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Drug Information For:
EVAMIST 1.53MG TOPICAL SP/56 SPRAYS
Ingredient Name:ESTRADIOL (es-tra-DYE-ol)
Drug Manufacturer:THER RX
Common Uses:This medicine is an estrogen hormone used to provide relief of moderate to severe menopausal symptoms such as hot flashes.
Before Using This Medicine:THIS MEDICINE SHOULD NOT BE USED TO PREVENT HEART DISEASE, HEART ATTACKS, STROKES, OR DEMENTIA. Estrogens may increase the risk of heart disease (including heart attack), stroke, dementia, serious blood clots (such as in the lungs or legs), cancer of the uterus, and breast cancer in some women. Tell your doctor right away if you have unusual vaginal bleeding while you use this medicine. Talk with your doctor if you have questions about the benefits and risks of using this medicine. THIS MEDICINE SHOULD BE USED FOR THE SHORTEST POSSIBLE TIME AT THE LOWEST EFFECTIVE DOSE TO MINIMIZE THE RISK OF THESE SIDE EFFECTS. Talk with your doctor regularly about your need to use this medicine. FOLLOW THE DIRECTIONS FOR USE VERY CAREFULLY. Do not allow others, especially CHILDREN, to come into contact with the area of your skin where this medicine has been applied. Young children who accidentally come into contact with this medicine may show unexpected signs of puberty (eg, breast budding in girls, breast enlargement in boys). If a child with whom you are in close contact unexpectedly starts to develop breasts or has other sexual changes, contact your doctor. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are also taking azole antifungals (eg, ketoconazole or itraconazole), barbiturates (eg, phenobarbital), carbamazepine, HIV protease inhibitors (eg, ritonavir), hydantoins (eg, phenytoin), macrolide antibiotics (eg, clarithromycin or erythromycin), rifampin, St. John's wort, or thyroid hormones (eg, levothyroxine). DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions including dementia or other memory problems, allergies, pregnancy, or breast-feeding. TELL YOUR DOCTOR if you have a history of uterus problems (eg, endometriosis, growths in the uterus, or uterine fibroids), abnormal mammogram, abnormal vaginal bleeding, a lump in the breast, fibrocystic breast disease, asthma, cancer, high blood cholesterol or lipid levels, high or low blood calcium levels, diabetes, heart problems, high blood pressure, heart attack, stroke, kidney problems, liver tumors, mental or mood problems (eg, depression), thyroid problems, migraine headaches, gallbladder or pancreas problems, seizures, lupus, chorea, the blood disease porphyria, a problem called hereditary angioedema, or yellowing of the eyes or skin during pregnancy or with past estrogen use. TELL YOUR DOCTOR if a member of your family has a history of blood clots (eg, in the lung, leg, eye), breast cancer, diabetes, lupus, or has been very overweight. TELL YOUR DOCTOR if you smoke, use tobacco, are very overweight, will be having surgery, or have hadyour uterus removed (hysterectomy). USE OF THIS MEDICINE IS NOT RECOMMENDED if you have undiagnosed abnormal vaginal bleeding; blood clots in the lungs, legs, or eyes; a history of blood clots; bleeding problems; a condition that may increase your risk of blood clots; known or suspected breast cancer or other estrogen-dependent cancer; a history of breast cancer; or a history of liver problems or liver disease. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are pregnant, suspect you may be pregnant, or if you have had a heart attack or stroke. Use of this medicine in CHILDREN is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
How to Use This Medicine:Follow the directions for using this medicine provided by your doctor. AN ADDITIONAL PATIENT INFORMATION LEAFLET is available with this medicine. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. YOU MUST PRIME THE PUMP before using it for the first time. To prime the pump, leave the cover on, hold the bottle in an upright position, and press the pump completely down 3 times. The pump is now ready for use. THIS MEDICINE IS APPLIED TO THE INSIDE OF THE FOREARM, between the elbow and wrist. Do not apply this medicine to any other area of the body besides the forearm. If you get this medicine on another area of your skin, wash that area of your skin with soap and water right away. APPLY THIS MEDICINE to clean, intact skin only. Be sure the area is completely dry before applying this medicine. DO NOT APPLY THIS MEDICINE to skin that is irritated or broken, to your face, to your breasts, or in or around the vagina. TO USE A DOSE OF THIS MEDICINE, hold the applicator upright and rest the plastic cone flat against the skin of your forearm. Be sure there are no gaps between the cone and your skin. Press the pump firmly and fully one time. Do NOT massage or rub the medicine in. If you are applying more than one spray, move the cone to an area of the skin next to but not touching the previous area. Then press the pump firmly and fully again. Replace the protective cover over the pump after use. Allow the area to dry for at least 2 minutes before dressing. WASH YOUR HANDS with soap and water immediately after using this medicine. Do not wash the application site for at least 1 hour after you apply this medicine. DO NOT ALLOW OTHER PEOPLE TO APPLY THIS MEDICINE FOR YOU. Do not allow other people or pets to come into contact with the site where you applied this medicine. If someone else comes into contact with this medicine, have them wash the area with soap and water right away. THIS MEDICINE IS FLAMMABLE. Avoid fire, flame, or smoking until the medicine has dried on your skin. THIS PUMP CONTAINS ENOUGH MEDICINE for 56 sprays (not counting the 3 sprays used to prime the pump). Throw away the pump after 56 sprays have been used, even if there is still medicine left in the pump. It may no longer give the correct amount of medicine with each dose. EATING GRAPEFRUIT or drinking grapefruit juice while you are using this medicine may increase the amount of this medicine in your blood, which may increase your risk for serious side effects. Talk with your doctor before including grapefruit or grapefruit juice in your diet. STORE THIS MEDICINE at room temperature between 68 and 77 degrees F (20 and 25 degrees C), away from heat and light. Do not freeze. Do not use this medicine after the expiration date on the container. Use this medicine at the same time each day. KEEP THIS MEDICINE out of the reach of children and away from pets. IF YOU MISS A DOSE OFTHIS MEDICINE, use it as soon as possible. If your next dose is less than 12 hours away, skip the missed dose and go back to your regular dosing schedule. DO NOT use 2 doses at once.
Cautions:DO NOT USE THIS MEDICINE if you have had an allergic reaction to it or are allergic to any ingredient in this product. DO NOT TAKE THIS MEDICINE if you have had a severe reaction (eg, swelling of the hands, face, lips, eyes, throat, or tongue; trouble swallowing or breathing; hoarseness) after taking this medicine. Laboratory and/or medical tests may be performed to monitor your progress or to check for side effects. You should have breast and pelvic exams, and a Pap test at least once a year. You should have periodic mammograms as determined by your doctor. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS. YOU SHOULD PERFORM monthly self-breast exams and receive yearly breast exams from your doctor while you are using this medicine. Report any lumps to your doctor immediately. Talk with your doctor if you are unsure how to properly perform a self-breast exam. TALK WITH YOUR DOCTOR REGULARLY (eg, every 3 to 6 months) about whether you need to continue taking this medicine. THIS MEDICINE MAY AFFECT CERTAIN LAB TEST RESULTS. Make sure your doctors and laboratory personnel know you are using this medicine. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using this medicine. TELL YOUR DOCTOR if you will be confined to a chair or bed for a long period of time (eg, a long plane ride, bedrest, or having surgery). You may need to stop this medicine 4 to 6 weeks beforehand. Talk to your doctor about the safe use of this medicine if any of these conditions apply to you. This medicine may cause dizziness. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. AVOID GETTING THIS MEDICINE IN YOUR EYES, nose, mouth, or vagina. IF you get it in any of these areas, rinse right away with warm clear water. THIS MEDICINE MAY CAUSE dark skin patches on your face (melasma). Exposure to the sun may make these patches darker. If patches develop, consult your doctor about the use of sunscreen or protective clothing when exposed to the sun, sunlamps, or tanning booths. CHECK WITH YOUR DOCTOR BEFORE you apply sunscreen to the application site while you are using this medicine. IF YOU WEAR CONTACT LENSES and you develop problems with them or with your vision, contact your doctor as soon as possible. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN THE ELDERLY because they may be more sensitive to the effects of the medicine. FOR WOMEN: DO NOT USE THIS MEDICINE if you are pregnant. IF YOU SUSPECT THAT YOU COULD BE PREGNANT, contact your doctor immediately. THIS MEDICINE IS EXCRETED in breast milk. DO NOTBREAST-FEED while using this medicine. IF YOU HAVE DIABETES, this medicine may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
Possible Side Effects:SIDE EFFECTS that may occur while using this medicine include breast pain or tenderness, breakthrough bleeding or spotting, mild fluid retention, hair loss, headache, mild nausea or vomiting, or stomach cramps or bloating. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience abnormal vaginal bleeding; breast lumps or pain; bulging eyes; calf pain, swelling, or tenderness; chest pain; coughing up blood; fainting; mental or mood changes (eg, depression); migraine headache; new or worsening memory problems; pelvic pain; severe or persistent dizziness or headache; severe or persistent stomach or back pain (with or without nausea or vomiting); shortness of breath; swelling of the hands or feet; symptoms of heart attack (eg, chest, jaw, or arm pain; sudden severe nausea or vomiting; shortness of breath; sudden unusual sweating); symptoms of liver problems (eg, dark urine, pale stools, yellowing of the skin or eyes); symptoms of stroke (eg, one-sided weakness, slurred speech, confusion); unusual vaginal discharge/itching/odor; vision loss or other vision changes; or vomiting. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty swallowing or breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; or unusual hoarseness. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Overdose:If overdose is suspected, contact your local poison control center or emergency room immediately.
Additional Information:DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.
Copyright 2014 Wolters Kluwer Health, Inc.