Estradiol patch (Absorbed through the skin)

Brand Name(s)

Vivelle-Dot, Climara, Menostar, Alora, Estraderm, Vivelle

There may be other brand names for this medicine.

How to Use This Medicine

Patch

• Your doctor will tell you how many patches to use, where to apply them, and how often to apply them. Do not use more patches or apply them more often than your doctor tells you to.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
• Wash your hands with soap and water before and after applying a patch.
• Leave the patch in its sealed wrapper until you are ready to put it on. Tear the wrapper open carefully. NEVER CUT the wrapper or the patch with scissors. Do not use any patch that has been cut by accident.
• The patient instructions will show the body areas where you can wear the patch. When putting on each new patch, choose a different place within these areas. Do not put the new patch on the same place you wore the last one. Be sure to remove the old patch before applying a new one. Do not apply the patch on or near your breasts.
• Do not put the patch over burns, cuts, or irritated skin.
• Put on a new patch if the old one has fallen off and cannot be reapplied.

If a dose is missed:

• If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the patches at room temperature in a closed container, away from heat, moisture, and direct light. Keep each patch in its unopened pouch until you are ready to use it.
• Fold the used patch in half with the sticky sides together. Throw any used patch away so that children or pets cannot get to it. You will also need to throw away old patches after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using a blood thinner such as warfarin (Coumadin®), St. John's wort, phenobarbital, carbamazepine (Tegretol®), rifampin (Rifadin®, Rifater®), erythromycin (E.E.S.®, Ery-tab®), clarithromycin (Biaxin®), itraconazole (Sporanox®), ketoconazole (Nizoral®), ritonavir (Norvir®), or thyroid medicine (levothyroxine, Synthroid®).
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, shortness of breath, or coughing up blood.
• Fever, chills, cough, sore throat, and body aches.
• Lumps in your breast.
• Numbness or weakness in your arm or leg, or on one side of your body.
• Pain in your lower leg (calf).
• Seizures.
• Sudden shortness of breath, coughing up blood.
• Swelling in your hands, ankles, or feet.
• Unusual vaginal bleeding, discharge, or itching.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Back or joint pain.
• Changes in weight or hair growth.
• Headache.
• Mild skin rash or itching.
• Nausea, vomiting, diarrhea, or stomach cramps.
• Nervousness, anxiety.
• Runny or stuffy nose.
• Skin discoloration.
• Skin redness or itching where the medicine is applied.
• Swollen or tender breasts.

Introduction

Estradiol (es-tra-DYE-ol)

Treats hot flashes and other symptoms of menopause or low amounts of estrogen. Also used to prevent osteoporosis after menopause.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to estradiol. You should not use this medicine if you have liver disease, breast cancer, or certain other types of cancer. You should not use this medicine if you have a history of blood clotting problems, or if you have had a heart attack or stroke in the past 12 months. Do not use this medicine if you may be pregnant, or if you have unusual vaginal bleeding that has not been checked by your doctor. This medicine should not be used to prevent heart disease, heart attack, or stroke.

Warnings While Using This Medicine

• It is unlikely that a postmenopausal woman may become pregnant. But, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Make sure your doctor knows if you are breastfeeding, or if you have endometriosis or a history of cancer. Tell your doctor if you have asthma, diabetes, epilepsy, gallbladder disease, high or low calcium in the blood, kidney disease, lupus, migraine headaches, porphyria, or thyroid problems. Your doctor should know if you have heart disease, high blood pressure, high blood cholesterol, or a family history of high cholesterol. Tell your doctor if you have ever had liver problems caused by pregnancy or estrogen.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.
• This medicine should not be used to treat or prevent heart disease, stroke, or dementia. Using large doses of this medicine over a long period of time may increase your risk of heart attack, stroke, blood clots, dementia, breast cancer, or uterine cancer. Talk with your doctor about this risk. If you still have your uterus (womb), ask your doctor if you should also use a progestin medicine.
• Your risk of heart disease or stroke from this medicine is higher if you smoke. Your risk is also increased if you have diabetes or high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.
• This medicine may also increase your risk of certain types of cancer. Talk to your doctor if you have concerns about this risk.
• Stop using this medicine and check with your doctor immediately if severe headache or sudden loss of vision or any other change in vision occurs while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088