Estrogens increase the risk of endometrial cancer in postmenopausal women. (See Endometrial Cancer under Cautions.)
Do not use estrogens with or without progestins for prevention of cardiovascular disease (see Cardiovascular Risk Reduction under Uses and Cardiovascular Disorders under Cautions) or dementia (see Alzheimer's Disease under Uses).
The Women’s Health Initiative (WHI) study of estrogen alone reported increased risks of stroke and DVT in postmenopausal women receiving approximately 7 years of therapy with conjugated estrogens 0.625 mg daily.
The WHI study of estrogen plus progestin reported increased risks of MI, stroke, invasive breast cancer, pulmonary embolism, and DVT in postmenopausal women receiving >5 years of therapy with conjugated estrogens 0.625 mg in conjunction with medroxyprogesterone acetate 2.5 mg daily.
The WHI Memory Study (WHIMS) reported increased risk of developing probable dementia in postmenopausal women ≥65 years of age receiving long-term therapy (4–5 years) with conjugated estrogens in conjunction with medroxyprogesterone acetate or conjugated estrogen alone. Not known whether this finding also applies to younger postmenopausal women.
Other dosages of conjugated estrogens with medroxyprogesterone and other combinations or dosage forms of estrogens with progestin not studied in WHI trials; in absence of comparable data, assume risks are similar.
Prescribe estrogens (with or without progestins) at the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman.
What is this medicine?
ESTRADIOL (es tra DYE ole) skin patches contain an estrogen. It is mostly used as hormone replacement in menopausal women. It helps to treat hot flashes and prevent osteoporosis. It is also used to treat women with low estrogen levels or those who have had their ovaries removed.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
abnormal vaginal bleeding
blood vessel disease or blood clots
breast, cervical, endometrial, ovarian, liver, or uterine cancer
This medicine is for external use only. Follow the directions on the prescription label. Tear open the pouch, do not use scissors. Remove the stiff protective liner covering the adhesive. Try not to touch the adhesive. Apply the patch, sticky side to the skin, to an area that is clean, dry and hairless. Avoid injured, irritated, calloused, or scarred areas. Do not apply the skin patches to your breasts or around the waistline. Use a different site each time to prevent skin irritation. Do not cut or trim the patch. Do not stop using except on the advice of your doctor or health care professional. Do not wear more than one patch at a time unless you are told to do so by your doctor or health care professional.
Contact your pediatrician regarding the use of this medicine in children. Special care may be needed.
A patient information sheet will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, apply it as soon as you can. If it is almost time for your next dose, apply only that dose. Do not apply double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular checks on your progress. You will need a regular breast and pelvic exam and Pap smear while on this medicine. You should also discuss the need for regular mammograms with your health care professional, and follow his or her guidelines for these tests.
This medicine can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your doctor or health care professional if you feel you are retaining fluid.
If you have any reason to think you are pregnant, stop taking this medicine right away and contact your doctor or health care professional.
Smoking increases the risk of getting a blood clot or having a stroke while you are taking this medicine, especially if you are more than 35 years old. You are strongly advised not to smoke.
If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your eye doctor or health care professional.
This medicine can increase the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone drug, with this medicine lowers the risk of developing this condition. Therefore, if your uterus has not been removed (by a hysterectomy), your doctor may prescribe a progestin for you to take together with your estrogen. You should know, however, that taking estrogens with progestins may have additional health risks. You should discuss the use of estrogens and progestins with your health care professional to determine the benefits and risks for you.
If you are going to have surgery or an MRI, you may need to stop taking this medicine. Consult your health care professional for advice before you schedule the surgery.
You may bathe or participate in other activities while wearing your patch. If the patch pulls loose or falls off, you may reapply it if the patch is sticky enough to stay on the skin. You should reapply the patch in a different area. Use a fresh patch if it will no longer stick.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
symptoms of vaginal infection like itching, irritation or unusual discharge
unusually weak or tired
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature below 30 degrees C (86 degrees F). Do not store any patches that have been removed from their protective pouch. Throw away any unused medicine after the expiration date. Dispose of used patches properly. Since used patches may still contain active hormones, fold the patch in half so that it sticks to itself prior to disposal.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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