Treatment of progesterone deficiencies such as: Treatment of dysmenorrhoea Treatment of endometriosis Treatment of secondary amenorrhoea Treatment of irregular cycles Treatment of dysfunctional uterine bleeding Treatment of pre-menstrual syndrom Treatment of threatened and habitual abortion, associated with proven progesterone deficiency Treatment of infertility due to luteal insufficiency
Dydrogesterone is an orally-active progestogen which produces a complete secretory endometrium in an estrogen-primed uterus thereby providing protection against the increased risk for endometrium hyperplasia and carcinogenesis induced by estrogens. It is indicated in all cases of endogenous progesterone deficiency. Dydrogesterone has no estrogenic, no androgenic, no thermogenic, no anabolic and no corticoid activity.
Recurrent miscarriage: 10 mg bid given cyclically until conception, then continuously until wk 20 of pregnancy, after which dose may be gradually reduced. Infertility: 10 mg bid. Menstrual disorders: 10 mg bid in a cyclical regimen. Endometriosis: 10 mg bid-tid cyclically or continuously. Threatened miscarriage: Initially, 40 mg followed by 10 mg or more every 8 hr, continued for a wk after symptoms are relieved. Reduce dose gradually after that unless symptoms return. Endometrial protection during menopausal hormonal replacement therapy: 10 mg 1-2 times daily in a cyclical regimen or 5 mg daily.
No interaction studies have been performed.
Hypersensitivity to the active substance or to any of the excipients. Known or suspected progestogen dependent neoplasms. Undiagnosed vaginal bleeding. Monitor closely for loss of vision, proptosis, diplopia, migraine, signs and symptoms of embolic disorders. CVD or renal impairment, epilepsy, asthma, other conditions which may be aggravated by fluid retention. Lactation.
Dizziness, nausea, headache, fatigue, emotional lability, irritability; abdominal pain and distention; muskuloskeletal pain.
From spontaneous surveillance systems to date, there is no evidence that dydrogesterone can not be used during pregnancy. Dydrogesterone is excreted in the milk of nursing mothers. A risk to the suckling child cannot be excluded. Dydrogesterone should not be used during breast-feeding. There is no evidence that dydrogesterone decreases fertility at therapeutic dose.
Dydrogesterone was well tolerated after oral dosing (maximum daily dose is 360 mg). No reports of ill effects from overdose have been recorded. If a large overdose is discovered within two or three hours and treatment seems desirable, gastric lavage is recommended. There are no specific antidotes and treatment should be symptomatic. Aforementioned information is also applicable for overdosing in children.
Store at below 30°C in a dry place protected from light. Keep out of reach of children.
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