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.
Allergy: Contact allergy, such as itching and redness, is known to occur with the application of estrogen to the skin. Although this allergy is extremely rare, people who develop skin reactions or contact sensitization to any component of the medication are at risk of developing a severe allergic reaction with continued use. If you have a skin reaction to the patch, contact your doctor for advice.
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. Your doctor may want to monitor your blood pressure more frequently while you are using estradiol-17β - levonorgestrel, especially if high doses of estrogen are used. Ask your doctor how often you should have your blood pressure checked.
Bone disease: If you have bone disease due to cancer or a metabolic condition causing too much calcium in your body, 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.
Breast and ovarian cancer: Studies indicate an increased risk of breast and ovarian cancer with long-term use of estrogen replacement therapy. Do not use estrogens if you have a history of breast cancer. Your doctor will monitor your condition closely if you have breast nodules, fibrocystic disease, an abnormal mammogram, or a strong family history of breast cancer. While taking estrogens, have regular breast examinations and become familiar with your breasts so you can let your doctor know if anything has changed. Do not apply the estradiol-17β - levonorgestrel patch to your breasts, as it may have harmful effects on the breast tissue.
Dementia: Women over age 65 receiving combined hormone replacement therapy (estrogen and progestin) 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 using this medication, as it may affect blood sugar control.
Fibroids: This medication may worsen fibroids by causing sudden enlargement, pain, or tenderness. If you notice these effects, contact your doctor.
Endometrial cancer: There is evidence from several studies that estrogen replacement therapy can increase the risk of cancer of the endometrium (lining of the uterus). Taking a progestin at the right time along with an estrogen reduces this risk of endometrial cancer to the same level as that of a woman who does not take estrogen. The levonorgestrel (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.
Fluid retention: Estrogen may cause fluid retention, which can worsen some medical conditions (e.g., heart disease, kidney disease, epilepsy, asthma). Talk to your doctor if you have any concerns.
Follow-up examinations: It is important to have a follow-up examination 3 to 6 months after starting this medication to assess your response to treatment. Examinations should be done at least once a year after the first one.
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 pressure, 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).
High cholesterol or triglycerides: Estrogen may increase triglyceride levels in those who already have high levels. Your doctor will monitor your cholesterol and triglyceride levels while you are taking this medication.
Kidney disease: Estrogen can affect how calcium and phosphorus are metabolized by your body. If you have 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.
Liver disease: People with active liver disease or liver tumours should not use estradiol-17β - levonorgestrel patches. If you have or have had 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 liver problems. Your doctor may do blood work to monitor your liver function while you are using estradiol-17β - levonorgestrel patches.
Other medical conditions: Women with epilepsy, migraine headaches, or asthma should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Pregnancy: Estrogen should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor.
Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are using estradiol-17β - levonorgestrel, 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.