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.

Estalis (Estradiol / Norethindrone)

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Brand

Estalis (Estradiol / Norethindrone)

Prescription Required

Strength
Qty
50 / 140mcg
50 / 250mcg

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  • Product Details

    Description

    Estalis is a prescription medication that treats menopausal symptoms in women. It is a combination of two hormones, estradiol and norethindrone acetate, which help replace the hormones the body stops making during and after menopause.

    Estradiol is a synthetic estrogen replacement, and norethindrone is a synthetic progesterone.


    Fact Table

    Formula

    C22H28O3.C18H24O2

    License

    US DailyMed

    Bioavailability

    50% - 100%

    Legal status

    Rx-Only

    Chemical Name

    Estradiol/norethisterone acetate

    Elimination half-life

    12-14 hours

    Dosage (Strength)

    LD 0.5/0.1mg 3 months, LD 1.0/0.5mg 1 month, 1.0/0.5mg 3 months

    Pregnancy

    Consult Doctor

    Brands

    Estalis

    Protein binding

    37- 61%

    PubChem CID

    none

    MedlinePlus

    a601041

    ChEBI

    -

    ATC code

    G03FA01

    DrugBank

    -

    KEGG

    -

    Routes of administration

    By mouth

    Directions

    Estalis is a patch that is applied to the skin. Your doctor determines the dose based on your needs and treatment response.

    The dosage forms include:

    • Estalis 140/50
    • Estalis 250/50

    Estalis patches are typically applied twice a week, and the patch should be left on the skin for 3-4 days of the seven-day cycle. Alternate application sites each time.

    Ingredients

    The active ingredients in Estalis are estradiol and norethindrone acetate.

    Interactions

    Common interactions with Estalis may include the following:

    • Anastrozole
    • Cosyntropin
    • Dehydroepiandrosterone
    • Exemestane
    • Fexinidazole
    • Fusidic Acid (Systemic)
    • Growth Hormone Analogs
    • Hemin
    • MetyraPONE
    • Ospemifene

    Cautions

    Do not use Estalis if you have a history of breast cancer, blood clots, or liver disease. The medication can increase the risk of these conditions.

    Tell your doctor if you experience any side effects while using Estalis, including breast lumps, unusual vaginal bleeding, or mood changes. Estalis can also increase the risk of certain cancers, such as ovarian and endometrial cancer.

    Side Effects

    Common adverse reactions may include:

    • Abdominal pain
    • Abnormal pap smear
    • Acne vulgaris
    • Application site reaction
    • Arthralgia
    • Back pain
    • Breast hypertrophy
    • Bronchitis
    • Constipation
    • Depression
    • Diarrhea
    • Dizziness
    • Dysmenorrhea
    • Dyspepsia
    • Emotional lability
    • Endometrial hyperplasia
    • Flatulence
    • Flu-like symptoms
    • Gastroenteritis
    • Headache
    • Hypermenorrhea
    • Infection
    • Insomnia
    • Leukorrhea
    • Limb pain
    • Mastalgia
    • Menstrual disease
    • Nasopharyngitis
    • Nausea
    • Nervousness
    • Ovarian cyst
    • Pain
    • Peripheral edema
    • Pharyngitis
    • Postmenopausal bleeding
    • Respiratory tract disease
    • Rhinitis
    • Sinusitis
    • Skin rash
    • Upper respiratory tract infection
    • Uterine fibroids
    • Vaginal hemorrhage
    • Vaginitis
    • Viral infection
    • Vulvovaginal candidiasis
    • Weakness
    • Weight gain

    References

    1. Estalis[package insert]. Dorval, Quebec: Novartis; 2014.


    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 : 11729

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