Estradiol 0.025mg 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
Hormone Replacement Therapy (HRT)
Pharmacologic Class
Estrogen Receptor Agonist
Pregnancy Category
Category X
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Estradiol is a type of estrogen, a female hormone. This patch delivers estradiol through your skin to help relieve symptoms of menopause, such as hot flashes and vaginal dryness. It can also help prevent bone loss (osteoporosis) after menopause. You apply a new patch to your skin twice a week.
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.
Before and after applying the patch, wash your hands thoroughly.
Place the patch on clean, dry, and healthy skin on either the lower belly or upper buttocks. With each new patch, move the application site to a different area.
Wait at least 7 days before applying a patch to the same site again.
Do not apply the patch to skin with any problems or irritations.
Avoid placing the patch on the breast or on skin where you have recently used creams, oils, lotions, powder, or other skin products, as this may affect the patch's adhesion.
Choose a hair-free site for the patch to ensure proper adhesion.
Do not apply the patch to the waistline or to an area where sitting may cause it to come off.
Do not cut or divide the patches, and do not use damaged patches.
Replacing a Patch
If the patch falls off, reapply it as soon as possible. If you are unable to reapply the patch, place a new one in a different area.
Wear only one patch at a time.
Disposing of Used Patches
After removing a used patch, fold the sticky sides together and dispose of it in a secure location where children and pets cannot access it.
Storage and Disposal
Store this medication at room temperature in a dry place, avoiding bathrooms.
Keep used patches out of reach of children and pets.
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.
Before and after applying the patch, wash your hands thoroughly.
Place the patch on clean, dry, and healthy skin on either the lower belly or upper buttocks. With each new patch, move the application site to a different area.
Wait at least 7 days before applying a patch to the same site again.
Do not apply the patch to skin with any problems or irritations.
Avoid placing the patch on the breast or on skin where you have recently used creams, oils, lotions, powder, or other skin products, as this may affect the patch's adhesion.
Choose a hair-free site for the patch to ensure proper adhesion.
Do not apply the patch to the waistline or to an area where sitting may cause it to come off.
Do not cut or divide the patches, and do not use damaged patches.
Replacing a Patch
If the patch falls off, reapply it as soon as possible. If you are unable to reapply the patch, place a new one in a different area.
Wear only one patch at a time.
Disposing of Used Patches
After removing a used patch, fold the sticky sides together and dispose of it in a secure location where children and pets cannot access it.
Storage and Disposal
Store this medication at room temperature in a dry place, avoiding bathrooms.
Keep used patches out of reach of children and pets.
Missed Dose
* If you miss a dose, apply a new patch as soon as you remember, after removing the old one.
Lifestyle & Tips
- Do not smoke, as smoking significantly increases the risk of blood clots, stroke, and heart attack, especially when taking estrogen.
- Maintain a healthy diet and engage in regular physical activity to support overall health and bone density.
- Limit alcohol intake.
- Perform regular breast self-exams and attend scheduled mammograms and doctor's appointments.
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:
Apply one 0.025 mg patch transdermally to the lower abdomen or buttocks twice weekly (every 3-4 days).
Dose Range:
0.025 - 0.1 mg
Condition-Specific Dosing:
menopausalSymptoms:
Initial dose typically 0.025 mg twice weekly, adjusted based on clinical response and tolerability. Lowest effective dose for shortest duration is recommended.
osteoporosisProphylaxis:
0.025 mg twice weekly may be used, but higher doses (e.g., 0.05 mg) may be more effective for bone density.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (except for specific conditions like hypogonadism, where dosing would differ and be individualized)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment generally needed, but monitor for fluid retention.
Moderate:
No specific dose adjustment generally needed, but monitor for fluid retention.
Severe:
Use with caution; monitor for fluid retention and potential for increased estrogen levels due to impaired excretion of metabolites.
Dialysis:
Use with caution; monitor for fluid retention and potential for increased estrogen levels.
Hepatic Impairment:
Mild:
Use with caution; monitor for adverse effects.
Moderate:
Use with caution; consider lower doses and close monitoring due to impaired estrogen metabolism.
Severe:
Contraindicated in severe hepatic dysfunction or active liver disease due to impaired metabolism and increased risk of cholestasis and other adverse effects.
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 (e.g., reproductive organs, breast, bone, brain, liver). This binding leads to a cascade of intracellular events, including gene transcription and protein synthesis, mediating the physiological effects of estrogen, such as maintaining female reproductive health, bone density, and influencing lipid metabolism.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 80% (transdermal, relative to oral), bypasses first-pass hepatic metabolism.
Tmax:
Approximately 1-2 days (for steady-state levels with transdermal patch).
FoodEffect:
Not applicable for transdermal administration.
Distribution:
Vd:
Approximately 1.2 L/kg (for estradiol).
ProteinBinding:
Approximately 98% (primarily to sex hormone-binding globulin (SHBG) and albumin).
CnssPenetration:
Limited (though estrogens do have central nervous system effects, the extent of penetration for therapeutic levels is not high).
Elimination:
HalfLife:
Approximately 1-2 hours (for circulating estradiol, but sustained release from patch provides continuous levels over days).
Clearance:
Approximately 650-900 mL/min/1.73mΒ².
ExcretionRoute:
Renal (primarily as glucuronide and sulfate conjugates).
Unchanged:
<1% (excreted unchanged in urine).
Pharmacodynamics
OnsetOfAction:
Gradual, typically within days to weeks for symptomatic relief.
PeakEffect:
Steady-state concentrations achieved within 1-2 weeks of continuous patch application.
DurationOfAction:
Sustained release over 3-4 days per 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) alone relative to placebo. The WHI Memory Study (WHIMS) reported an increased risk of probable dementia in postmenopausal women 65 years of age or older. Other doses of conjugated estrogens and other dosage forms of estrogens and progestins were not studied in the WHI and, in the absence of comparable data, these risks should be assumed to be similar. 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
Serious 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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:
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, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; fever with chills; bloating; or severe upset stomach or vomiting.
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe upset stomach or vomiting.
Signs of high blood pressure: severe headache or dizziness, passing out, or changes in eyesight.
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred eyesight.
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel.
Breast lump, breast pain or soreness, or nipple discharge.
Vaginal itching or discharge.
Abnormal vaginal bleeding.
Depression or other 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. If you experience swelling, weight gain, or trouble breathing, inform your doctor.
Blood Clots and High Calcium Levels
Seek medical attention immediately if you experience:
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, changes in color, or pain in a leg or arm; or trouble speaking or swallowing.
Signs of high calcium levels: weakness, confusion, fatigue, headache, upset stomach or vomiting, constipation, or bone pain.
Other Side Effects
Most medications can cause side effects, but many people experience none or only mild side effects. If you experience any of the following side effects or any other side effects that bother you or do not go away, contact your doctor or seek medical attention:
Dizziness or headache.
Hair loss.
Upset stomach or vomiting.
Constipation.
Stomach pain or cramps.
Bloating.
Enlarged breasts.
Tender breasts.
Vaginal bleeding or spotting.
Painful periods.
Signs of a common cold.
Nose or throat irritation.
Weight gain or loss.
Joint pain.
Leg cramps.
Changes in sex interest.
Irritation at the site of medication administration.
Reporting Side Effects
These are not all the possible side effects that may occur. If you have questions about side effects, contact your doctor. You can 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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:
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, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; fever with chills; bloating; or severe upset stomach or vomiting.
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe upset stomach or vomiting.
Signs of high blood pressure: severe headache or dizziness, passing out, or changes in eyesight.
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred eyesight.
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel.
Breast lump, breast pain or soreness, or nipple discharge.
Vaginal itching or discharge.
Abnormal vaginal bleeding.
Depression or other 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. If you experience swelling, weight gain, or trouble breathing, inform your doctor.
Blood Clots and High Calcium Levels
Seek medical attention immediately if you experience:
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, changes in color, or pain in a leg or arm; or trouble speaking or swallowing.
Signs of high calcium levels: weakness, confusion, fatigue, headache, upset stomach or vomiting, constipation, or bone pain.
Other Side Effects
Most medications can cause side effects, but many people experience none or only mild side effects. If you experience any of the following side effects or any other side effects that bother you or do not go away, contact your doctor or seek medical attention:
Dizziness or headache.
Hair loss.
Upset stomach or vomiting.
Constipation.
Stomach pain or cramps.
Bloating.
Enlarged breasts.
Tender breasts.
Vaginal bleeding or spotting.
Painful periods.
Signs of a common cold.
Nose or throat irritation.
Weight gain or loss.
Joint pain.
Leg cramps.
Changes in sex interest.
Irritation at the site of medication administration.
Reporting Side Effects
These are not all the possible side effects that may occur. If you have questions about side effects, contact your doctor. You can 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 chest pain or shortness of breath (signs of blood clot in lungs or heart attack).
- Sudden severe headache, dizziness, or vision changes (signs of stroke).
- Numbness or weakness in an arm or leg (signs of stroke).
- Swelling, warmth, or pain in your leg (signs of deep vein thrombosis).
- Abnormal vaginal bleeding (e.g., bleeding after menopause, unusually heavy or prolonged bleeding).
- New breast lump or changes in your breasts.
- Yellowing of your skin or eyes (jaundice).
- Severe abdominal pain.
- Mood changes or depression.
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, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
A history of certain health conditions, including:
+ Bleeding disorders
+ Blood clots or an increased risk of blood clots
+ Breast cancer
+ Liver problems or liver tumors
+ Heart attack
+ Stroke
+ Tumors that are sensitive to estrogen
Unexplained vaginal bleeding
Pregnancy or potential pregnancy. Note: This medication should not be taken during pregnancy.
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 if it is safe to take this medication with your other medications and health conditions. Do not initiate, stop, 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, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
A history of certain health conditions, including:
+ Bleeding disorders
+ Blood clots or an increased risk of blood clots
+ Breast cancer
+ Liver problems or liver tumors
+ Heart attack
+ Stroke
+ Tumors that are sensitive to estrogen
Unexplained vaginal bleeding
Pregnancy or potential pregnancy. Note: This medication should not be taken during pregnancy.
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 if it is safe to take this medication with your other medications and health conditions. Do not initiate, stop, 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 immobility may increase your risk of developing blood clots. If you have diabetes, it is crucial to closely monitor your blood sugar levels.
Be aware that medications like this one can cause high blood pressure. Follow your doctor's instructions for regular blood pressure checks. Additionally, have your blood work and bone density checked 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.
High triglyceride levels have been associated with this medication. If you have a history of high triglyceride levels, inform your doctor. This drug may cause dark skin patches on your face, so it is essential to avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear.
This medication may affect certain laboratory tests, so inform all your healthcare providers and lab workers that you are taking this drug. Smoking increases the risk of heart disease, so it is recommended that you do not smoke. Limit your alcohol consumption and discuss any concerns with your doctor. If you regularly consume grapefruit juice or eat grapefruit, consult 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. Follow the diet and exercise plan recommended by your doctor.
In some cases, this medication may affect growth in children and teenagers, so regular growth checks may be necessary. Discuss any concerns with your doctor. If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you are breastfeeding, consult with 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 immobility may increase your risk of developing blood clots. If you have diabetes, it is crucial to closely monitor your blood sugar levels.
Be aware that medications like this one can cause high blood pressure. Follow your doctor's instructions for regular blood pressure checks. Additionally, have your blood work and bone density checked 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.
High triglyceride levels have been associated with this medication. If you have a history of high triglyceride levels, inform your doctor. This drug may cause dark skin patches on your face, so it is essential to avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear.
This medication may affect certain laboratory tests, so inform all your healthcare providers and lab workers that you are taking this drug. Smoking increases the risk of heart disease, so it is recommended that you do not smoke. Limit your alcohol consumption and discuss any concerns with your doctor. If you regularly consume grapefruit juice or eat grapefruit, consult 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. Follow the diet and exercise plan recommended by your doctor.
In some cases, this medication may affect growth in children and teenagers, so regular growth checks may be necessary. Discuss any concerns with your doctor. If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you are breastfeeding, consult with 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). Overdose with transdermal patches is rare due to the controlled release mechanism.
Drug Interactions
Contraindicated Interactions
- Aromatase inhibitors (e.g., anastrozole, letrozole) - concurrent use would counteract their mechanism of action in breast cancer.
Major Interactions
- CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort) - may significantly decrease estradiol levels, reducing efficacy.
- CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, ketoconazole, ritonavir) - may increase estradiol levels, potentially increasing adverse effects.
- Thyroid hormone replacement (e.g., levothyroxine) - estrogens can increase thyroid-binding globulin, potentially increasing thyroid hormone requirements.
Moderate Interactions
- Corticosteroids (e.g., prednisone) - estrogens may decrease corticosteroid clearance, increasing their effects.
- Anticoagulants (e.g., warfarin) - estrogens may alter anticoagulant effects; monitor INR closely.
- Folic acid - high doses of folic acid may reduce estrogen levels.
- Grapefruit juice - may inhibit CYP3A4, potentially increasing estrogen levels (less significant for transdermal).
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Complete medical history and physical examination (including blood pressure, breast exam, pelvic exam)
Rationale: To identify contraindications, risk factors for adverse events (e.g., cardiovascular disease, breast cancer), and establish baseline health status.
Timing: Prior to initiation of therapy.
Mammogram
Rationale: To screen for pre-existing breast abnormalities or cancer.
Timing: Prior to initiation of therapy, and periodically thereafter as per screening guidelines.
Lipid profile
Rationale: To assess cardiovascular risk factors, as estrogens can affect lipid metabolism.
Timing: Prior to initiation of therapy.
Liver function tests (LFTs)
Rationale: To assess hepatic function, especially in patients with a history of liver disease.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood pressure
Frequency: Annually, or more frequently if clinically indicated.
Target: <120/80 mmHg
Action Threshold: Sustained elevation (e.g., >140/90 mmHg) warrants investigation and management.
Breast examination
Frequency: Annually by a healthcare provider, and monthly self-exam.
Target: Normal findings
Action Threshold: Any new lumps, pain, or nipple discharge warrants immediate investigation.
Mammogram
Frequency: As per national screening guidelines (e.g., every 1-2 years for women over 40-50).
Target: Normal findings
Action Threshold: Abnormal findings (e.g., suspicious lesions) warrant further diagnostic imaging and/or biopsy.
Pelvic examination (including Pap test if indicated)
Frequency: Annually, or as per screening guidelines.
Target: Normal findings
Action Threshold: Abnormal findings (e.g., abnormal bleeding, uterine fibroids, ovarian cysts) warrant further investigation.
Symptom assessment (e.g., hot flashes, vaginal dryness)
Frequency: Regularly, especially during dose titration and at annual visits.
Target: Improved or resolved symptoms with minimal side effects.
Action Threshold: Persistent or worsening symptoms, or intolerable side effects, warrant dose adjustment or consideration of alternative therapy.
Symptom Monitoring
- Signs and symptoms of thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction): sudden chest pain, shortness of breath, sudden severe headache, sudden vision changes, numbness or weakness in an arm or leg, swelling or pain in a leg.
- Abnormal vaginal bleeding (e.g., postmenopausal bleeding, irregular bleeding).
- Breast lumps or changes.
- Severe abdominal pain.
- Jaundice (yellowing of skin or eyes).
- Mood changes, depression.
Special Patient Groups
Pregnancy
Contraindicated during pregnancy. There is no indication for estrogen therapy in pregnancy, and there is evidence of fetal harm (e.g., genital abnormalities in female fetuses exposed to diethylstilbestrol, a synthetic estrogen).
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on fetal development, particularly genital abnormalities.
Second Trimester:
Not indicated; continued exposure could lead to fetal harm.
Third Trimester:
Not indicated; continued exposure could lead to fetal harm.
Lactation
Not recommended during lactation. Estrogens are excreted in breast milk and can reduce the quantity and quality of breast milk. Potential adverse effects on the infant are not well-established but generally avoided.
Infant Risk:
L3 (Moderate risk) - Potential for decreased milk production and excretion into breast milk. Monitor infant for potential effects, though generally considered low risk for direct harm to infant.
Pediatric Use
Not indicated for use in pediatric patients for menopausal symptoms. Safety and efficacy have not been established in this population. Use in specific conditions like hypogonadism would be individualized and at different doses.
Geriatric Use
Use with caution in women 65 years of age or older. The WHI study showed an increased risk of probable dementia in women 65 years of age or older treated with conjugated estrogens alone or in combination with medroxyprogesterone acetate. Use the lowest effective dose for the shortest duration. Close monitoring for adverse events, particularly cardiovascular and cognitive, is recommended.
Clinical Information
Clinical Pearls
- Apply the patch to a clean, dry, hairless area of the lower abdomen or buttocks. Avoid the breasts, waistline, or areas that may be rubbed by clothing.
- Rotate application sites to prevent skin irritation. Allow at least one week between applications to the same site.
- If a patch falls off, reapply the same patch or apply a new one to a different site. If it's close to the time for the next scheduled patch change, wait and apply a new patch at the regular time.
- Do not apply lotions, oils, or powders to the skin area where the patch will be applied, as this can interfere with adhesion.
- Transdermal estradiol bypasses first-pass hepatic metabolism, potentially leading to a more favorable lipid profile and less impact on clotting factors compared to oral estrogens, though cardiovascular risks still exist.
- For women with an intact uterus, a progestin must be co-administered to reduce the risk of endometrial hyperplasia and cancer associated with unopposed estrogen therapy.
Alternative Therapies
- Selective Estrogen Receptor Modulators (SERMs) (e.g., bazedoxifene/conjugated estrogens, ospemifene, tamoxifen, raloxifene)
- Non-hormonal therapies for hot flashes (e.g., SSRIs/SNRIs like paroxetine, venlafaxine; gabapentin; clonidine)
- Vaginal estrogen products for localized symptoms (e.g., creams, rings, tablets)
- Bisphosphonates or other anti-resorptive agents for osteoporosis prevention/treatment (if HRT is contraindicated or not desired for bone health)
Cost & Coverage
Average Cost:
Varies widely, typically $50 - $200+ per 8 patches (1 month supply)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 for generic versions; Tier 2 or Tier 3 for brand-name versions, depending on insurance plan formulary.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, 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 this 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.