What is the most important information I should know about estradiol topical?

Do not use this medication if you have any of the following conditions: liver disease, a bleeding disorder, a history of stroke or circulation problems, a hormone-related cancer such as breast or uterine cancer, or abnormal vaginal bleeding.

Estradiol topical can harm an unborn baby or cause birth defects. Do not use if you are pregnant.

Topical estradiol is absorbed through the skin and can cause premature puberty in a child who comes into contact with this medicine or with skin where the medicine was applied. Call your doctor if a child who has close contact with you develops swollen nipples or enlarged breasts.

Children should avoid coming into contact with skin areas where you have applied estradiol topical. If contact does occur, wash with soap and water right away. Cover treated areas with clothing to protect others from coming into contact with the skin where you apply this medicine.

Estrogens will not prevent heart disease, heart attack, stroke, breast cancer, or dementia, and may actually increase your risk of developing these conditions. Estrogens may also increase your risk of uterine or ovarian cancer.

Talk with your doctor about your individual risks before using estradiol long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

What is estradiol topical?

Estradiol is a form of estrogen, a female sex hormone that regulates many processes in the body.

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.

What should I discuss with my health care provider before using estradiol topical?

Estrogens will not prevent heart disease, heart attack, stroke, breast cancer, or dementia, and may actually increase your risk of developing these conditions. Estrogens may also increase your risk of uterine or ovarian cancer.

Talk with your doctor about your individual risks before using estradiol long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

You should not use estradiol topical if you have:

• a bleeding or blood-clotting disorder;
• liver disease;
• a history of stroke or circulation problems;
• abnormal vaginal bleeding that a doctor has not checked; or
• any type of breast, uterine, or hormone-dependent cancer.

To make sure you can safely use estradiol topical, tell your doctor if you have any of these other conditions:

• high blood pressure, angina, or heart disease;
• high cholesterol or triglycerides;
• kidney disease;
• asthma;
• epilepsy or other seizure disorder;
• migraines;
• diabetes;
• a thyroid disorder;
• depression;
• porphyria;
• lupus;
• low levels of calcium in your blood;
• gallbladder disease; or
• if you have had your uterus removed (hysterectomy).

FDA pregnancy category X. This medication can cause birth defects. Do not use estradiol topical if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication.

Estradiol can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

Estradiol increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estradiol may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using estradiol topical.

How should I use estradiol topical?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Apply estradiol topical only to clean, dry, unbroken skin. Do not apply to skin that is red or irritated. Never apply this medicine to the breasts.

To use the topical gel (such as Estrogel):

• Apply estradiol topical gel to the outside of your arm, from wrist to shoulder. Use the gel at the same time each day.
• Do not rub the gel in, but allow it to dry on your skin for at least 5 minutes before you dress.
• The gel form of this medicine is flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.

To use the topical emulsion (such as Estrasorb):

• Apply this medicine while you are sitting down. You will use two foil pouches each time you apply this medication, unless your doctor has told you otherwise.
• Cut or tear open the foil pouch and place the pouch on top of your left thigh, with the open end of the pouch pointing toward your knee.
• Hold the pouch with one hand and use the fingers of your other hand to gently push all of the medicine out of the pouch and onto your thigh.
• Spend at least 3 minutes rubbing the gel into your entire left thigh and calf. Rub any excess medicine onto your buttocks.
• Cut or tear open the second pouch and apply the medicine to your right leg using the same method described above.

To use the topical spray (such as Evamist):

• Apply the spray to the skin on the inside of your forearm, just below the elbow. Use the spray at the same time each day.
• Place the cone of the spray applicator directly to your skin and hold the pump upright. Press the pump fully one spray. If your doctor has prescribed more than one spray, choose a different place on your inside forearm for the second spray. Use only the number of sprays your doctor has recommended.
• Do not rub the spray in, but allow it to dry on your skin for at least 2 minutes before you dress. Do not wash your arm for at least 30 minutes after applying the spray.

Wash your hands with soap and water after applying the gel or emulsion. Avoid allowing other people to get this medicine on their skin. If this happens, wash the area thoroughly with soap and water.

Children should avoid coming into contact with skin areas where you have applied estradiol topical. If contact does occur, wash with soap and water right away. Cover treated areas with clothing to protect others from coming into contact with the skin where you apply this medicine.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using estradiol topical.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

If you are less than 12 hours late in using your medicine, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

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.

What should I avoid while using estradiol topical?

Do not apply sunscreen to your skin at the same time you apply estradiol topical.

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

Grapefruit and grapefruit juice may interact with estradiol and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

What are the possible side effects of estradiol topical?

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

Stop using estradiol topical and call your doctor at once if you have a serious side effect such as:

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
• sudden numbness or weakness, headache, confusion, or problems with vision, speech, or balance;
• pain, swelling, warmth, or redness in one or both legs;
• abnormal vaginal bleeding;
• pain, swelling, or tenderness in your stomach;
• jaundice (yellowing of the skin or eyes); or
• a lump in your breast.

Topical estradiol is absorbed through the skin and can cause premature puberty in a child who comes into contact with this medicine or with skin where the medicine was applied. Call your doctor if a child who has close contact with you develops swollen nipples or enlarged breasts.

Less serious side effects may include:

• nausea, vomiting, loss of appetite;
• swollen breasts;
• acne or skin color changes;
• vaginal pain, dryness, or discomfort, decreased sex drive, or difficulty having an orgasm;
• swelling, weight gain;
• migraine headaches, dizziness, depression; or
• break-through bleeding, vaginal itching or discharge.

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.

What other drugs will affect estradiol topical?

Tell your doctor about all other medications you use, especially:

• St. John's wort;
• a blood thinner such as warfarin (Coumadin, Jantoven);
• ritonavir (Norvir, Kaletra);
• carbamazepine (Carbatrol, Equetro, Tegretol) or phenobarbital (Luminal, Solfoton);
• an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or rifampin (Rifadin, Rifater, Rifamate, Rimactane).
• an antifungal medication such as ketoconazole (Extina, Ketozole, Nizoral, Xolegal) or itraconazole (Sporanox).

This list is not complete and other drugs may interact with estradiol topical. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about estradiol topical.