Generic Diane 35 (Cyproterone acetate and ethinylestradiol)

Introduction

Diane 35 is a combined oral contraceptive that contains the synthetic progestogen cyproterone acetate (2 mg) and the estrogen ethinylestradiol (.035 mg) in a single tablet. The product is manufactured by several pharmaceutical companies and is approved in the European Union and many other jurisdictions for specific therapeutic purposes. Its primary indication is the treatment of moderate to severe acne in women who also require contraception, and it is also licensed for the management of androgen-dependent conditions such as hirsutism. The formulation is supplied as a 21-day active-pill regimen followed by a 7-day hormone-free interval.

What is Diane 35?

• Classification: Combined oral contraceptive (COC) containing a progestogen (cyproterone acetate) and an estrogen (ethinylestradiol).
• Development history: Cyproterone acetate was first synthesized in the s as an anti-androgen; later, its combination with ethinylestradiol was formulated to provide both contraceptive efficacy and anti-androgenic activity.
• Manufacturer: Produced by several licensed manufacturers; the specific label may vary by country.
• Brand context: Diane 35 is marketed under brand names such as Diane-35 and Belara, all of which contain the same active ingredients.

How Diane 35 Works

Cyproterone acetate binds to androgen receptors, blocking the action of endogenous testosterone and dihydrotestosterone on the skin and hair follicles. This anti-androgenic effect reduces sebum production and slows the growth of terminal hair, addressing acne and hirsutism.

Ethinylestradiol suppresses the hypothalamic-pituitary-ovarian axis, inhibiting the mid-cycle surge of luteinizing hormone (LH) and preventing ovulation. The estrogen component also stabilizes the endometrial lining, reducing breakthrough bleeding.

Together, the two hormones provide reliable contraception while delivering a pharmacologic anti-androgenic effect. Onset of anti-androgenic action typically occurs within the first menstrual cycle, and contraceptive protection is achieved after seven consecutive active tablets. The drug is metabolized primarily by hepatic cytochrome P450 enzymes (CYP3A4) and has a half-life of approximately 24 hours for the estrogen component; cyproterone acetate has a longer elimination phase of 30-40 hours.

Conditions Treated with Diane 35

• Moderate to severe acne vulgaris in women who also need contraception. The anti-androgenic activity reduces sebum output, leading to fewer comedones and inflammatory lesions.
• Hirsutism (excessive terminal hair growth) associated with polycystic ovary syndrome (PCOS) or other hyperandrogenic states. By blocking androgen receptors, the medication slows hair growth and may promote shedding of existing terminal hairs.
• Contraception for women of reproductive age. The combined hormonal action reliably prevents ovulation when taken as directed.

These indications are supported by regulatory approvals (e.g., European Medicines Agency) and extensive clinical trial data demonstrating efficacy and safety in the target populations.

Off-Label and Investigational Uses of Diane 35

• Female pattern hair loss (androgenic alopecia). Small open-label studies have reported modest improvement in hair density when cyproterone acetate is combined with ethinylestradiol, likely due to androgen blockade. This use is not approved by regulatory agencies.
• Seborrheic dermatitis resistant to standard topical therapy. Some dermatologists have observed reduced scaling and erythema when patients are switched to a COC with anti-androgenic properties, but evidence remains limited.
• Adjunctive therapy in PCOS-related metabolic disturbances. Preliminary research suggests that the estrogen component may favorably influence lipid profiles, yet the overall impact on insulin resistance is inconclusive.

All off-label applications should be undertaken only under the direct supervision of a qualified healthcare provider, as safety and efficacy have not been formally established by the FDA, EMA, or comparable authorities.

Is Diane 35 the Right Medication for You?

• Suitable patients: Women of reproductive age who require reliable contraception and present with moderate to severe acne or clinically significant hirsutism. The medication is particularly advantageous when both contraceptive and anti-androgenic effects are desired.

• Clinical scenarios favoring use:

  • Persistent acne unresponsive to topical agents or oral antibiotics.
  • Hirsutism causing psychological distress, especially when associated with PCOS.
  • Need for a single-pill solution that addresses both contraception and dermatologic concerns.

• Contraindications:

  • History of thromboembolic disease (deep-vein thrombosis, pulmonary embolism).
  • Known or suspected estrogen-dependent neoplasia (e.g., breast cancer).
  • Active liver disease or severe hepatic impairment.
  • Uncontrolled hypertension or cardiovascular disease.
  • Pregnancy or breastfeeding.

Patients with any of these conditions should discuss alternative therapeutic options with their clinician.

Risks, Side Effects, and Interactions

Common

• Nausea, breast tenderness, and mild headache.
• Irregular menstrual bleeding, spotting, or breakthrough bleeding during the first three months.
• Weight fluctuations (generally modest).

Rare

• Mood changes, including depressive symptoms.
• Decreased libido.
• Skin pigmentation changes (melasma).

Serious

• Venous thromboembolism (VTE) - deep-vein thrombosis, pulmonary embolism.
• Arterial thrombosis - myocardial infarction, ischemic stroke.
• Hepatotoxicity - jaundice, elevated liver enzymes, hepatic adenoma.
• Severe allergic reactions - anaphylaxis, angioedema.

Drug-Drug and Drug-Food Interactions

• Enzyme inducers (e.g., rifampicin, carbamazepine, phenytoin, St. John’s wort) may reduce plasma concentrations of both cyproterone acetate and ethinylestradiol, decreasing contraceptive efficacy.
• Enzyme inhibitors (e.g., ketoconazole, erythromycin) can increase estrogen levels, potentially heightening the risk of VTE.
• Anticoagulants (warfarin) may have altered activity; more frequent INR monitoring is advised.
• Antiepileptic drugs that induce hepatic enzymes may necessitate additional non-hormonal contraceptive methods.
• Alcohol does not directly affect drug metabolism but may exacerbate liver strain; excessive consumption should be avoided.

Patients should disclose all current medications, including over-the-counter products and herbal supplements, to assess interaction risk.

Use: Dosing, Missed Dose, Overdose

• Standard regimen: One tablet containing 2 mg cyproterone acetate and .035 mg ethinylestradiol taken daily for 21 consecutive days, followed by a 7-day hormone-free interval during which withdrawal bleeding occurs.
• Missed dose: If a tablet is missed for less than 12 hours, take it as soon as remembered and continue with the next scheduled dose. If more than 12 hours have passed, skip the missed tablet, take the next dose at the usual time, and use a backup contraceptive method (e.g., barrier protection) for the next 7 days.
• Overdose: Symptoms may include nausea, vomiting, and severe abdominal pain. In the event of suspected overdose, seek immediate medical attention; supportive care and gastric decontamination may be indicated.
• Administration considerations: The tablet can be taken with or without food. Alcohol should be consumed in moderation, and patients should avoid operating heavy machinery if they experience dizziness or severe headache.

FAQ

• What should I do with Diane 35 if I am traveling across time zones?   Take the tablet at the same local time each day, adjusting only if the time change exceeds 12 hours. Use a reminder app or alarm to maintain consistency.

• Can I store Diane 35 in a humid environment such as a bathroom?   The tablets should be kept in a dry place at room temperature (15-30 °C). High humidity can degrade the active ingredients, so a cabinet away from moisture is recommended.

• Does the tablet’s color or imprint vary by country?   Yes, manufacturers may use different tablet colors or imprints to meet local regulatory requirements, but the dosage of cyproterone acetate and ethinylestradiol remains the same.

• Are there any dietary restrictions while taking Diane 35?   No specific foods must be avoided, but excessive grapefruit juice can inhibit CYP3A4 metabolism, potentially increasing estrogen levels. Moderation is advised.

• How does smoking affect the safety profile of Diane 35?   Smoking, especially in women over 35, significantly raises the risk of thromboembolic events when combined with estrogen-containing contraceptives. Smoking cessation is strongly recommended.

• Is it safe to use Diane 35 while on hormonal replacement therapy (HRT)?   Concurrent use of two estrogen-containing products can increase the risk of VTE. Patients should consult a healthcare professional before combining therapies.

• What is the shelf life of a pack of Diane 35?   Typically, the expiration date is printed on the packaging and is about two to three years from the date of manufacture, provided storage conditions are met.

• Can I take Diane 35 if I have a mild liver enzyme elevation?   Mild, stable elevations may be permissible, but regular monitoring of liver function tests is advisable. Significant liver disease is a contraindication.

• Do I need to inform my pharmacist about over-the-counter supplements?   Yes, because certain supplements (e.g., St. John’s wort) can induce hepatic enzymes and reduce contraceptive effectiveness.

• How does the 7-day hormone-free interval affect menstrual symptoms?   During the hormone-free week, withdrawal bleeding occurs, which may be lighter or heavier than a natural period. Some women experience cramping similar to menstrual cramps.

Glossary

Anti-androgen

A substance that blocks the effects of male hormones (androgens) at their receptor sites, reducing androgen-driven conditions such as acne and hirsutism.

Cytochrome P450 (CYP) enzymes

A family of liver enzymes responsible for metabolizing many drugs; CYP3A4 is the primary isoenzyme involved in the breakdown of both cyproterone acetate and ethinylestradiol.

Venous thromboembolism (VTE)

The formation of a blood clot in a vein, which can travel to the lungs (pulmonary embolism) and pose a serious health risk.

Withdrawal bleeding

Bleeding that occurs during the hormone-free interval of a combined oral contraceptive regimen, mimicking a menstrual period.

Buying Diane 35 from Our Online Pharmacy

Patients who encounter limited availability of Diane 35 through local pharmacies or who seek a cost-effective alternative can obtain the medication from our online pharmacy. We source the product exclusively from licensed, internationally recognized suppliers, ensuring that each batch meets stringent quality standards.

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Disclaimer

The information presented about Diane 35 is intended for general educational purposes and does not substitute professional medical advice. Treatment decisions, including any off-label applications, should be made under the guidance of a qualified healthcare provider. Readers are presumed to be responsible adults capable of making informed health choices. Our online pharmacy offers access to Diane 35 for individuals who may encounter limited availability through conventional pharmacies or who are seeking cost-effective generic alternatives. Always discuss any medication changes with a qualified professional before initiating, modifying, or discontinuing therapy.