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estradiol vaginal

Pronunciation

Generic Name: estradiol vaginal (systemic) (ES tra DYE ole VA jin ul (sis TEM ik))
Brand Name: Femring

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

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

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

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

Estradiol can harm an unborn baby or cause birth defects. Do not use if you are pregnant.

You should not use this medication if you have any of the following conditions: liver disease, a bleeding disorder, unusual vaginal bleeding, a history of breast or uterine cancer, or if you have ever had a heart attack, stroke, or a blood clot.

Slideshow: View Frightful (But Dead Serious) Drug Side Effects

Long-term use of estradiol may increase your risk of breast cancer, uterine cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risks before using estradiol vaginal long term.

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

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

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

  • liver disease;

  • a bleeding or blood-clotting disorder;

  • a history of heart attack, stroke, or blood clot;

  • unusual vaginal bleeding that a doctor has not checked; or

  • any type of breast, uterine, or hormone-dependent cancer.

To make sure estradiol is safe for you, tell your doctor about your other medical conditions, especially:

  • heart disease;

  • risk factors for coronary artery disease (such as diabetes, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease);

  • hereditary angioedema (an immune system disorder);

  • a history of jaundice caused by pregnancy or birth control pills;

  • a thyroid disorder;

  • kidney disease;

  • asthma;

  • epilepsy or other seizure disorder;

  • migraines;

  • endometriosis or uterine fibroid tumors;

  • lupus;

  • gallbladder disease; or

  • high levels of calcium in your blood.

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.

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. This medication can harm an unborn baby or cause birth defects. Do not use estradiol 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.

The estradiol vaginal ring does not prevent pregnancy and should not be used in place of effective birth control.

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 exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

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 the vaginal ring.

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 while using estradiol vaginal.

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

Keep the vaginal ring in its protective pouch until you are ready to use it. Store 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 or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include dizziness, drowsiness, stomach pain, nausea, vomiting, and vaginal bleeding.

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

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.

Estradiol vaginal (systemic) side effects

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.

Stop using this medication and 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, nausea, sweating, general ill feeling;

  • sudden numbness or weakness, sudden severe headache, sudden vision changes, problems with speech or balance;

  • sudden cough, wheezing, rapid breathing, coughing up blood;

  • pain, swelling, warmth, or redness in one or both legs;

  • swelling or tenderness in your stomach;

  • jaundice (yellowing of the skin or eyes);

  • unusual vaginal bleeding, a lump in your breast;

  • numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes; or

  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • mild headache, depressed mood;

  • breast swelling and tenderness, nipple discharge, vaginal itching or discharge;

  • mild nausea, stomach cramps, bloating;

  • acne or skin color changes, increased facial hair, thinning scalp hair;

  • 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.

See also: Side effects (in more detail)

Estradiol vaginal dosing information

Usual Adult Dose for Postmenopausal Symptoms:

Oral:
0.45 mg to 2 mg orally once a day.

Parenteral:
1 to 5 mg of estradiol cypionate IM every 3 to 4 weeks or 10 to 20 mg of estradiol valerate IM every 4 weeks.

Vaginal Ring:
0.05 mg/day or 0.1 mg/day vaginal ring. The ring should remain in place for 3 months and then be replaced by a new ring if therapy is to continue.

Topical:
0.025 to 0.1 mg/day (transdermal film) applied topically 1 or 2 times a week. Application sites vary according to manufacturer formulation and include the lower abdomen, upper thigh, buttocks, or upper arm. Systems should not be applied to the breasts.
0.05 mg/day (2 foil pouches of transdermal emulsion) applied topically to both legs each morning.
0.25 mg unit dose packet (0.1% transdermal gel) applied topically once daily to the upper right or left thigh at the same time daily.
1.25 g (one spray) EstroGel (0.75 mg/1.25 gm - 0.06% transdermal gel) applied topically to the arms at the same time daily.
1.53 mg (one spray) Evamist (1.53 mg/spray transdermal spray) applied topically to the forearm at the same time daily.
0.87 g (one spray) Elestrin (0.52 mg/1.087 g - 0.06% transdermal gel) applied topically to the upper arm at the same time daily.

Women currently on oral estrogen therapy and changing to a transdermal estradiol system should initiate transdermal therapy 1 week following discontinuation of oral estrogens (sooner if menopausal symptoms reappear). Changes between transdermal systems may be initiated without interruption of therapy.

In general, the duration of hormone therapy for the treatment of postmenopausal symptoms should be limited. Treatment for one to five years is generally sufficient. However, long-term therapy (for the treatment/prophylaxis of osteoporosis and for risk reduction of cardiovascular disease) may be considered during the time in which the patient is being treated for postmenopausal symptoms.

Because of the potential increased risks of cardiovascular events, breast cancer and venous thromboembolic events, use should be limited to the shortest duration consistent with treatment goals and risks for the individual woman, and should be periodically reevaluated. When used solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

Usual Adult Dose for Atrophic Urethritis:

Oral:
1 to 2 mg orally once a day.

Parenteral:
10 to 20 mg of estradiol valerate IM every 4 weeks.

Vaginal Ring:
0.05 mg/day or 0.1 mg/day vaginal ring. The ring should remain in place for 3 months and then be replaced by a new ring if therapy is to continue.

Topical:
0.025 to 0.1 mg/day (transdermal film) applied topically 1 or 2 times a week. Application sites vary according to manufacturer formulation and include the lower abdomen, upper thigh, buttocks, or upper arm. Systems should not be applied to the breasts.
1.25 g/day (estradiol gel) applied topically at the same time daily. If used solely for the treatment of vulvar and vaginal atrophy, topical vaginal products should be considered.

Women currently on oral estrogen therapy and changing to a transdermal estradiol system should initiate transdermal therapy 1 week following discontinuation of oral estrogens (sooner if menopausal symptoms reappear). Changes between transdermal systems may be initiated without interruption of therapy.

Because of the potential increased risks of cardiovascular events, breast cancer and venous thromboembolic events, use should be limited to the shortest duration consistent with treatment goals and risks for the individual woman, and should be periodically reevaluated. When used solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
In general, the duration of hormone therapy for the treatment of postmenopausal symptoms like atrophic vaginitis, kraurosis vulvae, or atrophic urethritis should be limited. Treatment for one to five years is generally sufficient.

Usual Adult Dose for Atrophic Vaginitis:

Oral:
1 to 2 mg orally once a day.

Parenteral:
10 to 20 mg of estradiol valerate IM every 4 weeks.

Vaginal Ring:
0.05 mg/day or 0.1 mg/day vaginal ring. The ring should remain in place for 3 months and then be replaced by a new ring if therapy is to continue.

Topical:
0.025 to 0.1 mg/day (transdermal film) applied topically 1 or 2 times a week. Application sites vary according to manufacturer formulation and include the lower abdomen, upper thigh, buttocks, or upper arm. Systems should not be applied to the breasts.
1.25 g/day (estradiol gel) applied topically at the same time daily. If used solely for the treatment of vulvar and vaginal atrophy, topical vaginal products should be considered.

Women currently on oral estrogen therapy and changing to a transdermal estradiol system should initiate transdermal therapy 1 week following discontinuation of oral estrogens (sooner if menopausal symptoms reappear). Changes between transdermal systems may be initiated without interruption of therapy.

Because of the potential increased risks of cardiovascular events, breast cancer and venous thromboembolic events, use should be limited to the shortest duration consistent with treatment goals and risks for the individual woman, and should be periodically reevaluated. When used solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
In general, the duration of hormone therapy for the treatment of postmenopausal symptoms like atrophic vaginitis, kraurosis vulvae, or atrophic urethritis should be limited. Treatment for one to five years is generally sufficient.

Usual Adult Dose for Hypoestrogenism:

Oral:
1 to 2 mg orally once a day.

Parenteral:
1.5 to 2 mg of estradiol cypionate IM once a month or 10 to 20 mg estradiol valerate IM every 4 weeks.

Topical:
0.025 to 0.1 mg/day (transdermal film) applied topically 1 or 2 times a week. Application sites vary according to manufacturer formulation and include the lower abdomen, upper thigh, buttocks, or upper arm. Systems should not be applied to the breasts.

Dosages should be titrated according to patient response. Therapy should be maintained with the minimum dosage that will achieve the desired clinical effect.

Usual Adult Dose for Oophorectomy:

Oral:
1 to 2 mg orally once a day.

Parenteral:
10 to 20 mg of estradiol valerate by IM every 4 weeks.

Topical:
0.025 to 0.1 mg/day (transdermal film) applied topically 1 or 2 times a week. Application sites vary according to manufacturer formulation and include the lower abdomen, upper thigh, buttocks, or upper arm. Systems should not be applied to the breasts.

Women currently on oral estrogen therapy and changing to a transdermal estradiol system should initiate transdermal therapy 1 week following discontinuation of oral estrogens (sooner if menopausal symptoms reappear). Changes between transdermal systems may be initiated without interruption of therapy.

Usual Adult Dose for Primary Ovarian Failure:

Oral:
1 to 2 mg orally once a day.

Parenteral:
10 to 20 mg of estradiol valerate by IM every 4 weeks.

Topical:
0.025 to 0.1 mg/day (transdermal film) applied topically 1 or 2 times a week. Application sites vary according to manufacturer formulation and include the lower abdomen, upper thigh, buttocks, or upper arm. Systems should not be applied to the breasts.

Women currently on oral estrogen therapy and changing to a transdermal estradiol system should initiate transdermal therapy 1 week following discontinuation of oral estrogens (sooner if menopausal symptoms reappear). Changes between transdermal systems may be initiated without interruption of therapy.

Usual Adult Dose for Breast Cancer--Palliative:

10 mg orally 3 times a day for at least 3 months. Estrogen therapy for breast cancer should be considered only for palliation in the treatment of metastatic disease in select patients

Usual Adult Dose for Osteoporosis:

Oral:
0.5 mg orally once a day.

Topical:
0.025 to 0.1 mg/day (transdermal film) applied topically 1 or 2 times a week. Systems should not be applied to the breasts.
14 mcg/day weekly (transdermal film) applied topically once a week.

Application sites vary according to manufacturer formulation and include the lower abdomen, upper thigh, buttocks, or upper arm.

In addition to hormonal therapy, adequate calcium intake is important for postmenopausal women who require treatment or prevention of osteoporosis. The average diet of older American women contains 400 to 600 mg of calcium per day. A suggested optimal intake is 1500 mg per day. If dietary intake is insufficient to achieve 1500 mg per day, supplementation may be useful in women who have no contraindication to calcium supplementation.

Long-term therapy (for more than 5 years) is generally necessary in order to obtain substantive benefits in reducing the risk of bone fracture. Maximal benefits are obtained if estrogen therapy is initiated as soon after menopause as possible. The optimal duration of therapy has not been definitively determined.

Women currently on oral estrogen therapy and changing to a transdermal estradiol system should initiate transdermal therapy 1 week following discontinuation of oral estrogens (sooner if menopausal symptoms reappear). Changes between transdermal systems may be initiated without interruption of therapy.

When used solely for the prevention of postmenopausal osteoporosis, approved non-estrogen treatments should carefully be considered, and estrogen and combined estrogen-progestin products should only be considered for women with significant risk of osteoporosis that outweighs the risks of the drug.

Usual Adult Dose for Prostate Cancer:

Oral:
1 to 2 mg orally 3 times a day.

Parenteral:
Estradiol valerate 30 mg IM every 1 to 2 weeks.

An apparent response should be noted within 3 months of initiation of therapy. Estrogen therapy for prostate cancer should be considered only for palliation in the treatment of metastatic disease in select patients.

What other drugs will affect estradiol vaginal (systemic)?

Tell your doctor about all other medicines you use, especially:

  • St. John's wort;

  • an antibiotic or antifungal medication (Biaxin, Ery-Tab, Erythrocin, Ketek, Mycobutin, Nizoral, Noxafil, Rifater, Sporanox, Vfend, Zithromax, Zmax, and others);

  • a barbiturate such as phenobarbital (Solfoton);

  • heart or blood pressure medication such as nicardipine (Cardene) or quinidine (Quin-G);

  • the hepatitis C medications boceprevir (Victrelis) or telaprevir (Incivek);

  • HIV/AIDS medication such as efavirenz (Sustiva, Atripla), fosamprenavir (Lexiva), indinavir (Crixivan), ritonavir (Norvir, Kaletra), and others;

  • seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), phenytoin (Dilantin), and others; or

  • thyroid replacement therapy (levothyroxine, Synthroid, Levothroid, Levoxyl, and others).

This list is not complete and there are many other drugs that can interact with estradiol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

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.
  • Disclaimer: 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.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.01. Revision Date: 2012-10-15, 10:56:35 PM.

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