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What is a Generic Drug?

A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.

The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.

Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.

Diane 35 (Cyproterone/Ethinyl Estradiol)

Brand

Diane 35 (Cyproterone/Ethinyl Estradiol)

Prescription Required

Strength
Qty
21 day
Generic

What is a Generic?

Generic Equivalent - Diane 35 (Cyproterone/Ethinyl Estradiol)

Prescription Required

Strength
Qty
21 day
2mg/.035mg

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  • Product Details

    Description

    Diane-35 is a combination oral medication containing 2 mg of cyproterone acetate and 0.035 mg of ethinyl estradiol per tablet. Cyproterone acetate is a progestogen with anti-androgenic properties, while ethinyl estradiol is a synthetic estrogen. Together, they work to reduce the effects of androgens (male hormones) that can cause conditions like severe acne and hirsutism (excessive hair growth) in women.

    Fact Table

    Formula

    C24H29ClO4 (Cyproterone Acetate), C20H24O2 (Ethinylestradiol)

    License

    EMA, National regulatory agencies (Rx only)

    Bioavailability

    Cyproterone acetate: ~88%, Ethinylestradiol: ~40–45%

    Legal status

    Prescription only (Rx)

    Chemical Name

    Cyproterone acetate + Ethinylestradiol

    Elimination half-life

    Cyproterone acetate: 1.6–4.3 days, Ethinylestradiol: ~13–27 hours

    Dosage (Strength)

    2 mg cyproterone acetate + 0.035 mg ethinylestradiol per tablet

    Pregnancy

    Contraindicated

    Brands

    Diane-35, Dianette, Cyestra-35, Estelle-35

    Protein binding

    Cyproterone acetate: ~96%, Ethinylestradiol: ~98%

    PubChem CID

    Cyp. Acetate: 5281014, EE: 5991

    MedlinePlus

    a601050 (ethinylestradiol), a699032 (cyproterone not listed separately)

    ChEBI

    Cyproterone acetate: 40575, EE: 42365

    ATC code

    G03HB01

    DrugBank

    Cyproterone acetate: DB04839, Ethinylestradiol: DB00977

    KEGG

    Cyproterone acetate: D07715, EE: D00119

    Routes of administration

    Oral

    Directions

    Diane-35 should be taken orally, one tablet daily at the same time each day, for 21 consecutive days, followed by a 7-day tablet-free interval. During this interval, a withdrawal bleed resembling menstruation usually occurs. Treatment duration depends on the severity of the condition and the response to therapy. It is essential to follow the prescribing physician's instructions regarding the length of use and to have regular evaluations to determine the necessity of continued treatment.

    Ingredients

    Active ingredients:

    • Cyproterone acetate (2 mg)
    • Ethinyl estradiol (0.035 mg)

    Inactive ingredients:

    • Corn starch
    • Lactose
    • Magnesium stearate
    • Povidone
    • Talc
    • Coating components: calcium carbonate, ferric oxide yellow, glycerol, sucrose, polyethylene glycol, povidone, talc, titanium dioxide, and wax.

    Contraindications

    Diane-35 is contraindicated in individuals with:

    • A history of or current thrombophlebitis or thromboembolic disorders
    • Cerebrovascular disorders
    • Myocardial infarction or coronary artery disease
    • Active liver disease or liver tumors (benign or malignant)
    • Known or suspected sex hormone-dependent malignancies
    • Undiagnosed abnormal vaginal bleeding
    • Severe diabetes with vascular changes
    • Presence or history of pancreatitis if associated with severe hypertriglyceridemia
    • Hypersensitivity to any of the components of Diane-35.

    Cautions

    Risk of Venous Thromboembolism (VTE): Diane-35 has been associated with an increased risk of VTE. It should not be used solely as an oral contraceptive. Patients should be evaluated for risk factors such as smoking, obesity, and prolonged immobilization before initiating treatment.

    Duration of Use: Diane-35 should be used for the shortest duration necessary to achieve therapeutic results. Continuous long-term use solely for contraception is not recommended.

    Monitoring: Regular follow-ups are essential to assess the ongoing need for treatment and to monitor for potential adverse effects.

    Side Effects

    Common side effects may include:

    • Nausea
    • Headache
    • Breast tenderness
    • Mood changes
    • Changes in body weight

    Serious side effects, which require immediate medical attention, include:

    • Signs of a blood clot (e.g., sudden shortness of breath, severe chest pain, swelling or pain in the legs)
    • Sudden vision loss or severe headaches
    • Yellowing of the skin or eyes (jaundice)
    • Severe abdominal pain.

    IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

    Product Code : 1468

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