Description

Diane-35 (ethinylestradiol, cyproterone acetate) Coated Tablets №21

Ingredients

Diane-35 tablets contain ethinylestradiol and cyproterone acetate as active ingredients. Each coated tablet also contains lactose, maize starch, povidone, magnesium stearate, talc, sucrose, glycol montanate, titanium dioxide, red and yellow iron oxide.

Mechanism of Action

Ethinylestradiol inhibits ovulation and alters cervical mucus, while cyproterone acetate acts as an anti-androgen by blocking androgen effects, reducing acne and hirsutism.

Pharmacological Properties

Ethinylestradiol and cyproterone acetate in Diane-35 tablets reduce acne lesions and seborrhea by suppressing androgen production and blocking androgen receptors in the skin. Ethinylestradiol also provides a contraceptive effect, regulating menstrual cycles in polycystic ovary syndrome.

Indications for Use

Diane-35 tablets are indicated for androgen-dependent diseases in women, including acne (especially severe forms), seborrhea, androgenetic alopecia, and mild hirsutism.

Contraindications

Avoid using Diane-35 tablets if you have a history of thromboembolic disorders, cerebrovascular disorders, coronary artery disease, hormone-dependent tumors, liver disease, or undiagnosed vaginal bleeding.

Side Effects

Common side effects may include nausea, headache, breast tenderness, and changes in menstrual flow. Serious side effects like thromboembolism and liver disorders are rare but possible.

Usage Instructions

The usual dosage is one tablet daily for 21 days, followed by a 7-day tablet-free interval. Take the tablets at the same time each day with liquid as needed. Follow healthcare provider instructions strictly.

Benefits Compared to Analogues

Diane-35 tablets offer effective treatment for androgen-dependent conditions with the added benefit of contraceptive effects, making it a comprehensive solution for women with acne and hirsutism.

Suitable Patient Groups

Diane-35 tablets are suitable for adult women with androgen-dependent conditions. It is not recommended for use in children, elderly individuals, or males.

Storage and Shelf Life

Store Diane-35 tablets in a cool, dry place below 25°C. Keep them out of reach of children. Check the expiry date on the packaging before use.

Packaging Description

Diane-35 tablets come in a package containing 21 coated tablets. The packaging is designed to protect the tablets from external factors and maintain their efficacy.

Clinical Evidence and Proven Effectiveness

Studies have shown the efficacy of Diane-35 tablets in improving acne and hirsutism in women with androgen-dependent conditions. Clinical trials, such as the study by Lucky et al. (2003), demonstrated a significant reduction in acne lesions and seborrhea after 6 months of treatment with Diane-35 tablets.