estradiol vaginal (systemic)

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 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.

Do not use this medication if you have any of the following conditions: a history of stroke, heart attack, or blood clot, a hormone-related cancer such as breast or uterine cancer, or abnormal vaginal bleeding that a doctor has not checked.

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, which 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.

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) may also be used for other purposes not 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 history of stroke, heart attack, or blood clot;
• abnormal vaginal bleeding that a doctor has not checked; or
• any type of breast, uterine, or hormone-dependent cancer.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use estradiol vaginal:

• angina (chest pain), heart disease;
• risk factors for coronary artery disease (such as smoking, being overweight, and having high blood pressure or high cholesterol);
• liver or 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).

Estradiol increases your risk of developing endometrial hyperplasia, which 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.

Estradiol vaginal should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

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.

How should I use estradiol vaginal (systemic)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label.

Wash your hands before and after inserting the vaginal ring.

To insert the estradiol vaginal ring:

• Squeeze the sides of the ring together and insert it into the vagina as far as possible. You should not be able to feel the ring once it is in place. If you can feel it, use a finger to push it in farther. It is not possible for the ring to go too far in or become lost.
• Leave the ring in place for 90 days. If the ring ever falls out, rinse it with warm water and reinsert it. If it slides down into the lower part of the vagina, use a finger to push it in farther. After 90 days, remove the ring. Your doctor may want you to replace it with a new ring.
• The ring does not need to be removed during sexual intercourse. Neither partner should be able to feel the ring when it is in place. If the ring is bothersome, you may remove it, rinse it with warm water, and reinsert it after intercourse.
• The estradiol vaginal ring does not prevent pregnancy and should not be used in place of effective birth control.

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.

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

If you need to have any type of surgery or be on bed rest, tell your surgeon or doctor ahead of time that you are using the estradiol vaginal ring. You may need to remove the ring 4 to 6 weeks before your surgery.

Keep the vaginal ring in its protective pouch until you are ready to use it. Store the pouch at room temperature away from moisture and heat.

What happens if I miss a dose?

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.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include breast tenderness, drowsiness, dizziness, nausea, vomiting, stomach pain, or vaginal bleeding.

What should I avoid while using estradiol vaginal (systemic)?

Avoid using other vaginal products without your doctor's advice.

What are the possible side effects of estradiol vaginal (systemic)?

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.

Call your doctor at once if you have any of these serious side effects:

• chest pain or heavy feeling, pain spreading to the arm or shoulder, sweating, general ill feeling;
• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, problems with vision, speech, or balance;
• pain or swelling in your lower leg (calf);
• heavy or unusual vaginal bleeding;
• severe constipation;
• symptoms of depression (sleep problems, weakness, mood changes);
• loss of appetite, increased thirst, muscle weakness, feeling tired or restless;
• pain, swelling, or tenderness in your stomach, jaundice (yellowing of the skin or eyes); or
• a lump in your breast.

Less serious side effects may include:

• swollen breasts;
• acne or skin color changes;
• decreased sex drive, impotence, or difficulty having an orgasm;
• migraine headache;
• vaginal pain, itching, or discharge;
• swelling of your ankles or feet; or
• changes in your menstrual periods, break-through bleeding.

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.

What other drugs will affect estradiol vaginal (systemic)?

Before using estradiol vaginal, tell your doctor if you are using any of the following drugs:

• St. John's wort;
• carbamazepine (Carbatrol, Tegretol)or phenobarbital (Luminal, Solfoton);
• a blood thinner such as warfarin (Coumadin);
• ritonavir (Norvir);
• rifampin (Rifadin, Rifater, Rifamate, Rimactane);
• thyroid replacement medication such as levothyroxine (Synthroid) and others;
• an antibiotic such as clarithromycin (Biaxin) or erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab); or
• an antifungal medication such as ketoconazole (Nizoral) or itraconazole (Sporanox).

This list is not complete and there may be other drugs that can interact with estradiol vaginal. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about estradiol vaginal (systemic).