Estradiol 0.05mg Patch (once 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
Pregnancy Category
Category X
FDA Approved
Mar 1986
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 thinning (osteoporosis) after menopause. You apply a new patch once 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.
Administration
Do not take this medication by mouth. It is for skin use 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.
Preparation and Application
Wash your hands before and after handling the patch to ensure cleanliness.
Choose a clean, dry, and healthy area of skin on your lower belly or upper buttocks for patch application.
Rotate the patch site with each new application, avoiding the same spot for at least 7 days.
Do not apply the patch to skin with any problems, such as irritation, cuts, or wounds.
Avoid applying the patch to the breast area.
Do not apply the patch to skin that has recently been treated with creams, oils, lotions, powder, or other skin products, as this may affect the patch's adhesion.
Select a hair-free area for patch application.
Avoid placing the patch on the waistline or on an area that may cause the patch to come off when sitting.
Do not cut or divide the patches, and do not use damaged patches.
Patch Replacement and Disposal
If the patch falls off, reapply it to the same area. If it cannot be reapplied, attach a new patch to a different area.
Wear only one patch at a time.
After removing a used patch, fold the sticky sides together and dispose of it in a secure location, out of reach of children and pets.
Storage and Disposal
Store the medication at room temperature in a dry place, avoiding bathrooms.
Dispose of used patches and packaging according to local regulations and guidelines.
Missed Dose
If you miss a dose, apply a new patch as soon as possible 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.
Administration
Do not take this medication by mouth. It is for skin use 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.
Preparation and Application
Wash your hands before and after handling the patch to ensure cleanliness.
Choose a clean, dry, and healthy area of skin on your lower belly or upper buttocks for patch application.
Rotate the patch site with each new application, avoiding the same spot for at least 7 days.
Do not apply the patch to skin with any problems, such as irritation, cuts, or wounds.
Avoid applying the patch to the breast area.
Do not apply the patch to skin that has recently been treated with creams, oils, lotions, powder, or other skin products, as this may affect the patch's adhesion.
Select a hair-free area for patch application.
Avoid placing the patch on the waistline or on an area that may cause the patch to come off when sitting.
Do not cut or divide the patches, and do not use damaged patches.
Patch Replacement and Disposal
If the patch falls off, reapply it to the same area. If it cannot be reapplied, attach a new patch to a different area.
Wear only one patch at a time.
After removing a used patch, fold the sticky sides together and dispose of it in a secure location, out of reach of children and pets.
Storage and Disposal
Store the medication at room temperature in a dry place, avoiding bathrooms.
Dispose of used patches and packaging according to local regulations and guidelines.
Missed Dose
If you miss a dose, apply a new patch as soon as possible after removing the old one.
Lifestyle & Tips
- Apply the patch to a clean, dry area of skin on your lower abdomen or buttocks. Avoid applying to breasts, waistline, or areas with excessive hair or scars.
- Rotate application sites to prevent skin irritation. Do not apply to the same site twice in a row.
- If a patch falls off, try to reapply it. If it doesn't stick, apply a new patch and continue your original schedule.
- Avoid exposing the patch to direct sunlight for prolonged periods.
- Discuss any unusual vaginal bleeding with your doctor immediately.
- Regularly perform breast self-exams and attend scheduled mammograms and physical exams.
- 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:
Apply one 0.05 mg/day patch transdermally once weekly. The patch should be worn continuously for 7 days and then replaced with a new patch.
Dose Range:
0.025 - 0.1 mg
Condition-Specific Dosing:
vasomotorSymptoms:
Initial dose typically 0.025 mg/day or 0.0375 mg/day patch applied weekly, adjusted based on response. 0.05 mg/day is a common effective dose.
preventionOfOsteoporosis:
0.025 mg/day patch applied weekly.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (except for specific conditions like Turner Syndrome, where dosing differs and is not typically weekly patch)
GenderDysphoria:
Dosing varies significantly and is individualized, often starting lower and titrating up. Not typically the 0.05mg/week patch for initial therapy.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
Use with caution; estrogen metabolism may be impaired. Monitor for adverse effects.
Dialysis:
Not available
Hepatic Impairment:
Mild:
Use with caution; estrogen metabolism may be impaired. Monitor for adverse effects.
Moderate:
Contraindicated due to impaired estrogen metabolism and increased risk of cholestasis.
Severe:
Contraindicated due to impaired estrogen metabolism and increased risk of cholestasis.
Pharmacology
Mechanism of Action
Estradiol is the primary estrogen secreted by the human ovary. It binds to estrogen receptors (ERΞ± and ERΞ²) in target tissues (e.g., uterus, breast, hypothalamus, pituitary, bone, cardiovascular system). This binding leads to gene transcription and protein synthesis, mediating the physiological effects of estrogen, including the alleviation of vasomotor symptoms, prevention of bone loss, and maintenance of urogenital tissue integrity. Transdermal administration provides sustained systemic levels of estradiol, bypassing first-pass hepatic metabolism.
Pharmacokinetics
Absorption:
Bioavailability:
High (transdermal bypasses first-pass metabolism, leading to higher bioavailability compared to oral)
Tmax:
Approximately 24-48 hours after patch application
FoodEffect:
Not applicable (transdermal)
Distribution:
Vd:
Approximately 1.2 L/kg
ProteinBinding:
Approximately 98% (primarily to sex hormone-binding globulin (SHBG) and albumin)
CnssPenetration:
Yes (estrogen receptors are present in the CNS)
Elimination:
HalfLife:
Approximately 1-2 hours (for estradiol itself, but sustained release from patch provides prolonged effect)
Clearance:
Not available
ExcretionRoute:
Renal (primarily as glucuronide and sulfate conjugates)
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Within days to weeks for symptomatic relief
PeakEffect:
Within 2-4 weeks for full therapeutic effect
DurationOfAction:
7 days (due to continuous release from patch)
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
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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of gallbladder problems, such as:
+ Pain in the upper right belly area, right shoulder area, or between the shoulder blades
+ Yellow skin or eyes
+ Fever with chills
+ Bloating
+ Severe upset stomach or vomiting
Signs of pancreatitis (pancreas problem), including:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
Eyesight changes or loss
Bulging eyes
Changes in how contact lenses feel
Breast lump, pain, or soreness
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, leading to swelling, weight gain, or breathing difficulties. Inform your doctor if you experience any of these symptoms.
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
Trouble 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
Upset stomach or vomiting
Constipation
Bone pain
Other Possible Side Effects
Most people do not experience severe side effects, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Dizziness or headache
Hair loss
Upset stomach or vomiting
Constipation
Stomach pain or cramps
Bloating
Enlarged or tender breasts
Vaginal bleeding or spotting
Painful periods
Common cold symptoms
Nose or throat irritation
Weight gain or loss
Joint pain
Leg cramps
Changes in sex interest
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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of gallbladder problems, such as:
+ Pain in the upper right belly area, right shoulder area, or between the shoulder blades
+ Yellow skin or eyes
+ Fever with chills
+ Bloating
+ Severe upset stomach or vomiting
Signs of pancreatitis (pancreas problem), including:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
Eyesight changes or loss
Bulging eyes
Changes in how contact lenses feel
Breast lump, pain, or soreness
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, leading to swelling, weight gain, or breathing difficulties. Inform your doctor if you experience any of these symptoms.
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
Trouble 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
Upset stomach or vomiting
Constipation
Bone pain
Other Possible Side Effects
Most people do not experience severe side effects, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Dizziness or headache
Hair loss
Upset stomach or vomiting
Constipation
Stomach pain or cramps
Bloating
Enlarged or tender breasts
Vaginal bleeding or spotting
Painful periods
Common cold symptoms
Nose or throat irritation
Weight gain or loss
Joint pain
Leg cramps
Changes in sex interest
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 chest pain or shortness of breath
- Sudden severe headache or migraine
- Sudden vision changes (e.g., partial or complete loss of vision)
- Sudden numbness or weakness, especially on one side of the body
- Slurred speech or difficulty speaking
- Severe pain, swelling, or redness in one leg
- Yellowing of the skin or eyes (jaundice)
- Unusual vaginal bleeding (e.g., bleeding after menopause, heavy bleeding, or bleeding between periods)
- New breast lump or changes in breasts
- Severe abdominal pain
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 or stroke
+ Tumors that are sensitive to estrogen
Unexplained vaginal bleeding
Pregnancy or suspected pregnancy. Do not take this medication if you are pregnant, as it may harm the fetus.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose 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 or stroke
+ Tumors that are sensitive to estrogen
Unexplained vaginal bleeding
Pregnancy or suspected pregnancy. Do not take this medication if you are pregnant, as it may harm the fetus.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose 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.
Be aware that medications like this one can cause high blood pressure. Follow your doctor's instructions for regular blood pressure checks. You should also have your blood work and bone density checked as directed 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.
This medication may cause an increase in triglyceride levels. If you have a history of high triglyceride levels, inform your doctor. You may also experience dark patches of skin on your face, so it is essential to avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear when going outside.
This medication may affect certain laboratory tests, so be sure to inform all your healthcare providers and lab workers 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. Follow 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 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 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.
Be aware that medications like this one can cause high blood pressure. Follow your doctor's instructions for regular blood pressure checks. You should also have your blood work and bone density checked as directed 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.
This medication may cause an increase in triglyceride levels. If you have a history of high triglyceride levels, inform your doctor. You may also experience dark patches of skin on your face, so it is essential to avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear when going outside.
This medication may affect certain laboratory tests, so be sure to inform all your healthcare providers and lab workers 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. Follow 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 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. Seek immediate medical attention or call a poison control center (1-800-222-1222).
Drug Interactions
Contraindicated Interactions
- Aromatase inhibitors (e.g., anastrozole, letrozole) - concurrent use would counteract their mechanism of action in breast cancer treatment.
Major Interactions
- CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort): May decrease estradiol levels, reducing efficacy.
- CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, ketoconazole, ritonavir, grapefruit juice): May increase estradiol levels, increasing risk of adverse effects.
- Thyroid hormone replacement therapy (e.g., levothyroxine): Estrogens can increase thyroid-binding globulin (TBG), potentially increasing the need for thyroid hormone.
Moderate Interactions
- Corticosteroids: Estrogens may decrease the clearance of corticosteroids, leading to increased effects.
- Warfarin: Estrogens may alter the effects of anticoagulants; monitor INR.
- Lamotrigine: Estrogens may decrease lamotrigine levels, potentially leading to loss of seizure control.
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, and establish baseline health status.
Timing: Prior to initiation of therapy.
Mammogram
Rationale: To screen for breast cancer before starting estrogen therapy.
Timing: Prior to initiation, as per screening guidelines.
Lipid profile
Rationale: Estrogens can affect lipid metabolism.
Timing: Prior to initiation.
Liver function tests (LFTs)
Rationale: To assess hepatic function, as estrogens are metabolized by the liver.
Timing: Prior to initiation, especially if history of liver disease.
Routine Monitoring
Blood pressure
Frequency: Annually, or more frequently if hypertension is present.
Target: <130/80 mmHg
Action Threshold: Sustained elevation requiring intervention.
Breast exam and mammogram
Frequency: Annually (breast exam); mammogram as per screening guidelines (e.g., every 1-2 years).
Target: Normal findings
Action Threshold: New lumps, pain, or abnormal mammogram findings require immediate investigation.
Pelvic exam and Pap test
Frequency: Annually (pelvic exam); Pap test as per screening guidelines.
Target: Normal findings
Action Threshold: Abnormal bleeding, pain, or Pap test results require investigation.
Symptoms of venous thromboembolism (VTE) or stroke
Frequency: Ongoing patient education and monitoring.
Target: Absence of symptoms
Action Threshold: Sudden chest pain, shortness of breath, leg swelling, severe headache, vision changes, or speech difficulties require immediate medical attention.
Symptom Monitoring
- Breast tenderness or pain
- Nausea
- Headache
- Fluid retention/bloating
- Mood changes
- Vaginal bleeding (especially if unexpected or heavy)
- Symptoms of VTE (e.g., leg pain/swelling, chest pain, shortness of breath)
- Symptoms of stroke (e.g., sudden numbness/weakness, vision changes, severe headache, confusion, speech difficulty)
Special Patient Groups
Pregnancy
Contraindicated in pregnancy. Estrogen use during pregnancy is associated with an increased risk of birth defects and should be avoided.
Trimester-Specific Risks:
First Trimester:
Increased risk of birth defects, particularly cardiovascular and limb defects, if exposure occurs during critical periods of organogenesis.
Second Trimester:
Not indicated; continued exposure may affect fetal development.
Third Trimester:
Not indicated; continued exposure may affect fetal development.
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 breastfed infant are unknown but generally not recommended.
Infant Risk:
L5 (Contraindicated - significant documented risk to infant or to milk production)
Pediatric Use
Not indicated for pediatric use for menopausal symptoms. Safety and efficacy have not been established in pediatric patients. Use in specific conditions like Turner Syndrome is off-label and requires specialized dosing.
Geriatric Use
Use with caution in women 65 years of age or older. The WHI study showed an increased risk of stroke and probable dementia in women 65 years of age or older receiving estrogen-alone therapy. Use the lowest effective dose for the shortest duration consistent with treatment goals. Monitor closely for adverse cardiovascular and cognitive effects.
Clinical Information
Clinical Pearls
- Transdermal estradiol bypasses first-pass hepatic metabolism, potentially leading to a more favorable lipid profile and lower risk of VTE compared to oral estrogens, though risks still exist.
- Ensure patients understand the importance of rotating patch application sites to minimize skin irritation.
- Emphasize the Black Box Warning regarding cardiovascular events, stroke, and cancer risks, and discuss these thoroughly with patients.
- For women with an intact uterus, progestin therapy is typically required in combination with estrogen to reduce the risk of endometrial hyperplasia and cancer.
- Consider transdermal route for patients with hypertriglyceridemia, liver disease (if not severe), or those at higher risk for VTE (after careful risk-benefit assessment).
Alternative Therapies
- Oral estrogens (e.g., conjugated estrogens, oral estradiol)
- Vaginal estrogens (for localized symptoms only)
- Selective Estrogen Receptor Modulators (SERMs) (e.g., bazedoxifene/conjugated estrogens, ospemifene, tamoxifen, raloxifene)
- Non-hormonal therapies for vasomotor symptoms (e.g., SSRIs/SNRIs like paroxetine, venlafaxine; gabapentin; clonidine)
- Bio-identical hormone therapy (compounded, not FDA-approved)
Cost & Coverage
Average Cost:
$50 - $200 per 4 patches (1 month supply)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic), Tier 3 or higher (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 this medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.