Estrace

Estrace is a prescription medicated cream used to treat symptoms of menopause including vaginal dryness. Estrace, in tablet form, is also used to treat conditions in which a woman's ovaries do not produce enough estrogen naturally (hypoestrogenism). It is used to help prevent osteoporosis after menopause and symptoms associated with prostate and breast cancer. 

Estrace contains estradiol which is a form of the hormone estrogen. It replaces estrogen that is not naturally produced by the ovaries.

This medication comes is available as a vaginal cream and an oral tablet. The cream is inserted into the vagina daily for one or two weeks. The tablet is usually taken daily. When treating relieving symptoms associated with cancer, it is usually taken three times a day. 

Common side effects of Estrace tablet include 

Common side effects of Estrace cream include headache, breast tenderness, and irregular vaginal bleeding or spotting. 

Estrace is a prescription medicated cream used to treat symptoms of menopause including vaginal dryness. Estrace, in tablet form, is also used to treat conditions in which a woman's ovaries do not produce enough estrogen naturally (hypoestrogenism). It is used to help prevent osteoporosis after menopause and symptoms associated with prostate and breast cancer. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Warner Chilcott (US), LLC

Serious side effects have been reported with Estrace. See the “Estrace Precautions” section.

Common side effects of Estrace tablet include the following:

• headache
• breast pain or tenderness
• nausea
• vomiting
• constipation
• gas
• heartburn
• weight gain or loss
• hair loss
• swelling, redness, burning, irritation or itching of the vagina
• vaginal discharge
• painful menstrual periods
• changes in mood
• change in sexual desire
• back, neck, or muscle pain
• runny nose or congestion
• cough
• unwanted hair growth

Common side effects of Estrace cream include the following:

• headache
• breast tenderness
• irregular vaginal bleeding or spotting
• stomach/abdominal cramps, bloating
• nausea and vomiting
• hair loss
• vaginal burning, irritation, and itching

This is not a complete list of Estrace side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Amiodarone (Cordarone, Pacerone)
• Antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral)
• Aprepitant (Emend)
• Carbamazepine (Carbatrol, Epitol, Tegretol)
• Cimetidine (Tagamet)
• Clarithromycin (Biaxin)
• Cyclosporine (Neoral, Sandimmune)
• Dexamethasone (Decadron, Dexpak)
• Diltiazem (Cardizem, Dilacor, Tiazac, others)
• Erythromycin (E.E.S, Erythrocin)
• Fluoxetine (Prozac, Sarafem)
• Fluvoxamine (Luvox)
• Griseofulvin (Fulvicin, Grifulvin, Gris-PEG)
• Lovastatin (Altocor, Mevacor)
• Medications for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase, Invirase) 
• Medications for thyroid disease
• Nefazodone
• Other medications that contain estrogen
• Phenobarbital
• Phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin)
• Rifampin
• Sertraline (Zoloft)
• Troleandomycin (TAO)
• Verapamil (Calan, Covera, Isoptin, Verelan)
• Zafirlukast (Accolate)
• St. John's Wort

This is not a complete list of Estrace drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Estrace including the following:

• bulging eyes
• yellowing of the skin or eyes
• itching
• loss of appetite
• fever
• joint pain
• stomach tenderness, pain, or swelling
• movements that are difficult to control
• hives
• rash or blisters on the skin
• swelling, of the eyes, face, lips, tongue, throat, hands, feet, ankles, or lower legs
• hoarseness
• wheezing
• difficulty breathing or swallowing

Do not take/use Estrace if you:

• are allergic to Estrace or to any of its ingredients
• have abnormal vaginal bleeding
• have a known or suspected history of breast cancer
• have a known or suspected estrogen-dependent cancer
• currently have or have a history of blood clots
• have had a stroke or heart attack in the last year
• have liver disease
• are pregnant or possibly pregnant

Grapefruit and grapefruit juice may interact with Estrace and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking/using Estrace, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Estrace or to any of its ingredients
• have or have ever had asthma
• have seizures
• have migraine headaches
• currently have or have had certain cancers
• currently have or have a history of blood clots
• have had a stroke or heart attack in the last year
• have endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body)
• have uterine fibroids (growths in the uterus that are not cancer)
• have or have had yellowing of the skin or eyes, especially during pregnancy or while you were using an estrogen product
• have very high or very low levels of calcium in your blood
• have porphyria (condition in which abnormal substances build up in the blood and cause problems with the skin or nervous system) or gallbladder, thyroid, pancreas, liver or kidney disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Estrace should not be used during pregnancy. There appears to be little or no increased risk of birth defects in children born to women who inadvertently used estrogens during early pregnancy. Talk to your doctor right away if you become pregnant while taking.using Estrace. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

Estrogen has been detected in human breast milk. Estrogen can decrease the quality or quantity of breast milk. Caution should be taken if Estrace is given to a nursing mother. 

Take/Use Estrace exactly as prescribed.

This medication is available as an oral tablet. It is usually taken once a day. 

This medication is available as a vaginal cream. It is usually inserted into the vagina once a day.

Estrace Vaginal Cream:

1. Remove cap from tube. (There is no seal on tube)
2. Do not separate plunger from applicator.
3. Screw threaded end of applicator onto the opened tube until secure.
4. Position upright in order to view the calibrated gram amounts.
5. Gently squeeze tube from the bottom to expel the prescribed amount of Estrace Vaginal Cream into the applicator. As cream is squeezed out, plunger will rise to indicate amount of grams.
6. Unscrew applicator from tube.
7. Replace cap onto tube.
8. Lie on back with knees drawn up. To deliver medication, gently insert applicator deeply into the vagina and press plunger downward to its original position.
9. To cleanse applicator: Pull plunger to remove it from barrel. Wash with mild soap and warm water. DO NOT BOIL OR USE HOT WATER.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

Estrace Vaginal Cream:

The recommended dose range of Estrace (estradiol) vaginal cream for the treatment of menopause symptoms is 2 to 4 g (marked on the applicator) daily for one or two weeks, then gradually reduced to one half initial dosage for a similar period. A maintenance dosage of 1 g, one to three times a week, may be used after restoration of the vaginal mucosa has been achieved.

Estrace Tablets:

1. Your doctor will prescribe the lowest dose and regimen that will control the symptoms associated with menopause. Your doctor will stop your medication as promptly as possible. Attempts to discontinue or taper medication should be made at 3-month to 6-month intervals. The usual initial dosage range is 1 to 2 mg daily of Estrace. The dose will be adjusted as necessary to control presenting symptoms. Administration should be cyclic (e.g., 3 weeks on and 1 week off).

2. For treatment of female hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.

Treatment is usually initiated with a dose of 1 to 2 mg daily of Estrace. Your doctor will adjust dose as necessary to control presenting symptoms. 

3. For treatment of breast cancer, for palliation only, in appropriately selected women and men with metastatic disease. the suggested dose is 10 mg three times daily for a period of at least three months.

4. For treatment of advanced androgen-dependent carcinoma of the prostate, for palliation only, the suggested dose is 1 to 2 mg three times daily. 

If you take/use too much Estrace, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Estrace is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Estrace at room temperature. 
• Keep this and all medicines out of the reach of children.

WARNING: ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER.

CLOSE CLINICAL SURVEILLANCE OF ALL WOMEN TAKING ESTROGENS IS IMPORTANT. ADEQUATE DIAGNOSTIC MEASURES, INCLUDING ENDOMETRIAL SAMPLING WHEN INDICATED, SHOULD BE UNDERTAKEN TO RULE OUT MALIGNANCY IN ALL CASES OF UNDIAGNOSED PERSISTENT OR RECURRING ABNORMAL VAGINAL BLEEDING. THERE IS CURRENTLY NO EVIDENCE THAT THE USE OF “NATURAL” ESTROGENS RESULTS IN A DIFFERENT ENDOMETRIAL RISK PROFILE THAN SYNTHETIC ESTROGENS OF EQUIVALENT ESTROGEN DOSE.

CARDIOVASCULAR AND OTHER RISKS 

ESTROGENS WITH AND WITHOUT PROGESTINS SHOULD NOT BE USED FOR THE PREVENTION OF CARDIOVASCULAR DISEASE OR DEMENTIA.

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 TO 79 YEARS OF AGE) DURING 5 YEARS OF TREATMENT WITH ORAL CONJUGATED ESTROGENS (CE 0.625 MG) COMBINED WITH MEDROXYPROGESTERONE ACETATE (MPA 2.5 MG) RELATIVE TO PLACEBO.

THE WOMEN’S HEALTH INITIATIVE MEMORY STUDY (WHIMS), A SUBSTUDY OF WHI, REPORTED INCREASED RISK OF DEVELOPING PROBABLE DEMENTIA IN POSTMENOPAUSAL WOMEN 65 YEARS OF AGE OR OLDER DURING 4 YEARS OF TREATMENT WITH ORAL CONJUGATED ESTROGENS PLUS MEDROXYPROGESTERONE ACETATE RELATIVE TO PLACEBO. IT IS UNKNOWN WHETHER THIS FINDING APPLIES TO YOUNGER POSTMENOPAUSAL WOMEN.

OTHER DOSES OF ORAL CONJUGATED ESTROGENS WITH MEDROXYPROGESTERONE ACETATE, AND OTHER COMBINATIONS AND DOSAGE FORMS OF ESTROGENS AND PROGESTINS WERE NOT STUDIED IN THE WHI CLINICAL TRIALS AND, IN THE ABSENCE OF COMPARABLE DATA, THESE RISKS SHOULD BE ASSUMED TO BE SIMILAR. BECAUSE OF THESE RISKS, ESTROGENS WITH OR WITHOUT PROGESTINS SHOULD BE PRESCRIBED AT THE LOWEST EFFECTIVE DOSES AND FOR THE SHORTEST DURATION CONSISTENT WITH TREATMENT GOALS AND RISKS FOR THE INDIVIDUAL WOMAN.