estradiol (oral, injectable, and vaginal)

(ess tra DYE ole)
Clinagen LA 40, Delestrogen, Depo-Estradiol, Estrace, Estrogel, Femring, Gynodiol, Valergen

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

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Estradiol increases the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone drug, with estradiol lowers the risk of developing this condition. Therefore, if your uterus has not been removed, your doctor may prescribe a progestin for you to take together with the estrogen. Visit your doctor regularly and report any unusual vaginal bleeding right away.

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Treatment with estradiol long-term may increase the risk of stroke. Because of this risk, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before taking estradiol long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.

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The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50-79 years of age) during 5 years of treatment with oral conjugated estrogens combined with medroxyprogesterone acetate.

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The Women's Health Initiative Memory Study (WHIMS) found that postmenopausal women 65 years of age or older who were treated with oral conjugated estrogens plus medroxyprogesterone acetate had an increased risk of developing dementia. It is unknown whether this finding applies to younger postmenopausal women or to women using estrogen only therapy.

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Have yearly physical exams and examine your breasts for lumps on a monthly basis while taking estradiol.

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Do not take estradiol if you are pregnant.

What is estradiol?

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

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Estradiol is used to treat symptoms of menopause such as hot flashes and dryness, burning, and irritation in the vaginal area; deficiency in ovary function (including underdevelopment of female sexual characteristics and some types of infertility); Turner's syndrome; some types of breast cancer in men and in postmenopausal women; degeneration of the vagina and urethra; and prostate cancer. In addition, estradiol is used to prevent osteoporosis.

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

What should I discuss with my healthcare provider before taking estradiol?

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Do not take estradiol without first talking to your doctor if you have

a circulation, bleeding, or blood-clotting disorder;

undiagnosed, abnormal vaginal bleeding; or

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

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Taking estradiol may not be recommended in some cases if you have any of the conditions listed above.

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Before taking estradiol, tell your doctor if you have

high blood pressure, angina, or heart disease;

a history of stroke or heart attack;

high levels of cholesterol or triglycerides in the blood;

liver disease;

kidney disease;

asthma;

epilepsy;

migraines;

diabetes;

depression;

gallbladder disease;

uterine fibroids; or

had a hysterectomy (uterus removed).

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You may not be able to take estradiol, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

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Estradiol is in the FDA pregnancy category X. This means that estradiol is known to cause birth defects in an unborn baby. Do not take this medication if you are pregnant or could become pregnant during treatment.

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Estradiol may decrease milk flow and have other effects on milk composition. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take estradiol?

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Take this medication exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

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Estradiol may be administered by mouth, injection, or inserted into the vagina. Your healthcare provider may administer injections of estradiol or will provide you with detailed instructions on how to administer the medication at home.

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Take each oral dose with a full glass of water.

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Take oral estradiol with food or milk to lessen stomach upset. Try to take oral doses at the same time daily.

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Use injectable estradiol exactly as directed by your healthcare provider. Do not inject any estradiol product that is discolored or has particles in it. Injectable estradiol stored at cool temperatures may develop crystals in the solution, which should dissolve as the solution warms to room temperature.

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Rotate injection sites as directed.

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Never reuse a needle or syringe. Dispose of all needles and syringes in an appropriate, puncture resistant disposal container.

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The Femring vaginal ring is inserted into the vaginal by you or your healthcare provider. To use the Femring vaginal ring:

Wash and dry your hands. Remove Femring from the pouch.

Squeeze the sides of the ring together or squeeze it into a figure-eight shape. Push the folded ring into the vagina (up and towards the lower back) as far as possible (into the upper 1/3 of the vagina). You should not be able to feel the ring once it is in position. If you can feel it, use a finger to push it further into the vagina. It is not possible for the ring to go too far in or become lost.

The ring should remain in place for 3 months. It should then be removed and replaced by a new ring, if prescribed by your doctor. To remove the ring, loop a finger through the ring and gently pull it from the vagina.

The ring does not need to be removed during sexual intercourse. It should not be felt by either partner. If it is bothersome, it can be removed, rinsed with warm water, and reinserted following intercourse.

If at any time the ring 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 reinsert it. If the ring falls out repeatedly, talk to your doctor.

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To use the Estrogel pump:

Before using the pump for the first time, it must be primed. Remove the large pump cover and fully depress the pump twice. Discard the unused gel by rinsing down the sink or placing it in the household trash in a manner that avoids accidental exposure or ingestion by household members or pets.

Apply EstroGel at the same time each day. You should apply your daily dose of gel to clean, dry, unbroken skin.

To apply the dose, collect the gel into the palm of your hand by pressing the pump firmly. Apply the gel to one arm using your hand. Spread the gel as thinly as possible over the entire area on the inside and outside of your arm from wrist to shoulder. It is not necessary to massage or rub in the gel. Allow the gel to dry for up to five minutes before dressing.

Wash your hands with soap and water after applying the gel to reduce the chance that the medicine will spread from your hands to other people. Alcohol based gels are flammable. Avoid fire, flame or smoking until the gel has dried.

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It is important to use estradiol regularly to get the most benefit.

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Your doctor may want you to have regularly scheduled blood tests or other medical evaluations during treatment with estradiol to monitor progress and side effects.

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Have yearly physical exams and examine your breasts for lumps on a monthly basis while taking estradiol.

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Store estradiol at room temperature away from moisture, heat, and direct light.

What happens if I miss a dose?

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Use the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and use only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose?

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An overdose of this medication is unlikely to threaten life. Consult an emergency room or poison control center for advice.

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Symptoms of an estradiol overdose may include nausea, vomiting, and breakthrough bleeding in women.

What should I avoid while taking estradiol?

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There are no restrictions on food, beverages, or activity while taking estradiol unless your doctor directs otherwise.

What are the possible side effects of estradiol?

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If you experience any of the following serious side effects, stop taking estradiol and seek emergency medical attention:

an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

shortness or breath or pain in the chest;

a painful, red, or swollen leg;

abnormal vaginal bleeding;

pain, swelling, or tenderness in the abdomen;

severe headache or vomiting, dizziness, faintness or changes in vision or speech;

yellowing of the skin or eyes; or

a lump in a breast.

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Other, less serious side effects may be more likely to occur. Continue to take estradiol and talk to your doctor if you experience

decreased appetite, nausea, or vomiting;

swollen or tender breasts;

acne or skin color changes;

decreased sex drive;

migraine headaches or dizziness;

water retention (swollen hands, feet, or ankles);

problems with wearing contact lenses;

depression; or

changes in menstrual cycle or breakthrough bleeding.

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Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect estradiol?

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Before taking estradiol, tell your doctor if you are taking any of the following medicines:

an anticoagulant (blood thinner) such as warfarin (Coumadin);

a thyroid medication such as Synthroid, Levoxyl, Levothroid, and others;

insulin or an oral diabetes medicine such as glipizide (Glucotrol) or glyburide (Diabeta, Micronase);

tamoxifen (Nolvadex);

didanosine (Videx);

phenytoin (Dilantin) or ethotoin (Peganone);

carbamazepine (Tegretol);

phenobarbital (Solfoton, Luminal);

primidone (Mysoline); or

rifampin (Rifadin).

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A dosage adjustment or special monitoring may be required during treatment if you are taking any of the medicines listed above.

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Drugs other than those listed here may also interact with estradiol. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Where can I get more information?

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Your pharmacist has additional information about estradiol written for health professionals that you may read.

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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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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.