Pronunciation: ES-tra-DYE-ol
Generic Name: Estradiol
Brand Name: Estrasorb
Estradiol Emulsion should not be used to prevent heart disease, heart attacks, strokes, or dementia. Estrogens with or without progestins 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 Emulsion. Talk with your doctor if you have questions about the benefits and risks of using Estradiol Emulsion.
Estradiol Emulsion 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 Emulsion.
Estradiol Emulsion is used for:
Treating certain conditions caused by menopause (eg, hot flashes; vaginal itching, burning, or dryness).
Estradiol Emulsion is an estrogen hormone used to provide the female hormone when the body no longer produces enough.
Do NOT use Estradiol Emulsion if:
- you are allergic to any ingredient in Estradiol Emulsion
- you are pregnant or suspect you may be pregnant
- you have abnormal vaginal bleeding of unknown cause
- you have known, suspected, or a history of breast cancer
- you have known or suspected cancers that are estrogen-dependent
- you have blood clots (eg, in the legs or lungs) or a history of blood clots
- you have had a recent (within the past year) heart attack or stroke
- you have liver problems
Contact your doctor or health care provider right away if any of these apply to you.
Before using Estradiol Emulsion:
Some medical conditions may interact with Estradiol Emulsion. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are planning to become pregnant
- 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 had yellowing of the eyes or skin during pregnancy or with past estrogen use
- if you have asthma, cancer, certain blood disorder (porphyria), depression, diabetes, epilepsy (seizures), eye or vision problems, fluid retention or swelling (edema), gallbladder disease, heart disease or other heart problems, high blood pressure, high cholesterol or triglyceride levels, high or low calcium levels in the blood, kidney problems, a certain type of liver growth (hemangioma), migraine headaches, pancreatitis, or thyroid problems
- if you have a history of an abnormal mammogram or breast lumps, endometriosis, ovarian cancer, or a family history of breast cancer
- if you or a family member have a history of blood clots (eg, in the legs or lungs) or lupus, or have been very overweight
- if you smoke or use tobacco products, you will be having surgery, or you will be on bedrest
- if you have had your uterus removed (hysterectomy)
Some MEDICINES MAY INTERACT with Estradiol Emulsion. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg, warfarin), corticosteroids (eg, prednisone), succinylcholine, or tacrine because their actions and the risk of their side effects may be increased by Estradiol Emulsion
- Anticoagulants (eg, warfarin) or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Estradiol Emulsion
- Barbiturates (eg, phenobarbital), hydantoins (eg, phenytoin), or rifampin because they may decrease Estradiol Emulsion's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if Estradiol Emulsion 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 Emulsion:
Use Estradiol Emulsion as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Estradiol Emulsion. Talk to your pharmacist if you have questions about this information.
- If you are switching from oral estrogen to Estradiol Emulsion, stop taking the oral estrogen and wait 1 week before using Estradiol Emulsion. However, if symptoms return, you may start using Estradiol Emulsion sooner.
- Wash your hands with soap and water both before and after using Estradiol Emulsion.
- Sit in a comfortable sitting position and apply Estradiol Emulsion to clean, dry skin of the leg. Cut or tear the pouch of medicine and empty the entire contents of the pouch onto the top of the thigh. Rub the medicine in well into the thigh and calf of the leg for 3 minutes until it is completely absorbed. Rub any medicine remaining on the hands onto the buttocks. If you are using two pouches of Estradiol Emulsion, apply the second pouch of medicine to the opposite leg in the same way.
- Allow the medicine to dry completely before covering with clothing to avoid transfer to other people.
- Grapefruit and grapefruit juice may increase the risk of Estradiol Emulsion's side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking Estradiol Emulsion.
- If you miss a dose of Estradiol Emulsion, use it as soon as possible. If it is almost time for your next dose, 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 Emulsion.
Important safety information:
- Estradiol Emulsion may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Estradiol Emulsion with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Estradiol Emulsion may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.
- Do NOT apply sunscreen to the application site for at least 25 minutes after applying Estradiol Emulsion.
- Estradiol Emulsion may increase the risk of blood clots. The risk may be greater if you smoke (especially in women older than 35 years).
- Contact your doctor if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention.
- Contact your doctor if vaginal discomfort occurs or if you suspect you have developed an infection while taking Estradiol Emulsion.
- Follow your doctor's instructions for examining your breasts, and report any lumps immediately.
- If you wear contact lenses and you develop problems with them, contact your doctor.
- 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 beforehand. You may need to stop taking Estradiol Emulsion at least 4 to 6 weeks beforehand as directed by your doctor.
- Nonprescription therapy to help prevent bone loss includes a weight-bearing exercise plan, as well as adequate daily calcium and vitamin D intake. Consult your doctor or pharmacist for more details.
- Estradiol Emulsion may increase the risk of breast and endometrial cancer.
- Diabetes patients - Estradiol Emulsion may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Estradiol Emulsion may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Estradiol Emulsion.
- Lab tests, including physical exams and blood pressure, may be performed while you use Estradiol Emulsion. 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.
- Use Estradiol Emulsion with caution in the ELDERLY; they may be more sensitive to its effects.
- Estradiol Emulsion should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use Estradiol Emulsion if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Estradiol Emulsion may be found in breast milk. If you are or will be breast-feeding while you use Estradiol Emulsion, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Estradiol Emulsion:
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; hair loss; mild irritation or redness at the application site; 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); back pain; breast discharge or lump in the breast; calf or leg pain or swelling; chest pain; confusion; coughing up blood; dark urine; depression; dizziness; fainting; fever; memory problems; mental or mood changes; migraine; muscle pain; one-sided weakness; nipple discharge; painful or difficult urination; persistent or severe breast pain or tenderness; persistent or severe headache, nausea, or vomiting; severe stomach pain or swelling; slurred speech; sudden shortness of breath; swelling of the hands, legs, or feet; unusual vaginal bleeding, discharge, itching, or odor; vision changes (eg, double vision, loss of vision); weakness or numbness of an arm or leg; 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. 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 excessive vaginal bleeding; severe nausea; vomiting.
Proper storage of Estradiol Emulsion:
Store Estradiol Emulsion 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 in original packaging until just before use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Estradiol Emulsion out of the reach of children and away from pets.
General information:
- If you have any questions about Estradiol Emulsion, please talk with your doctor, pharmacist, or other health care provider.
- Estradiol Emulsion 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 is a summary only. It does not contain all information about Estradiol Emulsion. 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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