ethinylestradiol + norgestimate: clinical use

Prescribing considerations

• Exclude pregnancy and investigate unexplained vaginal bleeding before initiation.
• Assess personal and family thrombotic history, smoking, age, body mass index, migraine, cardiovascular risk, liver disease, diabetes and interacting medicines.
• Explain venous and arterial thrombosis symptoms and that risk is greatest after first starting or restarting following a substantial break.
• Consider postpartum thrombotic risk and possible suppression of lactation.
• Persistent bleeding after previously regular cycles warrants assessment for pregnancy and non-hormonal causes.

Contraindications and cautions

• Current or previous venous thromboembolism, thrombophilia, major surgery with prolonged immobilisation, or high VTE risk.
• Current or previous arterial thrombosis, stroke or transient ischaemic attack, migraine with focal neurological symptoms, severe hypertension, vascular diabetes or severe dyslipidaemia.
• Acute or significant chronic liver disease, hepatic tumour, or known or suspected breast cancer.
• Hypersensitivity to an ingredient; the selected tablets contain lactose.
• Concomitant use with contraindicated ethinylestradiol-interacting hepatitis C regimens specified in the SmPC.

Monitoring

• Record blood pressure and relevant medical and family history before initiation or re-initiation.
• Review blood pressure, thrombotic risk factors, migraine or neurological symptoms, mood changes, bleeding pattern and medicine interactions.
• Promptly evaluate new persistent or severe headache, new migraine, significant hypertension, jaundice, suspected thrombosis or severe mood symptoms.
• Interpret relevant laboratory results cautiously because oral contraceptives can alter biochemical and coagulation parameters.

Clinical pharmacology

Norgestimate is rapidly converted to active progestogens, principally norelgestromin and norgestrel. Together with ethinylestradiol, it suppresses gonadotrophins and ovulation, with additional effects on cervical mucus, tubal motility and the endometrium.

Formulation and product differences

• The selected Lizinna product consists of round blue uncoated tablets marked “146” on one side.
• It contains lactose and is described as essentially sodium-free.
• Tablet appearance and excipients may differ between brands; check the supplied pack and leaflet.

Tablet

Route: Oral

Strengths: 250 micrograms + 35 micrograms