Estrogel

Generic name: Estradiol Topical (for Use On Skin)
Brand names: EstroGel Pump
Drug class: Estrogens

Usage of Estrogel

Estrogel is a clear, colorless gel medicine that contains an estrogen hormone called estradiol. Estrogens are female sex hormones made by a woman's ovaries that regulate many processes in the body.

Estrogel is a prescription medicine used to reduce certain symptoms of menopause such as moderate to severe hot flashes, and vaginal symptoms such as dryness, burning, and irritation.

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

Estrogel side effects

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

Stop using Estrogel 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 Estrogel 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.

Before taking Estrogel

You should not use Estrogel 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 Estrogel 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 Estrogel 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 Estrogel if you are breastfeeding a baby.

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How to use Estrogel

Use Estrogel 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 Estrogel 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 EstroGel:

Before using the pump for the first time, it must be primed. Remove the large pump cover, and fully depress the pump twice for the 93-gram pump or three times for the 50-gram pump and the 25-gram pump. Discard the unused gel by thoroughly rinsing down the sink or placing it in the household trash in a manner that avoids accidental exposure or ingestion by household members or pets. After priming, the pump is ready to use, and one complete pump depression will dispense the same amount of Estrogel each time.

Apply Estrogel at the same time each day. You should apply your daily dose of gel to clean, dry, unbroken skin. If you take a bath or shower or use a sauna, apply your Estrogel dose after your bath, shower, or sauna. If you go swimming, try to leave as much time as possible between applying your Estrogel dose and going swimming.

Be sure your skin is completely dry before applying Estrogel.

To apply the dose, collect the Estrogel into the palm of your hand by pressing the pump firmly and fully with one fluid motion without hesitation.

Apply the gel to one arm using your hand. Spread the Estrogel as thinly as possible over the entire area on the inside and outside of your arm from wrist to shoulder. Never apply Estrogel directly to the breast.

Always place the small protective cap back on the tip of the pump and the large pump cover over the top of the pump after each use.

Wash your hands with soap and water after applying the Estrogel to reduce the chance that the medicine will spread from your hands to other people.

It is not necessary to massage or rub in Estrogel. Simply allow the gel to dry for up to 5 minutes before dressing.

Estrogel is flammable. Avoid smoking or being near an open flame until the medicine has completely dried on your skin.

Wash your hands with soap and water after applying Estrogel. 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 Estrogel. 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 Estrogel at room temperature away from moisture and heat.

Warnings

You should not use Estrogel 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 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 Estrogel.

Children should avoid coming into contact with skin areas where you have applied Estrogel. Topical estradiol is absorbed through the skin and can cause side effects in a child who comes into contact with this medicine or with skin where Estrogel 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 of Estrogel may also increase your risk of breast cancer or blood clot.

What other drugs will affect Estrogel

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.

Disclaimer

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