Elestrin is estradiol 0.06% in a colorless, non-staining gel supplied in a non-aerosol, metered-dose pump container. Estradiol is a form of estrogen, a female sex hormone made in the ovaries that regulates many processes in the body.

Elestrin is used after menopause to reduce moderate to severe hot flashes.

Ovaries normally stop making estrogens when a woman is between 45 to 55 years old. This drop in body estrogen levels causes the “change of life” or menopause (the end of monthly menstrual periods). When 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”). In some women, the symptoms are mild, and they will not need estrogens. In other women, symptoms can be more severe and treatment with products such as Elestrin may help.

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 Elestrin gel 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 Elestrin 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 Elestrin gel.

You should not use Elestrin if you have:

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

• any type of breast, uterine, or hormone-dependent cancer;

• a history of heart attack, stroke, or blood clot (especially in your lung or your lower body);

• liver disease;

• a bleeding or blood-clotting disorder;

• if you are pregnant or may become pregnant; or

• if you have ever had an allergic reaction to estradiol topical.

Estradiol will not prevent heart disease, heart attack, stroke, breast cancer, or dementia, and may actually increase your risk of developing these conditions. Estradiol may also increase your risk of uterine or ovarian cancer. Talk with your doctor about your individual risks.

To make sure Elestrin is safe for you, tell your doctor if you have:

• unusual vaginal bleeding;

• heart disease;

• asthma;

• epilepsy or other seizure disorder;

• liver or kidney disease;

• hereditary angioedema;

• endometriosis;

• a thyroid disorder;

• lupus;

• high levels of calcium in your blood (hypercalcemia);

• migraines;

• gallbladder disease; or

• risk factors for coronary artery disease (such as diabetes, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, being older than 40, or if you have had a hysterectomy).

Do not use Elestrin if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine.

Estradiol can pass into breast milk and may harm a nursing baby. This medicine may also slow breast milk production. Do not use Elestrin if you are breastfeeding a baby.

Use Elestrin 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.

Elestrin comes with patient instructions for safe and effective use, and directions for priming the gel pump. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

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

• Elestrin is applied once daily to the upper arm using a metered-dose pump which delivers 0.87 gram of Elestrin gel per actuation. Dosage should be started with the lowest effective dose of Elestrin, which is one pump per day. Subsequent dosage adjustment may be made based upon the response. This dose should be periodically reassessed by the healthcare provider. Use the gel at the same time each day.

• Do not rub the Elestrin gel in, but allow it to dry on your skin for at least 5 minutes before you dress.

• Wash your hands with soap and water after applying Elestrin gel. 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 Elestrin. 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 Elestrin 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.

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.

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

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

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 Elestrin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Elestrin and 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 this medicine. Call your doctor if a child who has close contact with you develops swollen nipples or enlarged breasts.

Common Elestrin 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.