estradiol tablet – vaginal, Vagifem
WARNING: Estrogens, used alone or with another hormone (progestin), have rarely caused serious side effects. Discuss risks and benefits of hormone treatment with your doctor. Estrogens should not be used to prevent heart disease or dementia. Estrogens can increase the risk of cancer of the uterus. Taking a progestin can help decrease this risk. Tell your doctor right away if you have unusual vaginal bleeding. Estrogens can increase the risk of cancer of the ovaries, stroke, dementia, and serious blood clots in the legs. Estrogens alone do not appear to increase the risk of breast cancer when used for up to 7 years. Estrogen, when used with a progestin, can increase the risk of heart disease, stroke, serious blood clots, dementia, and cancer. This medication should be used at the lowest effective dose and for the shortest amount of time. Discuss the use of this medication with your doctor and check with him/her regularly to see if you still need to take it. If you will be taking this medication long-term, you should have regular exams as directed by your doctor. See also Notes section.
USES: This medication is a female hormone (estrogen). It is used by women to help reduce vaginal symptoms of menopause (such as dryness/burning/itching). These symptoms are caused by the body making less estrogen. When treating only vaginal symptoms of menopause, products applied directly inside the vagina (such as this medication) should be used first. Estrogens taken by mouth, absorbed through the skin, or injected may have greater risks of side effects.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Use this medication as directed by your doctor, usually once daily for the first 2 weeks, and then 2 times a week thereafter. The applicator comes packaged with the tablet inside. If the tablet falls out before using, throw it away and use a new applicator/tablet. Gently insert the applicator into the vagina as directed and press the plunger to release the medication. Throw away the applicator after use. The dosage is based on your medical condition and response to treatment. Use this medication regularly to get the most benefit from it. Follow your dosing schedule carefully. Tell your doctor if your condition does not improve or worsens.
SIDE EFFECTS: Nausea/vomiting, bloating, diarrhea, breast tenderness, headache, or weight changes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he/she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including mental/mood changes, breast lumps, unusual vaginal bleeding, increased or new vaginal irritation/itching/odor/discharge, severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine, swelling hands/ankles/feet. This medication may rarely cause serious problems from blood clots. Get medical help right away if you have any serious side effects, including chest/jaw/left arm pain, unusual sweating, sudden/severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes, pain/redness/swelling of legs, tingling/weakness/numbness in the arms/legs, trouble breathing, coughing up blood, sudden dizziness/fainting. A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including rash, itching/swelling, severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS: Before using estradiol, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of vaginal bleeding of unknown cause, certain cancers, blood clots, stroke, heart disease, liver/kidney disease, family medical history, blood clotting disorders, high blood pressure, diabetes, high cholesterol/triglyceride levels, obesity, lupus, underactive thyroid, mineral imbalance, hormone problem, uterus problems, gallbladder disease, asthma, seizures, migraine headaches, mental/mood disorders, blood disorder. Do not smoke or use tobacco. Estrogens combined with smoking further increase the risk of stroke, blood clots, high blood pressure, and heart attack, especially in women older than 35. Tell your doctor if you just had or will be having surgery, or if you will be confined to a chair or bed for a long time. These conditions increase your risk of getting blood clots. This drug may cause dark areas of the skin on the face. Sunlight may worsen this effect. Avoid prolonged sun exposure. Use a sunscreen and wear protective clothing when outdoors. If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur. This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. This medication passes into breast milk. It may reduce the quality and amount of breast milk produced. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. Keep a list of all the products you use and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval. Some products that may interact with this drug include aromatase inhibitors, fulvestrant, ospemifene, raloxifene, tamoxifen, toremifene. This medication may interfere with certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. Symptoms of overdose may include severe nausea/vomiting, unusual vaginal bleeding.
NOTES: Do not share this medication with others. Keep all regular medical and laboratory appointments. You should have regular complete physical exams which include laboratory and medical tests to monitor your progress and check for side effects. Follow your doctor’s instructions for examining your own breasts, and report any lumps right away. Consult your doctor for more details. Preventing or controlling high blood pressure, high cholesterol, and diabetes can help to reduce your chances of heart disease and stroke. Lifestyle changes that can help to control or prevent these diseases include reducing stress, eating a low fat/salt diet, losing weight if overweight, exercising regularly, and stopping smoking. Keep your mind active with mental exercises to help prevent dementia. Talk to your doctor about lifestyle changes that might benefit you.
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 away from light and moisture. Do not refrigerate. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.
CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
