Estradiol 0.1mg Patch (twice Wk)
WARNING: Do not use this drug to prevent heart disease or dementia. A study of women taking an estrogen with a progestin showed a raised chance of heart attack, stroke, blood clot, breast cancer, and dementia. The chance of stroke, blood clot, and dementia was also raised when the estrogen was taken alone. Not all products and doses were studied. It is not known if the same effects may happen with this drug.The chance of endometrial cancer may be raised with the use of estrogen alone in patients with a uterus. Use of a progestin along with estrogen may lower the risk. Call your doctor right away if you have unexplained or long-lasting vaginal bleeding.Use this drug for the shortest time needed at the lowest useful dose. Your doctor will talk with you on a regular basis to see if you need to keep taking this drug. @ COMMON USES: It is used to prevent soft, brittle bones (osteoporosis) after menopause.It is used to prevent or lower the signs of the change of life (menopause).It is used to add estrogen to the body when the ovaries have been taken out or do not work the right way.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Estrogen; Hormone Replacement Therapy
Pharmacologic Class
Estrogen receptor agonist
Pregnancy Category
Category X
FDA Approved
Mar 1991
DEA Schedule
Not Controlled
Overview
What is this medicine?
Estradiol is a hormone patch that releases estrogen into your body through your skin. It is used to relieve symptoms of menopause, such as hot flashes and night sweats, and to help prevent bone thinning (osteoporosis) after menopause. It works by replacing the estrogen your body no longer makes.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to use this medication as directed and follow all instructions carefully.
Application Instructions
Do not take this medication by mouth. It is for use on your skin only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Apply the patch at the same time every day to maintain a consistent routine.
Wash your hands before and after handling the patch to ensure cleanliness.
Place the patch on clean, dry, and healthy skin on your lower belly or upper buttocks. Rotate the application site with each new patch to avoid skin irritation.
Wait at least 7 days before applying a new patch to the same site.
Do not apply the patch to skin with any problems, such as cuts, wounds, or irritations.
Avoid applying the patch to the breast area.
Do not apply the patch to skin that has been treated with creams, oils, lotions, powders, or other skin products, as this may affect the patch's adhesion.
Choose a hair-free area for patch application to ensure better adhesion.
Avoid placing the patch on your waistline or on an area that may be subject to friction or pressure, which could cause the patch to come off.
Do not cut or divide the patches, as this may affect their effectiveness.
Do not use damaged patches, as they may not work properly.
Replacing a Patch
If the patch falls off, try to reapply it. If you're unable to reapply the patch, apply a new one to a different area.
Wear only one patch at a time to avoid overdose or increased side effects.
Disposing of Used Patches
After removing a used patch, fold the sticky sides together to prevent accidental exposure.
Dispose of used patches in a secure location where children and pets cannot access them.
Storage and Disposal
Store this medication at room temperature in a dry place, away from bathrooms and areas with high humidity.
Keep the medication out of reach of children and pets to avoid accidental ingestion or exposure.
Missed Dose
If you miss a dose, apply a new patch as soon as you remember, after removing the old one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to use this medication as directed and follow all instructions carefully.
Application Instructions
Do not take this medication by mouth. It is for use on your skin only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Apply the patch at the same time every day to maintain a consistent routine.
Wash your hands before and after handling the patch to ensure cleanliness.
Place the patch on clean, dry, and healthy skin on your lower belly or upper buttocks. Rotate the application site with each new patch to avoid skin irritation.
Wait at least 7 days before applying a new patch to the same site.
Do not apply the patch to skin with any problems, such as cuts, wounds, or irritations.
Avoid applying the patch to the breast area.
Do not apply the patch to skin that has been treated with creams, oils, lotions, powders, or other skin products, as this may affect the patch's adhesion.
Choose a hair-free area for patch application to ensure better adhesion.
Avoid placing the patch on your waistline or on an area that may be subject to friction or pressure, which could cause the patch to come off.
Do not cut or divide the patches, as this may affect their effectiveness.
Do not use damaged patches, as they may not work properly.
Replacing a Patch
If the patch falls off, try to reapply it. If you're unable to reapply the patch, apply a new one to a different area.
Wear only one patch at a time to avoid overdose or increased side effects.
Disposing of Used Patches
After removing a used patch, fold the sticky sides together to prevent accidental exposure.
Dispose of used patches in a secure location where children and pets cannot access them.
Storage and Disposal
Store this medication at room temperature in a dry place, away from bathrooms and areas with high humidity.
Keep the medication out of reach of children and pets to avoid accidental ingestion or exposure.
Missed Dose
If you miss a dose, apply a new patch as soon as you remember, after removing the old one.
Lifestyle & Tips
- Apply the patch to a clean, dry, hairless area of skin on your lower abdomen or buttocks. Avoid breasts, waistline, or areas that rub.
- Rotate application sites to prevent skin irritation. Do not apply to the same spot twice in a row.
- Change the patch twice a week (every 3-4 days) as directed by your doctor.
- If a patch falls off, reapply it or apply a new one. If it's close to your next scheduled change, just wait and apply a new patch at that time.
- Do not cut the patch.
- Discuss any concerns about long-term use with your doctor.
- Maintain a healthy lifestyle, including a balanced diet, regular exercise, and avoiding smoking, to support overall health and bone density.
Available Forms & Alternatives
Available Strengths:
- Estradiol 0.05mg Patch (once Wk)
- Estradiol 0.1mg Patch (once Wk)
- Estradiol 1mg Tablets
- Estradiol 2mg Tablets
- Estradiol 0.5mg Tablets
- Estradiol 0.025mg Patch (once Wk)
- Estradiol 0.075mg Patch (once Wk)
- Estradiol Tds 0.0375mg Patches 4s
- Estradiol Tds 0.06mg Patch 4s
- Estradiol 0.025mg Patch (twice Wk)
- Estradiol 0.075mg Patch (twice Wk)
- Estradiol 0.0375mg Patch (twice Wk)
- Estradiol 0.1mg Patch (twice Wk)
- Estradiol 0.05mg Patch (twice Wk)
- Estradiol 0.0375mg Patch (twice Wk
- Estradiol 10mcg Vaginal Tabs 8s
- Estradiol 10mcg Vaginal Tabs 18s
- Estradiol 0.01% Vag Cream 42.5gm
- Estradiol Val 20mg/ml Inj, 5ml
- Estradiol Valerate 40mg/ml Inj, 5ml
- Estradiol Valerate 40mg/ml Inj, 5ml
- Estradiol 0.5mg/day Top Gel Pk
- Estradiol 0.5mg/day Top Gel Pk
- Estradiol 1mg/day Top Gel Pk
- Estradiol 1mg/day Top Gel Pk
- Estradiol 0.75mg/day Top Gel Pk
- Estradiol 0.75mg/day Top Gel Pk
- Estradiol 0.25mg/day Top Gel Pk
- Estradiol 0.25mg/day Top Gel Pk
- Estradiol 1.25mg/day Top Gel Pk
- Estradiol 1.25mg/day Top Gel Pk
- Estradiol Valerate 10mg/ml Inj, 5ml
- Estradiol Val 20mg/ml Inj, 5ml
- Estradiol Valerate 10mg/ml Inj, 5ml
- Estradiol 1.25mg/day Top Gel Pk
- Estradiol 0.75mg/day Top Gel Pk
- Estradiol 1mg/day Top Gel Pk
- Estradiol 0.5mg/day Top Gel Pk
- Estradiol 0.25mg/day Top Gel Pk
- Estradiol 0.06% Gel 37.5gm(pumps)
- Estradiol 0.06% Gel 37.5gm(pumps)
Dosing & Administration
Adult Dosing
Standard Dose:
Estradiol 0.1 mg/day patch applied topically twice weekly (every 3-4 days)
Dose Range:
0.025 - 0.1 mg
Condition-Specific Dosing:
vasomotorSymptomsOfMenopause:
Initial dose typically 0.025 mg/day or 0.0375 mg/day patch, adjusted based on response to 0.05 mg/day, 0.075 mg/day, or 0.1 mg/day. The 0.1 mg/day patch is the highest dose for severe symptoms.
preventionOfPostmenopausalOsteoporosis:
Typically 0.025 mg/day patch, adjusted as needed to 0.05 mg/day. The 0.1 mg/day patch is generally not the starting dose for this indication unless severe vasomotor symptoms are also present and require it.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (not indicated for pediatric use)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended
Moderate:
No specific dose adjustment recommended
Severe:
Use with caution; monitor for fluid retention
Dialysis:
Use with caution; monitor for fluid retention
Hepatic Impairment:
Mild:
Use with caution; monitor for adverse effects
Moderate:
Use with caution; monitor for adverse effects. Estrogens are extensively metabolized by the liver.
Severe:
Contraindicated due to impaired estrogen metabolism and increased risk of cholestasis and other liver complications.
Pharmacology
Mechanism of Action
Estradiol is the primary estrogen secreted by the human ovary. It binds to and activates nuclear estrogen receptors (ERΞ± and ERΞ²) in target tissues, including the reproductive tract, breast, bone, and brain. This binding leads to gene transcription and protein synthesis, mediating the physiological effects of estrogen, such as maintaining female reproductive health, bone density, and modulating vasomotor stability.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 80% relative to oral estradiol, but highly variable due to transdermal delivery bypassing first-pass metabolism.
Tmax:
Approximately 2-4 hours after patch application.
FoodEffect:
Not applicable for transdermal patch.
Distribution:
Vd:
Approximately 1.2 L/kg (for estradiol)
ProteinBinding:
Approximately 98% (primarily to sex hormone-binding globulin [SHBG] and albumin)
CnssPenetration:
Yes (estradiol crosses the blood-brain barrier)
Elimination:
HalfLife:
Approximately 1-2 hours (for estradiol in plasma after absorption, but the patch provides sustained release)
Clearance:
Approximately 650-900 mL/min/mΒ² (for estradiol)
ExcretionRoute:
Renal (primarily as glucuronide and sulfate conjugates)
Unchanged:
<1% (in urine)
Pharmacodynamics
OnsetOfAction:
Within hours of application (systemic levels achieved)
PeakEffect:
Within days to weeks for full therapeutic effect (e.g., symptom relief)
DurationOfAction:
Sustained release over 3-4 days (until next patch application)
Safety & Warnings
BLACK BOX WARNING
Estrogens and progestins should not be used for the prevention of cardiovascular disease or dementia. The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50-79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative to placebo. The WHI estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis in postmenopausal women (50-79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (0.625 mg) relative to placebo. The WHI Memory Study (WHIMS) reported an increased risk of probable dementia in postmenopausal women 65 years of age or older. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes.
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades, yellow skin and eyes, fever with chills, bloating, or severe stomach upset or vomiting.
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe stomach upset or vomiting.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision.
Changes in eyesight or loss of vision, bulging eyes, or changes in how contact lenses feel.
Breast lump, breast pain or tenderness, or nipple discharge.
Vaginal itching or discharge.
Abnormal vaginal bleeding.
Depression or mood changes.
Memory problems or loss.
Fever.
Difficulty urinating or changes in urine output.
Pain while urinating.
This medication may cause fluid retention or swelling in the body. Inform your doctor if you experience swelling, weight gain, or breathing difficulties.
Blood Clots and High Calcium Levels
Seek immediate medical attention if you experience signs of a blood clot, such as:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color changes, or pain in a leg or arm
Difficulty speaking or swallowing
High calcium levels can occur in some people with cancer taking this medication. Contact your doctor right away if you experience:
Weakness
Confusion
Fatigue
Headache
Stomach upset or vomiting
Constipation
Bone pain
Other Possible Side Effects
Most medications can cause side effects, but many people experience none or only mild side effects. If you are concerned about any of the following side effects or if they persist, contact your doctor:
Dizziness or headache
Hair loss
Stomach upset or vomiting
Constipation
Stomach pain or cramps
Bloating
Breast enlargement or tenderness
Vaginal bleeding or spotting
Painful periods
Common cold symptoms
Nose or throat irritation
Weight gain or loss
Joint pain
Leg cramps
Changes in sex drive
* Irritation at the injection site
This is not an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes.
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades, yellow skin and eyes, fever with chills, bloating, or severe stomach upset or vomiting.
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe stomach upset or vomiting.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision.
Changes in eyesight or loss of vision, bulging eyes, or changes in how contact lenses feel.
Breast lump, breast pain or tenderness, or nipple discharge.
Vaginal itching or discharge.
Abnormal vaginal bleeding.
Depression or mood changes.
Memory problems or loss.
Fever.
Difficulty urinating or changes in urine output.
Pain while urinating.
This medication may cause fluid retention or swelling in the body. Inform your doctor if you experience swelling, weight gain, or breathing difficulties.
Blood Clots and High Calcium Levels
Seek immediate medical attention if you experience signs of a blood clot, such as:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color changes, or pain in a leg or arm
Difficulty speaking or swallowing
High calcium levels can occur in some people with cancer taking this medication. Contact your doctor right away if you experience:
Weakness
Confusion
Fatigue
Headache
Stomach upset or vomiting
Constipation
Bone pain
Other Possible Side Effects
Most medications can cause side effects, but many people experience none or only mild side effects. If you are concerned about any of the following side effects or if they persist, contact your doctor:
Dizziness or headache
Hair loss
Stomach upset or vomiting
Constipation
Stomach pain or cramps
Bloating
Breast enlargement or tenderness
Vaginal bleeding or spotting
Painful periods
Common cold symptoms
Nose or throat irritation
Weight gain or loss
Joint pain
Leg cramps
Changes in sex drive
* Irritation at the injection site
This is not an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Sudden severe headache, vision changes (e.g., loss of vision, double vision)
- Chest pain, shortness of breath, coughing up blood
- Pain, swelling, or redness in one or both legs
- Yellowing of the skin or eyes (jaundice), dark urine, severe stomach pain
- Unusual vaginal bleeding or spotting after menopause
- Lump in the breast or breast pain/tenderness
- Severe dizziness or fainting
- Swelling of hands, ankles, or feet
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
A history of certain health conditions, such as:
+ Bleeding disorders
+ Blood clots or an increased risk of blood clots
+ Breast cancer
+ Liver problems or liver tumors
+ Heart attack
+ Stroke
+ Tumors that are estrogen-dependent
Unexplained vaginal bleeding
Pregnancy or potential pregnancy. Note: This medication is contraindicated during pregnancy and should not be taken if you are pregnant.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine the safety of taking this medication in conjunction with your other treatments and health conditions. Do not initiate, terminate, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
A history of certain health conditions, such as:
+ Bleeding disorders
+ Blood clots or an increased risk of blood clots
+ Breast cancer
+ Liver problems or liver tumors
+ Heart attack
+ Stroke
+ Tumors that are estrogen-dependent
Unexplained vaginal bleeding
Pregnancy or potential pregnancy. Note: This medication is contraindicated during pregnancy and should not be taken if you are pregnant.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine the safety of taking this medication in conjunction with your other treatments and health conditions. Do not initiate, terminate, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before certain surgical procedures, and will provide guidance on when to resume taking it after the surgery or procedure.
If you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as prolonged inactivity may increase your risk of developing blood clots. Additionally, if you have diabetes (high blood sugar), it is crucial to closely monitor your blood sugar levels.
You should have your blood pressure checked regularly, as directed by your doctor, since medications like this one can cause high blood pressure. It is also important to undergo regular blood tests and bone density checks as recommended by your doctor.
Regular breast exams and gynecology check-ups are vital, and you should also perform breast self-exams as instructed by your doctor. The risk of certain side effects, such as heart attack, stroke, breast cancer, ovarian cancer, and others, may vary depending on factors like the duration of estrogen use, whether it is taken with or without a progestin, and other individual factors. Discuss the benefits and risks of using this medication with your doctor.
Be aware that this medication can cause high triglyceride levels, so inform your doctor if you have a history of elevated triglycerides. This drug may also cause dark skin patches on your face, so it is essential to avoid sun exposure, sunlamps, and tanning beds, and to use sunscreen and protective clothing and eyewear when going outside.
This medication may affect certain laboratory tests, so inform all your healthcare providers and lab personnel that you are taking this drug. Avoid smoking, as it increases the risk of heart disease, and limit your alcohol consumption. If you regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor.
To maximize the effectiveness of this medication, use it in conjunction with calcium and vitamin D supplements, and engage in weight-bearing exercises like walking or physical therapy, as directed by your doctor. Adhere to the diet and exercise plan recommended by your doctor.
In some cases, this medication may affect growth in children and teenagers, so they may require regular growth checks. Discuss this with your doctor. If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Finally, if you are breastfeeding, consult your doctor to discuss any potential risks to your baby.
If you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as prolonged inactivity may increase your risk of developing blood clots. Additionally, if you have diabetes (high blood sugar), it is crucial to closely monitor your blood sugar levels.
You should have your blood pressure checked regularly, as directed by your doctor, since medications like this one can cause high blood pressure. It is also important to undergo regular blood tests and bone density checks as recommended by your doctor.
Regular breast exams and gynecology check-ups are vital, and you should also perform breast self-exams as instructed by your doctor. The risk of certain side effects, such as heart attack, stroke, breast cancer, ovarian cancer, and others, may vary depending on factors like the duration of estrogen use, whether it is taken with or without a progestin, and other individual factors. Discuss the benefits and risks of using this medication with your doctor.
Be aware that this medication can cause high triglyceride levels, so inform your doctor if you have a history of elevated triglycerides. This drug may also cause dark skin patches on your face, so it is essential to avoid sun exposure, sunlamps, and tanning beds, and to use sunscreen and protective clothing and eyewear when going outside.
This medication may affect certain laboratory tests, so inform all your healthcare providers and lab personnel that you are taking this drug. Avoid smoking, as it increases the risk of heart disease, and limit your alcohol consumption. If you regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor.
To maximize the effectiveness of this medication, use it in conjunction with calcium and vitamin D supplements, and engage in weight-bearing exercises like walking or physical therapy, as directed by your doctor. Adhere to the diet and exercise plan recommended by your doctor.
In some cases, this medication may affect growth in children and teenagers, so they may require regular growth checks. Discuss this with your doctor. If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Finally, if you are breastfeeding, consult your doctor to discuss any potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Breast tenderness
- Abdominal pain
- Drowsiness/fatigue
- Withdrawal bleeding (in females)
What to Do:
Remove the patch immediately. Seek medical attention or call a poison control center (1-800-222-1222). Treatment is generally supportive.
Drug Interactions
Contraindicated Interactions
- Aromatase inhibitors (e.g., anastrozole, letrozole) - concurrent use would counteract their mechanism of action.
- Tamoxifen - may reduce efficacy of tamoxifen.
Major Interactions
- CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort) - may decrease estrogen levels, reducing efficacy.
- CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, ketoconazole, ritonavir, grapefruit juice) - may increase estrogen levels, increasing risk of adverse effects.
- Thyroid hormones (e.g., levothyroxine) - estrogens can increase thyroid-binding globulin (TBG), potentially increasing thyroid hormone requirements.
- Corticosteroids (e.g., prednisone) - estrogens may decrease corticosteroid clearance, increasing their effects and toxicity.
- Anticoagulants (e.g., warfarin) - estrogens may decrease the anticoagulant effect of warfarin; monitor INR closely.
Moderate Interactions
- Fluvoxamine - potential for increased estrogen levels.
- Cyclosporine - estrogens may inhibit cyclosporine metabolism, increasing its levels and toxicity.
- Theophylline - estrogens may decrease theophylline clearance, increasing its levels and toxicity.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Complete medical history and physical examination
Rationale: To identify contraindications, risk factors (e.g., cardiovascular disease, breast cancer, liver disease), and establish baseline health status.
Timing: Prior to initiation of therapy
Blood pressure
Rationale: Estrogens can affect blood pressure.
Timing: Prior to initiation of therapy
Lipid profile (total cholesterol, HDL, LDL, triglycerides)
Rationale: Estrogens can affect lipid metabolism.
Timing: Prior to initiation of therapy
Mammogram
Rationale: To screen for breast cancer before starting hormone therapy.
Timing: Prior to initiation of therapy (within 1 year)
Pelvic examination and Pap test
Rationale: To screen for gynecological conditions, including endometrial hyperplasia/cancer (if uterus intact) and cervical abnormalities.
Timing: Prior to initiation of therapy
Routine Monitoring
Blood pressure
Frequency: Annually, or more frequently if clinically indicated
Target: Normal limits
Action Threshold: Significant increase or hypertension development; consider discontinuation or alternative therapy.
Clinical breast examination
Frequency: Annually
Target: Normal
Action Threshold: New lumps, pain, or discharge; refer for further evaluation.
Mammogram
Frequency: As clinically indicated, typically every 1-2 years based on age and risk factors
Target: Normal
Action Threshold: Abnormal findings; refer for further evaluation.
Pelvic examination
Frequency: Annually, or as clinically indicated
Target: Normal
Action Threshold: Abnormal bleeding, pain, or other gynecological symptoms; refer for further evaluation.
Lipid profile
Frequency: Periodically, as clinically indicated (e.g., every 1-3 years)
Target: Optimal levels for cardiovascular health
Action Threshold: Significant adverse changes; consider lifestyle modifications or alternative therapy.
Symptom Monitoring
- New or worsening headaches/migraines
- Unusual vaginal bleeding or spotting
- Breast pain, tenderness, or lumps
- Swelling in ankles or legs (fluid retention)
- Abdominal pain or bloating
- Changes in vision
- Symptoms of blood clot (e.g., chest pain, shortness of breath, leg pain/swelling, sudden severe headache, speech changes)
- Symptoms of liver problems (e.g., yellowing of skin/eyes, dark urine, severe stomach pain)
Special Patient Groups
Pregnancy
Contraindicated in pregnancy. Estrogen use during pregnancy is associated with an increased risk of birth defects and should not be used.
Trimester-Specific Risks:
First Trimester:
Increased risk of congenital anomalies, particularly cardiovascular and limb defects, if exposed during early pregnancy.
Second Trimester:
Not applicable, as use is contraindicated.
Third Trimester:
Not applicable, as use is contraindicated.
Lactation
Contraindicated during lactation. Estrogens are excreted in breast milk and can reduce the quantity and quality of breast milk. Potential adverse effects on the nursing infant are unknown but possible.
Infant Risk:
L5 (Contraindicated - significant documented hazard to infant)
Pediatric Use
Not indicated for pediatric use. Safety and efficacy have not been established in pediatric patients.
Geriatric Use
Use with caution in women 65 years of age or older. Increased risk of stroke and probable dementia has been reported in women 65 years of age or older receiving estrogen-alone therapy. The lowest effective dose for the shortest duration should be used. Close monitoring for adverse cardiovascular and cognitive events is recommended.
Clinical Information
Clinical Pearls
- Transdermal estradiol bypasses first-pass hepatic metabolism, which may result in a more favorable lipid profile and potentially lower risk of venous thromboembolism (VTE) compared to oral estrogens, though VTE risk is still present.
- For women with an intact uterus, a progestin must be co-administered to reduce the risk of endometrial hyperplasia and cancer.
- The 0.1 mg/day patch is the highest available dose and is typically reserved for severe vasomotor symptoms or when lower doses are ineffective.
- Patients should be educated on proper patch application and rotation to ensure consistent drug delivery and minimize skin irritation.
- Regular re-evaluation of the need for continued therapy is crucial, as hormone therapy should be used for the shortest duration consistent with treatment goals.
Alternative Therapies
- Other forms of hormone therapy (e.g., oral conjugated estrogens, oral estrogen/progestin combinations)
- Selective Estrogen Receptor Modulators (SERMs) (e.g., bazedoxifene/conjugated estrogens for vasomotor symptoms and osteoporosis prevention, ospemifene for dyspareunia)
- Non-hormonal therapies for vasomotor symptoms (e.g., SSRIs/SNRIs like paroxetine, venlafaxine; gabapentin; clonidine)
- Bisphosphonates, denosumab, teriparatide for osteoporosis prevention/treatment
Cost & Coverage
Average Cost:
$100 - $300 per 8 patches (1 month supply)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic), Tier 3 or higher (for brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.