Posology : מינונים

4.2. Posology and method of administration
The recommended dosages should be strictly observed.
Whatever the indication and route of administration (oral or vaginal), the dosage should never exceed 200mg per dose.

Oral administration
This medicinal product should be taken on an empty stomach preferably in the evening before going to bed.
Usually, the dosage is 200 to 300 mg of progesterone daily in two intakes: one in the morning, preferably 2 hours after breakfast, another one to two in the evening (at bedtime) , on an empty stomach.

In luteal insufficiency (premenstrual syndrome, benign mastopathy, menstrual irregularities), dose is from 200 to 300 mg daily:
- either 200 mg in one intake at bedtime,
- or 300 mg in two intakes.
for 10 days per cycle, usually from the 17th to the 26th day, inclusive.

For the premenopause: the dose is 300 mg daily, divided into two intakes, i.e., 100 mg preferably two hours after breakfast and 200 mg at bedtime for 10 days (from the 17th to the 26th day of the cycle) up to 20 days (from the 7th to the 26th day of the cycle).
For menopause (HRT):
Isolated therapy is not recommended (risk of endometrial hyperplasia). Progesterone is therefore combined at a dose of 200 mg .
The usual dose is 200 mg daily for 12 to 14 days per month, if the patient does not wish to have regular cyclic bleeding. The total daily dose should be taken at bedtime in conjunction with estrogen administered at the lowest effective dose (i.e. that which induces a mean E2 plasma level above 60 pg/ml). The great majority of patients will become amenorrheic during the first year of treatment.

This treatment must be followed by the total discontinuation of any replacement therapy for approximately one week during which a deprivation hemorrhage is often observed.

If the patient wishes to have regular cyclic bleeding, the dose is 300 mg daily for 10 days per month, divided into two intakes, i.e. 100 mg in the morning and 200 mg at bedtime. The estrogen dose has to be increased (i.e. 3 mg percutaneous 17β estradiol per day).

In these indications the vaginal route is used, at the same dosages as the oral route, in cases of side effects due to progesterone (drowsiness after oral absorption).

Vaginal administration the capsules must be inserted deep into the vagina.

On the average, the dosage is 200 mg of progesterone daily distributed into two doses: one in the morning, another one in the evening.

In case of partial luteal insufficiencies (dysovulation, menstrual irregularities), the treatment should be carried out during 10 days per cycle, usually from the 17th to the     26th day, on the basis of 200 mg per day.

Progesterone substitution of ovary deprived women during complete deficiency (donation of ovocytes): progesterone dose is 100 mg on the 13th and 14th days of the transfer cycle, then 200 mg per day 15th to the 25th day of the cycle in one or two intakes. From the 26th day, the dose is increased in case of onset of pregnancy by 100 mg per day each week reaching a maximum of 600 mg per day divided into 3 intakes.
This dosage will be continued until the 60th day and until the 12th week of pregnancy and no further.

Supplementation of the luteal phase during IVF, 400 mg-600 mg per day, in two to three divided doses, starting on the evening of the HCG injection until the 12th week of pregnancy.

During the threat of abortion or prevention of repeated abortion due to luteal insufficiency, the recommended dose is 200 mg to 400 mg per day in 2 intakes until the 12th week of amenorrhea and no further.

Supplementation of the luteal phase during spontaneous or induced cycles, in cases of hypofertility or primary or secondary sterility, particularly through dysovulation.
The recommended posology is from 200 mg to 300 mg per day in two intakes, from the 17th day of the cycle during 10 days. The treatment must be repeated, as soon as possible, in the case of amenorrea and diagnosis of pregnancy until the 12th week of pregnancy.