estradiol and norethindrone (topical patches)
What is the most important information I should know about estradiol and norethindrone?
Estradiol increases the risk of developing endometrial hyperplasia, a condition that may lead to cancer of the lining of the uterus. Using a progestin, such as norethindrone, with estradiol lowers the risk of developing this condition. Visit your doctor regularly and report any unusual vaginal bleeding right away.
Treatment with estrogens long-term may increase the risk of heart attack, stroke, breast cancer, and blood clots in the lungs or legs. Because of these risks, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before using estradiol and norethindrone long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.
Have yearly physical exams and examine your breasts for lumps on a monthly basis while using estradiol and norethindrone.
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Do not use this medication if you are pregnant. |
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Do not place the transdermal patch on your breasts or at your waistline where tight-fitting clothing may interfere with its functioning. |
What should I discuss with my healthcare provider before using estradiol and norethindrone?
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Do not use estradiol and norethindrone without first talking to your doctor if you have |
- a circulation, bleeding, or blood-clotting disorder;
- undiagnosed, abnormal vaginal bleeding; or
- any type of breast, uterine, or hormone-dependent cancer. or
Using estradiol and norethindrone may be dangerous in some cases if you have any of the conditions listed above.
Before using estradiol and norethindrone, tell your doctor if you have
- high blood pressure, angina, or heart disease;
- high levels of cholesterol or triglycerides in your blood;
- kidney disease;
- liver disease;
- asthma;
- epilepsy;
- migraines;
- depression;
- diabetes;
- gallbladder disease;
- uterine fibroids; or
- had a hysterectomy (uterus removed).
You may not be able to use estradiol and norethindrone, or you may need a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
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Estradiol and norethindrone is in the FDA pregnancy category X. This means that estradiol and norethindrone will cause birth defects in an unborn baby. Do not use estradiol and norethindrone if you are pregnant or could become pregnant during treatment. |
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Estradiol and norethindrone may decrease milk flow and have other effects on milk composition. Do not use estradiol and norethindrone without first talking to your doctor if you are breast-feeding a baby. |
How should I use estradiol and norethindrone?
Use estradiol and norethindrone exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
To use estradiol and norethindrone patches:
- Apply each patch to a smooth (fold free), clean, dry area on your lower abdomen. The area should not be oily, damaged, or irritated.
- Do not use the patch on your breasts or at your waistline, where clothing may interfere with its use.
- After opening a pouch, remove one side of the protective liner, taking care not to touch the adhesive part with your fingers. Immediately apply the patch. Remove the second side of the protective liner and press the patch firmly in place with your hand for at least 10 seconds, making sure there is good contact, especially around the edges.
- Replace the patch on the same two days each week (every 3 to 4 days) as directed by your doctor. Only one patch should be worn at any time.
- Allow at least 1 week to pass between applications of the patch to a given area.
- Do not cut the patches.
- After a patch is in place, it should not be exposed the sun for prolonged periods of time.
- Take care so the patch does not come off during bathing or other activities. If a patch falls off for any reason, reapply it to another site on your lower abdomen. If it will not stick, apply a new patch to a new site. Continue changing the patch on your regular schedule.
- Removal of the patch should be done carefully and slowly to avoid irritation of the skin. If any adhesive remains on the skin, allow it to dry for 15 minutes. Then gently rub the area with an oil-based cream or lotion.
- Your doctor may prescribe two different patches for you. In this treatment regimen, use the estrogen-only patch for the first 14 days of a 28-day cycle, according to the product directions. Then, use the estradiol and norethindrone patches for the remaining 14 days, according to the product directions. Follow your doctor's instructions or ask your pharmacist for help if you do not remember. Monthly withdrawal bleeding often occurs with this regimen.
Have yearly physical exams and examine your breasts for lumps on a monthly basis while using estradiol and norethindrone.
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Store the patches in their sealed foil pouches at room temperature away from moisture, heat, and direct light for up to 6 months from the date you receive them from the pharmacy or the expiration date, whichever comes first. |
What happens if I overdose?
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An overdose of estradiol and norethindrone is unlikely to occur and is not likely to threaten life. If you do suspect an overdose, or if a patch has been ingested, call an emergency room or poison control center for advice. |
Symptoms of a estradiol and norethindrone overdose may include nausea, vomiting, and withdrawal bleeding may occur in females.
What should I avoid while using estradiol and norethindrone?
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After a patch is in place, it should not be exposed the sun for prolonged periods of time. |
There are no restrictions on food, beverages, or activity while using estradiol and norethindrone unless your doctor directs otherwise.
What are the possible side effects of estradiol and norethindrone?
Treatment with estrogens long-term may increase the risk of heart attack, stroke, breast cancer, and blood clots in the lungs or legs. Because of these risks, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before using estradiol and norethindrone long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.
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If you experience any of the following serious side effects, stop using estradiol and norethindrone and seek emergency medical attention or notify your doctor immediately: |
- an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
- sharp chest pain, coughing of blood or shortness of breath (possible blood clot in the lung );
- pain in the calf (possible blood clot in the leg);
- crushing chest pain or heaviness in the chest (possible heart attack);
- sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (possible stroke);
- partial or complete loss of vision (possible clot in the eye);
- stomach pain or tenderness, yellowing of the skin or eyes, fever, fatigue, loss of appetite, dark-colored urine, or light-colored stools (possible liver problems); or
- new or changing breast lumps.
Other, less serious side effects may be more likely to occur. Continue to use estradiol and norethindrone and talk to your doctor if you experience
- nausea and vomiting;
- tenderness or enlargement of the breasts;
- weakness;
- swelling of the hands or feet;
- spotty darkening of the skin, particularly on the face;
- difficulty in wearing contact lenses;
- vaginal irritation or discomfort;
- a rash or reaction at the patch application site; or
- changes in menstrual cycle, painful menstruation, or breakthrough bleeding.
Estradiol increases the risk of developing endometrial hyperplasia, a condition that may lead to cancer of the lining of the uterus. Using a progestin, such as norethindrone, with estradiol lowers the risk of developing this condition. Visit your doctor regularly and report any unusual vaginal bleeding right away.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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