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

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 03-05-2026