"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.
Vivelle-Dot Patient Information including How Should I Take
In this Article
- What is estradiol transdermal (Vivelle-Dot)?
- What are the possible side effects of estradiol transdermal?
- What is the most important information I should know about estradiol transdermal?
- What should I discuss with my healthcare provider before using estradiol transdermal?
- How should I use estradiol transdermal?
- What happens if I miss a dose?
- What happens if I overdose?
- What should I avoid while using estradiol transdermal?
- What other drugs will affect estradiol transdermal?
- Where can I get more information?
What should I discuss with my healthcare provider before using estradiol transdermal?
Do not use estradiol transdermal if you have:
- a bleeding or blood-clotting disorder;
- a history of stroke or circulation problems;
- abnormal vaginal bleeding that a doctor has not checked; or
- any type of breast, uterine, or hormone-dependent cancer.
To make sure you can safely use estradiol transdermal, tell your doctor if you have any of these other conditions:
- high blood pressure, angina, or heart disease;
- high cholesterol or triglycerides;
- liver disease;
- kidney disease;
- epilepsy or other seizure disorder;
- gallbladder disease; or
- if you have had your uterus removed (hysterectomy).
Estradiol increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estradiol may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using estradiol transdermal.
Long-term estradiol treatment may increase your risk of stroke. Talk with your doctor about your individual risks before using estradiol long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.
FDA pregnancy category X. This medication can cause birth defects. Do not use estradiol transdermal if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication.
Estradiol can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.
How should I use estradiol transdermal?
Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Apply the skin patch to clean, dry skin on your stomach, lower back, or buttocks. Choose a different spot within these skin areas each time you apply a new patch. Avoid skin that is oily, irritated, or damaged.
Press the patch in place firmly for about 10 seconds, especially around the edges.
Do not apply a skin patch to your breasts. Do not apply a patch where it might be rubbed off by tight clothing, such as under an elastic waistband.
If a patch falls off, try putting it back on to a different skin area, pressing the patch into place for 10 seconds. If the patch will not stick you may apply a new one.
Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using estradiol transdermal.
The estradiol transdermal patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.
Store at room temperature away from moisture and heat.
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