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EstroGel®
(estradiol gel)

Read this PATIENT INFORMATION before you start using EstroGel (estradiol gel) , and read the patient information each time you refill your EstroGel (estradiol gel) prescription. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms and their treatment.

What is EstroGel (estradiol gel) ?

EstroGel is a clear, colorless gel medicine that contains estradiol (an estrogen hormone) which is absorbed through the skin into the bloodstream.

How is EstroGel (estradiol gel) used?

EstroGel (estradiol gel) is used after menopause to:

• Reduce moderate to severe hot flashes

Estrogens are hormones made by a woman's ovaries. The ovaries normally stop making estrogens when a woman is between 45 and 55 years old. This drop in body estrogen levels causes the "change of life" or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes "surgical menopause."

When the estrogen levels begin dropping, some women have very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden intense episodes of heat and sweating ("hot flashes" or "hot flushes"). In some women, the symptoms are mild, and they will not need estrogen treatment. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether you still need treatment with EstroGel (estradiol gel) .

• Treat moderate to severe dryness, itching, and burning in or around your vagina

You and your healthcare provider should talk regularly about whether you still need treatment with EstroGel (estradiol gel) to control these problems. If you use EstroGel (estradiol gel) only to treat your dryness, itching, and burning in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.

Who should not use EstroGel (estradiol gel) ?

Do not start using EstroGel (estradiol gel) if you:

• Have unusual vaginal bleeding
• Currently have or have had certain cancers
  Estrogens may increase the chance of getting certain types of cancer, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use EstroGel (estradiol gel) .
• Had a stroke or heart attack in the past year
• Currently have or have had blood clots
• Currently have or have had liver problems
• Are allergic to EstroGel (estradiol gel) or any of its ingredients
  See the list of ingredients in EstroGel (estradiol gel) at the end of this leaflet.
• Think you may be pregnant

Tell your healthcare provider:

• If you are breastfeeding
  The hormone in EstroGel (estradiol gel) can pass into your breast milk.
• About all of your medical problems
  Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), migraine, endometriosis, lupus, or problems with your heart, liver, thyroid, kidneys, or high calcium levels in your blood.
• About all the medicines you take
  This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how EstroGel (estradiol gel) works. EstroGel (estradiol gel) may also affect how your other medicines work.
• If you are going to have surgery or will be on bedrest You may need to stop taking estrogens.

How should I use EstroGel (estradiol gel) ?

EstroGel (estradiol gel) is available in a metered-dose pump that delivers a measured amount of estradiol to the skin each time the pump is depressed.

It is important that you read and follow these directions on how to use the EstroGel (estradiol gel) pump properly.

1. 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 3 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. After priming, the pump is ready to use, and 1 complete pump depression will dispense the same amount of EstroGel (estradiol gel) each time.
2. Apply EstroGel (estradiol gel) 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 (estradiol gel) dose after your bath, shower, or sauna. If you go swimming, try to leave as much time as possible between applying your EstroGel (estradiol gel) dose and going swimming.
3. Be sure your skin is completely dry before applying EstroGel (estradiol gel) .
4. To apply the dose, collect the gel into the palm of your hand by pressing the pump firmly and fully once, as illustrated.
5. Apply the gel to the skin of one arm using your hand. Spread the gel as thinly as possible over the entire area on the inside and outside of your arm from wrist to shoulder, as illustrated.
6. 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.
7. Wash your hands with soap and water after applying the gel to reduce the chance that the medicine will spread from your hands to other people.
8. It is not necessary to massage or rub in EstroGel (estradiol gel) . Simply allow the gel to dry for up to 5 minutes before dressing.
9. Alcohol-based gels are flammable. Avoid fire, flame or smoking until the gel has dried.
10. Once dry, EstroGel (estradiol gel) is odorless.
11. Never apply EstroGel (estradiol gel) directly to the breast. Do not allow others to apply the gel for you.
12. The EstroGel (estradiol gel) 93-gram pump contains enough medicine to allow for initial priming of the pump twice and delivery of 64 daily doses. After you have initially primed the pump twice and dispensed 64 doses, you will need to discard the pump.
13. The EstroGel (estradiol gel) 50-gram pump contains enough medicine to allow for initial priming of the pump 3 times and delivery of 32 daily doses. After you have initially primed the pump 3 times and dispensed 32 doses, you will need to discard the pump.
14. The EstroGel (estradiol gel) 25-gram pump contains enough medicine to allow for initial priming of the pump 3 times and delivery of 14 daily doses. After you have initially primed the pump 3 times and dispensed 14 doses, you will need to discard the pump.

What should I do if someone else is exposed to EstroGel (estradiol gel) ?

If someone else is exposed to EstroGel (estradiol gel) by direct contact with the gel, that person should wash the area of contact with soap and water as soon as possible. The longer the gel is in contact with the skin before washing, the greater the chance that the other person will absorb some of the estrogen hormone. This is especially important for men and children.

What should I do if I get EstroGel (estradiol gel) in my eyes?

If you get EstroGel (estradiol gel) in your eyes, rinse your eyes right away with warm, clean water to flush out any gel. Seek medical attention if needed.

What should I do if I miss a dose?

If you miss a dose, do not double the dose on the next day to catch up. If your next dose is less than 12 hours away, it is best just to wait and apply your normal dose the next day. If it is more than 12 hours until the next dose, apply the dose you missed, and resume your normal dosing the next day.

What should I avoid while using EstroGel (estradiol gel) ?

It is important that you do not spread the medicine to others, especially men and children. Be sure to wash your hands after applying EstroGel (estradiol gel) . Do not allow others to make contact with the area of skin where you applied the gel for at least 1 hour after application. Alcohol-based gels are flammable. Avoid fire, flame or smoking until the gel has dried.

What are the possible side effects of estrogens?

Side effects are grouped by how serious they are and how often they happen when you are treated.

Serious but less common side effects include:

• Breast cancer
• Cancer of the uterus
• Stroke
• Heart attack
• Blood clots
• Dementia
• Gallbladder disease
• Ovarian cancer
• High blood pressure
• Liver problems
• High blood sugar
• Enlargement of benign tumors of the uterus ("fibroids")

Some of the warning signs of these serious side effects include:

• Breast lumps
• Unusual vaginal bleeding
• Dizziness and faintness
• Changes in speech
• Severe headaches
• Chest pain
• Shortness of breath
• Pains in your legs
• Changes in vision
• Vomiting
• Yellowing of the skin, eyes or nail beds

Call your healthcare provider right away if you have any of these warning signs, or any other unusual symptoms that concern you.

Less serious but common side effects include:

• Headache
• Breast pain
• Irregular vaginal bleeding or spotting
• Stomach/abdominal cramps, bloating
• Nausea and vomiting
• Hair loss
• Fluid retention
• Vaginal yeast infection

These are not all of the possible adverse events of EstroGel (estradiol gel) . For more information, ask your healthcare provider or pharmacist.

What can I do to lower my chances of having an adverse event with EstroGel (estradiol gel) ?

• Talk with your healthcare provider regularly about whether you should continue using EstroGel (estradiol gel) .
• If you have a uterus, talk with your healthcare provider about whether the addition of a progestin (a different prescribed hormone) is right for you. The addition of a progestin is generally recommended for women with a uterus to reduce the chance of getting cancer of the uterus.
• See your healthcare provider right away if you get vaginal bleeding while using EstroGel (estradiol gel) .
• Have a pelvic exam, breast exam and mammogram (breast x-ray) every year unless your healthcare provider tells you otherwise. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
• If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances of getting heart disease. Ask your healthcare provider for ways to lower your chances of getting heart disease.

General information about the safe and effective use of EstroGel (estradiol gel)

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use EstroGel (estradiol gel) for conditions for which it was not prescribed. Do not give EstroGel (estradiol gel) to other people, even if they have the same symptoms you have. It may harm them.

Keep EstroGel (estradiol gel) out of the reach of children.

This leaflet provides a summary of the most important information about EstroGel (estradiol gel) . If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about EstroGel (estradiol gel) that is written for health professionals. You can get more information by calling the toll-free number, 1-877-204-1013.

What are the ingredients in EstroGel?

EstroGel contains estradiol (an estrogen hormone), purified water, alcohol, triethanolamine, and carbomer 934P.

EstroGel (estradiol gel) should be stored with the cap on securely. Do not freeze. The gel should not be used after the date printed on the end of the metered-dose pump after the term "Exp." (expiration date).

Last reviewed on RxList: 2/12/2008
This monograph has been modified to include the generic and brand name in many instances.