estradiol vaginal (systemic)

Brand name(s):

estradiol, Femring

What is the most important information I should know about estradiol vaginal (systemic)?

Some estradiol products placed directly into the vagina are used for "local" treatment of vaginal menopause symtoms 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 that are used for systemic treatment of symptoms.

Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, or abnormal vaginal bleeding. This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Estradiol increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estradiol may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using estradiol vaginal.

Long-term estradiol treatment may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using estradiol long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using estradiol.

What is estradiol vaginal (systemic)?

Estradiol is a form of estrogen. Estrogen is a female sex hormone necessary for many processes in the body.

Estradiol vaginal (systemic) is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation.

Estradiol vaginal (systemic) may also be used for purposes other than those listed in this medication guide.

What should I discuss with my health care provider before using estradiol vaginal (systemic)?

Do not use estradiol vaginal if you have:

a bleeding or blood-clotting disorder;
a history of stroke or circulation problems;
abnormal vaginal bleeding that a doctor has not checked; or
any type of breast, uterine, or hormone-dependent cancer.

Before using estradiol vaginal, tell your doctor if you have:

high blood pressure, angina, or heart disease;
high cholesterol or triglycerides;
liver disease;
kidney disease;
asthma;
epilepsy or other seizure disorder;
migraines;
diabetes;
depression;
gallbladder disease;
uterine fibroids;
a narrow, short, or prolapsed vagina;
vaginal irritation or infection; or
if you have had your uterus removed (hysterectomy).

If you have any of these conditions, you may not be able to use estradiol vaginal, or you may need a dosage adjustment or special tests during treatment.

Long-term estradiol treatment may increase your risk of stroke. Talk with your doctor about your individual risks before using estradiol long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

FDA pregnancy category X. This medication can cause birth defects. Do not use estradiol vaginal if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. 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.

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