Generic Name: estradiol (ES-tra-DYE-ol)
Brand Name: Examples include Estraderm and Vivelle
Vivelle patch should not be used to prevent heart disease, heart attacks, strokes, or dementia. Estrogens have been shown to increase the risk of heart disease (including heart attack), stroke, dementia, serious blood clots (eg, in the lungs or legs), cancer of the uterus, and breast cancer in some women. Tell your doctor right away if you have unusual vaginal bleeding while you use Vivelle patch. Talk with your doctor if you have questions about the benefits and risks of using Vivelle patch.
Vivelle patch should be used for the shortest possible time at the lowest effective dose to minimize the risk of these side effects. Talk with your doctor regularly about your need to use Vivelle patch.
Vivelle patch is used for:
Treating conditions due to menopause (eg, hot flashes; vaginal itching, burning, or dryness), preventing osteoporosis (brittle bones) in certain women who have already gone through menopause, or replacing estrogen if the ovaries do not produce enough or are removed. It may also be used for other conditions as determined by your doctor.
Vivelle patch is an estrogen hormone. It works by replacing natural estrogens in women who can no longer produce enough estrogen.
Do NOT use Vivelle patch if:
- you are allergic to any ingredient in Vivelle patch
- you have had a severe reaction (eg, swelling of the hands, face, lips, eyes, throat, or tongue; trouble swallowing or breathing; hoarseness) after taking Vivelle patch
- you are pregnant or think you may be pregnant
- you have known or suspected breast cancer or another estrogen-dependent growth (eg, cancer of the uterus), or you have a history of breast cancer
- you have a history of liver problems or liver disease
- you have abnormal vaginal bleeding of an unknown cause
- you have active blood clots (eg, of the legs or lungs), a history of blood clots, bleeding problems, or a condition that may increase your risk of blood clots
- you have had a heart attack or stroke
Contact your doctor or health care provider right away if any of these apply to you.
Before using Vivelle patch:
Some medical conditions may interact with Vivelle patch. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a condition called hereditary angioedema
- if you have a history of breast lumps, breast disease, or an abnormal mammogram, or if a member of your family has had breast cancer
- if you have yellowing of the whites of the eyes or skin during pregnancy or with past estrogen use, if you have a vaginal infection or a history of uterus problems (eg, fibroids, endometriosis, abnormal vaginal bleeding, cancer), or if you have had your uterus removed (hysterectomy
- if you have a history of asthma, depression, memory problems, diabetes, seizures, gallbladder disease, pancreatitis, heart problems, high blood calcium levels, high blood pressure, low blood levels of parathyroid hormone, or porphyria
- if you have a history of kidney or liver problems, cancer, migraines, thyroid problems, swelling, or chorea (jerky, involuntary movements of the face, arms, or legs)
- if you or a member of your family has had high cholesterol or triglyceride levels, blood clots (eg, in the leg or lung), or lupus, or has been very overweight; or if you smoke, use tobacco, are very overweight, will be having surgery, or will be confined to a bed or chair for a period of time
Some MEDICINES MAY INTERACT with Vivelle patch. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Azole antifungals (eg, itraconazole, ketoconazole), clarithromycin, erythromycin, or ritonavir because they may increase the risk of Vivelle patch's side effects
- Anticoagulants (eg, warfarin) because their actions and side effects may be increased by Vivelle patch
- Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), rifampin, or St. John's wort because they may decrease Vivelle patch's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if Vivelle patch may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Vivelle patch:
Use Vivelle patch as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Vivelle patch. Talk to your pharmacist if you have questions about this information.
- If you are switching from oral estrogen to Vivelle patch, stop taking the oral estrogen and wait 1 week before using Vivelle patch. However, if your symptoms return, you may start using Vivelle patch sooner.
- The patch is usually replaced twice a week (about every 3 to 4 days), or as directed by your doctor. Follow the dosing schedule carefully.
- Do not open the sealed pouch containing the patch until ready to use. Open the pouch and remove the patch from the protective liner. Apply the patch to a clean, dry, hairless area of the body, such as the lower abdomen or buttocks. Press the patch firmly against the skin for about 10 seconds to be sure the patch stays on. If the system lifts off of your skin, press down to reapply. Wear only 1 system at any one time.
- Do not cut or tear the patch. Do not apply a patch if the pouch seal is broken or if the patch has been damaged.
- Do not place the patch on the breast. Make sure the application site is free of any powder, oil, lotion, cuts, or irritation. Avoid applying to the waistline because tight clothing may rub the patch off. If you have any questions about where to apply the patch, contact your doctor or pharmacist for instructions. You may wear the patch while bathing, swimming, or showering. Make sure the patch does not come loose during these activities.
- When it is time to change the patch, remove it slowly. After removing the used patch, fold it in half with the sticky sides together. Discard the patch out of the reach of children and away from pets.
- Apply a new patch to a different area to prevent skin irritation. It is best to rotate the areas where the patch is applied, allowing at least 1 week in between applications to the same site. If the area around the patch becomes red, itchy, or irritated, try a new site. If the irritation continues or becomes worse, notify your doctor promptly.
- Grapefruit and grapefruit juice may increase the risk of Vivelle patch's side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking Vivelle patch.
- If you miss a dose of Vivelle patch, use it as soon as possible. If a patch falls off, reapply it or apply a new patch and wear it for the rest of the scheduled period, then resume your usual dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Vivelle patch.
Important safety information:
- Vivelle patch may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Vivelle patch with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Vivelle patch is for external use only. Do not get it in your mouth.
- Vivelle patch may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker, and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.
- Vivelle patch may increase the risk of blood clots. The risk may be greater if you smoke (especially in women older than 35 years old).
- Contact your health care provider if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention.
- Contact your health care provider if vaginal discomfort occurs or if you suspect you have developed an infection while taking Vivelle patch.
- Follow your doctor's instructions for examining your breasts and report any lumps immediately.
- If you wear contact lenses and you develop problems with them, contact your doctor.
- If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken while you are taking Vivelle patch.
- Nondrug therapy to help prevent bone loss includes a weight-bearing exercise plan, as well as adequate daily calcium and vitamin D intake. Consult your doctor or pharmacist for more details.
- Vivelle patch may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Vivelle patch.
- Diabetes patients - Vivelle patch may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Lab tests, including physical exams and blood pressure, may be performed while you use Vivelle patch. You should have breast and pelvic exams, and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. Be sure to keep all doctor and lab appointments.
- Use Vivelle patch with caution in the ELDERLY; they may be more sensitive to its effects, especially stroke and dementia.
- Vivelle patch should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use Vivelle patch if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Vivelle patch may be found in breast milk. If you are or will be breast-feeding while you use Vivelle patch, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Vivelle patch:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Breakthrough bleeding or spotting; Hair loss; headache; mild breast pain or tenderness; mild nausea or vomiting; skin redness/irritation at the application site; stomach cramps or bloating
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; breast lumps or pain; calf or leg pain, swelling, or tenderness; chest pain; coughing up blood; fainting; fever; mental or mood changes (eg, depression); new or worsening memory problems; pelvic pain; severe or persistent dizziness or headache; severe or persistent stomach or back pain (with or without nausea or vomiting); shortness of breath; swelling of hands or feet; symptoms of heart attack (eg, chest, jaw, or arm pain; sudden severe nausea or vomiting; shortness of breath; sudden unusual sweating); symptoms of liver problems (eg, dark urine, pale stools, yellowing of the skin or eyes); symptoms of stroke (eg, one-sided weakness, slurred speech, confusion); unusual vaginal discharge, itching, or odor; unusual tiredness or weakness.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Vivelle patch:
Store Vivelle patch at room temperature, 68 to 77 degrees F (20 to 25 degrees C). Store in original packaging until just before use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Vivelle patch out of the reach of children and away from pets.
- If you have any questions about Vivelle patch, please talk with your doctor, pharmacist, or other health care provider.
- Vivelle patch is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Vivelle patch or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Vivelle patch. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Vivelle patch. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Vivelle patch.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.