Climara 0.1mg/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
Hormone Replacement Therapy (HRT)
Pharmacologic Class
Estrogen Receptor Agonist
Pregnancy Category
Category X
FDA Approved
Sep 1994
DEA Schedule
Not Controlled
Overview
What is this medicine?
Climara patches contain the hormone estradiol, which is a form of estrogen. It's used to help relieve symptoms of menopause, such as hot flashes and vaginal dryness. It can also help prevent bone thinning (osteoporosis) after menopause. The patch delivers the hormone through your skin into your bloodstream.
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.
Application Instructions
Apply this medication only to your skin, avoiding the mouth, nose, and eyes, as it may cause burning.
Use the medication at the same time every day to maintain a consistent routine.
Before and after applying the medication, wash your hands thoroughly.
Choose a clean, dry, and healthy area of skin on your lower belly or upper buttocks to apply the patch. Rotate the application site with each new patch, waiting at least 7 days before reusing the same site.
Avoid applying the patch to skin with any problems, such as irritation, cuts, or wounds.
Do not apply the patch to the breast or to areas where you have recently used 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 areas that may cause the patch to come off when sitting.
Do not cut or divide the patches, and do not use damaged patches.
Managing the Patch
If the patch falls off, reapply it to the same site. If you are unable to reapply the patch, apply a new one 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 this medication at room temperature in a dry place, avoiding bathrooms.
Dispose of used patches and packaging in a secure location, following 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.
Application Instructions
Apply this medication only to your skin, avoiding the mouth, nose, and eyes, as it may cause burning.
Use the medication at the same time every day to maintain a consistent routine.
Before and after applying the medication, wash your hands thoroughly.
Choose a clean, dry, and healthy area of skin on your lower belly or upper buttocks to apply the patch. Rotate the application site with each new patch, waiting at least 7 days before reusing the same site.
Avoid applying the patch to skin with any problems, such as irritation, cuts, or wounds.
Do not apply the patch to the breast or to areas where you have recently used 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 areas that may cause the patch to come off when sitting.
Do not cut or divide the patches, and do not use damaged patches.
Managing the Patch
If the patch falls off, reapply it to the same site. If you are unable to reapply the patch, apply a new one 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 this medication at room temperature in a dry place, avoiding bathrooms.
Dispose of used patches and packaging in a secure location, following 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
- Do not smoke, as smoking increases the risk of serious cardiovascular side effects (blood clots, stroke, heart attack) with estrogen therapy.
- Maintain a healthy diet and engage in regular weight-bearing exercise to support bone health.
- Attend all scheduled medical appointments and screenings (e.g., mammograms, pelvic exams).
- Report any unusual symptoms or side effects to your doctor promptly.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One Climara 0.1 mg/day transdermal patch applied 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:
vasomotorSymptomsOfMenopause:
One 0.1 mg/day patch applied once weekly. Lowest effective dose for shortest duration.
vulvarAndVaginalAtrophy:
One 0.1 mg/day patch applied once weekly. Lowest effective dose for shortest duration.
preventionOfPostmenopausalOsteoporosis:
One 0.1 mg/day patch applied once weekly. Consider other non-estrogen treatments first. If used, lowest effective dose for shortest duration.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment generally required.
Moderate:
No specific dose adjustment generally required, but use with caution.
Severe:
Use with caution; monitor for fluid retention and adverse effects. No specific dose adjustment guidelines.
Dialysis:
Not specifically studied; use with caution and monitor for adverse effects.
Hepatic Impairment:
Mild:
Use with caution; monitor for adverse effects.
Moderate:
Use with caution; estrogens are extensively metabolized by the liver. Consider lower doses or alternative therapies.
Severe:
Contraindicated in severe liver disease or dysfunction.
Confidence:
Medium
Pharmacology
Mechanism of Action
Estradiol is the primary estrogen secreted by the human ovary. It binds to and activates specific estrogen receptors (ERΞ± and ERΞ²) located in target tissues (e.g., female reproductive organs, breast, hypothalamus, pituitary, bone, liver). This binding forms a ligand-receptor complex that translocates to the nucleus, where it interacts with estrogen response elements (EREs) on DNA, leading to altered gene transcription and protein synthesis. This action mediates the physiological effects of estrogen, including the relief of menopausal symptoms and maintenance of bone density.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 80% (transdermal bypasses first-pass hepatic metabolism compared to oral)
Tmax:
Approximately 2-3 days (for steady-state levels with weekly patch)
FoodEffect:
Not applicable for transdermal patch
Distribution:
Vd:
Approximately 1.2 L/kg
ProteinBinding:
Approximately 98% (primarily to sex hormone-binding globulin [SHBG] and albumin)
CnssPenetration:
Limited for estradiol itself, but some metabolites may cross the blood-brain barrier.
Elimination:
HalfLife:
Approximately 17-20 hours (for transdermal estradiol, reflecting sustained release)
Clearance:
Approximately 650-1000 mL/min/1.73mΒ²
ExcretionRoute:
Primarily renal (as glucuronide and sulfate conjugates), small amount via bile/feces.
Unchanged:
<1% (in urine)
Pharmacodynamics
OnsetOfAction:
Gradual, typically within a few weeks for full symptomatic relief.
PeakEffect:
Steady-state concentrations are generally achieved within 3-4 days of patch application.
DurationOfAction:
7 days (due to continuous release from the patch)
Safety & Warnings
BLACK BOX WARNING
Estrogens and Estrogen Plus Progestin Therapy:
1. Cardiovascular Disorders: Estrogen-alone therapy and estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease. The Women's Health Initiative (WHI) study reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women receiving estrogen-alone therapy. The WHI study also reported increased risks of myocardial infarction (MI), stroke, DVT, and pulmonary embolism (PE) in postmenopausal women receiving estrogen plus progestin therapy.
2. Malignant Neoplasms: The WHI study reported an increased risk of invasive breast cancer in women receiving estrogen plus progestin therapy. Estrogen-alone therapy increases the risk of endometrial cancer in a woman with a uterus. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurrent abnormal genital bleeding. There is an increased risk of ovarian cancer with estrogen-alone therapy and estrogen plus progestin therapy.
3. Probable Dementia: The WHI Memory Study (WHIMS) reported an increased risk of probable dementia in postmenopausal women 65 years of age or older receiving estrogen-alone therapy or estrogen plus progestin therapy.
1. Cardiovascular Disorders: Estrogen-alone therapy and estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease. The Women's Health Initiative (WHI) study reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women receiving estrogen-alone therapy. The WHI study also reported increased risks of myocardial infarction (MI), stroke, DVT, and pulmonary embolism (PE) in postmenopausal women receiving estrogen plus progestin therapy.
2. Malignant Neoplasms: The WHI study reported an increased risk of invasive breast cancer in women receiving estrogen plus progestin therapy. Estrogen-alone therapy increases the risk of endometrial cancer in a woman with a uterus. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurrent abnormal genital bleeding. There is an increased risk of ovarian cancer with estrogen-alone therapy and estrogen plus progestin therapy.
3. Probable Dementia: The WHI Memory Study (WHIMS) reported an increased risk of probable dementia in postmenopausal women 65 years of age or older receiving estrogen-alone therapy or estrogen plus progestin therapy.
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
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 help right away:
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 or pain
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 or weight gain. 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, such as:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, changes in color, or pain in a leg or arm
Trouble speaking or swallowing
High calcium levels can occur in some people with cancer taking this medication. If you experience signs of high calcium levels, such as:
Weakness
Confusion
Fatigue
Headache
Upset stomach or vomiting
Constipation
Bone pain
contact your doctor right away.
Other Side Effects
Most people experience no side effects or only mild side effects while taking this medication. However, if you experience any of the following side effects, contact your doctor or seek medical help if they bother you or persist:
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 site of administration
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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 help right away:
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 or pain
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 or weight gain. 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, such as:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, changes in color, or pain in a leg or arm
Trouble speaking or swallowing
High calcium levels can occur in some people with cancer taking this medication. If you experience signs of high calcium levels, such as:
Weakness
Confusion
Fatigue
Headache
Upset stomach or vomiting
Constipation
Bone pain
contact your doctor right away.
Other Side Effects
Most people experience no side effects or only mild side effects while taking this medication. However, if you experience any of the following side effects, contact your doctor or seek medical help if they bother you or persist:
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 site of administration
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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, shortness of breath, or coughing up blood (signs of pulmonary embolism)
- Sudden severe headache, dizziness, vision changes, slurred speech, or weakness/numbness on one side of the body (signs of stroke)
- Pain, swelling, or redness in one leg (signs of deep vein thrombosis)
- Chest pain or pressure, pain spreading to arm/back/neck/jaw, nausea, sweating (signs of heart attack)
- Unusual vaginal bleeding or spotting after menopause
- Lump in the breast or breast changes
- Yellowing of the skin or eyes (jaundice)
- Severe abdominal pain
- Swelling of hands, ankles, or feet (fluid retention)
- Severe 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. 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 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 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. Do not initiate, stop, or adjust the dosage 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 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 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. Do not initiate, stop, or adjust the dosage 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 if so, will instruct you on when to resume taking it after the surgery or procedure.
If you anticipate being 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, it is crucial to closely monitor your blood sugar levels.
Be aware that medications like this one can cause high blood pressure. Therefore, it is essential to have your blood pressure checked regularly, as advised by your doctor. You should also 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 drug, so inform your doctor if you have a history of elevated triglyceride levels. This medication may also 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 when going outside.
This medication may interfere with certain laboratory tests, so be sure to inform all your healthcare providers and lab personnel that you are taking this drug. Avoid smoking, as it increases the risk of heart disease, and limit your alcohol consumption. If you regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor.
To maximize the effectiveness of this medication, use it in conjunction with calcium and vitamin D supplements and engage in weight-bearing exercises, such as walking or physical therapy, as recommended by your doctor. Adhere to the diet and exercise plan outlined by your doctor.
In some cases, this medication may affect growth in children and teenagers, so regular growth checks may be necessary. 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 anticipate being 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, it is crucial to closely monitor your blood sugar levels.
Be aware that medications like this one can cause high blood pressure. Therefore, it is essential to have your blood pressure checked regularly, as advised by your doctor. You should also 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 drug, so inform your doctor if you have a history of elevated triglyceride levels. This medication may also 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 when going outside.
This medication may interfere with certain laboratory tests, so be sure to inform all your healthcare providers and lab personnel that you are taking this drug. Avoid smoking, as it increases the risk of heart disease, and limit your alcohol consumption. If you regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor.
To maximize the effectiveness of this medication, use it in conjunction with calcium and vitamin D supplements and engage in weight-bearing exercises, such as walking or physical therapy, as recommended by your doctor. Adhere to the diet and exercise plan outlined by your doctor.
In some cases, this medication may affect growth in children and teenagers, so regular growth checks may be necessary. 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 women)
What to Do:
Remove the patch. There is no specific antidote. Treatment is symptomatic and supportive. Contact a poison control center or seek immediate medical attention. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Contraindicated Interactions
- Aromatase inhibitors (e.g., anastrozole, letrozole, exemestane) - concurrent use may reduce efficacy of aromatase inhibitors.
- Tamoxifen (relative contraindication for concurrent use in breast cancer patients due to potential for estrogenic effects).
Major Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, St. John's Wort): May significantly decrease estradiol plasma concentrations, leading to reduced therapeutic effect and increased risk of breakthrough bleeding. Dose adjustment of estradiol or alternative therapy may be needed.
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice): May increase estradiol plasma concentrations, potentially leading to increased adverse effects. Monitor for increased estrogenic effects.
- Warfarin: Estrogens can alter the effects of oral anticoagulants, potentially decreasing their anticoagulant effect. Close monitoring of INR and anticoagulant dose adjustment is recommended.
- Thyroid hormones (e.g., levothyroxine): Estrogens can increase thyroid-binding globulin (TBG), leading to decreased free thyroid hormone levels. Patients on thyroid hormone replacement may require an increased dose of thyroid hormone. Monitor thyroid function.
Moderate Interactions
- Corticosteroids (e.g., prednisone): Estrogens can decrease the clearance of corticosteroids, leading to increased plasma concentrations and potential for increased corticosteroid effects. Monitor for signs of corticosteroid toxicity.
- Cyclosporine: Estrogens may inhibit the metabolism of cyclosporine, leading to increased plasma concentrations and potential for toxicity. Monitor cyclosporine levels.
- Theophylline: Estrogens may decrease the clearance of theophylline, leading to increased plasma concentrations and potential for toxicity. Monitor theophylline levels.
Minor Interactions
- Not many specific minor interactions are consistently cited for transdermal estradiol beyond those affecting CYP3A4 or protein binding.
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.
Mammogram
Rationale: To screen for breast cancer before initiating estrogen therapy.
Timing: Prior to initiation of therapy, as appropriate for age and risk factors.
Lipid profile
Rationale: To assess cardiovascular risk factors.
Timing: Prior to initiation of therapy.
Liver function tests (LFTs)
Rationale: To assess hepatic function, especially if there is a history of liver disease.
Timing: Prior to initiation of therapy.
Routine Monitoring
Annual physical examination (including blood pressure, breast exam, pelvic exam)
Frequency: Annually
Target: Normal for age and individual
Action Threshold: Abnormal findings require further investigation.
Mammogram
Frequency: Periodically, as per national guidelines (e.g., every 1-2 years)
Target: No suspicious findings
Action Threshold: Suspicious findings require immediate follow-up.
Assessment of symptoms and overall well-being
Frequency: Regularly (e.g., every 3-6 months initially, then annually)
Target: Symptom relief with minimal side effects
Action Threshold: Persistent or worsening symptoms, or intolerable side effects, warrant re-evaluation of dose or therapy.
Evaluation of need for continued therapy
Frequency: Annually
Target: Lowest effective dose for shortest duration
Action Threshold: Re-evaluate risks vs. benefits, especially for long-term use.
Symptom Monitoring
- Hot flashes (frequency, severity)
- Night sweats
- Vaginal dryness or irritation
- Mood changes, irritability, depression
- Sleep disturbances
- Breast tenderness or pain
- Abnormal vaginal bleeding (spotting, heavy bleeding, postmenopausal bleeding)
- Signs of blood clots (e.g., sudden chest pain, shortness of breath, pain/swelling in leg, sudden severe headache, vision changes)
- Signs of liver problems (e.g., yellowing of skin/eyes, dark urine, persistent nausea/vomiting, abdominal pain)
- Fluid retention (e.g., swelling in ankles/feet, weight gain)
Special Patient Groups
Pregnancy
Contraindicated in pregnancy (Category X). Estrogen therapy during pregnancy is not indicated and there is no evidence of benefit. There is an increased risk of birth defects in children born to mothers who took diethylstilbestrol (DES) during pregnancy, though this risk has not been established for other estrogens.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on fetal development, though not definitively established for estradiol.
Second Trimester:
Not indicated.
Third Trimester:
Not indicated.
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 nursing infant have not been fully evaluated.
Infant Risk:
L4 (Possibly hazardous). Potential for decreased milk production and excretion into breast milk. Monitor infant for potential estrogenic effects (e.g., breast enlargement).
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. Increased risk of stroke and DVT 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 and risks.
Clinical Information
Clinical Pearls
- Climara patches should be applied to a clean, dry, hairless area of the trunk (abdomen or buttocks). Avoid applying to the breasts, waistline, or areas that may be rubbed by clothing.
- Rotate application sites weekly to prevent skin irritation. Do not apply to the same site more than once every 7 days.
- If a patch falls off, try to reapply it. If it does not stick, apply a new patch for the remainder of the 7-day dosing interval.
- For women with an intact uterus, a progestin must be co-administered with estrogen therapy to reduce the risk of endometrial hyperplasia and cancer.
- Estrogen therapy should be used at the lowest effective dose for the shortest duration consistent with treatment goals and risks.
- Patients should be advised to report any abnormal vaginal bleeding immediately, as it may indicate endometrial pathology.
- Discuss the Black Box Warnings regarding cardiovascular events, breast cancer, endometrial cancer, and dementia with patients before initiating therapy.
Alternative Therapies
- Other forms of estrogen therapy (oral tablets, vaginal rings, gels, sprays)
- Selective Estrogen Receptor Modulators (SERMs) for specific indications (e.g., ospemifene for dyspareunia, bazedoxifene/conjugated estrogens for vasomotor symptoms and osteoporosis prevention)
- Non-hormonal therapies for vasomotor symptoms (e.g., SSRIs/SNRIs like paroxetine, venlafaxine; gabapentin; clonidine)
- Lifestyle modifications (e.g., diet, exercise, stress reduction, avoiding triggers for hot flashes)
- Bisphosphonates or other anti-resorptive agents for osteoporosis prevention/treatment.
Cost & Coverage
Average Cost:
$150 - $300 per 4 patches (1 month supply)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for brand name), Tier 1 (for generic)
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. 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 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.