estradiol vaginal (systemic)

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

You should not use this medicine if you have: undiagnosed vaginal bleeding, liver disease, a bleeding disorder, if you will have major surgery, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.

What is estradiol vaginal (systemic)?

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 (such as dryness, burning, and irritation). Other vaginal estradiol products are used for treating vaginal menopause symptoms and symptoms that affect 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 directly applied.

This medication guide provides information about estradiol vaginal for systemic treatment of certain symptoms of menopause, including hot flashes and vaginal dryness, burning, or irritation.

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

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

• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease;
• a history of heart attack, stroke, or blood clot;
• an increased risk of having blood clots due to a heart problem or a hereditary blood disorder; or
• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.

Using this medicine can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.

Tell your doctor if you have ever had:

• heart disease;
• liver problems, or jaundice caused by pregnancy or taking hormones;
• kidney disease;
• gallbladder disease;
• asthma;
• epilepsy or other seizure disorder;
• migraines;
• lupus;
• endometriosis or uterine fibroid tumors;
• hereditary angioedema;
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
• a thyroid disorder; or
• high levels of calcium in your blood.

How should I use estradiol vaginal?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

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 and have a mammogram every year while using estradiol.

If you need major surgery or will be on long-term 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.

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?

What should I avoid while using estradiol vaginal?

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

Grapefruit may interact with estradiol and lead to unwanted side effects. Avoid the use of grapefruit products.

What are the possible side effects of estradiol vaginal?

• heart attack symptoms --chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• 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 --sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
• swelling or tenderness in your stomach;
• jaundice (yellowing of the skin or eyes);
• memory problems, confusion, unusual behavior;
• unusual vaginal bleeding, pelvic pain;
• a lump in your breast; or
• high levels of calcium in your blood --nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common side effects may include:

• nausea, vomiting, bloating, stomach cramps;
• headache;
• breast pain or tenderness;
• swelling in your hands or feet, weight gain;
• thinning scalp hair; or
• vaginal itching or discharge, changes in your menstrual periods, breakthrough 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?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can affect estradiol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about systemic vaginal estradiol.

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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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