Brand Name

Estrace {Warner Chilcott}

Generic Name

estradiol, pronounced es tra DYE ole

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Drug Guide

The information contained in the following drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.

What is Estrace?

Estrace is used to treat symptoms of menopause like hot flashes, vaginal dryness and vaginal irritation. You may also be prescribed Estrace to help prevent osteoporosis if you are a postmenopausal woman, or to replace estrogen if you are a woman with ovarian failure or other conditions that cause a lack of natural estrogen in your body. Estrace may also be used as part of cancer treatment in women and men.

Estrace may be used for purposes not described in this medication guide.

Key Facts About Estrace

Estrace is estradiol and is a form of estrogen. Estrogen is a female sex hormone produced by the ovaries, and is necessary for many processes in your body.

Estrace is in FDA pregnancy category X. Estrace can harm your unborn baby and cause birth defects. You should not use Estrace if you are pregnant, and you must tell your doctor immediately if you become pregnant during treatment with this medication. We know that Estrace can pass into breast milk and may harm a nursing baby, and it may also slow your breast milk production. You should not breast-feed while you are taking Estrace.

Estrace should not be used to prevent heart disease, stroke, or dementia, because it may actually increase your risk of developing these conditions. Talk to your doctor if you are concerned about your risk for developing any of these conditions.

Taking Estrace, or any hormones may increase your risk of blood clots, stroke, or a heart attack, particularly if you have diabetes, high blood pressure, high cholesterol or triglycerides, if you are overweight or if you smoke.

Estrace treatment, if used long-term can increase your risk of breast cancer, ovarian cancer, or uterine cancer. You should talk with your doctor about your individual risks before using Estrace for a prolonged period of time. Your doctor may wish to evaluate your treatment every 3 to 6 months to determine if you should continue taking Estrace.

It is possible that taking progestin while also taking Estrace may lower your risk of uterine cancer. If you have not had your uterus removed your doctor may prescribe progestin for you to take while you are being treated with Estrace. Talk to your doctor if you are concerned about your risk for uterine cancer.

Before You Take Estrace

If you are allergic to estradiol you should not use Estrace.

If you have an allergy to any medications or food dyes you should tell your doctor before starting treatment with Estrace.

If you have a historyuncontrolled high blood pressure, heart disease, a blood-clotting disorder, circulation problems or a previous heart attack, stroke or blood clot caused by a birth control pill you should not use Estrace.

Do not use Estrace if you have endometriosis, lupus or porphyria without talking to your doctor first.

If you have had low levels of calcium in your blood, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you smoke and are over 35, or if you have ever had breast or uterine cancer you may not be a candidate for a Estrace.

Tell your doctor if you have severe migraine headaches (with aura, numbness, weakness, or vision changes), jaundice caused by pregnancy or birth control pills, diabetes, a hysterectomy, a blood clot (especially in your lungs or lower body), an underactive thyroid or gallbladder disease before using Estrace.

Tell your doctor before starting treatment with Estrace if you have depression, seizures or epilepsy, a history of irregular menstrual cycles, toxic shock syndrome, or easy vaginal irritation.

Let your doctor know if you have a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram before using Estrace.

If you have varicose veins, high cholesterol or triglycerides, if you smoke or if you are overweight inform your doctor before beginning treatment with Estrace.

Estrace Drug Interactions

You should inform your doctor if you are taking any of the following:

• AIDS or HIV drugs
• antibiotics, like clarithromycin (Biaxin) or erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab)
• antifungal medications, like ketoconazole (Extina, Ketozole, Nizoral, Xolegal)
• barbiturates like phenobarbital (Solfoton)
• blood thinners like warfarin (Coumadin)
• carbamazapine (Carbatrol, Tegretol)
• phenytoin (Dilantin)
• rifampin (Rifadin, Rifater, Rifamate, Rimactane)
• ritonavir (Norvir)
• St. John’s wort

Other drugs you take that are not listed may interact with Estrace. You should tell your doctor about all of the medications you use. This includes prescription drugs, vitamins, supplements and herbal products, and over the counter medications. You should not begin taking a new medication without telling your doctor first.

Directions for Using Estrace

Use Estrace exactly as your doctor has prescribed you to. Do not use it in larger or smaller amounts or for shorter or longer than recommended. Estrace comes with patient instructions for so you can use this medication safely and effectively. Be sure to follow these instructions carefully.

You should have regular physical exams and mammograms, and self-examine your breasts for lumps each month while using Estrace. Your doctor should check your progress every 3 to 6 months to evaluate whether you should continue taking Estrace.

If you need medical tests or surgery, or if you will need to be on bed rest, you may need to stop using Estrace for a short period of time. Be sure to tell any doctor or surgeon who treats you should know that you are being treated with Estrace.

You should not smoke while you take Estrace, as it will increase your risk of developing blood clots, a stroke, or a heart attack.

If you miss a dose of Estrace you should take it as soon as you remember. If it is almost time for your next dose you should skip the dose you missed.

Estrace needs to be stored in a cool, dry place, away from heat and moisture.

Estrace Side Effects

Contact your doctor at once if you have a serious side effect such as:

• allergic reaction including breathing difficulties, hives and swelling of your face, lips, throat or tongue
• breast lump
• chest pain or a heavy feeling with pain spreading to your arm or shoulder, nausea, sweating and a general ill feeling
• feeling faint, like you might pass out
• headache that is severe or sudden with confusion, problems with vision, speech or balance
• jaundice or a yellowing of your skin or eyes
• nausea and upper stomach pain, with vomiting and increased thirst
• numbness and weakness that is sudden, or on one side of your body
• pain and swelling and tenderness in your stomach
• swelling in your hands, ankles, feet or legs, along with warmth and redness
• vaginal bleeding that is unusual, especially if you are past menopause
• wheezing and cough along with rapid breathing and a fast heart rate

Less serious side Estrace effects may include:

• bloating
• breast pain, tenderness and swelling
• darkening of facial skin
• freckles or darkening of facial skin
• loss of scalp hair
• menstrual cycle changes, break-through bleeding
• nausea
• stomach cramps
• vaginal discharge or itching
• vomiting

It should be noted that this is not a complete list of possible side effects of Estrace. You should contact your physician for a complete list and medical advice regarding these effects.

Estrace Description and Dosing

Estrace is available in tablet form in the following dosages:

0.5 mg tablets are white to off-white, oval, flat-faced, beveled-edge, scored and debossed with 720 / ½ on the scored side and WC on the other side.

1 mg tablets are light purple, oval, flat-faced, beveled-edge, scored and debossed with 721 /
1 on the scored side and WC on the other side.

2 mg tablets are green, oval, flat-faced, beveled-edge, scored and debossed with 722 / 2 on the scored side and WC on the other side.

You should take Estrace exactly as your doctor has directed you to. Do not change your dose of Estrace or stop taking this medication without talking to your doctor first.

If you believe that you have overdosed with Estrace you should seek medical help immediately.

Ingredients in Estrace

Estrace contains estradiol as the main and active ingredient. Other inactive ingredients include Colloidal silicon dioxide, corn starch, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, and sodium starch glycolate. In addition, the 1 mg also contains FD&C blue no. 1 Aluminum Lake and D&C red no. 27 Aluminum Lake. The 2 mg also contains FD&C blue no. 1 Aluminum Lake and FD&C yellow no. 5 (tartrazine) Aluminum Lake.

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The information contained in this drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.