Source: Υπουργείο Υγείας (CY) Revision Year: 2021 Publisher: Remedica Ltd Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
Ova-mit is indicated for the treatment of ovulatory failure in women desiring pregnancy.
Good levels of endogenous oestrogen provide a favourable prognosis for ovulatory response induced by Ova-mit, Ova-mit therapy is ineffective in patients with primary pituitary or primary ovarian failure.
The recommended dose for the first course of Ova-mit 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.
The importance of properly timed coitus cannot be over-emphasised (i.e. at about the time of ovulation). For regularity of cyclic ovulatory response it is also important that each course of Ova-mit be started on or about the fifth cycle day, once ovulation has been established. Ova-mit therapy follows the rule of diminishing returns, such that likelihood of conception diminishes with each succeeding course of therapy. Before starting treatment, patients and their male partners should be advised of the possibility of multiple pregnancy and its potential hazards if conception occurs in relation to Ova-mit therapy.
Not recommended.
Efficacy and safety of clomifene for more than 6 treatment cycles have not been demonstrated.
Oral administration.
Toxic effects of acute overdosage of clomifene citrate 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. Protected from light and moisture.
PVC/Aluminium blisters. Pack-size of 10 tablets.
PP containers with PE closure. Pack-sizes of 100 and 1000 tablets.
Not all pack sizes may be marketed.
No special requirements.
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