Activella (Estradiol / Norethindrone)

Also Known as Activelle

Prescription medicineOnly Available By Prescription
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Strength Pack Size Qty
Strength
LD 1.0/0.5mg 1 month
Pack Size
Qty
Strength
LD 0.5/0.1mg 3 months
Pack Size
Qty
Strength
1.0/0.5mg 3 months
Pack Size
Qty

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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.

Description

Activella (estradiol/norethindrone acetate) is a medication consisting of two hormones to treat moderate to severe symptoms of menopause and vulvar and vaginal atrophy as a caused by menpause in women who have a uterus. Postmenopausal women who have a uterus also take Activella to prevent osteoporosis.


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

Activella

Protein binding

37- 61%

PubChem CID

none

MedlinePlus

a601041

ChEBI

-

ATC code

G03FA01

DrugBank

-

KEGG

-

Routes of administration

By mouth

Directions

Follow the instructions on the label of your prescription and read the information that comes with your prescription. 

Activella is available in 1 mg/0.5 mg and 0.5 mg/0.1 mg tablets.

  • Activella 1 mg/0.5 mg or Activella 0.5 mg/0.1 mg tablets are prescribed to treat moderate to severe symptoms of menopause and to prevent osteoporosis in women who have a uterus.
  • Activella 1 mg/0.5 mg is prescribed to treat moderate to severe symptoms of vulvar and vaginal atrophy as a result of menopause in women who have a uterus.

Activella dosage:

Take one tablet by mouth one time a day.

Ingredients

Estradiol and norethindrone acetate are the active ingredients contained in each tablet of Activella. Lactose monohydrate, starch (corn), copovidone, talc, magnesium stearate, hypromellose, and triacetin are the inactive ingredients. The 0.5 mg/0.1 mg also contains hydroxypropylcellulose.

Contraindications

  • Avoid taking Activella if you:
    • have unusual vaginal bleeding without a cause.
    • have, think you have, or have ever had breast cancer.
    • have or suspect that you have estrogen-dependent neoplasia.
    • have an active blood clot or have ever had a blood clot in your veins or lungs.
    • have or have ever had a stroke or heart attack.
    • are allergic to any of the ingredients contained in Activella.
    • have liver conditions.
    • have a blood condition such as protein C, protein S, or antithrombin deficiency.
    • are pregnant or suspect that you are pregnant.

Cautions

WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER AND PROBABLE DEMENTIA

See full prescribing information for complete boxed warning

Estrogen Plus Progestin Therapy

  • Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia 
  • The Women's Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke and myocardial infarction (MI) 
  • The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer
  • The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmeno- pausal women 65 years of age and older
    Estrogen-Alone Therapy
  • There is an increased risk of endometrial cancer in a woman with a uterus who use unopposed estrogens 
  • Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia 
  • The WHI estrogen-alone substudy reported increased risks of stroke and DVT 
  • The WHIMS estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older
    • Before you start taking Activella, inform your doctor of: 
      • Any medications you take
      • Your allergies
      • Your medical problems and medical history
      • Your pregnancy or breastfeeding status and/or plans
    • Activella can increase your risk for gallbladder disease.
    • If you lose your vision or experience other vision problems while taking Activella, seek medical attention right away.
  • If you experience yellowing of your skin or the whites of your eyes while taking Activella, seek medical medical attention right away. 
  • High calcium levels in the blood can occur in women who take Activella and have breast cancer or bone cancer. 
  • High blood triglyceride levels that can cause pancreatitis can occur during treatment with Activella.
    • High blood pressure can occur during treatment with Activella.
  • Your thyroid function should be checked during treatment with Activella if you are taking thyroid replacement.
  • Low blood calcium levels can occur in women who have hypoparathyroidism and take Activella. 
  • Fluid retention can occur during treatment with Activella.
  • The symptoms of certain conditions, including hereditary angioedema, asthma, diabetes, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas can occur during treatment with Activella. Women who have these conditions are recommended to use caution.

Side Effects

Call your doctor if you experience side effects that worry you or persist. Activella's side effects include back pain, headache, pain in the extremity, nausea, diarrhea, gastroenteritis, sleep problems, mood changes, upper respiratory tract infection, sinusitis, nasopharyngitis, weight gain, pain in the breast, post-menopausal bleeding, excessive uterine fibroid vaginal bleeding, ovarian cyst, thickening of the endometrium, viral infection, moniliasis genital, and accidental injury.

Reference:

Activella (estradiol/norethindrone acetate) tablets, for oral use. Plainsboro, NJ: Novo Nordisk Inc.; 2013.



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.

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