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Activella (Estradiol / Norethindrone)
Also Known as Activelle
Prescription Required
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Product Details
Description
Activella (estradiol/norethindrone acetate) contains two types of hormones in order to treat moderate to severe symptoms of menopause and vulvar and vaginal atrophy as a result of menopause in women who have a uterus. It's also used to prevent osteoporosis in postmenopausal women who have a uterus.
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
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ATC code
G03FA01
DrugBank
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KEGG
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Routes of administration
By mouth
Directions
The instructions that are on the label of your Activella prescription should be followed.
Activella comes in 1 mg/0.5 mg and 0.5 mg/0.1 mg tablets.
- Activella 1 mg/0.5 mg and Activella 0.5 mg/0.1 mg are the strengths used to treat moderate to severe symptoms of menopause in women who have a uterus and to prevent osteoporosis in postmenopausal women who have a uterus.
- Activella 1 mg/0.5mg is used 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 should be taken by mouth once daily.
Ingredients
The active ingredients in each tablet of Activella are estradiol and norethindrone acetate. The inactive ingredients include lactose monohydrate, starch (corn), copovidone, talc, magnesium stearate, hypromellose, and triacetin. Hydroxypropylcellulose is an additional ingredient in the 0.5 mg/0.1 mg tablet.
Contraindications
- Do not take Activella if you have undiagnosed irregular vaginal bleeding.
- Do not take Activella if you have or ever had breast cancer.
- Do not take Activella if you have or think you have estrogen-dependent neoplasia.
- Do not take Activella if you have an active blood clot or have ever had a blood clot in your veins or lungs.
- Do not take Activella if you have or have ever had a stroke or heart attack.
- Do not take Activella if you are allergic to any of its ingredients.
- Do not take Activella if you have liver problems.
- Do not take Activella if you have a blood disorder such as protein C, protein S, or antithrombin deficiency.
- Do not take Activella if you are pregnant or think 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
- Be sure to discuss the following with your doctor before you begin treatment with Activella:
- All the medications you take. These include prescription and over-the-counter medications in addition to vitamins and herbal supplements.
- Your allergies.
- Your health conditions and medical history.
- If you are pregnant, think you are pregnant, or plan to become pregnant.
- If you are nursing or plan to nurse your baby.
- Your risk for gallbladder problems may be increased with the use of Activella.
- Seek medical care immediately if you experience vision loss during treatment with Activella.
- Seek medical care immediately if you develop yellowing of your skin or whites of your eyes during treatment with Activella.
- Activella can cause high levels of calcium in women who have breast cancer or bone cancer.
- Activella can cause high levels of triglycerides in the blood that an lead to pancreatitis.
- Activella can cause high blood pressure.
- If you are on thyroid replacement therapy, your thyroid function should be checked during treatment with Activella.
- Activella can cause low blood calcium levels in women who have hypoparathyroidism.
- Activella can cause fluid retention.
- Activella can worsen the symptoms of certain conditions such as hereditary angioedema, asthma, diabetes, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas. Caution should be used in women who have these conditions.
Side Effects
Contact your doctor right away if you develop symptoms that concern you or won't go away. The most common Activella side effects are back pain, headache, pain in the extremity, nausea, diarrhea, gastroenteritis, sleep problems, mood changes, upper respiratory tract infection, sinusitis, nasopharyngitis, weight gain, pain of 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.Product Code : 6116
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