Generic Name: estradiol (ES-tra-DYE-ol)
Brand Name: EstroGel
EstroGel 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 EstroGel gel. Talk with your doctor if you have questions about the benefits and risks of using EstroGel gel.
EstroGel 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 EstroGel gel.
EstroGel gel is used for:
Treating certain moderate to severe symptoms of menopause (eg, hot flashes; vaginal itching, burning, or dryness).
EstroGel 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 EstroGel gel if:
- you are allergic to any ingredient in EstroGel gel
- you have had a severe reaction (eg, swelling of the hands, face, lips, eyes, throat, or tongue; trouble swallowing or breathing; hoarseness) after taking EstroGel gel
- you are pregnant or think you may be pregnant
- you have undiagnosed abnormal vaginal bleeding
- you have known or suspected breast cancer or another estrogen-dependent cancer, or you have a history of breast cancer
- you have liver problems or liver disease
- you have active blood clots (eg, of the legs or lungs), a history of blood clots, or a condition which may increase your risk of blood clots
- you have had a heart attack or stroke in the past 12 months
Contact your doctor or health care provider right away if any of these apply to you.
Before using EstroGel gel:
Some medical conditions may interact with EstroGel 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 condition called hereditary angioedema
- if you have a history of breast lumps, breast disease, or an abnormal mammogram, or if a member of your family has had breast cancer
- if you have a vaginal infection or a history of uterus problems (eg, fibroids, endometriosis, abnormal vaginal bleeding, cancer), or you have had your uterus removed (hysterectomy)
- if you have a history of asthma, depression, memory problems, diabetes, seizures, gallbladder disease, pancreatitis, heart problems, heart attack, stroke, high blood cholesterol or triglyceride levels, high blood calcium levels, high blood pressure, low blood levels of parathyroid hormone, or porphyria
- if you have a history of kidney or liver problems, yellowing of the skin or eyes, cancer, lupus, migraines, thyroid problems, or chorea (jerky, involuntary movements of the face, arms, or legs)
- if you smoke, use tobacco, are very overweight, will be having surgery, or will be confined to a bed or chair for a period of time
- if a member of your family has had high cholesterol or triglyceride levels, blood clots (eg, in the leg or lung), or lupus, or has been very overweight
Some MEDICINES MAY INTERACT with EstroGel gel. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Azole antifungals (eg, ketoconazole), macrolide antibiotics (eg, erythromycin), or protease inhibitors (eg, ritonavir) because they may increase the risk of EstroGel gel's side effects
- Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), rifamycins (eg, rifampin), or St. John's wort because they may decrease EstroGel gel's effectiveness
- Thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by EstroGel gel
This may not be a complete list of all interactions that may occur. Ask your health care provider if EstroGel 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 EstroGel gel:
Use EstroGel gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with EstroGel gel. Talk to your pharmacist if you have questions about this information.
- EstroGel gel is applied to the area between the wrist and shoulder. Apply EstroGel gel to clean, intact skin only. Be sure the area is completely dry before applying EstroGel gel.
- Do not apply EstroGel 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 EstroGel 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. Prime the pump as directed by the patient leaflet that comes with EstroGel gel. 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 EstroGel gel.
- Allow the medicine to dry for at least 5 minutes before dressing.
- Do not allow others to apply EstroGel gel for you. Do not allow others to come into contact with the application site for at least 1 hour after you apply EstroGel gel. If someone else comes into contact with EstroGel gel, have them wash the area with soap and water right away.
- Discard the pump after the labeled number of doses has 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. If you are unsure of the number of doses in your container, ask your pharmacist.
- Use EstroGel gel at the same time each day.
- If you miss a dose of EstroGel 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 EstroGel gel.
Important safety information:
- EstroGel gel may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke.
- EstroGel 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 EstroGel gel.
- If you will be swimming, wait for as long as possible before going into the water after applying EstroGel gel.
- EstroGel gel is flammable. Do not store or use near heat or an open flame. Avoid fire, flame, or smoking until the medicine has dried on your skin.
- Eating grapefruit or drinking grapefruit juice may increase the risk of EstroGel gel's side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking EstroGel gel.
- Tell your doctor or dentist that you take EstroGel gel before you receive any medical or dental care, emergency care, or surgery. If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor at least 4 to 6 weeks beforehand. You may need to stop taking EstroGel gel or take other special precautions for a period of time.
- EstroGel 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 - EstroGel gel may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- EstroGel gel may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using EstroGel gel.
- Lab tests, including physical exams, cholesterol levels, and blood pressure, may be performed while you use EstroGel gel. You should have breast and pelvic exams, and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Follow your doctor's instructions for examining your own breasts. Report any lumps immediately.
- Talk with your doctor regularly (eg, every 3 to 6 months) about whether you need to continue taking EstroGel gel.
- Use EstroGel gel with caution in the ELDERLY; they may be more sensitive to its effects.
- EstroGel gel is not approved for use in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use EstroGel gel if you are pregnant. If you think you may be pregnant, contact your doctor right away. EstroGel gel is found in breast milk. If you are or will be breast-feeding while you use EstroGel gel, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of EstroGel 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:
Seek medical attention right away if any of these SEVERE side effects occur:
Breast pain or tenderness; hair loss; headache; mild fluid retention; mild nausea or vomiting; spotting or breakthrough bleeding; stomach cramps or bloating.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal vaginal bleeding; breast lumps or pain; bulging eyes; calf pain, swelling, or tenderness; chest pain; coughing up blood; fainting; mental or mood changes (eg, depression); migraine headache; new or worsening memory problems; pelvic pain; severe or persistent dizziness or headache; severe or persistent stomach or back pain (with or without nausea or vomiting); shortness of breath; swelling of the hands or feet; symptoms of heart attack (eg, chest, jaw, or arm pain; sudden severe nausea or vomiting; shortness of breath; sudden unusual sweating); symptoms of liver problems (eg, dark urine, pale stools, yellowing of the skin or eyes); symptoms of stroke (eg, one-sided weakness, slurred speech, confusion); unusual vaginal discharge/itching/odor; vision loss or other vision changes; vomiting.
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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include abnormal vaginal bleeding; breast tenderness; drowsiness or fatigue; nausea and vomiting; stomach pain.Proper storage of EstroGel gel:
Store EstroGel 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 EstroGel gel out of the reach of children and away from pets.
- If you have any questions about EstroGel gel, please talk with your doctor, pharmacist, or other health care provider.
- EstroGel 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take EstroGel gel or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about EstroGel gel. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to EstroGel gel. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using EstroGel gel.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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