"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?
You should not use this medication if you are allergic to estradiol, if you are pregnant, or if you have:
- liver disease;
- a bleeding or blood-clotting disorder;
- a history of heart attack, stroke, or blood clot;
- unusual 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 about all of your medical conditions, especially:
- heart disease;
- risk factors for coronary artery disease (such as diabetes, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, or if you have had a hysterectomy);
- hereditary angioedema (an immune system disorder);
- a history of jaundice caused by pregnancy or birth control pills;
- a thyroid disorder;
- kidney disease;
- epilepsy or other seizure disorder;
- endometriosis or uterine fibroid tumors;
- gallbladder disease; or
- high levels of calcium in your blood.
Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin to take while you are using estradiol, to help lower this risk. Report any unusual vaginal bleeding right away.
Long-term use of estradiol may increase your risk of breast cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risks before using estradiol transdermal long term.
FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use estradiol if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective 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.
If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using estradiol.
Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. 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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