DIANE 35 TAB 21/TAB

Indications

Approved Uses

Treatment of moderate to severe acne related to androgen sensitivity (with or without seborrhoea) and/or hirsutism in women of reproductive age; it provides contraception during treatment but is not indicated solely for contraception.

Off-Label Uses

PCOS-related hyperandrogenism (acne/hirsutism) when other options are unsuitable; not recommended as routine contraception alone due to VTE risk.

Dosage & Administration

Maximum Dose

1 tablet orally once daily (cyproterone acetate 2 mg/ethinylestradiol 0.035 mg) for 21 days per cycle as supplied in a 21-tablet blister.

Children's Dosage

Not approved for use before menarche; not applicable in prepubertal children

Dose Adjustment Notes

No dose titration is used; reassess periodically and generally continue for 3-4 cycles after symptoms improve, then consider stopping; avoid use in active/severe liver disease and manage reduced efficacy with enzyme inducers by using alternative/backup contraception.

Side Effects

Common Side Effects

Nausea, abdominal pain, headache, breast tenderness/pain, mood changes (including depressed mood), weight change, and unscheduled bleeding/spotting.

Side Effect Frequency

Common (≥1%): nausea/abdominal pain, headache, breast pain/tenderness, mood changes/depressed mood, weight change, breakthrough bleeding/spotting. Serious but rare: venous/arterial thromboembolism, hypertension, hepatic problems.

Safety & Warnings

Contraindications

Contraindicated in: current/history of VTE or ATE (DVT/PE, stroke, MI), known thrombophilia or severe/multiple thrombosis risk factors, migraine with aura/focal neurologic symptoms, severe hepatic disease or liver tumors, known/suspected sex-steroid-dependent malignancy (e.g., breast cancer), undiagnosed vaginal bleeding, pregnancy, hypersensitivity to components; also contraindicated during major surgery with prolonged immobilization.

Warnings & Precautions

Key warnings/precautions: increased VTE/ATE risk (higher with smoking, age >35, obesity, thrombophilia, immobilization/surgery-stop before major surgery/prolonged immobilization), discontinue immediately if thrombosis symptoms occur; monitor blood pressure; stop if jaundice/hepatic dysfunction occurs; not protective against STIs; use only for androgen-dependent conditions (not solely for contraception) with periodic reassessment of ongoing need.

Age Restriction

Use only in women of reproductive age after menarche; not indicated before menarche and not indicated after menopause.

Drug Interactions

Interaction Severity

MAJOR: Enzyme inducers (e.g., rifampicin/rifabutin, carbamazepine, phenytoin, phenobarbital, primidone, topiramate at higher doses, some antiretrovirals, St John’s wort) → reduced hormone levels and contraceptive failure. MODERATE: Strong CYP3A4 inhibitors (e.g., azole antifungals, macrolides, some HIV/HCV therapies) may increase hormone exposure and adverse effects; etoricoxib can increase ethinylestradiol exposure. MODERATE/CLINICALLY IMPORTANT: COCs can reduce lamotrigine levels → loss of seizure control.

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Contraindicated

Children

Not approved for use before menarche; not applicable in prepubertal children

Elderly

Not applicable - indicated only in women of reproductive age

Liver Impairment

No dose adjustment-use is contraindicated in severe hepatic disease and in hepatic tumors; discontinue if clinically significant liver function abnormalities or jaundice develop.

Storage & Patient Advice

Stopping the Medicine

May be stopped at the end of any active tablet cycle; stop immediately if symptoms/signs of thromboembolism, severe new headache/migraine with neurologic symptoms, visual disturbance, jaundice/hepatic dysfunction, or significant BP elevation occur; for acne/hirsutism, reassess periodically and discontinue once the androgen-dependent condition has resolved (often after several additional cycles to reduce relapse).

Pharmacology

Mechanism of Action

Inhibits ovulation via suppression of gonadotropins; increases cervical mucus viscosity and induces endometrial changes; cyproterone acetate provides anti‑androgen effects by androgen receptor antagonism (and reduced androgen activity), while ethinylestradiol increases SHBG, lowering free testosterone.

Half-Life

Cyproterone acetate: ~1.6-2.3 days (≈38-54 hours); Ethinylestradiol: ~12-26 hours (often cited ~24 hours).

Product Information

Available Dosage Forms

Coated tablet

Composition per Dose

Each coated tablet: Cyproterone acetate 2mg + Ethinylestradiol 0.035mg

Generic Availability

Yes

OTC Alternatives

No OTC equivalent; nonprescription alternatives are limited to nonhormonal contraception (e.g., condoms) and OTC acne therapies (e.g., benzoyl peroxide/adapalene where available) which do not treat hirsutism or provide contraception.

Hormone Type

Combined

Method

Oral

Legal Disclaimer - Al Mujtama Pharmacy The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment. Al Mujtama Pharmacy assumes no legal or medical liability for: Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist Any discrepancy between the information provided and the product's package insert or SFDA guidelines Any misuse of medication resulting from personal interpretation of the content displayed Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication. By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation. Your health is a trust - always consult your doctor first.