Posology : מינונים

4.2   Posology and method of administration
Posology
The following dosage regimens are recommended for treatment with Duphaston. The quantities can be adjusted according to the seriousness of the disorder to be treated and the individual patients’ responses to the treatment.

Regulation of the cycle
It is possible to achieve a cycle lasting 28 days by giving 1 tablet of Duphaston a day from the 11th to the 25th day of the cycle.

Endometriosis
1 to 3 tablets of Duphaston a day from the 5th to the 25th day of the cycle or for the entire cycle. Dosages of 10 mg several times a day should be spread over the day. It is recommended to start treatment with the highest dosage.

Dysmenorrhoea
1 to 2 tablets of Duphaston a day from the 5th to the 25th day of the cycle. Dosages of 10 mg several times a day should be spread over the day. It is recommended to start the treatment with the highest dosage.


Infertility as a result of corpus luteum insufficiency
1 tablet of Duphaston a day from the 14th to the 25th day of the cycle.
Treatment should be continued for at least 6 consecutive cycles. It is advisable to continue this treatment for the first months of any pregnancy at dosages as indicated for habitual abortion.

Luteal support as part of an Assisted Reproductive Technology (ART) treatment 1 tablet of Duphaston three times a day (30 mg daily) starting at the day of oocyte retrieval and continuing for 10 weeks if pregnancy is confirmed.

Threatened abortion
Starting dose: 4 tablets of Duphaston at once followed by 1 tablet of Duphaston 10 mg every 8 hours. Dosages of 10 mg several times a day should be spread over the day. It is recommended that treatment should start at the highest dose.
If the symptoms persist or recur during the treatment, the dose should be increased by 1 tablet of Duphaston every 8 hours.
The effective dose should be maintained for one week after symptoms have ceased; it can then be gradually reduced. If the symptoms recur, the treatment should be resumed immediately at the effective dose.

Habitual abortion
1 tablet of Duphaston a day up to the 20th week of pregnancy; the dose can then be gradually reduced. Treatment should preferably be started before conception.
If the symptoms of threatened abortion occur during treatment, treatment should be continued as described for that indication.

Dysfunctional uterine bleeding
Bleeding is stopped by 2 tablets of Duphaston a day for 5 to 7 days. The blood loss is reduced considerably within a few days. A few days after the end of this treatment, a heavy withdrawal bleed occurs and the patient should be warned about this.
Subsequent heavy bleeding can be prevented by prescribing a prohylactic dose of 1 tablet of Duphaston a day from the 11th to the 25th day of the cycle, if necessary combined with an oestrogen for 2 to 3 cycles. After this the treatment can be discontinued, in order to check that the patient has a normal cycle again.

Secondary amenorrhoea
1 or 2 tablets of Duphaston per day from the 11th to the 25th day of the cycle to give optimum secretion transformation of the endometrium, that is adequately prepared with an endogenous or exogenous oestrogen.
Pre-menstrual syndrome:
10 mg twice daily from day 11 to day 26 of the cycle.

There is no relevant use of dydrogesterone before the menarche. The safety and efficacy of dydrogesterone in adolescents aged from 12 to 18 years has not been established.

Method of administration
For oral use.
For administration of higher doses, the tablets should be taken evenly distributed over the day.