Dydrogesterone

May be taken with or without food.

Known or suspected progestogen dependent neoplasms (e.g. meningioma), undiagnosed abnormal vaginal bleeding; any contraindications associated with estrogen (when dydrogesterone is used in combination with estrogen). Existing or history of serious liver disorders (as long as liver function is not normalised). Lactation.

Patient with existing or history of depression, porphyria; diabetes, predisposition to cholestasis; herpes gestationis, otosclerosis; known thrombophilic states, risk factors for venous thromboembolism (e.g. SLE, cancer, major surgery, prolonged immobilisation, obesity [BMI >30 kg/m²], use of estrogens). Hepatic impairment. Pregnancy. Patient Counselling This drug may cause mild somnolence or dizziness, if affected, do not drive or operate machinery. Monitoring Parameters Rule out malignancy in all cases of undiagnosed abnormal vaginal bleeding (e.g. endometrial sampling). Screen for complete personal and family medical history prior to initiating and reinstituting hormone replacement therapy. Perform routine physical examination (e.g. breast and pelvic exam, mammogram, blood pressure, Papanicolau smear) periodically before and during treatment.

Significant: Breakthrough bleeding and spotting (particularly during the 1st months of therapy); venous thromboembolism (e.g. DVT, pulmonary embolism); increased risk of ischaemic stroke, MI, coronary artery disease, and breast cancer (particularly during combined estrogen-progestogen therapy); CNS effects (e.g. dizziness, drowsiness). Rarely, increased risk of ovarian cancer. Gastrointestinal disorders: Nausea, vomiting, abdominal pain. Hepatobiliary disorders: Abnormal hepatic function. Investigations: Increased weight. Nervous system disorders: Migraine, headache. Psychiatric disorders: Depressed mood. Reproductive system and breast disorders: Menstrual disorders (including metrorrhagia, menorrhagia, amenorrhoea, oligomenorrhoea, dysmenorrhoea, and irregular menstruation), breast tenderness or pain. Skin and subcutaneous tissue disorders: Rash, pruritus, urticaria.

Increased metabolism with CYP enzyme inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, efavirenz, nevirapine).

Oestrogens & Progesterones & Related Synthetic Drugs

G03DB01 - dydrogesterone ; Belongs to the class of pregnadien derivative progestogens used in progestogenic hormone preparations.