"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
CombiPatch Patient Information including How Should I Take
In this Article
- What are estradiol and norethindrone (CombiPatch)?
- What are the possible side effects of estradiol and norethindrone (CombiPatch)?
- What is the most important information I should know about estradiol and norethindrone (CombiPatch)?
- What should I discuss with my healthcare provider before using estradiol and norethindrone (CombiPatch)?
- How should I use estradiol and norethindrone (CombiPatch)?
- What happens if I miss a dose (CombiPatch)?
- What happens if I overdose (CombiPatch)?
- What should I avoid while using estradiol and norethindrone (CombiPatch)?
- What other drugs will affect estradiol and norethindrone (CombiPatch)?
- Where can I get more information?
What should I discuss with my healthcare provider before using estradiol and norethindrone (CombiPatch)?
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;
- 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.
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.
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 (CombiPatch)?
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.
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.
Additional CombiPatch Information
CombiPatch - User Reviews
CombiPatch User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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