Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Estraderm there are no specific foods that you must exclude from your diet when receiving Estraderm.
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA
Estrogen-Alone Therapy
Endometrial Cancer
There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.
Cardiovascular Disorders and Probable Dementia
Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia.
The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo.
The WHI Memory Study (WHIMS) estrogen-alone ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens.
Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
Estrogen Plus Progestin Therapy
Cardiovascular Disorders and Probable Dementia
Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia.
The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary emboli (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.
The WHIMS estrogen plus progestin ancillary study of the WHI reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) plus MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
Breast Cancer
The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.
In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins.
Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
Tell your healthcare provider if you are pregnant or plan to become pregnant. Estraderm should not be used during pregnancy.
Serious, but less common side effects include:
- Heart attack
- Stroke
- Blood clots
- Dementia
- Breast cancer
- Cancer of the lining of the uterus (womb)
- Cancer of the ovary
- High blood pressure
- High blood sugar
- Gallbladder disease
- Liver problems
- Enlargement of benign tumors of the uterus (“fibroids”)
- Severe allergic reactions
Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:
- New breast lumps
- Unusual vaginal bleeding
- Changes in vision or speech
- Sudden new severe headaches
- Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
- Swollen lips, tongue and face
Less serious, but common side effects include:
- Headache
- Breast pain
- Irregular vaginal bleeding or spotting
- Stomach or abdominal cramps, bloating
- Nausea and vomiting
- Hair loss
- Fluid retention
- Vaginal yeast infection
These are not all the possible side effects of Estraderm. For more information, ask your healthcare provider or pharmacist for advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Estraderm is not recommended for use in breastfeeding women primarily because estrogens have been shown to decrease the amount and quality of breast milk. Estrogens may be excreted in human breast milk, however, the amount that passes into the milk may be very low.
How and where to apply Estraderm
Each Estraderm system is individually sealed in a protective pouch. Tear open this pouch at the indentation (do not use scissors) and remove the system. Bubbles in the patch are normal.
A stiff protective liner covers the adhesive side of the patch — the side that will be placed against your skin. This liner must be removed before applying the patch. Slide the protective liner sideways between your thumb and index finger. Then hold the patch at one edge. Remove the protective liner and discard it. Try to avoid touching the adhesive.
Apply the adhesive side of the patch to a clean, dry area of the skin on the trunk of the body (including the buttocks and abdomen).
The site selected should be one that is not exposed to sunlight. Some women may find that it is more comfortable to wear Estraderm on the buttocks. Do not apply Estraderm to your breasts. The sites of application must be rotated, with an interval of at least 1 week allowed
between applications to a particular site. The area selected should not be oily, damaged, or irritated. Avoid the waistline, since tight clothing may rub the patch off. Apply the patch immediately after opening the pouch and removing the protective liner. Press the patch firmly in place with the palm of your hand for about 10 seconds, making sure there is good contact, especially around the edges.
The Estraderm patch should be worn continuously until it is time to replace it with a new patch. You may wish to experiment with different locations when applying a new patch, to find ones that are most comfortable for you and where clothing will not rub on the patch.
When to Apply Estraderm
The Estraderm patch should be replaced twice weekly. Your Estraderm package contains a calendar checklist on the back to help you remember a schedule. Mark the 2-day schedule you plan to follow. Always change the patch on the 2 days of the week you have marked.
When changing the patch, remove the used Estraderm patch and discard it. Any adhesive that might remain on your skin can be easily rubbed off. Then place the new Estraderm patch on a different skin site. (The same skin site should not be used again for at least 1 week after removal of the patch.)
Please note: Contact with water when you are bathing, swimming, or showering will not affect the patch. In the unlikely event that a patch should fall off, put this same patch back on and continue to follow your original treatment schedule. If necessary, you may apply a new patch but continue to follow your original schedule.
To lower your chances of getting a serious side effect with Estraderm:
- Talk with your healthcare provider regularly about whether you should continue using Estraderm
- If you have a uterus, talk to your healthcare provider about whether the addition of a progestin is right for you. The addition of a progestin is generally recommended for women with a uterus to reduce the chance of getting cancer of the uterus (womb)
- See your healthcare provider right away if you get vaginal bleeding while using Estraderm.
- Have a pelvic exam, breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often
- If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances for getting heart disease.
Estraderm is a prescription medication used to treat the symptoms of menopause including hot flashes and vaginal dryness. It is also used to treat conditions in which a woman’s ovaries do not produce enough estrogen naturally, and to prevent osteoporosis in women who have gone through menopause.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Estraderm (generic: estradiol) is a prescription medication used to treat the symptoms of menopause including hot flashes and vaginal dryness. It is also used to treat conditions in which a woman’s ovaries do not produce enough estrogen naturally, and to prevent osteoporosis in women who have gone through menopause. Estraderm contains estradiol, a form of the hormone estrogen. It works to reduce symptoms of menopause, and to prevent osteoporosis, by replacing estrogen that the ovaries no longer produce.
The Estraderm patch comprises four layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are:
- a transparent polyester/ethylene vinyl acetate copolymer film
- a drug reservoir of estradiol USP and alcohol USP gelled with hydroxypropyl cellulose NF
- an ethylene-vinyl acetate copolymer membrane
- an adhesive formulation of light mineral oil NF and polyisobutylene.
- A protective liner of siliconized polyester film is attached to the adhesive surface and must be removed before the patch can be used.
The active component of the patch is estradiol. The remaining components of the patch are pharmacologically inactive. Alcohol is also released from the patch during use.
Tell your healthcare provider:
- If you have any unusual vaginal bleeding. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
- About all of your medical problems. Your healthcare provider may need to check you more carefully if you have certain conditions such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
- About all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Estraderm works. Estraderm may also affect how other medicines work.
- If you are going to have surgery or will be on bed rest
You may need to stop using Estraderm if you are breast feeding. The hormone in Estraderm can pass into your breast milk.
Do not start using Estraderm if you:
- Have unusual vaginal bleeding
- Currently have or have had certain cancers (Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast or uterus. See “FDA Warning”. If you have or have had cancer, talk with your healthcare provider about whether you should use Estraderm.)
- Had a stroke or heart attack
- Currently have or have had blood clots
- Currently have or have had liver problems
- Have been diagnosed with a bleeding disorder
- Are allergic to Estraderm or any of its ingredients
- Think you may be pregnant
Do not store above 30°C (86°F).
Do not store unpouched. Apply immediately upon removal from the protective pouch.
Keep this and all medicines out of the reach of children.