"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.
Prempro, Premphase Patient Information including How Should I Take
In this Article
- What are conjugated estrogens and medroxyprogesterone (Prempro, Premphase)?
- What are the possible side effects of conjugated estrogens and medroxyprogesterone (Prempro, Premphase)?
- What is the most important information I should know about conjugated estrogens and medroxyprogesterone (Prempro, Premphase)?
- What should I discuss with my healthcare provider before taking conjugated estrogens and medroxyprogesterone (Prempro, Premphase)?
- How should I take conjugated estrogens and medroxyprogesterone (Prempro, Premphase)?
- What happens if I miss a dose (Prempro, Premphase)?
- What happens if I overdose (Prempro, Premphase)?
- What should I avoid while taking conjugated estrogens and medroxyprogesterone (Prempro, Premphase)?
- What other drugs will affect conjugated estrogens and medroxyprogesterone (Prempro, Premphase)?
- Where can I get more information?
What should I discuss with my healthcare provider before taking conjugated estrogens and medroxyprogesterone (Prempro, Premphase)?
Do not use this medication if you have:
- a history of heart attack, stroke, or blood clot (especially in your lung or your lower body);
- abnormal vaginal bleeding that a doctor has not checked;
- a bleeding or blood-clotting disorder;
- liver disease; or
- any type of breast, uterine, or hormone-dependent cancer.
To make sure you can safely take conjugated estrogens and medroxyprogesterone, tell your doctor if you have any of these other conditions:
- high blood pressure, heart disease, or circulation problems;
- a personal or family history of stroke;
- liver or kidney disease;
- epilepsy or other seizure disorder;
- underactive thyroid;
- high cholesterol or triglycerides;
- high or low levels of calcium in your blood;
- systemic lupus erythematosus (SLE); or
- gallbladder disease.
Conjugated estrogens increase your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. The medroxyprogesterone contained in this medication may lower this risk. If your uterus has not been removed, talk with your doctor about your specific risk of developing uterine cancer while taking conjugated estrogens and medroxyprogesterone.
Long-term use of conjugated estrogens and medroxyprogesterone may increase your risk of breast cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risks before using this medication long term, especially if you smoke or are overweight. 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 harm an unborn baby or cause birth defects. Do not use conjugated estrogens and medroxyprogesterone 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.
Conjugated estrogens and medroxyprogesterone 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.
Do not give this medication to anyone under 18 years old without the advice of a doctor.
How should I take conjugated estrogens and medroxyprogesterone (Prempro, Premphase)?
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.
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.
The 28-day Premphase treatment consists of two differently colored pills, 14 of each color. Carefully follow the patient instructions about which pills to take on days 1 through 14 and which pills to take on days 15 through 28.
You may take this medication with or without food. Try to take the medicine at the same time each day.
Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while using this medication.
Use this medication regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
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 taking conjugated estrogens and medroxyprogesterone.
This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using conjugated estrogens and medroxyprogesterone.
Store at room temperature away from moisture and heat. Keep the medicine container tightly closed.
Additional Prempro, Premphase Information
Prempro, Premphase - User Reviews
Prempro, Premphase 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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