Estradiol GelGeneric Name:
Estradiol (ES-tra-DYE-ol)Brand Name:
Estradiol Gel should not be used to prevent heart disease, heart attacks, strokes, or dementia. Estrogens have been shown to increase the risk of heart disease (including heart attack), stroke, dementia, serious blood clots (eg, in the lungs or legs), cancer of the uterus, and breast cancer in some women. Tell your doctor right away if you have unusual vaginal bleeding while you use Estradiol Gel. Talk with your doctor if you have questions about the benefits and risks of using Estradiol Gel.
Estradiol Gel should be used for the shortest possible time at the lowest effective dose to minimize the risk of these side effects. Talk with your doctor regularly about your need to use Estradiol Gel.
Estradiol Gel is used for:
Treating moderate to severe symptoms of menopause (eg, hot flashes; vaginal itching, burning, or dryness).
Estradiol Gel is an estrogen hormone. It works by replacing estrogen in the body when it no longer produces enough on its own.
Do NOT use Estradiol Gel if:
- you are allergic to any ingredient in Estradiol Gel
- you are pregnant or suspect you may be pregnant
- you have undiagnosed abnormal vaginal bleeding
- you have a history of blood clots (eg, in the lungs, legs, eyes); endometrial, cervical, or vaginal cancer; estrogen-dependent growths; breast cancer; or liver problems
- you have had a heart attack or stroke within the past 12 months
Contact your doctor or health care provider right away if any of these apply to you.
Before using Estradiol Gel:
Some medical conditions may interact with Estradiol Gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of endometriosis, growths in the uterus, abnormal mammogram, abnormal vaginal bleeding, a lump in the breast, or fibrocystic breast disease, or if a family member has had breast cancer
- if you have dementia or other memory problems, or abnormal blood calcium levels
- if you have a history of asthma, cancer, high blood cholesterol or lipid levels, diabetes, heart problems, high blood pressure, heart attack or stroke, kidney problems, liver tumor, mental or mood problems (eg, depression), underactive thyroid, migraine headaches, gallbladder or pancreas problems, seizures (eg, epilepsy), lupus, chorea, or the blood disease porphyria
- if you smoke, are very overweight, or will be having surgery
- if you have a history of yellowing of the eyes or skin during pregnancy or with past estrogen use
- if a member of your family has a history of blood clots (eg, in the legs, lungs, eyes), diabetes, lupus, or obesity
- if you have had your uterus removed (hysterectomy)
Some MEDICINES MAY INTERACT with Estradiol Gel. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Azole antifungals (eg, ketoconazole), HIV protease inhibitors (eg, ritonavir), or macrolide antibiotics (eg, erythromycin) because they may increase the risk of Estradiol Gel's side effects
- Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), rifampin, or St. John's wort because they may decrease Estradiol Gel's effectiveness
- Thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Estradiol Gel
This may not be a complete list of all interactions that may occur. Ask your health care provider if Estradiol Gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Estradiol Gel:
Use Estradiol Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Estradiol Gel. Talk to your pharmacist if you have questions about this information.
- Estradiol Gel is applied to the area between the wrist and shoulder. Apply Estradiol Gel to clean, intact skin only. Be sure the area is completely dry before applying Estradiol Gel.
- Do not apply Estradiol Gel to skin that is irritated or broken. Do not apply it to your face, in or around the vagina, or to your breasts.
- If you take a bath or shower, or use a sauna around the time of your dose, apply Estradiol Gel afterwards. Be sure the area is completely dry before applying the medicine.
- You must prime the pump before using it for the first time. To do this, remove the cap, unlock the pump, and press down on the spout 2 times. Discard any medicine that comes out by rinsing it down the sink or placing it in the trash can, out of the reach of children and pets. The pump is now ready for use.
- Press the pump firmly and fully to dispense the medicine into the palm of your hand. Apply the medicine to one arm only. Spread it as thinly as possible over the inside and outside of your entire arm from wrist to shoulder. You do not need to rub it in. Replace the cap after each use.
- Wash your hands with soap and water after using Estradiol Gel.
- Allow the medicine to dry for at least 5 minutes before dressing.
- Do not allow others to apply Estradiol Gel for you. Do not allow others to come into contact with the application site for at least 1 hour after you apply Estradiol Gel. If someone else comes into contact with Estradiol Gel, have them wash the area with soap and water right away.
- This pump contains 64 doses. Throw away the pump after 64 doses have been used, even if there is still medicine left in the pump. It may no longer give the correct amount of medicine with each dose.
- Use Estradiol Gel at the same time each day.
- If you miss a dose of Estradiol Gel, use it as soon as possible. If your next dose is less than 12 hours away, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Estradiol Gel.
Important safety information:
- Estradiol Gel is for external use only. Do not get it in your eyes, nose, vagina, or mouth. If you get it in any of these areas, rinse right away with warm clean water.
- Check with your doctor before you apply sunscreen to the application site while using Estradiol Gel.
- If you will be swimming, wait for as long as possible before going into the water after applying Estradiol Gel.
- Estradiol Gel is flammable. Avoid fire, flame, or smoking until the medicine has dried on your skin.
- Eating grapefruit or drinking grapefruit juice may increase the risk of Estradiol Gel's side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking Estradiol Gel.
- Tell your doctor or dentist that you take Estradiol Gel before you receive any medical or dental care, emergency care, or surgery. If possible, Estradiol Gel should be stopped at least 4 to 6 weeks before surgery or any time you might be confined to a bed or chair for a long period of time (such as a long plane flight, car ride, bedrest, or illness).
- Estradiol Gel may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or wear protective clothing when exposed to the sun, sunlamps, or tanning booths.
- If you wear contact lenses and you develop problems with them, contact your doctor.
- Diabetes patients - Estradiol Gel may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Estradiol Gel may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Estradiol Gel.
- Lab tests and medical exams, including breast exams, mammograms, Pap tests, physicals, and blood pressure, may be performed while you use Estradiol Gel. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Examine your breasts monthly as directed by your doctor. Report any lumps right away.
- Estradiol Gel should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use Estradiol Gel if you are pregnant. If you think you may be pregnant, contact your doctor right away. Estradiol Gel is found in breast milk. If you are or will be breast-feeding while you use Estradiol Gel, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Estradiol Gel:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Breast pain or tenderness; headache; mild hair loss; mild nausea or vomiting; spotting or breakthrough bleeding; stomach cramps or bloating.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); blurred or double vision, vision loss, or other vision changes; breast lump or discharge; calf or leg pain or swelling; chest pain; confusion; coughing up blood; fainting; memory problems; mental or mood changes (eg, depression); migraine headache; numbness of an arm or leg; one-sided weakness; persistent or recurring abnormal vaginal bleeding; severe or persistent headache or dizziness; severe or persistent stomach pain, nausea, or vomiting; shortness of breath; slurred speech; swelling of the hands, legs, or feet; vaginal discharge, itching, or odor; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include abnormal vaginal bleeding; or severe or persistent nausea or vomiting.Proper storage of Estradiol Gel:
Store Estradiol Gel at room temperature, between 68 and 77 degrees F (20 and 25 degrees C) with the cap secured. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Estradiol Gel out of the reach of children and away from pets.
- If you have any questions about Estradiol Gel, please talk with your doctor, pharmacist, or other health care provider.
- Estradiol Gel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Estradiol Gel. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
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