EstroGel Pump for use on skin

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.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin to take while you are using estradiol, to help lower this risk. Report any unusual vaginal bleeding right away.

Read all patient information, medication guides, and instruction sheets provided to you. 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. 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. Cover treated areas with clothing to protect others from coming into contact with the skin where you apply this medicine.

Your doctor should check your progress on a regular basis (every 3 to 6 months) 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.

If you need surgery or medical tests or if you will be on 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.

Store at room temperature away from moisture and heat.

Use the missed dose as soon as you remember. If you are more than 12 hours late, skip the missed dose. Do not use extra medicine to make up the missed dose.

Get emergency medical help if you have 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:

• abnormal vaginal bleeding;

• a lump in your breast;

• confusion, problems with memory or concentration;

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

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

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

Common side effects may include:

• breast pain;

• headache;

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

• thinning scalp hair; or

• nausea, vomiting, bloating, stomach cramps.

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.

Other drugs may interact with estradiol topical, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.