The recommended dose for the first course of Clomid (Clomifene Citrate BP) is 50 mg (1 tablet) daily for 5 days. Therapy may be started at any time in the patient who has had no recent uterine bleeding. If progestin-induced bleeding is planned, or if spontaneous uterine bleeding occurs before therapy, the regimen of 50 mg daily for 5 days should be started on or about the fifth day of the cycle. When ovulation occurs at this dosage, there is no advantage to increasing the dose in subsequent cycles of treatment.
If ovulation appears not to have occurred after the first course of therapy, a second course of 100 mg daily (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. Increase of the dosage or duration of therapy beyond 100 mg/day for 5 days should not be undertaken.
The majority of patients who are going to respond will respond to the first course of therapy, and 3 courses should constitute an adequate therapeutic trial. If ovulatory menses have not yet occurred, the diagnosis should be re-evaluated. Treatment beyond this is not recommended in the patient who does not exhibit evidence of ovulation.
Long-term cyclic therapy.
Not recommended.
Efficacy and safety of clomifene for more than 6 treatment cycles have not been demonstrated.
Special Populations
Special care with lower dosage or duration of treatment is particularly recommended if unusual sensitivity to pituitary gonadotrophin is suspected, such as in patients with polycystic ovary syndrome (see section 5.1).
Method of Administration
Oral.
Pregnancy: See section 4.6.
Liver disease: Clomid (Clomifene Citrate BP) therapy is contraindicated in patients with liver disease or a history of liver dysfunction.
Hormone-Dependent Tumours or Abnormal uterine bleeding: Clomid is contraindicated in patients with hormone-dependent tumours or in patients with abnormal uterine bleeding of undetermined origin.
Ovarian cyst: Clomid should not be given in the presence of an ovarian cyst, except polycystic ovary, since further enlargement of the cyst may occur. Patients should be evaluated for the presence of ovarian cyst prior to each course of treatment.
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