ovarian enlargement may occur during or shortly after therapy; instruct to inform physician if any abdominal/pelvic pain, weight gain, discomfort, or distention occurs after taking therapy. Inform that preexisting or family history of hyperlipidemia and use of higher than recommended dose and/or longer duration of treatment may increase risk of hypertriglyceridemia. Inform of the increased chance of multiple pregnancy (eg, bilateral tubal pregnancy, coexisting tubal and intrauterine pregnancy), and the potential complications/hazards of multiple pregnancy.


15-30°C (59-86°F). Protect from heat, light, and excessive humidity.


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