Vivelle-Dot

Vivelle-Dot Drug Information

• Vivelle-Dot Overview

  Vivelle-Dot is a female hormone (estrogen). Vivelle-Dot is used by women to help reduce symptoms of menopause (such as hot flashes, vaginal dryness). These symptoms are caused by the body making less estrogen. If you are using Vivelle-Dot to treat symptoms only in and around the vagina, products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected. Vivelle-Dot may also be used by women who are not able to produce enough estrogen (for example, due to hypogonadism, primary ovarian failure). Certain estrogen products may also be used by women after menopause to prevent bone loss (osteoporosis). However, there are other medications (such as raloxifene, bisphosphonates including alendronate) that are also effective in preventing bone loss and may be safer. These medications should be considered for use before estrogen treatment.

• Vivelle-Dot Warnings

  Estrogens, either used alone or with another hormone (progestin), have rarely caused very serious side effects. Discuss the risks and benefits of hormone treatment with your doctor. Estrogens should not be used to prevent heart disease or dementia. Estrogens can increase the risk of cancer of the uterus (endometrial cancer). Taking a progestin as directed by your doctor can help decrease this risk. Tell your doctor right away if you have any unusual vaginal bleeding. In postmenopausal women, estrogens can increase the risk of cancer of the ovaries, stroke, dementia, and serious blood clots in the legs. Estrogens alone do not appear to increase the risk of breast cancer when used for up to 7 years. Estrogen, when used with a progestin, can increase the risk of heart disease (such as heart attacks), stroke, serious blood clots in the lungs/legs, dementia, and cancer of the breast/ovaries. The risk for serious side effects may depend on the dose of estrogen and the length of time Vivelle-Dot is used. Therefore, Vivelle-Dot should be used at the lowest effective dose and for the shortest amount of time. Discuss the use of Vivelle-Dot with your doctor and check with him/her regularly (for example, every 3 to 6 months) to see if you still need to use Vivelle-Dot. If you will be using Vivelle-Dot long-term, you should have regular complete physical exams (for example, once a year) as directed by your doctor. See also Notes section.

• How to Use Vivelle-Dot

  Read the Patient Information Leaflet if available from your pharmacist before you start using Vivelle-Dot and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Peel off the backing from the patch and apply the patch to a clean, dry area of the body as directed. This patch should only be applied to certain areas of the body. Different brands of patches are applied to different areas of the body. If you have any questions about where to apply the patch, ask your doctor or pharmacist. Press the patch firmly in place for about 10 seconds to make sure it stays on. Do not apply the patch on the breast or on oily, broken, or irritated skin. Avoid applying the patch to areas of the skin where it might be easily rubbed off (such as the waistline). Use Vivelle-Dot as directed by your doctor. The patch is usually replaced twice a week (every 3 to 4 days). Follow the dosing schedule carefully. The Dosage of Vivelle-Dot is based on your medical condition and response to treatment. When replacing your patch, make sure to apply the new patch to a different area. Wait at least 1 week before applying a patch to the same area. Fold the old patch in half with the sticky side together and throw away in the trash away from children and pets. Do not flush the patch down the toilet. If a patch falls off, reapply it to a different area. If the patch does not stick completely, then apply a new patch and wear it for the rest of the scheduled period. Do not wear 2 patches at the same time. Use Vivelle-Dot regularly to get the most benefit from it. To help you remember, change the patch on the same days each week. It may help to mark your calendar as a reminder. Tell your doctor if your condition does not improve or if it worsens.

• Vivelle-Dot Precautions

  Before using estradiol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Vivelle-Dot may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using Vivelle-Dot, tell your doctor or pharmacist your medical history,vaginal bleeding of unknown cause, certain cancers (such as breast cancer, cancer of the uterus/ovaries), blood clots, stroke, heart disease (such as heart attack), liver disease, kidney disease, family medical history (especially breast lumps, cancer, blood clots), family or personal history of a certain swelling disorder (angioedema), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, diabetes, high cholesterol/triglyceride levels, obesity, lupus, underactive thyroid (hypothyroidism), mineral imbalance (low or high level of calcium in the blood), a certain hormone problem (hypoparathyroidism), uterus problems (such as fibroids, endometriosis), gallbladder disease, asthma, seizures, migraine headaches, a certain blood disorder (porphyria), mental/mood disorders (such as dementia, depression). Do not smoke or use tobacco. Estrogens combined with smoking further increases your risk of stroke, blood clots, high blood pressure, and heart attack, especially in women older than 35. Tell your doctor if you just had or will be having surgery, or if you will be confined to a chair or bed for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are taking an estrogen product. You may need to stop Vivelle-Dot for a time or take special precautions. If you are going to have an MRI test, tell testing personnel that you are using this patch. Some patches may contain metals that can cause serious burns during an MRI. Ask your doctor whether you will need to remove your patch before the test and apply a new patch afterward, and how to do so properly. Vivelle-Dot may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur. Children may be more sensitive to the side effects of Vivelle-Dot. It may affect their growth/development. Discuss the possible effects of Vivelle-Dot with the doctor, and monitor your child's growth periodically. Vivelle-Dot must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away. Vivelle-Dot passes into breast milk. It may reduce the quality and amount of breast milk produced. Consult your doctor before breast-feeding.

• Vivelle-Dot Misdose

  If you forget to replace a patch at the scheduled time, replace it as soon as you remember. Do not use more than one patch at a time.

• Vivelle-Dot Interactions

  Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.aromatase inhibitors (such as anastrozole, exemestane, letrozole), fulvestrant, ospemifene, raloxifene, tamoxifen, toremifene, tranexamic acid. Vivelle-Dot may interfere with certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use Vivelle-Dot.

• Vivelle-Dot Side Effects

  Skin redness/irritation at the application site, nausea/vomiting, bloating, breast tenderness, headache, or weight changes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed Vivelle-Dot because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using Vivelle-Dot do not have serious side effects. Tell your doctor right away if you have any serious side effects,mental/mood changes (such as depression, memory loss), breast lumps, unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged/recurrent bleeding), increased or new vaginal irritation/itching/odor/discharge, severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine, swelling hands/ankles/feet, increased thirst/urination. Vivelle-Dot may rarely cause serious problems from blood clots (such as heart attacks, strokes, deep vein thrombosis, pulmonary embolism). Get medical help right away if you have any serious side effects,chest/jaw/left arm pain, unusual sweating, sudden/severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (such as partial/complete blindness), pain/redness/swelling of legs, tingling/weakness/numbness in the arms/legs, trouble breathing, coughing up blood, sudden dizziness/fainting. A very serious allergic reaction to Vivelle-Dot is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction,rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

  List of Vivelle-Dot side effects

• Vivelle-Dot Storage

  Store at room temperature. Do not remove the patch from the pouch until ready for use. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard Vivelle-Dot when it is expired or no longer needed (See How to Use section).