"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.
Vagifem Patient Information including How Should I Take
In this Article
- What is estradiol vaginal (local) (Vagifem)?
- What are the possible side effects of estradiol vaginal (local) (Vagifem)?
- What is the most important information I should know about estradiol vaginal (local) (Vagifem)?
- What should I discuss with my healthcare provider before using estradiol vaginal (local) (Vagifem)?
- How should I use estradiol vaginal (local) (Vagifem)?
- What happens if I miss a dose (Vagifem)?
- What happens if I overdose (Vagifem)?
- What should I avoid while using estradiol vaginal (local) (Vagifem)?
- What other drugs will affect estradiol vaginal (local) (Vagifem)?
- Where can I get more information?
What should I discuss with my healthcare provider before using estradiol vaginal (local) (Vagifem)?
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 vaginal, tell your doctor if you have any of these other conditions:
- 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);
- 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 vaginal 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 vaginal (local) (Vagifem)?
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.
This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Wash your hands before and after inserting estradiol vaginal.
You should not be able to feel the vaginal ring once it is in place. Leave the vaginal ring in place for 90 days, then remove it. Your doctor may want you to replace it with a new ring.
Use the applicator provided to measure the prescribed dose of estradiol vaginal cream. Take apart the cream applicator and wash it with mild soap and warm water after each use.
Each estradiol vaginal tablet is supplied in a single-use disposable applicator. Throw the tablet applicator away after one use.
Your doctor should check your progress on a regular basis (every 3 to 6 months). Self-examine your breasts for lumps on a monthly basis while using estradiol vaginal.
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.
Store at room temperature away from moisture and heat. Keep the vaginal ring in its protective pouch until you are ready to use it.
Additional Vagifem Information
- Vagifem Drug Interactions Center: estradiol vagl
- Vagifem Side Effects Center
- Vagifem Overview including Precautions
- Vagifem FDA Approved Prescribing Information including Dosage
Vagifem - User Reviews
Vagifem 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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