estradiol vaginal (local)

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Pronunciation: ES tra DYE ole VA jin ul (LO kul)

Brand: Estrace Vaginal, Estring, Vagifem

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

You should not use estradiol if you have: liver disease, a bleeding disorder, unusual vaginal bleeding, history of a hormone-dependent cancer (such as breast, uterine, ovarian, or thyroid cancer), or if you have ever had a heart attack, stroke, or a blood clot.

Do not use if you are pregnant.

Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Call your doctor at once if you have any unusual vaginal bleeding while using this medicine.

Estradiol should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions. Long-term use may also increase your risk of breast cancer or blood clot.

Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

What is estradiol vaginal (local)?

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 that are used for local treatment of symptoms. Estradiol vaginal (local) is used to treat vaginal symptoms of menopause such as dryness, burning, and itching.

Estradiol vaginal (local) may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using estradiol vaginal (local)?

You should not use this medicine if you are allergic to estradiol, if you are pregnant, or if you have:

  • unusual vaginal bleeding that a doctor has not checked;
  • liver disease;
  • a bleeding or blood-clotting disorder;
  • a recent history of heart attack or stroke;
  • a history of hormone-dependent cancer (such as breast, uterine, ovarian, or thyroid cancer); or
  • if you have ever had a blood clot (especially in your lung or your lower body).

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

To make sure estradiol is safe for you, tell your doctor if you have:

  • heart disease;
  • risk factors for coronary artery disease (such as diabetes, lupus, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, or if you have had a hysterectomy);
  • a history of jaundice caused by pregnancy or birth control pills;
  • hereditary angioedema (an immune system disorder);
  • a thyroid disorder;
  • kidney disease;
  • asthma;
  • epilepsy or other seizure disorder;
  • migraines;
  • porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
  • endometriosis or uterine fibroid tumors;
  • gallbladder disease;
  • high or low levels of calcium in your blood; or
  • if you have had your uterus removed (hysterectomy).

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. Estradiol can harm an unborn baby or cause birth defects. Do not use 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.

Estradiol can pass into breast milk. This medication may slow breast milk production. Tell your doctor if you are breast-feeding a baby.

How should I use estradiol vaginal (local)?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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.

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 estradiol vaginal.

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.

Use the applicator provided to measure the prescribed dose of estradiol vaginal cream. Take apart the cream applicator and wash it with mild soap and warm water after each use.

Each estradiol vaginal tablet is supplied in a single-use disposable applicator. Throw the tablet applicator away after one use.

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, and have regular mammograms while using estradiol transdermal.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using estradiol.

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

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed 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.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

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

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.

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

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:

  • unusual vaginal bleeding;
  • swelling or tenderness in your stomach;
  • jaundice (yellowing of the skin or eyes);
  • memory problems, confusion;
  • a lump in your breast;
  • dangerously high blood pressure --severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety, confusion, severe chest pain, shortness of breath, irregular heartbeats, seizure;
  • heart attack symptoms --chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • high blood sugar --increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss;
  • high levels of calcium in your blood --nausea, vomiting, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling tired or restless;
  • low levels of calcium in your blood --numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes;
  • signs of a stroke --sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot in the lung --chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
  • signs of a blood clot in your leg --pain, swelling, warmth, or redness in one or both legs.

Common side effects may include:

  • light vaginal bleeding or spotting;
  • nausea, vomiting, stomach pain;
  • headache;
  • vaginal itching or discharge;
  • breast pain; or
  • swelling, bloating, weight gain.

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 (local)?

Other drugs may interact with estradiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

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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