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Estrogen increases the risk that you will develop endometrial cancer (cancer of the lining of the uterus [womb]). The longer you use estrogen, the greater the risk that you will develop endometrial cancer. If you have not had a hysterectomy (surgery to remove the uterus), you may be given another medication called a progestin to take with vaginal estrogen. This may decrease your risk of developing endometrial cancer but may increase your risk of developing certain other health problems, including breast cancer. Before you begin using vaginal estrogen, tell your doctor if you have or have ever had cancer and if you have unusual vaginal bleeding. Call your doctor immediately if you have abnormal or unusual vaginal bleeding during your treatment with vaginal estrogen. Your doctor will watch you closely to help ensure you do not develop endometrial cancer during or after your treatment.
In a large study, women who took estrogen with progestins by mouth had a higher risk of heart attacks, strokes, blood clots in the lungs or legs, breast cancer, and dementia (loss of ability to think, learn, and understand). Women who use vaginal estrogen alone or with progestins may also have a higher risk of developing these conditions. Tell your doctor if you smoke or use tobacco, if you have had a heart attack or a stroke in the past year, and if you or anyone in your family has or has ever had blood clots or breast cancer. Also tell your doctor if you have or have ever had high blood pressure, high blood levels of cholesterol or fats, diabetes, heart disease, lupus (a condition in which the body attacks its own tissues causing damage and swelling), breast lumps, or an abnormal mammogram (x-ray of the breasts used to find breast cancer).
The following symptoms can be signs of the serious health conditions listed above. Call your doctor immediately if you experience any of the following symptoms while you are using vaginal estrogen: sudden, severe headache; sudden, severe vomiting; speech problems; dizziness or faintness; sudden complete or partial loss of vision; double vision; weakness or numbness of an arm or a leg; crushing chest pain or chest heaviness; coughing up blood; sudden shortness of breath; difficulty thinking clearly, remembering, or learning new things; breast lumps or other breast changes; discharge from nipples; or pain, tenderness, or redness in one leg.
You can take steps to decrease the risk that you will develop a serious health problem while you are using vaginal estrogen. Do not use vaginal estrogen alone or with a progestin to prevent heart disease, heart attacks, strokes, or dementia. Use the lowest dose of estrogen that controls your symptoms and only use vaginal estrogen as long as needed. Talk to your doctor every 3 to 6 months to decide if you should use a lower dose of estrogen or should stop using the medication.
You should examine your breasts every month and have a mammogram and a breast exam performed by a doctor every year to help detect breast cancer as early as possible. Your doctor will tell you how to properly examine your breasts and whether you should have these exams more often than once a year because of your personal or family medical history.
Tell your doctor if you are having surgery or will be on bed rest. Your doctor may tell you to stop using vaginal estrogen 4 to 6 weeks before the surgery or bed rest to decrease the risk that you will develop blood clots.
Talk to your doctor regularly about the risks and benefits of using vaginal estrogen.
WHY is this medicine prescribed?
Vaginal estrogen is used to treat vaginal dryness, itching, and burning; painful or difficult urination; and sudden need to urinate immediately in women who are experiencing or have experienced menopause (change of life; the end of monthly menstrual periods). Femring® brand vaginal ring is also used to treat hot flushes ('hot flashes'; sudden strong feelings of heat and sweating) in women who are experiencing menopause. Premarin® brand vaginal cream is also used to treat kraurosis vulvae (a condition that may cause vaginal dryness and discomfort in women or girls of any age). Imvexxy® brand vaginal inserts are used for the treatment of dyspareunia (difficult or painful sexual intercourse) in menopausal women. Vaginal estrogen is in a class of medications called hormones. It works by replacing estrogen that is normally produced by the body.
HOW should this medicine be used?
Vaginal estrogen comes as a flexible ring, a vaginal insert, as a tablet to insert in the vagina, and as a cream to apply to the inside of the vagina. Estrogen vaginal rings are usually inserted in the vagina and left in place for 3 months. After 3 months, the ring is removed, and a new ring may be inserted if treatment is still needed. Vaginal estrogen inserts are usually inserted once daily at the same time for 2 weeks, then used once every 3 to 4 days (twice weekly) as long as treatment is needed. Estrogen vaginal tablets are usually inserted once a day for the first 2 weeks of treatment and then are inserted twice a week as long as treatment is needed. Estrace® brand vaginal cream is usually applied once daily for 2 to 4 weeks, and then applied one to three times a week. Premarin® brand vaginal cream product is usually applied according to a rotating schedule that alternates several weeks when the cream is applied every day with one week when the cream is not applied. Use vaginal estrogen at around the same time of day every time you use it. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use vaginal estrogen exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
To use the vaginal ring, follow these steps:
To use the vaginal tablet, follow these steps:
To use the vaginal insert (Imvexxy® ), follow these steps:
To use the vaginal cream, follow these steps:
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before using vaginal estrogen,
What SPECIAL DIETARY instructions should I follow?
Talk to your doctor about eating grapefruit and drinking grapefruit juice while using this medicine.
What should I do IF I FORGET to take a dose?
Apply or insert the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose or apply extra cream to make up for a missed dose.
What SIDE EFFECTS can this medicine cause?
Vaginal estrogen may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
Estrogen may increase your risk of developing cancer of the ovaries or gallbladder disease that may need to be treated with surgery. Talk to your doctor about the risks of using vaginal estrogen.
Estrogen may cause growth to slow or stop early in children who receive large doses for a long time. Vaginal estrogen may also affect the timing and speed of sexual development in children. Your child's doctor will monitor her carefully during her treatment with estrogen. Talk to your child's doctor about the risks of giving this medication to your child.
Vaginal estrogen may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( http://www.fda.gov/Safety/MedWatch ) or by phone (1-800-332-1088).
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach.http://www.upandaway.org
What should I do in case of OVERDOSE?
If someone swallows vaginal estrogen, uses extra tablets or rings, or applies extra cream, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include the following:
What OTHER INFORMATION should I know?
Keep all appointments with your doctor.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are using vaginal estrogen.
Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
¶ This branded product is no longer on the market. Generic alternatives may be available.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: August 15, 2018.
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