IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

ESTRADIOL/ETHINYL ESTRADIOL - ORAL

(ess-truh-DYE-all/ETH-ih-nill ess-truh-DYE-all)

COMMON BRAND NAME(S): Estinyl, Estrace, Gynodiol

WARNING: 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 in combination with another hormone (progestin) for replacement therapy can infrequently cause heart disease (e.g., heart attacks), stroke, serious blood clots (pulmonary embolism and deep venous thrombosis), dementia, and cancer of the breast. These risks appear to depend on the length of time this drug is used and the amount of estrogen per dose. Therefore, this medication should be used for the shortest possible length of time at the lowest effective dose, so you obtain the benefits and minimize the chance of serious side effects from long-term treatment. Consult your doctor or pharmacist for details. If you use this drug for an extended period, you should be evaluated at least once a year. See Notes section. This medication is not effective in preventing or treating a tendency toward miscarriages (natural habitual abortion) nor the threat of miscarriage. This drug must not be used during pregnancy because its use may result in birth defects or cancer later in the child's life. See Precautions section.

USES: This medication is a female hormone and is usually given to women who no longer produce the proper amount. It is used to reduce menopause symptoms (e.g., hot flashes, vaginal dryness), to prevent bone loss (osteoporosis) in people at high risk, to treat certain cancers in men and women (e.g., certain types of metastatic breast cancer), and to treat other conditions as determined by your doctor. If you are only being treated for vaginal menopause symptoms, products applied locally such as vaginal creams, tablets, or rings should be considered before products taken by mouth or absorbed through the skin. There are several medications (e.g., raloxifene or bisphosphonates) that are safe and effective to prevent or treat bone loss. These medicines should be considered for use before estrogen therapy. If you have other medical conditions as well, and are prescribed estrogens for more than one condition, consult your doctor about your treatment plan and its options.

HOW TO USE: Take this medication by mouth as directed by your doctor. It may be taken with food or immediately after a meal to prevent stomach upset. The dosage is based on your medical condition and response to therapy. Follow the dosing schedule carefully. Read the Patient Information Leaflet available from your pharmacist. Consult your doctor or pharmacist if you have any questions.

SIDE EFFECTS: Dizziness, lightheadedness, headache, stomach upset, bloating, nausea, weight changes, increased/decreased interest in sex, and breast tenderness may occur. If any of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., severe depression, memory loss), calf pain/swelling, sudden severe headache, chest pain, trouble breathing, one-sided weakness, slurred speech, vision changes (e.g., change in contact lens fit, loss of vision), breast lumps, swelling of hands or feet, changes in vaginal bleeding (e.g., spotting, breakthrough bleeding or prolonged bleeding), unusual vaginal discharge/itching/odor, yellowing of the eyes or skin. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: undiagnosed abnormal vaginal bleeding, cancer (e.g., breast cancer - also see USES section), blood clots, active/recent stroke or heart attack, liver disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: family medical history (especially breast lumps and cancer), asthma, diabetes, seizures, migraine headaches, heart disease (high blood pressure, heart attacks, congestive heart failure), kidney disease, low thyroid hormone (hypothyroidism), abnormal calcium level in the blood, depression, high blood pressure during pregnancy (toxemia), yellowing of skin and eyes (cholestatic jaundice) during pregnancy or with past estrogen use, womb problems (e.g., uterine fibroids endometriosis), cholesterol or lipid problems, gallbladder disease, excessive weight gain, certain blood disorder (porphyria), any allergies - especially to tartrazine (a yellow dye) or aspirin. If you will be having surgery or will be confined to a chair or bed for a long period of time (e.g., a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking this drug. This drug may make you dizzy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. This drug may cause a patchy darkening of the skin on the face (melasma). Sunlight may intensify this darkening and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding use of sunscreens and protective clothing. Cigarette smoking can increase the chance of blood clots while taking this medication (especially in women over the age of 35). If this medicine is used in children, their growth pattern should be monitored as this drug might stunt their growth. This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. This medication may pass into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this medication is not recommended.

DRUG INTERACTIONS: Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: corticosteroids (e.g., prednisone), hydantoins (e.g., phenytoin), warfarin. Also tell your doctor or pharmacist if you are taking any medications which affect certain liver enzymes (CYP450-3A4 enzymes), such as: azole antifungals (e.g., ketoconazole, itraconazole), carbamazepine, cimetidine, macrolide antibiotics (e.g., clarithromycin, erythromycin), phenobarbital, rifamycins (e.g., rifampin), ritonavir, St. John's wort. This product can affect the results of certain lab tests. Make sure laboratory personnel and your doctors know you use this drug. Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include: severe nausea/vomiting or excessive vaginal bleeding.

NOTES: Do not share this medication with others. Keep all appointments with your doctor and the laboratory. You should have a complete physical examination, including blood pressure measurements, breast and pelvic examination, and a PAP test (for vaginal cancer), at least once a year. You should also have periodic mammograms as determined by your doctor. Follow your doctor's instructions for examining your own breasts, and report any lumps immediately. Non-drug therapy to help prevent bone loss includes a weight-bearing exercise plan, adequate daily calcium and vitamin D. Consult your doctor or pharmacist for more details.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59 and 86 degrees F (15 and 30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Developed by First DataBank, Inc., San Bruno, CA
Copyright 2004 by First DataBank, Inc.