Estrogel

Generic Name: estradiol topical (for use on skin) (ess tra DYE ol TOP ik al)
Brand Names: Divigel, Elestrin Pump, Estrasorb, Estrogel Pump, Evamist

What is 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 used to treat certain symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation.

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

Important information

You should not use Estrogel if you have any of the following conditions: a history of heart attack, stroke, or blood clot (especially in your lung or your lower body), 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.

Estrogel can harm an unborn baby or cause birth defects. Do not use if you are pregnant. Do not use Estrogel if you are breast-feeding a baby. 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. Call your doctor if a child who has close contact with you develops swollen nipples or enlarged breasts. Children should avoid coming into contact with skin areas where you have applied Estrogel. If contact does occur, wash with soap and water right away. Cover treated areas with clothing to protect others from coming into contact with the skin where you apply this medicine.

Slideshow: Flashback: FDA Drug Approvals 2013

Estrogens will not prevent heart disease, heart attack, stroke, breast cancer, or dementia, and may actually increase your risk of developing these conditions. Estrogens may also increase your risk of uterine or ovarian cancer.

Talk with your doctor about your individual risks before using Estrogel long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

Before using Estrogel

Estrogens will not prevent heart disease, heart attack, stroke, breast cancer, or dementia, and may actually increase your risk of developing these conditions. Estrogens may also increase your risk of uterine or ovarian cancer.

Talk with your doctor about your individual risks before using Estrogel long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

You should not use Estrogel if you have:

  • 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;

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

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

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

To make sure you can safely use Estrogel, tell your doctor if you have any of these other conditions:

  • high blood pressure, angina, or heart disease;

  • high cholesterol or triglycerides;

  • kidney disease;

  • asthma;

  • hereditary angioedema;

  • epilepsy or other seizure disorder;

  • migraines;

  • endometriosis;

  • diabetes;

  • a thyroid disorder;

  • depression;

  • porphyria;

  • lupus;

  • gallbladder disease; or

  • low levels of calcium in your blood.

FDA pregnancy category X. Estrogel can cause birth defects. Do not use Estrogel if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. Estradiol can pass into breast milk and may harm a nursing baby. Estrogel may also slow breast milk production. Do not use if you are breast-feeding a baby.

See also: Pregnancy and breastfeeding warnings (in more detail)

Estradiol increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estradiol may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using Estrogel.

How should I use Estrogel?

Use Estrogel exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. 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 Estrogel to the breasts.

  • 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 the 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. If contact does occur, wash with soap and water right away. Cover treated areas with clothing to protect others from coming into contact with the skin where you apply this medicine.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using Estrogel.

Store Estrogel at room temperature away from moisture and heat.

What happens if I miss a dose?

If you are less than 12 hours late in using your medicine, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

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.

What should I avoid?

Do not apply sunscreen to your skin at the same time you apply Estrogel. Avoid getting this medication in your eyes, and rinse thoroughly with water if this does happen.

Grapefruit and grapefruit juice may interact with estradiol and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Estrogel side effects

Get emergency medical help if you have any of these 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 a serious side effect such as:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  • sudden numbness or weakness, headache, confusion, or problems with vision, speech, or balance;

  • pain, swelling, warmth, or redness in one or both legs;

  • abnormal vaginal bleeding;

  • pain, swelling, or tenderness in your stomach;

  • jaundice (yellowing of the skin or eyes); or

  • a lump in your breast.

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. Call your doctor if a child who has close contact with you develops swollen nipples or enlarged breasts.

Less serious Estrogel side effects may include:

  • nausea, vomiting, loss of appetite;

  • swollen breasts;

  • acne or skin color changes;

  • vaginal pain, dryness, or discomfort, decreased sex drive, or difficulty having an orgasm;

  • swelling, weight gain;

  • migraine headaches, dizziness, depression; or

  • break-through bleeding, vaginal itching or discharge.

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.

See also: Side effects (in more detail)

What other drugs will affect Estrogel?

Tell your doctor about all other medications you use, especially:

  • St. John's wort;

  • a blood thinner such as warfarin (Coumadin, Jantoven);

  • ritonavir (Norvir, Kaletra);

  • carbamazepine (Carbatrol, Equetro, Tegretol) or phenobarbital (Luminal, Solfoton);

  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or rifampin (Rifadin, Rifater, Rifamate, Rimactane).

  • an antifungal medication such as ketoconazole (Extina, Ketozole, Nizoral, Xolegal) or itraconazole (Sporanox).

This list is not complete and other drugs may interact with Estrogel. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about Estrogel.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 7.01. Revision Date: 2012-06-13, 1:50:54 PM.

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