Estradiol topical (for the skin) is used to treat certain symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation.

Estradiol topical may also be used for purposes not listed in this medication guide.

You should not use this medicine if you have: undiagnosed vaginal bleeding, liver disease, bleeding problems, an increased risk of blood clots, if you will have major surgery, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.

Do not use if you are pregnant.

Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Report any unusual vaginal bleeding right away.

Using this medicine can increase your risk of blood clots, stroke, heart attack, or cancer of the breast, uterus, or ovaries. Estradiol should not be used to prevent heart disease, stroke, or dementia.

Estradiol topical is absorbed through the skin and can cause side effects in a child who comes into contact with the skin where you have applied the medicine.

Topical estradiol comes as a gel in single dose packets and in a pump that dispenses measured amounts of the medication to apply to the skin once a day. Topical estradiol also comes as a spray to apply to the skin as 1 to 3 sprays once a day in the morning. Estradiol gel may be applied at any time of day, but should be applied at around the same time of day every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use topical estradiol exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Topical estradiol products are manufactured differently and are used in slightly different ways. Be sure that you know which topical brand you are using and how and where you should apply it. Read the manufacturer's instructions for use that came with your topical estradiol product carefully. These instructions describe how to apply topical estradiol gel or spray. Be sure that you understand these directions. Ask your healthcare provider if you have any questions about how to apply this medication.

If you are using estradiol gel in a pump, you should apply it in a thin layer to one arm, from the wrist to the shoulder. If you are using estradiol gel in single dose packets, you should apply it in a thin layer to one thigh, on the front of the thigh. If you are using estradiol, you should apply it to the inner arm. Do not apply estradiol gel or spray to your breasts or your genital area. Be sure that the skin where you will apply topical estradiol is clean and completely dry, and is not red, irritated, or broken.

If you take a bath or a shower, apply topical estradiol after you have dried your skin completely. Read the manufacturer's patient information about your topical estradiol product for information about when you can wash, shower, bathe, or swim after you apply the medication.

Estradiol gel and spray may catch fire. When you apply topical estradiol, do not smoke or go near a fire or open flame until the medication dries.

Topical estradiol is only for use on the skin. Be careful not to get topical estradiol in your eyes. If you do get topical estradiol in your eyes, wash them with plenty of warm water right away. Call a doctor if your eyes become irritated.

You should apply topical estradiol yourself. If someone else applies the medication to your skin, they should wear disposable gloves and wash their hands well with soap and water after removing the gloves.

Talk to you doctor about applying other skin preparations, including sunscreen, to skin where topical estradiol gel or spray is applied.

Estradiol topical may control your symptoms but will not cure your condition. Continue to use estradiol topical even if you feel well. Do not stop using estradiol topical without talking to your doctor. If you stop using estradiol topical, your symptoms may return.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Use the medicine at the same time each day.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Wash your hands with soap and water after applying the medicine. Do not allow other people to get this medicine on their skin. If this happens, wash the area thoroughly with soap and water.

Do not allow a child to come into contact with the skin where you have applied estradiol topical. Topical estradiol is absorbed through the skin and can cause premature puberty in a child who comes into contact with this medicine. Cover treated areas with clothing to protect others from coming into contact with the skin where you apply this medicine.

If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using estradiol.

Estradiol may increase your risk of developing a condition that can lead to uterine cancer. To help lower this risk, your doctor may also want you to take a progestin. Report any unusual vaginal bleeding right away.

Your doctor should check your progress on a regular basis to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms while using estradiol topical.

Store at room temperature away from moisture and heat.

Estradiol topical may be flammable. Do not use near high heat or open flame. Do not smoke until the medicine has completely dried on your skin.

You should not use estradiol if you are allergic to it, or if you have:

• unusual vaginal bleeding that has not been checked by a doctor;

• liver disease;

• a history of heart attack, stroke, or blood clot;

• an increased risk of having blood clots due to a heart problem or a hereditary blood disorder; or

• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.

Do not use estradiol if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Using estradiol can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.

Estradiol topical should not be used to prevent heart disease, stroke, or dementia. estradiol topical may actually increase your risk of developing these conditions.

Tell your doctor if you have ever had:

• heart disease;

• liver problems, or jaundice caused by pregnancy or taking hormones;

• kidney disease;

• gallbladder disease;

• asthma;

• epilepsy or other seizure disorder;

• migraines;

• lupus;

• endometriosis or uterine fibroid tumors;

• hereditary angioedema;

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

• a thyroid disorder; or

• high levels of calcium in your blood.

Using estradiol may increase your risk of cancer of the breast, uterus, or ovaries. Talk with your doctor about this risk.

Estradiol lowers the hormone needed to produce breast milk and can slow breast milk production. Tell your doctor if you are breastfeeding.

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 12 hours. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, stomach pain, breast tenderness, drowsiness, and vaginal bleeding.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not freeze topical estradiol. Keep estradiol gel away from open flame. Dispose of your estradiol gel pump after you have used 64 doses even if it is not completely empty.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.

Avoid getting estradiol topical in your eyes. If this does happen, rinse with water.

Wait at least 25 minutes after applying estradiol topical before you apply sunscreen to the same skin area.

Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while using estradiol.

Grapefruit may interact with estradiol and lead to unwanted side effects. Avoid the use of grapefruit products.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Estradiol topical may cause serious side effects. Call your doctor at once if you have:

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• signs of a blood clot--sudden numbness or weakness, sudden vision loss, slurred speech, stabbing chest pain, coughing up blood, pain or warmth in one or both legs;

• swelling or tenderness in your stomach, severe stomach pain spreading to your back, nausea and vomiting;

• jaundice (yellowing of the skin or eyes);

• memory problems, confusion, unusual behavior;

• unusual vaginal bleeding, pelvic pain;

• a lump in your breast; or

• high calcium levels--confusion, tiredness, nausea, vomiting, loss of appetite, constipation, increased thirst or urination, weight loss.

Topical estradiol is absorbed through the skin of a child who comes into contact with estradiol topical. Call your doctor if a child in close contact with you develops swollen nipples or enlarged breasts.

Common side effects of estradiol topical may include:

• nausea, vomiting, stomach cramps;

• bloating, swelling, weight gain;

• breast pain or tenderness;

• headache;

• vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding;

• thinning scalp hair; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can affect estradiol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to topical estradiol.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using topical estradiol.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.