estradiol-levonorgestrel

This medication is given to women who no longer produce the amount of female hormone (estrogen) they produced before menopause. It is a very effective treatment for reducing episodes of flushing and sweating of the upper body and face, commonly called hot flashes. This medication is a combination of 2 female hormones: an estrogen (estradiol) and a progestin (levonorgestrel). A progestin is added to estrogen replacement therapy to reduce the risk of cancer of the uterus. A woman who has had her uterus removed does not need progestin and should not be treated with this combination medication. If you need treatment only for vaginal menopause symptoms (e.g., vaginal dryness), products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected. This medication may also be used to prevent bone loss (osteoporosis) in people at high risk who cannot take non-estrogen drugs. There are several other medications (e.g., raloxifene, bisphosphonates such as alendronate) that are safe and effective to prevent or treat bone loss. These medicines should be considered for use before estrogen treatment.

If you miss a dose, use it as soon as you remember. If a patch falls off, reapply the old patch to another area on the lower abdomen. If the old patch will not stick completely, discard it. Apply a new patch and wear it for the rest of the 7-day period, then resume your usual dosing schedule. Do not double the dose to catch up.

Read the Patient Information Leaflet available from your pharmacist. Consult your doctor or pharmacist if you have any questions. One patch is usually worn for 1 week and then replaced, or use as directed by your doctor. Follow the dosing schedule carefully. Do not open the sealed pouch container until ready to use. Open the pouch and remove the patch from the protective liner. Apply the patch to a clean, dry area on the lower stomach below your belly button and press firmly for about 10 seconds to make sure the patch stays on. Do not place the patch on the breast or on oily, red, or damaged skin. 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. After 1 week, remove the patch, fold it in half with the sticky sides together and discard in the trash away from children and pets. Do not it flush down the toilet. Apply a new patch to a different area to prevent skin irritation. 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. If a patch falls off, reapply it or apply a new patch and wear it for the rest of the 7-day period.

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/herbal products you may use, especially of: corticosteroids (e.g., prednisone), anti-seizure drugs (e.g., carbamazepine, phenobarbital, phenytoin), warfarin. 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), cimetidine, macrolide antibiotics (e.g., clarithromycin, erythromycin), rifamycins (e.g., rifampin), HIV protease inhibitors (e.g., ritonavir, amprenavir), 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. 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.

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. Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. Since you may also need to take calcium and vitamin D supplements and make lifestyle changes, consult your doctor for specific advice. Additional lifestyle changes (e.g., reducing stress, eating a low fat/low salt diet, losing weight if you are overweight) to control or prevent high blood pressure, high cholesterol, and diabetes help to prevent heart disease and strokes. Keep your mind active with mental exercises to help prevent dementia. Discuss with your doctor lifestyle changes that might benefit you. You can also manage hot flashes by keeping a cool body temperature (e.g., using a fan, drinking cool beverages, dressing lightly/in layers, avoiding hot/spicy foods). Limiting caffeine and alcohol, exercising regularly, and learning relaxation techniques may help reduce hot flashes. Vaginal lubricants can help lessen discomfort during intercourse.

If overdose is suspected, remove the patch. 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. Symptoms of overdose may include: severe nausea/vomiting or excessive vaginal bleeding.

Before using estradiol/levonorgestrel, 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. 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, hysterectomy (uterus removed), 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 (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, being overweight (obesity), certain blood disorders (porphyria), lupus. 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. If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Consult your eye doctor if these problems occur. 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 the 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). Bathing, swimming, or showering may loosen the patch. After any of these activities always check that the patch is securely in place. If this medicine is used in children, their growth pattern should be monitored because it may stunt 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 is not effective for preventing a miscarriage and should not be used for this purpose. This medication may pass into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Store the sealed pouches 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 (See How to Use section).

Dizziness, light-headedness, headache, stomach upset, bloating, nausea, weight changes, increased/decreased interest in sex, breast tenderness, or skin redness/irritation at the application site may occur. If any of these 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., depression, memory loss), breast lumps, nipple discharge, swelling of the hands/feet, painful menstrual periods, unusual vaginal bleeding (e.g., spotting, breakthrough bleeding, prolonged/returning bleeding), yellowing eyes/skin, stomach/abdominal pain, worsening of seizures, signs of worsening diabetes control (e.g., increased thirst and urination). This medication may rarely cause very serious problems such as heart attacks, stroke, and blood clots. Seek immediate medical attention if you experience any of the following: chest/jaw/left arm pain, sudden severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (e.g., double vision, loss of vision), pain/redness/swelling/weakness of the arms/legs, calf pain/swelling that is warm to the touch, trouble breathing, coughing up blood, sudden dizziness/fainting. 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.

Rarely, very serious side effects have occurred when estrogen-only and combination hormone replacement therapies (estrogen and progestin HRT) are used after menopause. Discuss the risks and benefits of hormone treatment and your personal health history with your doctor. Combination HRT should not be used to prevent heart disease or dementia. Combination HRT can rarely cause heart disease (e.g., heart attacks), stroke, serious blood clots (pulmonary embolism and deep venous thrombosis), dementia, and breast cancer. The risk for stroke and breast cancer increases with age, especially for women older than 75. Estrogens may also increase the risk of cancer of the ovaries. 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 minimize the chance of serious side effects from long-term treatment. Discuss the details with your doctor and check with him/her regularly (e.g., every 3-6 months) to see if you still need to use this medication. If you use this drug for an extended time, you should have a complete physical exam at regular intervals (e.g., once a year) or as directed by your doctor. See Notes section.