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Combipatch (Estradiol / Norethindrone Acetate)
Also Known as Estalis Continuous
Prescription Required
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Product Details
Description
CombiPatch is a patch that contains a combination of hormones used to treat women with a uterus who suffer from menopausal symptoms, vaginal atropy due to menopause, and low estrogen levels caused by hypogonadism, castration, or primary ovarian failure.
Estradiol and norethindrone acetate are the hormones in CombiPatch.
CombiPatch is available in the following strengths:
- 0.05 mg estradiol with 0.14 mg norethindrone acetate
- 0.05 mg estradiol with 0.25 mg norethindrone acetate
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)
50mcg/140 mcg, 50mcg/250mcg
Pregnancy
Consult Doctor
Brands
Combipatch
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
Patches
Directions
Carefully read and follow the instructions that come with your prescription. Use CombiPatch as your doctor has prescribed. If you have any questions, talk to your doctor or pharmacist.
Application
CombiPatch should be applied to smooth, clean, dry, and intact skin of the lower abdomen. Do not place the patch on or near the breasts or at the waistline where it could be rubbed off by clothing. You should rotate the application sites, allowing at least one week between applications to the same site. You should wear only one patch at a time during the 3- or 4-day dosing interval. Avoid exposing the patch to the sun for long periods of time.
Removal
Slowly remove the patch. If there is adhesive remaining, allow your skin to dry for 15 minutes, then gently rub the area with an oily cream or lotion to remove the residual adhesive.
Storage
CombiPatch systems should be stored in their sealed foil pouches in the refrigerator between 36°F and 46°F. Keep CombiPatch away from children and pets.Ingredients
Estradiol and norethindrone acetate are contained in each CombiPatch transdermal system.
Contraindications
Do not use CombiPatch if you have any of the following conditions:
- Abnormal vaginal bleeding that has not be diagnosed
- Active, suspected, or a history of breast cancer
- Active or suspected estrogen-dependent cancer
- Active or a history of blood clots in the legs or lungs
- Active stroke or heart attack
- Previous allergic reaction or swelling with CombiPatch use
- Liver problems
- Blood clotting disorders such as protein C, protein S, or antithrombin deficiency
- Current or suspected pregnancy
Cautions
CombiPatch has a FDA Boxed Warning against the use of estrogens and progestins for preventing cardiovascular disease or dementia. The FDA Boxed Warning also warns that estrogen plus progestin therapy can increase the risk of blood clots in the legs or lungs, stroke, and heart attack in postmenopausal women. Further, the FDA Boxed Warning warns that estrogen plus progestin therapy can increase the risk of dementia and breast cancer in women. Estrogen alone has been shown to increase the risk of endometrial cancer in women with a uterus. Estrogen alone has also been shown to increase the risk of stroke, blood clots, and dementia in postmenopausal women. Estrogens with or without progestins should be used at the lowest dose possible and for the shortest duration of time while meeting treatment goals.
- Before you start treatment with CombiPatch, be sure to inform your doctor:
- Of any medications you take
- Your allergies
- Your health history and medical problems
- If you are pregnant or breastfeeding
- The risk of gallbladder disease that requires surgery is increased in postmenopasual women who are taking estrogens.
- High calcium levels can occur in women who have breast or bone cancer and are taking estrogens.
- Blood clots in the retina of the eyes can occur in women who take estrogens.
- Swelling of the eyes, face, tongue, legs, ankles, or fingers can occur with the use of CombiPatch. Seek medical care immediately if any of these occur.
- Severe allergic reactions that include hives, itching, or swelling can occur with the use of CombiPatch. Seek medical care immediately if any of these occur.
- Estrogens may cause an increase in blood pressure.
- Estrogens may increase triglyceride levels in the blood that can lead to pancreatitis.
- Women who are taking estrogens and thyroid hormone replacement therapy may need a dose increase in their hormone replacement therapy.
- Fluid retention can occur with the use of estrogens.
- Worsening of asthma, diabetes, seizures, migraines, lupus, and benign liver tumors can occur with the use of estrogens. Caution should be used in women who have any of these conditions.
Side Effects
CombiPatch side effects include stomach pain, diarrhea, depression, sore throat, application site reactions, breast pain, and vaginal inflammation. However, these are not the only side effects that can occur.
Reach out to your doctor immediately with any concerning or persistent side effects.
Reference:
- CombiPatch (estradiol/norethindrone acetate transdermal system). Miami, FL: Noven Pharmaceuticals, Inc.; 2021.
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 : 13219
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