GENERIC NAME: ESTROGENS CREAM - VAGINAL (ESS-trow-jens)
WARNING: Estrogens given alone and with another hormone (progestin) for replacement therapy after menopause have sometimes caused rare but very serious side effects. Discuss the risks and benefits of hormone treatment and your personal health history with your doctor.
Estrogens have been reported to increase the chance of cancer of the uterus (endometrial cancer). Taking a progestin with estrogen decreases this risk. Tell your doctor immediately if you have any unusual vaginal bleeding.
Estrogens may also increase your risk of cancer of the ovaries, stroke, dementia, and serious blood clots in the legs. Estrogen given in combination with progestin 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. Some of 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 can obtain the benefits and reduce the chance of serious side effects from long-term treatment. Also, the risks are greater with estrogen products taken by mouth, absorbed through the skin, or injected because more estrogen gets into the blood. Therefore, if you need treatment only for vaginal menopause symptoms, products applied directly inside the vagina are preferred and should be considered first. Discuss the details with your doctor and check with him/her regularly (e.g., every 3 to 6 months) to see if you still need to use this medication.
Estrogen treatment alone does not appear to increase your risk of breast cancer when used for up to 7 years after menopause. However, talk to your doctor about the risks if you need to take estrogen for a longer period.
If you use this drug for an extended period, you should have a complete physical exam at regular intervals (e.g., once a year) or as directed by your doctor. See Notes section.
USES: This medication contains female estrogen hormones and is usually given to women who no longer produce the amount of estrogen they produced before menopause. It is a very effective treatment for reducing vaginal menopause symptoms (e.g., dryness, burning, itching).
HOW TO USE: Use this medication as prescribed. Follow the instructions and dosing schedule carefully.Fill the applicator with the medication according to directions. Insert the applicator high into the vagina and press the plunger to release the medication. Clean the applicator with warm soapy water and rinse well. Do not boil or use hot water to clean the applicator.Read the Patient Information Leaflet available from your pharmacist. Consult your doctor or pharmacist if you have any questions.Inform your doctor if your symptoms persist or worsen.
SIDE EFFECTS: Vaginal irritation, dizziness, light-headedness, 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 or pharmacist promptly.Remember that your doctor has prescribed this medication because he or 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 immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., severe depression, memory loss), vision changes (e.g., change in contact lens fit, loss of vision), swelling of hands or feet, breast lumps, unusual vaginal bleeding (e.g., spotting, breakthrough bleeding, prolonged/recurrent bleeding), unusual vaginal discharge/itching/odor, yellowing eyes or skin.Seek immediate medical attention if any of these unlikely but very serious side effects occur: calf pain/swelling, sudden severe headache, chest pain, trouble breathing, weakness on one side of the body, slurred speech.A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), 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.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.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, certain cancers (e.g., breast cancer, especially non-metastatic type), current/history of blood clots, history of stroke or heart attack.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, liver disease, heart disease (e.g., high blood pressure, congestive heart failure), kidney disease, low thyroid hormone (hypothyroidism), a certain hormone problem (hypoparathyroidism), abnormal calcium level in the blood, depression, high blood pressure during pregnancy (toxemia), yellowing eyes or skin (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).If you will be having surgery or will be confined to a chair or bed for a long period of time (such as on a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are using this drug.This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. 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 using this medication (especially in women over the age of 35).This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately.It is unknown if this drug passes into breast milk. Estrogens may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this medication is not recommended.
DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: other vaginal products.This product can affect the results of certain lab tests. Make sure laboratory personnel and your doctors know you use this drug.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. This medicine may be harmful if swallowed. Symptoms of overdose may include: severe nausea/vomiting or excessive vaginal bleeding.
NOTES: Do not share this medication with others. Keep all medical and laboratory appointments. You should have a complete physical examination that includes blood pressure measurements and breast/pelvic examinations at regular intervals (e.g., once a year) or as directed by your doctor. Follow your doctor's instructions on how to examine your own breasts and report any lumps immediately. You should also be regularly screened for cervical cancer (e.g., Pap test) and have periodic mammograms as determined by your doctor. Consult your doctor for more details.To help manage hot flashes, keep a cool body temperature (e.g., use a fan, drink cool beverages, dress lightly/in layers, avoid hot/spicy foods). Limiting caffeine and alcohol, exercising regularly, and learning relaxation techniques may also help reduce hot flashes. Vaginal lubricants can help lessen discomfort during intercourse.
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 below 86 degrees F (30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines 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 for more details about how to safely discard your product.
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