Source: Υπουργείο Υγείας (CY) Revision Year: 2015 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Duinum (Clomifene citrate BP) is indicated for the treatment of ovulatory failure in women desiring pregnancy. Duinum is indicated only for patients in whom ovulatory dysfunction is demonstrated. Other causes of infertility must be excluded or adequately treated before giving Duinum.
The recommended dose for the first course of Duinum (Clomifene citrate BP) is 50mg (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 50mg 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 100mg daily (two 50mg 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 100mg/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.
Not recommended.
The relative safety of long-term cyclic therapy has not been conclusively demonstrated and, since the majority of patients will ovulate following 3 courses, long-term cyclic therapy is not recommended, i.e. beyond a total of about 6 cycles (including 3 ovulatory cycles).
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).
Oral administration.
Toxic effects of acute over dosage of clomifene have not been reported but the number of overdose cases recorded is small.
In the event of overdose, appropriate supportive measures should be employed.
5 years.
Store below 25°C in the original package.
Blister pack:
Base: 250 micron PVC.
Foil: 20 micron hard-tempered aluminium (in cardboard cartons).
Pack sizes: 10 and 30 tablets.
Not all pack sizes may be marketed.
No special precautions for disposal.
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