"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.
Delestrogen Patient Information including How Should I Take
In this Article
- What is estradiol injection (Delestrogen)?
- What are the possible side effects of estradiol injection?
- What is the most important information I should know about estradiol injection?
- What should I discuss with my health care provider before using estradiol injection?
- How should I use estradiol injection?
- What happens if I miss a dose?
- What happens if I overdose?
- What should I avoid while using estradiol injection?
- What other drugs will affect estradiol injection?
- Where can I get more information?
What should I discuss with my health care provider before using estradiol injection?
Do not use estradiol injection 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.
Before using estradiol injection, tell your doctor if you have:
- 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).
If you have any of these conditions, you may need a dose adjustment or special tests to safely use estradiol injection.
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 injection.
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 injection 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 injection?
Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label.
Estradiol injection is given as an shot into a muscle. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.
This medicine is usually given once every 4 weeks. Follow your doctor's instructions.
Do not draw your estradiol dose into a syringe until you are ready to give yourself an injection. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.
Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using estradiol injection.
Store this medication at room temperature away from moisture and heat.
Additional Delestrogen Information
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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