Estrasorb is topical emulsion containing estradiol. Estradiol is a form of estrogen, a female sex hormone that regulates many processes in the body.

Estrasorb is used to after menopause to reduce moderate to severe hot flashes. The ovaries normally stop making estrogens when a woman is between 45 to 55 years old. When the estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating (“hot flashes” or “hot flushes”). In some women, the symptoms are mild, and they will not need estrogens. In other women, symptoms can be more severe.

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

You should not use Estrasorb if you have any of the following conditions: a history of heart attack, stroke, or blood clot, a bleeding or blood-clotting disorder, liver disease, abnormal vaginal bleeding, history of an allergic reaction to estradiol topical, or a hormone-related cancer such as breast or uterine cancer.

Do not use Estrasorb if you are pregnant.

Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Call your doctor at once if you have any unusual vaginal bleeding while using Estrasorb.

Children should avoid coming into contact with skin areas where you have applied Estrasorb. Topical estradiol is absorbed through the skin and can cause side effects in a child who comes into contact with Estrasorb or with skin where the medicine was applied.

Estradiol should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions. Long-term use may also increase your risk of breast cancer or blood clot.

Use Estrasorb exactly as prescribed by your doctor. 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 Estrasorb 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 Estrasorb topical emulsion:

• Apply Estrasorb while you are sitting comfortably. 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 Estrasorb emulsion out of the pouch and onto your thigh.

• Spend at least 3 minutes rubbing the Estrasorb emulsion into your entire left thigh and calf. Rub any excess medicine onto your buttocks.

• Cut or tear open the second pouch and apply the Estrasorb emulsion to your right leg using the same method described above.

Wash your hands with soap and water after applying the 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 Estrasorb. 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 Estrasorb for a short time. Any doctor or surgeon who treats you should know that you are using estradiol.

Store Estrasorb 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 Estrasorb emulsion to make up the missed dose.

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.

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

Avoid getting Estrasorb emulsion 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.

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

Stop using Estrasorb 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 Estrasorb 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.