국가: 남아프리카
언어: 영어
출처: South African Health Products Regulatory Authority (SAHPRA)
Schering
DUPHASTON 10 mg TABLETS Solvay Pharmaceuticals SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): DUPHASTON 10 mg TABLETS COMPOSITION 1 tablet contains dydrogesterone (9beta,10alpha-pregna-4,6-diene-3,20-dione) 10 mg. PHARMACOLOGICAL CLASSIFICATION A. 21.8.2 Progesterones without estrogens. PHARMACOLOGICAL ACTION Dydrogesterone is an orally active progestogen which acts directly on the uterus, producing a complete secretory endometrium in an estrogen-primed uterus. At therapeutic levels, dydrogesterone has no contraceptive effect as it does not inhibit or interfere with ovulation or the corpus luteum. Furthermore, Duphaston is non-androgenic, non-estrogenic, non-corticoid, non-anabolic and is not excreted as pregnanediol. INDICATIONS Irregular duration of cycles and irregular occurrence and duration of periods caused by progesterone deficiency. Combined with an estrogenic substance, Duphaston can be applied in secondary amenorrhoea, dysfunctional uterine bleeding and post-menopausal complaints where endogenous progesterone deficiency is implicated. CONTRA-INDICATIONS Duphaston should not be given to patients with undiagnosed vaginal bleeding nor to those with a history of thromboembolic disorders. DOSAGE AND DIRECTIONS FOR USE In general The dosage schemes below are meant as general recommendations. For optimal therapeutic effect, the dosages are to be adapted to the nature and severity of the disorder. In irregular cycles due to endogenous progesterone deficiency Duphaston 5 to 10 mg is recommended especially in irregular cycles due to shortened luteal phase (ie pre-menopause). Treatment should be repeated for several cycles. In secondary amenorrhoea Administration of Duphaston in combination with an estrogen is usually recommended as in these conditions endogenous progesterone deficiency is nearly al 전체 문서 읽기