Climara 0.025mg/day Patches 4's
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
Pharmacologic Class
Estrogen Receptor Agonist
Pregnancy Category
Category X
FDA Approved
Mar 1994
DEA Schedule
Not Controlled
Overview
What is this medicine?
Climara is a patch that you apply to your skin once a week. It contains the hormone estradiol, which is a form of estrogen. It's used to help relieve symptoms of menopause like hot flashes and vaginal dryness, 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 skin use only. Avoid getting it 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 your lower belly or upper buttocks. With each new patch, choose a different site to avoid skin irritation.
Wait at least 7 days before applying a patch to the same site again.
Avoid applying the patch to skin with problems, such as cuts, wounds, or irritations.
Do not apply the patch to your breast or to 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 it adheres properly.
Avoid placing the patch on your waistline or on a site that may cause it to come off when sitting.
Do not cut or divide the patches, and do not use damaged patches.
Managing Patch Issues
If the patch falls off, try to reapply it. If you're unable to reapply the patch, place a new one on a different area.
Wear only one patch at a time to avoid excessive medication.
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.
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 skin use only. Avoid getting it 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 your lower belly or upper buttocks. With each new patch, choose a different site to avoid skin irritation.
Wait at least 7 days before applying a patch to the same site again.
Avoid applying the patch to skin with problems, such as cuts, wounds, or irritations.
Do not apply the patch to your breast or to 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 it adheres properly.
Avoid placing the patch on your waistline or on a site that may cause it to come off when sitting.
Do not cut or divide the patches, and do not use damaged patches.
Managing Patch Issues
If the patch falls off, try to reapply it. If you're unable to reapply the patch, place a new one on a different area.
Wear only one patch at a time to avoid excessive medication.
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.
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
- Apply the patch to a clean, dry area of skin on your lower abdomen or buttocks. Avoid the waistline, breasts, or irritated skin.
- Rotate the application site with each new patch to prevent skin irritation.
- Do not apply cream, lotion, or oil to the skin area where you plan to apply the patch.
- If a patch falls off, try to reapply it. If it doesn't stick, apply a new patch for the remainder of the 7-day dosing interval.
- Avoid direct sunlight or prolonged heat exposure to the patch site (e.g., hot tubs, saunas) as this may increase estrogen absorption.
- Regular exercise and a calcium/vitamin D rich diet are important for bone health, especially if using for osteoporosis prevention.
- Quit smoking, as smoking increases the risk of blood clots and other serious side effects with estrogen therapy.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
0.025 mg/day patch applied once weekly
Dose Range:
0.025 - 0.1 mg
Condition-Specific Dosing:
vasomotorSymptoms:
Initial dose 0.025 mg/day, adjusted as needed to control symptoms. Apply once weekly.
vulvarAndVaginalAtrophy:
Initial dose 0.025 mg/day, adjusted as needed. Apply once weekly.
osteoporosisPrevention:
0.025 mg/day patch applied once weekly. Consider higher doses (e.g., 0.05 mg/day) if bone mineral density response is inadequate, but use lowest effective dose.
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, but use with caution.
Moderate:
No specific dose adjustment recommended, but use with caution.
Severe:
No specific dose adjustment recommended, but use with caution. Estrogens are primarily metabolized by the liver.
Dialysis:
Not specifically studied; use with caution due to potential for fluid retention and exacerbation of renal disease.
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 in severe hepatic impairment due to impaired estrogen metabolism and potential for cholestasis.
Pharmacology
Mechanism of Action
Estradiol is the primary estrogen secreted by the human ovary. It binds to and activates 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 the development and maintenance of female reproductive organs and secondary sex characteristics. In menopausal women, it replaces declining endogenous estrogen levels to alleviate symptoms like hot flashes and vaginal atrophy, and to prevent bone loss.
Pharmacokinetics
Absorption:
Bioavailability:
Transdermal administration bypasses first-pass hepatic metabolism, resulting in more stable serum estradiol concentrations and a higher estradiol-to-estrone ratio compared to oral administration.
Tmax:
Approximately 24-48 hours after patch application.
FoodEffect:
Not applicable for transdermal patch.
Distribution:
Vd:
Not specifically quantified for transdermal, but estrogens distribute widely throughout the body.
ProteinBinding:
Approximately 98% bound to plasma proteins, primarily sex hormone-binding globulin (SHBG) and albumin.
CnssPenetration:
Yes (estrogens cross the blood-brain barrier and have effects on the CNS).
Elimination:
HalfLife:
Approximately 1-2 hours (for circulating estradiol), but the transdermal system provides sustained release, leading to a longer effective half-life from the patch reservoir.
Clearance:
Not specifically quantified for transdermal, but rapid hepatic clearance.
ExcretionRoute:
Primarily renal (as glucuronide and sulfate conjugates), with some biliary excretion.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Symptomatic relief may begin within days to weeks.
PeakEffect:
Steady-state serum concentrations typically achieved within 2-3 days of initial patch application.
DurationOfAction:
One week (due to weekly 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 study also reported an increased risk 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), an ancillary study of WHI, reported an increased risk of probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily oral conjugated estrogens plus medroxyprogesterone acetate and in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily oral conjugated estrogens alone relative to placebo. These risks apply to all estrogen-alone and estrogen plus progestin products. Estrogen-alone therapy should not be used in women with a uterus because of the increased risk of endometrial cancer.
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 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 problems), 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
While many people may not experience side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical help:
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 potential side effects. If you have questions or concerns, consult 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 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 problems), 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
While many people may not experience side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical help:
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 potential side effects. If you have questions or concerns, consult 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:
- Unusual vaginal bleeding or spotting
- New breast lump or changes in existing breast lumps
- Pain, swelling, or tenderness in your legs
- Sudden chest pain or shortness of breath
- Sudden severe headache, dizziness, or vision changes
- Yellowing of your skin or eyes (jaundice)
- Severe abdominal pain
- Signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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 sensitive to estrogen
Unexplained vaginal bleeding
Pregnancy or suspected pregnancy, as this medication is contraindicated during pregnancy
This medication may interact with other medications or health conditions. Therefore, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss your health problems with your doctor to ensure it is safe to take this medication.
* Never start, stop, or change the dose of any medication without consulting your doctor first.
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 sensitive to estrogen
Unexplained vaginal bleeding
Pregnancy or suspected pregnancy, as this medication is contraindicated during pregnancy
This medication may interact with other medications or health conditions. Therefore, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss your health problems with your doctor to ensure it is safe to take this medication.
* Never start, stop, or change the dose of any medication without consulting your doctor first.
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 anticipate being inactive for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor. Prolonged inactivity may increase your risk of developing blood clots.
If you have diabetes (high blood sugar), it is crucial to closely monitor your blood sugar levels while taking this medication.
Be aware that medications like this one can cause high blood pressure. Follow your doctor's instructions for regular blood pressure checks.
Regularly schedule blood work and bone density tests as recommended by your doctor. Additionally, maintain a routine of regular breast exams and gynecology check-ups, and perform breast self-exams as instructed by your doctor.
The risk of certain side effects, such as heart attack, stroke, breast cancer, and ovarian cancer, 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 medication may cause dark skin patches on your face, so it is essential to avoid sun exposure, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear when outdoors.
Be aware that this medication may affect certain laboratory test results. Inform all your healthcare providers and laboratory personnel that you are taking this medication.
Smoking can increase your risk of heart disease, so it is recommended that you do not smoke. Discuss smoking cessation options with your doctor if needed.
Limit your alcohol consumption while taking this medication. If you regularly drink 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. Adhere to the diet and exercise plan recommended by your doctor.
In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary, so 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.
If you are breastfeeding, consult with your doctor to discuss any potential risks to your baby.
If you anticipate being inactive for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor. Prolonged inactivity may increase your risk of developing blood clots.
If you have diabetes (high blood sugar), it is crucial to closely monitor your blood sugar levels while taking this medication.
Be aware that medications like this one can cause high blood pressure. Follow your doctor's instructions for regular blood pressure checks.
Regularly schedule blood work and bone density tests as recommended by your doctor. Additionally, maintain a routine of regular breast exams and gynecology check-ups, and perform breast self-exams as instructed by your doctor.
The risk of certain side effects, such as heart attack, stroke, breast cancer, and ovarian cancer, 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 medication may cause dark skin patches on your face, so it is essential to avoid sun exposure, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear when outdoors.
Be aware that this medication may affect certain laboratory test results. Inform all your healthcare providers and laboratory personnel that you are taking this medication.
Smoking can increase your risk of heart disease, so it is recommended that you do not smoke. Discuss smoking cessation options with your doctor if needed.
Limit your alcohol consumption while taking this medication. If you regularly drink 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. Adhere to the diet and exercise plan recommended by your doctor.
In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary, so 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.
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 women)
What to Do:
Remove the patch immediately. Seek medical attention if symptoms are severe or persistent. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Contraindicated Interactions
- Aromatase inhibitors (e.g., anastrozole, letrozole, exemestane) - concurrent use would counteract the effect of the aromatase inhibitor in breast cancer treatment.
Major Interactions
- CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort) - may decrease estrogen levels, reducing therapeutic effect.
- CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, ketoconazole, ritonavir, grapefruit juice) - may increase estrogen levels, potentially increasing adverse effects.
- Thyroid hormone replacement therapy (e.g., levothyroxine) - estrogens can increase thyroid-binding globulin (TBG), leading to decreased free thyroid hormone levels and potentially increased thyroid hormone dose requirements.
- Corticosteroids (e.g., prednisone) - estrogens may decrease the clearance of corticosteroids, leading to increased corticosteroid effects and toxicity.
Moderate Interactions
- Warfarin - estrogens may alter the effects of anticoagulants; monitor INR.
- Lamotrigine - estrogens may decrease lamotrigine levels, potentially leading to loss of seizure control.
- Cyclosporine - estrogens may inhibit cyclosporine metabolism, increasing cyclosporine levels and toxicity.
- Theophylline - estrogens may decrease the clearance of theophylline, increasing theophylline levels and toxicity.
Minor Interactions
- Not specifically documented for minor interactions with transdermal estradiol, but general caution with drugs that affect liver enzymes.
Monitoring
Baseline Monitoring
Complete medical history and physical examination (including blood pressure, breast exam, pelvic exam, Pap test)
Rationale: To identify contraindications, risk factors, and establish baseline health status.
Timing: Prior to initiation of therapy.
Lipid profile
Rationale: Estrogens can affect lipid metabolism; establish baseline.
Timing: Prior to initiation.
Liver function tests
Rationale: To assess hepatic function, especially given hepatic metabolism of estrogens.
Timing: Prior to initiation, if clinically indicated.
Mammogram
Rationale: To screen for breast cancer before starting hormone therapy.
Timing: Prior to initiation, as per screening guidelines.
Routine Monitoring
Annual physical examination (including blood pressure, breast exam, pelvic exam, Pap test)
Frequency: Annually
Target: Normal for age
Action Threshold: Any abnormal findings require further investigation.
Mammogram
Frequency: Annually or as per screening guidelines
Target: Normal
Action Threshold: Abnormal findings require further investigation.
Symptoms of endometrial hyperplasia/cancer (e.g., abnormal vaginal bleeding)
Frequency: Ongoing
Target: Absence of symptoms
Action Threshold: Any abnormal bleeding requires prompt investigation to rule out malignancy.
Symptoms of thromboembolic events (e.g., leg pain/swelling, chest pain, shortness of breath)
Frequency: Ongoing
Target: Absence of symptoms
Action Threshold: Immediate medical attention required for any suspected event.
Blood pressure
Frequency: Annually or more frequently if hypertension is present
Target: <130/80 mmHg
Action Threshold: Sustained elevation requires management.
Symptom Monitoring
- Abnormal vaginal bleeding or spotting
- Breast lumps or pain
- Leg pain, swelling, or tenderness (signs of DVT)
- Sudden chest pain or shortness of breath (signs of PE)
- Sudden severe headache, dizziness, or vision changes (signs of stroke)
- Yellowing of skin or eyes (jaundice)
- Severe abdominal pain
- Mood changes, depression
- Fluid retention, swelling of ankles/feet
Special Patient Groups
Pregnancy
Contraindicated in pregnancy. Estrogen use during pregnancy is associated with an increased risk of birth defects and is not indicated.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on fetal development, including genital abnormalities.
Second Trimester:
Not indicated; continued exposure could lead to adverse effects.
Third Trimester:
Not indicated; continued exposure could lead to adverse effects.
Lactation
Not recommended during lactation. Estrogens are excreted in breast milk and may reduce the quantity and quality of breast milk. Potential adverse effects on the nursing infant are unknown but possible.
Infant Risk:
Risk level L3 (Moderate concern) - Estrogens are excreted into breast milk and may affect milk production and potentially the infant. Use generally avoided.
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. The WHIMS study showed an increased risk of probable dementia in women 65 years of age or older receiving estrogen-alone or estrogen plus progestin therapy. Consider 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, leading to a more favorable estradiol-to-estrone ratio and potentially lower risk of VTE compared to oral estrogens, though VTE risk is still present.
- The 0.025 mg/day patch is the lowest available dose and is often used for osteoporosis prevention or as a starting dose for vasomotor symptoms.
- Always consider adding a progestin for women with an intact uterus to reduce the risk of endometrial hyperplasia and cancer.
- Emphasize the importance of patch rotation to prevent skin irritation and ensure consistent absorption.
- Patients should be advised to remove the old patch before applying a new one.
- Regularly reassess the need for continued hormone therapy, aiming for the lowest effective dose for the shortest duration.
Alternative Therapies
- 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)
- Bisphosphonates, denosumab, teriparatide for osteoporosis prevention/treatment
- Lifestyle modifications (diet, exercise, stress reduction) for menopausal symptoms.
Cost & Coverage
Average Cost:
Varies widely, typically $100-$300+ per 4 patches (1 month supply)
Generic Available:
Yes
Insurance Coverage:
Often Tier 2 or 3 for brand, Tier 1 for generic. Coverage varies by insurance plan.
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure 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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.