Pregina Dosage/Direction for Use

General Considerations: The workup and treatment of candidates for clomifene citrate therapy should be supervised by physicians experienced in the management of gynecologic or endocrine disorders. Clomifene should only be given to appropriately chosen anovulatory patients. The therapeutic objective should be balanced with potential risks. These should be discussed with the patient and others who are involved in the achievement of a pregnancy. The plan of therapy should be outlined in advance.
Data suggest that clomifene treatment of 100 mg/day for 5 days is more effective compared with 50 mg/day for 5 days. However, an increased incidence of ovarian hyperstimulation and other adverse effects may be expected. It is recommended that clomifene be usually started with the lowest effective dose and increased only in those patients who do not respond to the first course of treatment. Special care in dosage is particularly recommended if unusual sensitivity to pituitary gonadotropin is suspected, such as in patients with PCOS.
Recommended Dosage: First Course: 50 mg once a day for five (5) days.
Treatment may be started at any time in the patient who has had no recent uterine bleeding. Start clomifene therapy about the 5th day of the menstrual cycle if progestin-induced bleeding is planned or if spontaneous uterine bleeding occurs prior to therapy. When ovulation occurs at this dose, there is no advantage to increasing the dose in subsequent treatment cycles.
If ovulation appears not to have occurred after the first course of therapy, a second course of 100 mg once a 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. Increasing the dose or duration of therapy beyond 100 mg per day for 5 days should never be undertaken.
The majority of patients who respond do so during the first course of therapy; three (3) courses should constitute an adequate therapeutic trial. If ovulatory menses have not occurred, the diagnosis should be re-evaluated. Treatment beyond this is not recommended in the patient who does not exhibit evidence of ovulation.
In most patients, ovulation will take place 6 to 12 days after completion of therapy. Coitus should be timed to coincide with the expected time of ovulation. Appropriate tests to determine ovulation may be useful during this time.
Long-term cyclic therapy (more than a total of 6 cycles, including 3 ovulatory cycles) with clomifene is not recommended. The relative safety of long-term cyclic administration of clomifene citrate has not been established.