Home - Gynecology - Diane-35® | Ethinylestradiol and Cyproterone Acetate | Contraception | DengYueRX
Description
Indication & Scope
Diane-35® is a prescription anti-androgen combined hormonal contraceptive indicated for the treatment of moderate to severe androgen-sensitive acne (with or without seborrhea), hirsutism, and hyperandrogenic manifestations associated with polycystic ovary syndrome (PCOS) in women of reproductive age.For acne, it should be used only after topical therapy or systemic antibiotic treatment has failed.
- Mechanism: Cyproterone acetate blocks androgen receptors and reduces androgen production, while ethinylestradiol suppresses ovulation, increases sex hormone-binding globulin (SHBG), and lowers circulating free androgens.
- Drug Class: Combined anti-androgen oral hormonal contraceptive.
- Clinical Use: Treatment of androgen-related acne, hirsutism, hyperandrogenism associated with PCOS, and oral contraception.
| Generic Name | Ethinylestradiol and Cyproterone Acetate Tablets |
| Brand Name | Diane-35® |
| Ingredient | Cyproterone Acetate + Ethinylestradiol |
| Dosage Form | Sugar-coated Tablet |
| Package | 21 tablets/carton |
| Conditions Treated | Androgen-sensitive acne, hirsutism, hyperandrogenism associated with PCOS, oral contraception |
| Taboos | Pregnancy, breastfeeding, thromboembolic disorders, severe liver disease, hormone-dependent malignancy, hypersensitivity |
| Place of origin | Germany |
| Prescription type | Prescription Only (Rx) |
| Storage Conditions | Store at room temperature in a dry place, protected from moisture and light. |
| Manufacturer | Bayer Weimar GmbH und Co. KG |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval Number | HJ20170209 |
| Approval Date | January 04, 2023 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: Take one tablet orally once daily at the same time each day for 21 consecutive days, followed by a 7-day tablet-free interval. Start the next pack on the 8th day, regardless of whether withdrawal bleeding has ended.
Time: It is recommended to start on the first day of menstruation. Withdrawal bleeding usually occurs 2–3 days after the last tablet.
Instructions for use: Swallow the tablet with water and follow the order indicated on the blister pack. If a tablet is missed by 12 hours or less, take it immediately. If more than 12 hours have elapsed, contraceptive protection may be reduced and additional barrier contraception should be used for 7 days. Treatment for acne or hirsutism generally requires 3–6 months before clinical improvement can be assessed.
Interaction: Enzyme-inducing medicines (e.g., rifampicin, carbamazepine, oxcarbazepine, topiramate, and St. John’s wort) may reduce contraceptive and anti-androgen efficacy. Do not use concurrently with other hormonal contraceptives.
Side effects: Common adverse reactions include breakthrough bleeding, breast tenderness, headache, nausea, mood changes, weight changes, and decreased libido. Rare but serious reactions include venous or arterial thromboembolism, myocardial infarction, stroke, severe liver disorders, and hypersensitivity reactions.
Important Notice
This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indication, and regional regulatory requirements.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
What is Diane-35® (Ethinylestradiol and Cyproterone Acetate Tablets) used for?
Diane-35® is used to treat androgen-sensitive acne, hirsutism, and hyperandrogenic symptoms associated with PCOS, while also providing oral contraception.
Can Diane-35® (Ethinylestradiol and Cyproterone Acetate Tablets) be used only for contraception?
No. Diane-35® is primarily indicated for women requiring treatment of androgen-related conditions. Although it provides effective contraception, it should not be used solely as a routine contraceptive unless clinically appropriate.
When should I start taking Diane-35® (Ethinylestradiol and Cyproterone Acetate Tablets)?
It is recommended to start on the first day of your menstrual period, take one tablet daily for 21 days, followed by a 7-day break, then begin the next pack.
How long does Diane-35® (Ethinylestradiol and Cyproterone Acetate Tablets) take to improve acne?
Clinical improvement is generally observed after 3–6 months of continuous treatment.
Diane-35® | Ethinylestradiol and Cyproterone Acetate | Contraception | DengYueRX
INN: Ethinylestradiol and Cyproterone Acetate
Indications: Moderate to Severe Acne, Hirsutism & Oral Contraception
Dosage Form: Sugar-coated Tablet
Strength: Cyproterone Acetate 2 mg + Ethinylestradiol 0.035 mg/Tablet
$14.62 Original price was: $14.62.$12.43Current price is: $12.43.