Estradiol Hemihydrate / Levonorgestrel

What it is and how it works

Estradiol replaces the endogenous oestrogen lost at the menopause and relieves vasomotor and urogenital symptoms. Levonorgestrel, a synthetic progestogen delivered continuously from the same patch, opposes oestrogen-induced endometrial proliferation and so reduces the risk of endometrial hyperplasia. Transdermal delivery avoids first-pass hepatic metabolism.

Indications

Continuous combined HRT for oestrogen-deficiency symptoms in postmenopausal women with an intact uterus, usually more than 12 months after the last menstrual period.

Dosage and administration (summary)

One patch applied to clean, dry, intact skin of the lower trunk or buttock once a week and replaced every 7 days, rotating application sites; the lowest effective dose should be used for the shortest necessary duration.

Contraindications

Known, past or suspected breast cancer or other oestrogen-dependent malignancy, undiagnosed genital bleeding, untreated endometrial hyperplasia, current or previous venous thromboembolism or known thrombophilia, active arterial thromboembolic disease, acute or significant liver disease and porphyria.

Warnings and precautions

HRT is associated with increased risks of breast cancer, venous thromboembolism, stroke and, with long-term use, ovarian cancer; benefits and risks should be reassessed at least annually. Unexpected or persistent bleeding requires investigation, and treatment should be stopped if jaundice, migraine-type headache, a marked rise in blood pressure or thrombosis occurs.

Pregnancy

Not indicated in pregnancy; treatment must be stopped if pregnancy occurs.

Storage and supply

Store below 25 °C in the original sealed sachet; do not refrigerate or freeze.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.