estradiol hemihydrate + progesterone: clinical use

Prescribing considerations

• Licensed for postmenopausal oestrogen-deficiency symptoms in women with an intact uterus; experience in women older than 65 is limited.
• Assess personal and family history, thromboembolic and cardiovascular risks, cancer risks, unexplained bleeding, liver disease and relevant comorbidities before starting or restarting.
• Review benefit–risk periodically and investigate concerning bleeding.
• Plan around major surgery or prolonged immobility because oral combined HRT increases venous thromboembolism risk.

Contraindications and cautions

• Known, previous or suspected breast cancer
• Known or suspected oestrogen-dependent malignancy
• Unexplained genital bleeding or untreated endometrial hyperplasia
• Previous or current venous thromboembolism or a known thrombophilic disorder
• Active or recent arterial thromboembolic disease
• Acute liver disease, or previous liver disease with abnormal liver function
• Porphyria
• Hypersensitivity to an active ingredient or excipient

Monitoring

• Symptom control and continuing benefit–risk balance
• Blood pressure and relevant cardiovascular or thromboembolic risk factors
• New breast symptoms and appropriate breast screening
• Bleeding pattern, with investigation of concerning or persistent bleeding
• Closer follow-up where liver disease, hypertriglyceridaemia, cardiac or renal dysfunction, diabetes, migraine or interacting medicines are relevant

Clinical pharmacology

Contains synthetic 17β-estradiol and micronised progesterone that are chemically and biologically identical to the corresponding endogenous hormones. Both undergo oral absorption and hepatic first-pass metabolism.

Formulation and product differences

• A fixed oral combination in one soft capsule rather than separate oestrogen and progestogen products.
• Food increases progesterone exposure, supporting administration with food.
• Unlike transdermal oestrogen, this oral formulation undergoes hepatic first-pass metabolism and carries the thromboembolic considerations of oral HRT.
• Contains gelatin and Allura Red.

Capsule

Route: Oral

Strengths: 1 mg + 100 mg