Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Note the following important information about estrogen replacement therapy:
The Women's Health Initiative (WHI) study results indicated an increased risk of heart attack, stroke, breast cancer, blood clots in the lungs, and blood clots in the leg veins in postmenopausal women during 5 years of treatment with 0.625 mg conjugated equine estrogens and 2.5 mg medroxyprogesterone compared to women receiving sugar tablets. Other combinations of estrogen and progestins were not studied. However, until additional data are available, the risks should be assumed to be similar for other hormone replacement products. Therefore,
- estrogens with or without progestins should be used at the lowest dose that relieves your menopausal symptoms for the shortest time period possible, as directed by your doctor; and
- estrogens with or without progestins should not be used to prevent heart disease, heart attacks, or strokes.
Bleeding: If you miss taking several doses of this medication, vaginal bleeding may occur. Also, irregular menstrual bleeding may occur while taking drospirenone - estradiol, especially within the first 6 months of starting this medication. This decreases with time and women may experience no bleeding after using this medication for a while.
Blood clotting disorders: Estrogens with or without progestins are associated with an increased risk of blood clots in the lungs (pulmonary embolism) and legs (deep vein thrombosis). This risk also increases with age, a personal or family history of blood clots, smoking, and obesity. The risk of blood clots is also increased if you are immobilized for prolonged periods and with major surgery. If possible, this medication should be stopped 4 weeks before major surgery. Talk about the risk of blood clots with your doctor.
Blood pressure: Women may experience increased blood pressure when using hormone replacement therapy. Ask your doctor how often you should have your blood pressure checked.
Breast and ovarian cancer: Studies indicate an increased risk of breast and ovarian cancer with the use of combined estrogen and progestin therapy. If you have a history of breast cancer, you should not use estrogens. If your family has a history of breast cancer or if you have a history of breast lumps, breast biopsies, or abnormal mammograms, your doctor will monitor your condition closely while you are using estrogens.
Have a mammogram before starting hormone replacement therapy. Have regular breast examinations and become familiar with your breasts so you can let your doctor know if anything has changed.
Dementia: Women over age 65 receiving combined hormone replacement therapy may be at increased risk of developing dementia (loss of memory and intellectual function). If you are over 65, talk to your doctor about whether you should be tested for dementia.
Diabetes: If you have diabetes, your doctor should closely monitor your condition while you are taking this medication, as it may affect blood sugar control.
Endometrial cancer: There is evidence that estrogen replacement therapy can increase the risk of cancer of the endometrium (lining of the uterus). Women who have an intact uterus and are taking estradiol alone are at risk for developing a condition called endometrial hyperplasia, which can lead to the development of cancer of the uterus (endometrial cancer). The drospirenone (progestin) in this medication should counteract the risk of endometrial cancer.
Endometriosis: Estrogen replacement therapy can cause endometriosis to reappear or get worse. If you have or have had endometriosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Familial hypertriglyceridemia: If you have a condition known as familial hypertriglyceridemia (a disorder leading to high levels of fats known as triglycerides in the blood), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Follow-up examinations: It is important to have a follow-up examination 3 to 6 months after starting this medication to assess the response to treatment. Examinations should be done at least once a year after the first one. Make sure you keep all appointments made with your doctor.
Gallbladder disease: This medication can aggravate gallbladder disease or increase the risk of developing it. If you have gallbladder disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Heart disease and stroke: Studies indicate an increased risk of heart disease and stroke with estrogen (with or without progestin) for postmenopausal women. Get immediate medical attention if you experience symptoms of a heart attack (chest pain, tightness, or pressures; sweating; nausea; feeling of impending doom) or stroke (sudden dizziness, headache, loss of speech, changes in vision, weakness or numbness in the arms and legs).
Hypercalcemia and kidney disease: Prolonged use of estrogens can change the metabolism of calcium and phosphorus. If you have a disorder that changes the levels of calcium and phosphorus in the blood, such as metabolic or malignant bone diseases or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Kidney or liver disease: If you have or have had kidney or liver problems, you may require special monitoring by your doctor while you use this medication. Make sure to tell your doctor if you have ever had kidney or liver problems.
Other medical conditions: Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed, if you have any of the following conditions:
- heart disease
- reduced kidney function
Uterine fibroids: Existing uterine fibroids may increase in size during estrogen use. This increase is usually minimal. However, if pain or tenderness occurs, inform your doctor as soon as possible. In some cases, the medication may need to be stopped.
Pregnancy: This medication must not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: Estrogen passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. This medication is not recommended for breast-feeding women.
Children: The safety and effectiveness of using this medication have not been established for children. This medication is not intended for use by children.