ethinylestradiol + gestodene: clinical use

Prescribing considerations

• Assess thromboembolic history, smoking, migraine, cardiovascular risks, obesity, planned surgery or immobility, postpartum status and interacting medicines.
• Gestodene-containing combined hormonal contraceptives have a higher estimated VTE risk than products containing levonorgestrel, norethisterone or norgestimate.
• Rule out pregnancy and assess breast cancer, liver disease, diabetes complications and psychiatric symptoms.
• Counsel about thromboembolism symptoms, interactions and lack of STI protection.

Contraindications and cautions

• Current or previous venous thromboembolism, thrombophilia, major surgery with prolonged immobilisation, or high VTE risk from multiple factors.
• Current or previous arterial thrombosis, stroke or transient ischaemic attack; migraine with focal neurological symptoms; or high arterial risk.
• Severe hypertension, diabetes with vascular involvement or severe dyslipoproteinaemia.
• Severe active liver disease, liver tumours, current or previous breast cancer, or hypersensitivity to an ingredient.
• Concomitant use with hepatitis C combinations listed in the selected product information.

Monitoring

• Measure blood pressure and document relevant medical and family history before initiation or re-initiation.
• Reassess thrombotic and cardiovascular risks, medicines, bleeding pattern, mood and acceptability.
• Investigate persistent or newly developed unscheduled bleeding and exclude pregnancy where indicated.
• Tell laboratories about oral contraceptive use because some biochemical and coagulation tests can be affected.

Clinical pharmacology

A fixed oestrogen–progestogen combination that suppresses the mid-cycle gonadotrophin surge and ovulation, thickens cervical mucus and alters endometrial receptivity. Gestodene is extensively protein-bound, including to sex hormone-binding globulin; both components undergo hepatic metabolism.

Formulation and product differences

• Femodene ED is a sugar-coated everyday presentation containing active and larger placebo tablets; it contains lactose and sucrose.
• Akizza is a film-coated active-tablet-only presentation containing lactose.
• Pack appearance, inactive ingredients and storage requirements differ; check product-specific documentation when switching.

Tablet

Route: Oral

Strengths: 20 micrograms + 75 micrograms, 30 micrograms + 75 micrograms, 75 micrograms + 20 micrograms, 75 micrograms + 30 micrograms