Cyproterone Compound

What it is and how it works

Contains cyproterone acetate 2 mg, an antiandrogen with progestogenic activity, and ethinylestradiol 35 micrograms. The combination reduces androgen effects on the pilosebaceous unit and suppresses ovulation, so it also acts as a contraceptive.

Indications

Moderate to severe acne related to androgen sensitivity and/or hirsutism in women of reproductive age, when topical therapy and systemic antibacterials have failed.

Dosage and administration (summary)

One tablet daily for 21 days, followed by a 7-day tablet-free interval; discontinue 3–4 months after the condition has resolved.

Contraindications

Concurrent use of another hormonal contraceptive; current or past venous or arterial thromboembolism, thrombophilia, migraine with aura, severe hepatic disease or liver tumours, meningioma, sex-steroid-dependent malignancy and undiagnosed vaginal bleeding.

Warnings and precautions

The risk of venous thromboembolism is higher than with levonorgestrel-containing combined oral contraceptives. Blood pressure should be checked regularly, and depressed mood may occur. Should not be used solely for contraception.

Pregnancy

Contraindicated in pregnancy.

Storage and supply

Store below 25 °C in the original package.

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