If you are experiencing a medical emergency please dial 911 immediately
Pronunciation: ES tra DYE ole VA jin ul (sis TEM ik)
Estradiol can harm an unborn baby or cause birth defects. Do not use if you are pregnant.
You should not use this medication if you have any of the following conditions: liver disease, a bleeding disorder, unusual vaginal bleeding, a history of breast or uterine cancer, or if you have ever had a heart attack, stroke, or a blood clot.
Long-term use of estradiol may increase your risk of breast cancer, uterine cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risks before using estradiol vaginal long term.
Estradiol vaginal should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.
Estradiol is a form of estrogen, a female sex hormone that regulates many processes in the body.
Some estradiol products placed directly into the vagina are used for "local" treatment of vaginal menopause symptoms involving the secretions and surrounding tissues of the vagina. Other vaginal estradiol products are used for treating menopause symptoms affecting the vagina as well as other parts of the body (such as hot flashes). This type of vaginal estradiol has "systemic" effects, meaning that it can affect parts of the body other than where the medicine is placed or applied.
The information in this leaflet is specific to estradiol vaginal products used for systemic treatment of symptoms. Estradiol vaginal (systemic) is used to treat certain symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation.
Estradiol should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.
Estradiol vaginal (systemic) may also be used for purposes not listed in this medication guide.
You should not use this medication if you are allergic to estradiol, if you are pregnant, or if you have:
To make sure estradiol is safe for you, tell your doctor about your other medical conditions, especially:
Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin to take while you are using estradiol, to help lower this risk. Report any unusual vaginal bleeding right away.
Long-term use of estradiol may increase your risk of breast cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risks before using estradiol vaginal long term.
FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use estradiol if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medication.
The estradiol vaginal ring does not prevent pregnancy and should not be used in place of effective birth control.
Estradiol can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.
Use 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.
Wash your hands before and after inserting the vaginal ring.
You should not be able to feel the vaginal ring once it is in place. Leave the vaginal ring in place for 90 days, then remove it. Your doctor may want you to replace it with a new ring. The ring does not need to be removed during sexual intercourse. If the ring is bothersome, you may remove it, rinse it with warm water, and reinsert it after intercourse.
To remove the ring, loop a finger through the ring and gently pull it from the vagina. Call your doctor if you have trouble removing a vaginal ring.
Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis while using estradiol vaginal.
If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using estradiol.
Keep the vaginal ring in its protective pouch until you are ready to use it. Store at room temperature away from moisture and heat.
Remove the vaginal ring and insert a new one as soon as you remember. Do not use an extra vaginal ring to make up the missed wearing time.
If a vaginal ring falls out, rinse it with warm water and reinsert it. If it slides down into the lower part of the vagina, use your finger to push it in farther.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include dizziness, drowsiness, stomach pain, nausea, vomiting, and vaginal bleeding.
Avoid using other vaginal products without your doctor's advice.
Grapefruit and grapefruit juice may interact with estradiol and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Remove the vaginal ring and seek emergency medical attention if you have: fever with nausea, vomiting, diarrhea, muscle pain, dizziness, fainting, and/or sunburn-like skin rash. These may be signs of a life-threatening disease called toxic shock syndrome.
Stop using this medication and call your doctor at once if you have any of these serious side effects:
Less serious side effects may include:
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.
Tell your doctor about all other medicines you use, especially:
This list is not complete and there are many other drugs that can interact with estradiol. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you.
Your pharmacist can provide more information about estradiol vaginal.
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.
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