Chlormadinone / Ethinylestradiol

What it is and how it works

Ethinylestradiol and chlormadinone acetate suppress ovulation mainly by inhibiting gonadotrophin secretion, and alter cervical mucus and endometrium to hinder sperm penetration and implantation. Chlormadinone acetate has anti-androgenic activity, which may benefit androgen-related skin conditions.

Indications

Hormonal contraception in women.

Dosage and administration (summary)

Oral (chlormadinone acetate 2 mg / ethinylestradiol 0.03 mg): 1 tablet daily at the same time for 21 days, followed by a 7-day tablet-free interval.

Contraindications

Current or past venous or arterial thromboembolism, or known thrombophilia; migraine with aura; cerebrovascular or coronary artery disease; severe or multiple cardiovascular risk factors (e.g. severe hypertension, diabetes with vascular involvement, smoking over 35 years of age); severe hepatic disease or liver tumours; known or suspected sex-hormone-dependent malignancy; undiagnosed vaginal bleeding; pregnancy.

Warnings and precautions

Combined hormonal contraceptives increase the risk of venous thromboembolism, highest in the first year of use; risk factors should be assessed before prescribing. Blood pressure should be monitored; efficacy may be reduced by vomiting, diarrhoea or enzyme-inducing drugs (e.g. rifampicin, carbamazepine, St John’s wort). Discontinue if migraine with aura, jaundice or severe hypertension develops.

Pregnancy

Contraindicated in pregnancy; discontinue if pregnancy occurs.

Storage and supply

Store below 30 °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.