dydrogesterone + estradiol hemihydrate: clinical use

Prescribing considerations

• Confirm the licensed indication and product-specific menopause-timing criteria.
• Assess personal and family history and breast, endometrial, cardiovascular, thrombotic and hepatic risks.
• Review benefit–risk regularly and investigate new or persistent unscheduled bleeding.
• Consider perioperative thrombotic risk with major surgery or prolonged immobility.
• Use closer supervision with fibroids, endometriosis, hypertension, diabetes, migraine, epilepsy, gallstones, systemic lupus erythematosus, asthma, cardiac or renal dysfunction, or hypertriglyceridaemia.

Contraindications and cautions

• Known, previous or suspected breast cancer
• Known or suspected oestrogen-dependent malignancy or progestogen-dependent neoplasm
• Meningioma or a history of meningioma
• Unexplained genital bleeding or untreated endometrial hyperplasia
• Previous idiopathic or current venous thromboembolism, or a known thrombophilic disorder
• Active or recent arterial thromboembolic disease
• Acute liver disease, or previous liver disease while liver tests remain abnormal
• Porphyria
• Hypersensitivity to an ingredient
• Rare hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption

Monitoring

• Review symptom control, adverse effects and continuing benefit–risk.
• Check blood pressure and reassess thrombotic risk.
• Investigate clinically significant unscheduled bleeding.
• Continue appropriate breast screening and advise reporting breast changes.
• Monitor for neurological features suggesting meningioma; stop treatment if diagnosed.
• Use targeted liver, lipid, thyroid or medicine-level monitoring when warranted.

Clinical pharmacology

Estradiol is biologically equivalent to endogenous estradiol and is extensively metabolised after oral absorption. Dydrogesterone is an orally active progestogen rapidly converted to active dihydrodydrogesterone; it provides endometrial opposition without intrinsic oestrogenic or androgenic activity.

Formulation and product differences

• The film-coated pack contains white estradiol-only tablets and grey tablets containing estradiol with dydrogesterone.
• Both tablet types contain lactose and must be taken in the sequence shown on the blister.
• This is a sequential formulation and should not be confused with continuous-combined products containing the same active ingredients.

Tablet

Route: Oral

Strengths: 0.5 mg + 2.5 mg, 1 mg + 10 mg, 1 mg + 5 mg