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 is known to occur with the application of estrogen to the skin. Although it is an extremely rare event, if you develop contact allergy to any component of the medication, you may experience a severe allergic reaction with its continued use.
If you experience persistent redness or itching where the patch is applied, contact your doctor.
Blood clotting: This medication can increase the risk of blood clots in the groin, legs or lungs, heart, or brain. If you have or have had a heart attack, a stroke, heart disease, a blood clot in your leg, or have medical conditions that increase your risk of blood clots, you should not use this medication.
You may be more at risk of developing blood clots if you have severe varicose veins, severe obesity (body mass index [BMI] more than 30 kg/m2), or have a family history of blood clots. Discuss with your doctor whether any special monitoring is needed.
The risk is also increased if you are immobilized for prolonged periods and if you are having 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: This medication can increase blood pressure. If your blood pressure increases while using this medication, contact your doctor. Your doctor will check your blood pressure before you start using this medication and will monitor your blood pressure while you are using this medication.
Bone disease: If you have bone disease due to cancer or a metabolic condition causing too much calcium in your body, you should 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 cancer: Studies indicate an increased risk of breast cancer with long-term use of estrogen replacement therapy. If you have breast nodules, fibrocystic disease, abnormal mammograms, or a strong family history of breast cancer, you should 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.
Your doctor may suggest that you have a mammogram before starting this medication and at regular intervals while you are using it.
Other known risk factors for the development of breast cancer, such as not having children, obesity, early onset of menstruation, late age at first full-term pregnancy, and late age at menopause, should also be evaluated. If you are taking estrogens, you should have regular breast examinations and should learn how to do breast self-examination.
If you have or have had breast cancer, you should not use this medication.
This medication must not be applied to the 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 your concerns.
Diabetes: Estrogens may affect blood sugar control. If you have diabetes or are at risk of developing diabetes (e.g., have a family history of diabetes, have high blood pressure or high cholesterol, or are obese), carefully monitor your blood glucose levels while using this medication.
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 norethindrone (progestin) in this medication should counteract the risk of endometrial cancer.
If you develop any abnormal vaginal bleeding while using this medication, contact your doctor. If you have or have had endometrial cancer, you should not use this medication.
Fibroids: This medication may worsen fibroids, causing sudden enlargement, pain, or tenderness. If you notice these effects, contact your doctor.
Fluid retention: Estrogen may cause fluid retention and may worsen heart problems, kidney problems, or asthma. If you experience worsening of these conditions while using this medication, contact your doctor.
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. 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) while taking this medication, get immediate medical attention.
High cholesterol or triglycerides: Estrogen may increase triglyceride levels if you already have high levels or have diabetes. This has been observed particularly when estrogen is taken orally and the risk is reduced with use of the patch. Ask your doctor if monitoring of your triglyceride levels is recommended.
Kidney function: If you have reduced kidney function, you may be more at risk of developing high blood calcium and phosphorus levels while using this medication. Discuss with your doctor whether any special monitoring is needed.
Liver function: If you have reduced liver function you should not use this medication. 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 this medication.
If you experience symptoms of liver problems (e.g., yellowing of the skin or eyes, abdominal pain, loss of appetite, dark urine, pale stools, nausea, or vomiting), contact your doctor immediately.
Migraine headaches: If you have migraines with aura (headache is associated with symptoms such as flashes of light, tingling sensations, blind spots, muscle weakness, or difficulty speaking either before or during the headache), you should not use this medication.
If you have migraine without aura, estrogen can aggravate your migraines. Talk to your doctor if you notice any change in your migraine pattern while taking estrogen.
Ovarian cancer: There are studies that have found the use of hormone replacement therapy for longer than 5 years is associated with an increased risk cancer of the ovaries. If you have or have had ovarian cancer, you should not use this medication.
Seizures: Estrogens may increase your risk of having a seizure. If you have a seizure disorder or a history of seizures, 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.
Thyroid disease: Estrogen may affect how thyroid hormone is used by the body. If you are taking thyroid medication to supplement an underactive thyroid gland, 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.
Pregnancy: This medication should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor.
Breast-feeding: Estrogen and progestin pass into breast milk. Women who are breast-feeding should not use this medication.
Children: The safety and effectiveness of using this medication have not been established for children.