Utrogestan

/ CTS

The dosage and the treatment regimen will be determined by the physician only.
The recommended dosage is usually:
Oral administration (swallowing): 1 capsules a day at bedtime In cases where a higher dose is needed, 200 mg should be taken at bedtime and an additional 100 mg in the morning.
Vaginal administration: 1 -3 capsules a day, preferably divided doses as instructed by the physician.

Oral administration: Progesterone deficiency, in particular: Premenstrual syndrome, menstrual irregularities due to dysovulation or anovulation, benign mastopathy, premenopause. In menopause, as an adjunct to estrogen replacement therapy (in order to avoid endometrial hyperplasia and carcinoma).
Vaginal administration: As an alternative to oral route, with the following additional indications: Progesterone substitution for ovary deprived women in a situation of total progesterone deficiency (oocyte donation programs), supplementation of the luteal phase during in vitro fertilization cycles (IVF). Supplementation of the luteal phase during spontaneous or induced cycles, in cases of hypofertility or primary or secondary ovarian failure, particularly through dysovulation; in cases of threatening abortion or prevention of repeated abortions due to proven luteal insufficiency; for all other progesterone indications, in the case of adverse events due to progesterone (somnolence after oral administration); contraindications of the oral route of administration (hepatopathy).

Severe liver dysfunction, hypersensitivity to the active substance or to any of the excipients or suspected or confirmed breast or genital organ neoplasia.

* Presence of uterine bleeding, do not prescribe before establishing a cause, particularly with endometrial investigations.
* Because of the metabolic risks and risks of thromboembolism, administration should be discontinued in the event of:
– occular disorders such as reduced vision, diplopia and retinal vascular lesions
– venous thromboembolic or thrombotic events, regardless of territory
– severe headaches
* History of venous thrombosis, should be monitored closely.
* Appearance of amenorrhea during treatment, ensure that she is not pregnant.
* In early miscarriage the only effect of progesterone in this situation is to delay removal of a deceased embryo. Progesterone should therefore be limited to situations in which corpus luteum secretion is insufficient.
* Should only be used in pregnancy during the first trimester and only by the vaginal route. It’s not a treatment of threatening premature labour.
See prescribing information for full details.

Breakthrough bleeding or spotting, breast tenderness, sleeplessness, dizziness, headaches, skin rash, itching, jaundice.
See prescribing information for full details.

Concurrent use (over 3 months) of barbiturates, carbamazepine, hydantoins or rifampicin. Activated charcoal, griseofulvin, cyclosporin, theophyllines, troleandomycin. Progesterone administration for a minimum of 12 days per cycle is strongly recommended in oestrogen hormone therapy for the menopause.

Pregnancy
Use of this medicine is not contraindicated in pregnancy, including the first weeks of pregnancy.
Lactation
Secretion of progesterone into breast milk has not been studied in detail. It should therefore be avoided in women who are breast-feeding.

The usual dosage may be excessive in some people because of persistence or recurrence of unstable endogenous progesterone secretion, particular sensitivity to the substance or excessively low concomitant blood oestrodiol concentrations. In these situations:
-the dosage should be reduced or the progesterone should be administered at bedtime in the evening, 10 days per cycle, if drowsiness or fleeting dizziness occurs.
-treatment should be started later in the cycle (such as on day 19 instead of day 17) if the cycle is shortened or spotting occurs.
-check that oestrodiol concentrations are sufficient in the perimenopausal period and in hormone-replacement therapy for the menopause.
Vaginal administration, no overdose has been reported to date with the vaginal form, the undesirable effects described above could be signs of an overdose. They resolve spontaneously when the dosage is reduced.

Cases of drowsiness and dizziness have been reported with oral use.
Attention should be drawn to the risks of drowsiness and/or dizziness associated with the oral use of this medicine, particularly in the case of patients who drive or operate machinery. Ingestion of the capsules at bedtime will avoid such problems.