estradiol hemihydrate + levonorgestrel: clinical use

Prescribing considerations

• Licensed for postmenopausal oestrogen-deficiency symptoms more than one year after menopause; experience above age 65 is limited.
• Assess personal and family history and breast, pelvic, cardiovascular, thromboembolic and hepatic risk as clinically indicated.
• Closely supervise relevant fibroids, endometriosis, hypertension, migraine, diabetes, epilepsy, asthma, systemic lupus erythematosus, gallstones or liver disorders.
• Investigate persistent, heavy or newly occurring unscheduled bleeding.

Contraindications and cautions

• Known, previous or suspected breast cancer or another oestrogen-dependent malignancy
• Undiagnosed genital bleeding or untreated endometrial hyperplasia
• Previous idiopathic or current venous thromboembolism, or a known thrombophilic disorder
• Active or recent arterial thromboembolic disease, including angina or myocardial infarction
• Acute liver disease, or previous liver disease while liver tests remain abnormal
• Hypersensitivity to an ingredient or porphyria

Monitoring

• Review benefits and risks at least annually, with follow-up tailored to clinical risk.
• Monitor blood pressure, symptom response, adverse effects and bleeding pattern.
• Maintain appropriate breast screening and advise reporting new breast changes.
• Stop and assess if pregnancy, jaundice, deteriorating liver function, a significant blood-pressure rise or new migraine-type headache occurs.

Clinical pharmacology

Estradiol is biologically equivalent to endogenous human estradiol and replaces reduced ovarian oestrogen. Levonorgestrel opposes oestrogen-driven endometrial proliferation. Transdermal delivery avoids hepatic first-pass metabolism.

Formulation and product differences

• The product is a transparent continuous-combined matrix patch containing estradiol hemihydrate and levonorgestrel.

Transdermal patch

Route: Transdermal

Strengths: 50 micrograms + 7 micrograms/24 hours