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Generic Name: estradiol acetate (ES-tra-dye-ole ASS-uh-tate)
Brand Name: Femtrace
Estrogens have been reported to increase the chance of womb (endometrial) cancer in women who have been through menopause, especially in women with a uterus who receive estrogen-only hormone therapy. Estrogens may also increase the risk of cancer of the ovary or breast. Estrogen-containing products should not be used to prevent heart disease. Estrogen given with another hormone (progestin) for replacement therapy can infrequently cause heart disease (eg, heart attacks), stroke, serious blood clots in the legs or lungs (pulmonary embolism/deep vein thrombosis), dementia, and cancer of the breast. These risks appear to depend on the length of time Femtrace is used and the amount of estrogen per dose. Therefore, Femtrace should be used for the shortest possible length of time at the lowest effective dose so that you obtain the benefits and minimize the chance of serious side effects from long-term treatment. Consult your doctor or pharmacist for details. If using Femtrace for an extended period, you should be evaluated at least once a year. Femtrace is not effective in preventing or treating a tendency toward miscarriage, nor the threat of miscarriage. Femtrace should not be used during pregnancy because its use may result in birth defects or cancer later in the child's life.
Femtrace is used for:
Treating moderate to severe vasomotor symptoms (eg, hot flashes) associated with menopause.
Femtrace is an estrogen hormone. It works by replacing natural estrogens in women who no longer produce enough estrogen on their own.
Do NOT use Femtrace if:
- you are allergic to any ingredient in Femtrace
- you are pregnant or suspect you may be pregnant, have recently given birth or are breast-feeding, or have vaginal bleeding of abnormal or unknown cause
- you have known or suspected breast cancer (unless directed by your doctor), a history of breast cancer, or you have cancers that are estrogen-dependent
- you have a history of blood clots in the legs or lungs (eg, deep vein thrombosis, pulmonary embolism), liver problems, or the blood disease porphyria
- you have had a stroke or heart attack in the past year
Contact your doctor or health care provider right away if any of these apply to you.
Before using Femtrace:
Some medical conditions may interact with Femtrace. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a family history of breast cancer, or you have breast lumps or disease or an abnormal mammogram
- if you have yellowing of the whites of the eyes or skin during pregnancy or with past estrogen use, or high blood pressure during pregnancy (toxemia)
- if you have a vaginal infection or womb problems (eg, uterine fibroids/endometriosis, abnormal vaginal bleeding, other uterine problems)
- if you have a history of eye or vision problems, abnormal calcium levels in the blood, asthma, cancer, cholesterol or lipid problems, depression, diabetes, epilepsy, excessive weight gain, gallbladder disease, heart disease or other heart problems, high blood pressure, kidney or liver disease, low thyroid hormone levels, lupus, migraine headaches, pancreas disease, seizures, or yellowing of the skin or eyes
- if you smoke or will be having surgery
Some MEDICINES MAY INTERACT with Femtrace. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Hydantoins (eg, phenytoin), barbiturates (eg, phenobarbital), or rifampin because they may decrease Femtrace's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if Femtrace may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Femtrace:
Use Femtrace as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Femtrace. Talk to your pharmacist if you have questions about this information.
- Take Femtrace by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Grapefruit and grapefruit juice may increase the risk of Femtrace's side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking Femtrace.
- If you miss a dose of Femtrace, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Femtrace.
Important safety information:
- Femtrace may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Femtrace with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Limit alcoholic beverages while you are taking Femtrace.
- Femtrace may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.
- Femtrace may increase the risk of blood clots. The risk may be greater if you smoke (especially in women older than 35 years of age).
- Contact your health care provider if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention.
- Contact your health care provider if vaginal discomfort occurs or if you suspect you have developed an infection while taking Femtrace.
- Follow your doctor's instructions for examining your breasts, and report any lumps immediately.
- If you wear contact lenses and you develop problems with them, contact your doctor.
- If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking Femtrace.
- Nonprescription therapy to help prevent bone loss includes a weight-bearing exercise plan, as well as adequate daily calcium and vitamin D intake. Consult your doctor or pharmacist for more details.
- Diabetes patients - Femtrace may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Lab tests, including physical exams and blood pressure, may be performed while you use Femtrace. You should have breast and pelvic exams, and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. Be sure to keep all doctor and lab appointments.
- Femtrace may interfere with certain lab tests, including blood clotting tests, thyroid function tests, blood cholesterol tests, glucose tolerance, and the metyrapone test. Be sure your doctor and lab personnel know you are taking Femtrace.
- Femtrace should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use Femtrace if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Femtrace may be found in breast milk. If you are or will be breast-feeding while you use Femtrace, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Femtrace:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Abnormal hair growth; breast tenderness; changes in sex drive; cramps; dizziness; flushing; hair loss; headache; lightheadedness; nausea; stomach bloating and upset; swelling.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; breast lumps; changes in vaginal bleeding (eg, spotting, breakthrough bleeding, prolonged bleeding); changes in speech; coughing of blood; mental/mood changes (eg, severe depression, memory loss); migraine headache; pain in calves or chest; pain, swelling, or tenderness in the stomach; severe headache or vomiting; sudden shortness of breath; swelling of hands or feet; unusual vaginal discharge, itching, or odor; vision changes (eg, double vision, changes in contact lens fit, loss of vision); weakness or numbness of an arm or leg; weight changes; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include excessive vaginal bleeding; severe nausea; vomiting.Proper storage of Femtrace:
Store Femtrace at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Femtrace out of the reach of children and away from pets.
- If you have any questions about Femtrace, please talk with your doctor, pharmacist, or other health care provider.
- Femtrace is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Femtrace or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Femtrace. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Femtrace. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Femtrace.