Generic: Estradiol (estrogen) and levonorgestrel (progesterone)
Estradiol(estrogen) and levonorgestrel(progesterone) is a hormone combination skin patch for the treatment of moderate to severe hot flashes and other symptoms of menopause or low amounts of estrogen.
Osteoporosis after menopause can also be prevented by this drug combination patch. The hormones from the patch are absorbed through your skin into your body.
This drug works by acting as hormone replacement to prevent symptoms of feeling of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating in women during menopause. This drug requires a prescription.
2 What to Know Before Using
Before taking this drug, the risks and benefits for your body should be discussed with your healthcare provider. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals.
Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications. Use of estradiol and levonorgestrel combination skin patch is contraindicated in the pediatric population while safety and efficacy have not been established. No documentation of any geriatric-specific problems relating to use of this drug combination skin patch.
Caution is required in elderly patients while taking this drug since they are more likely to have breast cancer, stroke, or dementia. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit since fetal abnormalities have been reported in pregnant animals or women.
This drug may alter milk production or composition and you should monitor the infant for side effects and adequate milk intake if an alternative to this drug is not prescribed. Discuss with your healthcare professional the potential risks and benefits before taking this drug while breastfeeding.
Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.
Inform your healthcare professional if you are taking any other drugs such as Tranexamic Acid, Bupropion, Carbamazepine, Ceritinib, Crizotinib, Dabrafenib, Darunavir, Dasabuvir, Donepezil, Eliglustat, Fentanyl, Idelalisib, Isotretinoin, Lumacaftor, Nilotinib, Piperaquine, Pixantrone, Sugammadex, Theophylline, Tizanidine, Topotecan, Ulipristal, Acitretin, Alprazolam, Amprenavir, Aprepitant, Atazanavir, Bacampicillin, Betamethasone, Bexarotene, Bosentan, Clarithromycin, Colesevelam, Cyclosporine, Delavirdine, Efavirenz, Eslicarbazepine, Acetate, Etravirine, Fosamprenavir, Fosaprepitant, Fosphenytoin, Ginseng, Griseofulvin, Ketoconazole, Lamotrigine, Levothyroxine, Licorice, Modafinil, Mycophenolate, Mofetil, Mycophenolic Acid, Nelfinavir, Oxcarbazepine, Perampanel, Phenobarbital, Phenytoin, Prednisolone, Primidone, Rifabutin, Rifampin, Rifapentine, Ritonavir, Rosuvastatin, Rufinamide, Selegiline, St John's Wort, Tacrine, Telaprevir, Tipranavir, Topiramate, Troglitazone, Troleandomycin, Voriconazole, and Warfarin. Intake of specific food or using alcohol or tobacco with magnesium is associated with an increased risk of certain side effects.
Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco. Inform your healthcare provider for any other medical problems such as abnormal or unusual vaginal bleeding or blood clots, breast cancer, history of heart attack, liver disease or protein C or protein S deficiency, or other known blood clotting disorders, stroke, surgery with a long period of inactivity, estrogen-dependent tumors, angioedema, anaphylaxis, asthma, cancer, diabetes, edema, endometriosis, epilepsy, gallbladder disease, heart disease, hereditary angioedema, hypercalcemia (high calcium in the blood) or Hypertension (high blood pressure) or Hypertriglyceridemia, hypocalcemia, hypothyroidism, jaundice during pregnancy or from using hormonal therapy in the past, liver tumors, migraine headache, porphyria, systemic lupus erythematosus, or kidney disease.
This drug must be taken exactly as directed by your doctor. To prevent any side effects, take this drug exactly as directed in the label or as prescribed by your healthcare professional. Use this drug on the skin only and prevent it from getting in your eyes, nose, mouth, breast, vagina, or any areas in skin with cuts, scrapes, or burns.
Immediately rinse with water if this drug gets into these areas. Carefully follow the directions on the label or as prescribed by your healthcare professional. Proper hand washing is recommended before using this drug.
Carefully tear open the pouch when you are ready to put the patch on your skin. Do not cut it. Peel off the backing from the patch and apply the patch to a clean, dry, and hair-free area of the lower stomach or upper buttock area. This area must be free of powder, oil, or lotion for the patch to stick on to your skin. Press the patch firmly in place with your hand for about 10 seconds. Do not apply the patch on the breast or over any skin folds.
Do not apply the patch on oily, broken, burned, or irritated skin, or areas with skin conditions. Avoid applying the patch on the waistline or other places where tight clothing may rub it off. Wear the patch at all times until it is time to put on a new patch. Do not expose it to the sun for long periods of time.
Make sure to apply the new patch to a different area of your lower abdomen when replacing your patch. Wait at least 1 week before applying a patch to the same area. When changing a patch, slowly peel it off from your skin. If you have any patch adhesive left on your skin, allow it to dry for 15 minutes and gently rub the sticky area with oil or lotion to remove it.
It is best to change your patch on the same days of each week to help you remember. You may take a bath, shower, or swim while using this medicine. Doing so will not affect the patch. If a patch falls off, just put it back on a different area. If the patch does not stick completely, put on a new patch but continue to follow your original schedule for changing your patch.
Fold the patch in half with the sticky side together and place it in a sturdy child-proof container. Throw this container in the trash away from children and pets. Do not flush the patch down the toilet. The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed.
The dosage of this drug you take depends on the medical problem for which you are using this drug. Adults with hot flashes and other symptoms caused by menopause, are usually prescribed to apply one transdermal patch (0.045 mg of estradiol and 0.015 mg of levonorgestrel) to the lower stomach or upper buttocks area once a week.
The same must also be done to prevent osteoporosis in adult women. Use in children is not recommended. A missed dose should be taken as soon as possible. However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.
4 Precautions to Take
Your healthcare provider should closely monitor the effectiveness of this drug as well as check for unwanted effects. Unwanted effects can be detected using pelvic exam, breast exam, and mammogram.
Pregnancy is very unlikely in postmenopausal women. But it is important to that this drug has teratogenic effects. Increased risk for having blood clots, strokes, or heart attacks have been associated with this drug.
This risk may continue even after you stop using the drug and this risk is amplified if you have hypertension, high cholesterol in your blood, diabetes, or if you are overweight or smoke cigarettes. Contact emergency medical services immediately if you experience confusion, difficulty speaking, double vision, headaches, an inability to move arms, legs or facial muscle, or an inability to speak.
Risks of breast cancer, endometrial cancer, or uterine cancer are increased with prolonged use of this drug. Consult with your healthcare professional about the risk and benefits of this drug and if you should also use a progestin drug if you still have your uterus.
Inform your healthcare professional immediately if you have unusual vaginal bleeding. Women 65 years of age and older taking this drug may have increase risks of dementia. Before any kind of surgery or emergency treatment, inform the medical doctor or dentist in charge that you are using this drug.
This drug may also affect the results of certain medical tests. Consult with your healthcare professional immediately if you experience severe headache or sudden loss of vision or any other change in vision occurs while you are taking this drug.
You may be referred to an ophthalmologist to have your eyes checked. Consult with your healthcare professional before drinking grapefruit juice, or take any other prescription or non-prescription drugs, and herbal or vitamin supplements.
5 Potential Side Effects
Side effects may vary for each individual and prompt medical attention should be given if they occur.
Consult with your healthcare professional immediately if you experience symptoms of acid or sour stomach, anxiety, backache, belching, change in vaginal discharge, chest pain or discomfort, clear or bloody discharge from the nipple, confusion, cough, difficulty with speaking, difficulty with swallowing, dimpling of the breast skin, dizziness or lightheadedness, double vision, fainting, fast heartbeat, full or bloated feeling or pressure in the stomach, headache, heartburn, hives, itching, or rash, inability to move the arms, legs, or facial muscles, inability to speak, indigestion, inverted nipple, loss of appetite, lump in the breast or under the arm, nausea, pain or discomfort in the arms, jaw, back, or neck pain or feeling of pressure in the pelvis pain, redness, or swelling in the arm or leg, persistent crusting or scaling of the nipple, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue redness or swelling of the breast, slow speech, sore on the skin of the breast that does not heal, stomach discomfort, upset, or pain, sudden shortness of breath or troubled breathing, sweating, swelling of the abdominal or stomach, area tightness in the chest, unusual tiredness or weakness, vaginal bleeding, or vomiting.
Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.
If any of the following side effects persists, or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.
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