"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.
Prefest Patient Information including How Should I Take
In this Article
- What is estradiol and norgestimate ?
- What are the possible side effects of estradiol and norgestimate ?
- What is the most important information I should know about estradiol and norgestimate ?
- What should I discuss with my healthcare provider before taking estradiol and norgestimate ?
- How should I take estradiol and norgestimate ?
- What happens if I miss a dose ?
- What happens if I overdose ?
- What should I avoid while taking estradiol and norgestimate ?
- What other drugs will affect estradiol and norgestimate ?
- Where can I get more information?
What should I discuss with my healthcare provider before taking estradiol and norgestimate ?
You should not take estradiol and norgestimate if you are allergic to it, or if you have:
- liver disease;
- circulation problems;
- a recent history of heart attack or stroke;
- unusual vaginal bleeding that a doctor has not checked;
- a history of breast, uterine, or hormone-dependent cancer;
- if you have ever had a blood clot (especially in your lung or your lower body); or
- if you are pregnant.
Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you have risk factors such as diabetes, high blood pressure, high cholesterol or triglycerides, smoking, or being overweight.
To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:
- heart disease, high blood pressure;
- kidney disease;
- epilepsy or other seizure disorder;
- gallbladder disease;
- underactive thyroid;
- high levels of calcium in your blood; or
- if you have had your uterus removed (hysterectomy).
Long-term estrogen treatment may increase your risk of breast cancer, ovarian cancer, or uterine cancer. Talk with your doctor about your individual risks before using this medication long-term. Taking progestin while using estradiol may lower your risk of uterine cancer. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using estradiol and norgestimate.
FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use estradiol and norgestimate if you are pregnant. Tell your doctor right away if you become pregnant during treatment.
Estradiol and norgestimate can pass into breast milk and may harm a nursing baby. Estrogens may also slow breast milk production. You should not breast-feed while you are taking this medication.
Estradiol and norgestimate should not be used to prevent heart disease, stroke, or dementia, because this medication may actually increase your risk of developing these conditions.
How should I take estradiol and norgestimate ?
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take the medicine at the same time each day.
Estradiol and norgestimate usually comes in a pack of pills that are different colors. In most cases, you will take a pill of one color for three days in a row, followed by taking a pill of the other color for the next three days. This cycle is then repeated throughout your treatment.
Each time you start a new pack, start with the first tablet in the first row of pills. Your medication may come with stickers to mark your weekday schedule on the pack.
Be sure to have a new pack of this medication ready to start on the day after you have finished an entire pill pack.
Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while using estradiol and norgestimate. Your doctor should check your progress every 3 to 6 months to determine whether you should continue this treatment.
If you need medical tests or surgery, 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 taking estradiol and norgestimate.
Store at room temperature away from moisture, heat, and light.
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