Drospirenone / Ethinylestradiol

What it is and how it works

Contains drospirenone, a spironolactone-derived progestogen with antimineralocorticoid and antiandrogenic activity, combined with ethinylestradiol (typically 3 mg/30 micrograms or 3 mg/20 micrograms). It inhibits ovulation and alters cervical mucus and the endometrium.

Indications

Oral contraception; some low-dose (24/4 regimen) products are also authorised for moderate acne or premenstrual dysphoric disorder in women choosing oral contraception.

Dosage and administration (summary)

One tablet daily at about the same time, either 21 active tablets followed by a 7-day break or according to the 24/4 or 28-day pack sequence.

Contraindications

Current or past venous or arterial thromboembolism, thrombophilia, migraine with aura, severe or multiple cardiovascular risk factors (including smoking over 35 years), severe hepatic disease or liver tumours, severe renal impairment or acute renal failure, sex-steroid-dependent malignancy and undiagnosed vaginal bleeding.

Warnings and precautions

Venous thromboembolism risk is higher than with levonorgestrel-containing pills. Because of its antimineralocorticoid activity, plasma potassium should be checked in the first cycle in patients with renal impairment or taking potassium-sparing drugs. Efficacy may be reduced by vomiting, diarrhoea and enzyme-inducing drugs.

Pregnancy

Not indicated 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.