Generic Name: estradiol (ES-tra-DYE-ol)
Brand Name: Elestrin
Elestrin 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 Elestrin gel. Talk with your doctor if you have questions about the benefits and risks of using Elestrin gel.
Elestrin 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 Elestrin gel.
Elestrin gel is used for:
Treating certain moderate to severe symptoms of menopause (eg, hot flashes).
Elestrin 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 Elestrin gel if:
- you are allergic to any ingredient in Elestrin 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 Elestrin 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
Contact your doctor or health care provider right away if any of these apply to you.
Before using Elestrin gel:
Some medical conditions may interact with Elestrin 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, 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 Elestrin 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 Elestrin gel's side effects
- Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), rifamycins (eg, rifampin), or St. John's wort because they may decrease Elestrin gel's effectiveness
- Thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Elestrin gel
This may not be a complete list of all interactions that may occur. Ask your health care provider if Elestrin 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 Elestrin gel:
Use Elestrin gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Elestrin gel. Talk to your pharmacist if you have questions about this information.
- Elestrin gel is applied to the area between the shoulder and the upper arm. Apply Elestrin gel to clean, intact skin only. Be sure the area is completely dry before applying Elestrin gel.
- Do not apply Elestrin 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 Elestrin 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 10 times. Discard any medicine that comes out in the trash can, out of the reach of children and pets. The pump is now ready for use.
- To use a dose of Elestrin gel, hold the pump with the tip facing the upper arm. Press the pump firmly and fully to dispense the medicine. Use 2 fingers to spread the medicine over the entire area of the upper arm and shoulder. Gently rub Elestrin gel in. Return the spout to the locked position and replace the cap after each use.
- Wash your hands with soap and water after using Elestrin gel.
- Allow the medicine to dry for at least 5 minutes before dressing.
- Do not allow others to apply Elestrin gel for you. Do not allow others to come into contact with the application site for at least 2 hours after you apply Elestrin gel. If someone else comes into contact with Elestrin gel, have them wash the area with soap and water right away.
- This pump contains 100 doses. Throw away the pump after 100 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 Elestrin gel at the same time each day.
- If you miss a dose of Elestrin 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 Elestrin gel.
Important safety information:
- Elestrin 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.
- Elestrin 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.
- Do not apply sunscreen to the application site for at least 25 minutes after applying Elestrin gel. Do not apply sunscreen to the application site for more than 7 days in a row.
- If you will be swimming, wait at least 2 hours before going into the water after applying Elestrin gel.
- Elestrin 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 Elestrin gel's side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking Elestrin gel.
- Tell your doctor or dentist that you take Elestrin 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 Elestrin gel or take other special precautions for a period of time.
- Elestrin 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 - Elestrin gel may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Elestrin gel may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Elestrin gel.
- Lab tests, including physical exams, cholesterol levels, and blood pressure, may be performed while you use Elestrin 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 Elestrin gel.
- Use Elestrin gel with caution in the ELDERLY; they may be more sensitive to its effects.
- Elestrin gel is not approved for use in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use Elestrin gel if you are pregnant. If you think you may be pregnant, contact your doctor right away. Elestrin gel is found in breast milk. If you are or will be breast-feeding while you use Elestrin gel, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Elestrin 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 ( http://www.aapcc.org), or emergency room immediately. Symptoms may include abnormal vaginal bleeding; breast tenderness; drowsiness or fatigue; nausea and vomiting; stomach pain.Proper storage of Elestrin gel:
Store Elestrin gel at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat and light. Keep Elestrin gel out of the reach of children and away from pets.
- If you have any questions about Elestrin gel, please talk with your doctor, pharmacist, or other health care provider.
- Elestrin 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 Elestrin 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 Elestrin gel. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Elestrin 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 Elestrin 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.