About Esclim:

Common uses: This medicine 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, 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 medicines (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.

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Additional Information:

Chemical Name: ESTRADIOL (es-tra-DYE-ol)

Mexican name is Evorel

Before using: 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/breast. Estrogen-containing medicines 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, dementia, and cancer of the breast. These risks appear to depend on the length of time this medicine is used and the amount of estrogen per dose. Therefore, this medicine 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 medicine for an extended period, you should be evaluated at least once yearly (see CAUTIONS section). This medicine is not effective in preventing/treating a tendency toward miscarriages nor the threat of miscarriage. This medicine must not be used during pregnancy because its use may result in birth defects or cancer later in the child's life (see CAUTIONS section). 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 taking corticosteroids (e.g., prednisone), hydantoins (e.g., phenytoin), or warfarin. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking any medicines which may affect certain liver enyzymes (CYP450-3A4 enzymes) including azole antifungals (e.g., ketoconazole, itraconazole), carbamazepine, cimetidine, macrolide antibiotics (e.g., clarithromycin, erythromycin), phenobarbital, rifamycins (e.g., rifampin), ritonavir, or St. John's wort. DO NOT START OR STOP ANY MEDICINE without doctor or pharmacist approval. Inform your doctor of any other medical conditions including a family medical history (e.g., especially breast lumps/cancer), asthma, diabetes, seizures, migraine headaches, kidney disease, heart disease (e.g., high blood pressure, heart attacks, congestive heart failure), low thyroid hormone (hypothyroidism), abnormal calcium level in the blood, depression, high blood pressure during pregnancy, yellowing of eyes/skin during pregnancy or with past estrogen use, womb problems (e.g., uterine fibroids/endometriosis), cholesterol/lipid problems, gallbladder disease, excessive weight gain, certain blood disorder (porphyria), allergies, pregnancy, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have certain medical conditions including undiagnosed abnormal vaginal bleeding, certain cancers (e.g., breast cancer, especially non-metastatic type), blood clots, liver disease, or active/recent stroke or heart attack. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.

Directions: Follow the directions for using this medicine provided by your doctor. This medicine may come with a patient leaflet. Ask your doctor, nurse, or pharmacist any questions you may have about this medicine. The patch is usually replaced twice a week (about every 3 to 4 days), or as directed by your doctor. Follow the dosing schedule carefully. Do not open the sealed pouch containing the patch until ready to use. Open the pouch and remove the patch from the protective liner. Apply the patch to a clean, dry, hairless area on the trunk (torso) or hips, usually on the stomach or the buttocks, but not on the arms or legs. Do not apply to a site that is exposed to sunlight. Press the patch firmly against the skin for about 10 seconds to be sure the patch stays on. Do not place the patch on the breast. Avoid applying to the waistline since tight clothing may rub the patch off. Do not put the patch on areas where sitting may loosen it. When it is time to change the patch, remove it and dispose of properly. Apply a new patch to a different area to prevent skin irritation. It is best to rotate the areas where the patch is applied, allowing at least 1 week in between applications to the same site. If the area around the patch becomes red, itchy, or irritated, try a new site. If the irritation continues or becomes worse, notify your doctor promptly. STORE THIS MEDICINE at room temperature according to the package instructions, in the original sealed pouch, away from heat, moisture, and light. IF YOU MISS A DOSE OF THIS MEDICINE, use it as soon as possible. If a patch falls off, reapply it or apply a new patch and wear it for the rest of the scheduled period, then resume your usual dosing schedule. Do NOT use 2 doses at once.

Cautions: KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using this medicine. You should have a complete physical examination, including blood pressure measurements, breast and pelvic examinations, 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. THIS MEDICINE MAY ALTER CERTAIN LAB RESULTS. Make sure laboratory personnel and your doctors know that you are using this medicine. 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 medicine. 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. LIMIT ALCOHOLIC BEVERAGES while using this medicine. THIS MEDICINE 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 medicine (especially in women over the age of 35). 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 CHILDREN as it might stunt their growth. If used in children, their growth pattern should be monitored. FOR WOMEN: THIS MEDICINE HAS BEEN SHOWN TO CAUSE HARM to the human fetus. DO NOT USE THIS MEDICINE if you are pregnant. IF YOU SUSPECT THAT YOU COULD BE PREGNANT, contact your doctor immediately. IT IS UNKNOWN IF THIS MEDICINE IS EXCRETED in breast milk. IF YOU ARE OR WILL BE BREAST-FEEDING while taking this medicine, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects: SIDE EFFECTS, that may go away during treatment, include dizziness, lightheadedness, headache, stomach upset, bloating, nausea, weight changes, increased/decreased interest in sex, breast tenderness, or skin redness/irritation at the application site. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience 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/feet, changes in vaginal bleeding (e.g., spotting, breakthrough bleeding, or prolonged bleeding), unusual vaginal discharge/itching/odor, or yellowing of the eyes/skin. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, severe dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

Drug interactions: Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your medicines interact with each other. Check drug interactions

If you take too much: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include severe nausea and vomiting and excessive vaginal bleeding.

Additional information: Non-drug therapy to help prevent bone loss includes a weight-bearing exercise plan and adequate daily intake of calcium and vitamin D. Consult your doctor or pharmacist for more details. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children and pets. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.

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Dosage and amounts subject to availability:
.25 mg 8 patches
.50 mg 8 patches

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FDA Warns on Black-Market IUDs : WASHINGTON -- Many intrauterine devices (IUDs) sold over the Internet from foreign pharmacies are not approved in the U.S. and are possibly dangerous, the FDA said. The agency said an investigation disclosed that patients in Rhode Island, Massachusetts, and Kentucky had received unapproved IUDs from healthcare providers who had bought them from foreign pharmacies, presumably to save money. In a "Dear Colleague" letter to providers, the FDA said it had uncovered distribution of "unapproved versions of FDA-approved products such as Mirena, Implanon, Copper-T, and ParaGard; as well as products not approved for use in the U.S., such as T-Safe." These products may not be as effective or safe as FDA-approved IUDs, the agency warned. Women who believe they may have received an unapproved IUD should use another contraceptive method and talk to their healthcare providers, the FDA recommended. The FDA also advised physicians to use extra caution when asked to insert IUDs provided by patients. Healthcare providers should verify that products are authentic FDA-approved devices and were purchased from a licensed U.S.-based supplier. The agency also noted that billing Medicaid or private insurers for unapproved medical products could bring criminal fraud charges. "To reduce the chance of receiving an unapproved or adulterated medical product, your Internet purchases should be made from state-licensed distributors or pharmacies located in the U.S.," the FDA said. It recommended buying only from Internet pharmacies displaying a logo from the National Association of Boards of Pharmacy, known as the VIPPS seal for Verified Internet Pharmacy Practice Sites. "Healthcare providers should be aware that purchasing medical products from websites that are outside of the U.S. may be illegal and may increase the risk of receiving a potentially harmful product, since many websites sell products that are not FDA approved and could be manufactured in other countries." The FDA first became aware of the problem in Rhode Island, but its probe turned up unapproved products in the two other states. The investigation is continuing, the agency said.

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