Climara 0.075mg/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); Estrogen
Pharmacologic Class
Estrogen Receptor Agonist
Pregnancy Category
Category X
FDA Approved
Mar 1995
DEA Schedule
Not Controlled
Overview
What is this medicine?
Climara patches contain a hormone called estradiol, which is a form of estrogen. It's used by women after menopause to help with symptoms like hot flashes, night sweats, and vaginal dryness. It can also help prevent bone thinning (osteoporosis). The patch delivers the hormone through your skin directly 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, 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 or areas where you have recently used creams, oils, lotions, powders, 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 areas 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, reapply it to the same area. If you're unable to reapply the patch, place a new one in a different area.
Wear only one patch at a time.
Disposing of Used Patches
After removing a used patch, fold the sticky sides together and dispose of it in a secure location, out of reach of children and pets.
Storage and Disposal
Store this medication at room temperature in a dry place, avoiding bathrooms.
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, 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 or areas where you have recently used creams, oils, lotions, powders, 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 areas 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, reapply it to the same area. If you're unable to reapply the patch, place a new one in a different area.
Wear only one patch at a time.
Disposing of Used Patches
After removing a used patch, fold the sticky sides together and dispose of it in a secure location, out of reach of children and pets.
Storage and Disposal
Store this medication at room temperature in a dry place, avoiding bathrooms.
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: Smoking significantly increases the risk of serious cardiovascular events (blood clots, heart attack, stroke) when using estrogen therapy.
- Maintain a healthy diet and regular exercise: This supports overall cardiovascular health and bone density.
- Limit alcohol intake: Excessive alcohol can affect liver function and estrogen metabolism.
- Rotate application sites: Apply the patch to a different area of the lower abdomen or buttocks each week to avoid skin irritation.
- Avoid applying to breasts or waistline (where clothing may rub).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply one Climara 0.075 mg/day transdermal system once weekly to a clean, dry area of the skin on the trunk of the body (abdomen or buttocks). Rotate application sites.
Dose Range:
0.025 - 0.1 mg
Condition-Specific Dosing:
vasomotorSymptoms:
Initial dose typically 0.025 mg/day, titrated up as needed. 0.075 mg/day is a common effective dose.
vulvarAndVaginalAtrophy:
Initial dose typically 0.025 mg/day, titrated up as needed.
osteoporosisPrevention:
0.025 mg/day to 0.05 mg/day, 0.075 mg/day may be used if lower doses are insufficient.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (not indicated for pediatric use)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended, but use with caution due to potential fluid retention.
Dialysis:
Considerations: No specific dose adjustment, but monitor for fluid retention and cardiovascular effects.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended for transdermal route, as first-pass metabolism is bypassed.
Moderate:
Use with caution; estrogens are extensively metabolized by the liver. Monitor for adverse effects.
Severe:
Contraindicated in severe liver disease or dysfunction.
Pharmacology
Mechanism of Action
Estradiol is the primary estrogen secreted by the human ovary. It binds to and activates nuclear estrogen receptors (ERΞ± and ERΞ²) in target tissues, forming a hormone-receptor complex that interacts with estrogen response elements (EREs) on DNA. This interaction modulates gene transcription, leading to the synthesis of specific proteins responsible for the physiological effects of estrogens, including the development and maintenance of the female reproductive system and secondary sex characteristics. In menopausal women, it replaces declining endogenous estrogen, alleviating symptoms like hot flashes and vaginal atrophy, and preventing bone loss.
Pharmacokinetics
Absorption:
Bioavailability:
Transdermal delivery bypasses first-pass hepatic metabolism, resulting in a more favorable estradiol to estrone ratio compared to oral administration. The 0.075 mg/day patch delivers approximately 0.075 mg of estradiol per day.
Tmax:
Steady-state concentrations are generally achieved within 24-48 hours after initial application. Peak concentrations (Cmax) typically occur within 1-2 days after patch application.
FoodEffect:
Not applicable for transdermal patch.
Distribution:
Vd:
Approximately 1.2 L/kg (for estradiol)
ProteinBinding:
Highly protein bound (approximately 98%) to sex hormone-binding globulin (SHBG) and albumin.
CnssPenetration:
Limited, but estrogens do have effects on the central nervous system (e.g., thermoregulation, mood).
Elimination:
HalfLife:
Estradiol has a short plasma half-life (approximately 1 hour), but the transdermal patch provides continuous release, maintaining therapeutic levels over the 7-day application period. The effective half-life from the patch is longer, reflecting the sustained release.
Clearance:
High systemic clearance (approximately 600-700 mL/min/kg for estradiol).
ExcretionRoute:
Primarily renal excretion of conjugated metabolites.
Unchanged:
<1% (of estradiol is excreted unchanged)
Pharmacodynamics
OnsetOfAction:
Symptomatic relief (e.g., hot flashes) may begin within days to weeks, with full effect often seen after several weeks of consistent use.
PeakEffect:
Steady-state concentrations are achieved within 1-2 days of patch application, maintaining consistent therapeutic levels throughout the week.
DurationOfAction:
7 days (duration of patch application)
Safety & Warnings
BLACK BOX WARNING
Estrogens and estrogen plus progestin therapies 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) receiving daily conjugated equine estrogens (CEE) alone or in combination with medroxyprogesterone acetate (MPA) compared to placebo. The WHI Memory Study (WHIMS) reported an increased risk of probable dementia in postmenopausal women 65 years of age or older receiving CEE alone or in combination with MPA compared to placebo. These risks should be weighed against the benefits of therapy, and estrogens should be prescribed at the lowest effective dose for the shortest duration consistent with treatment goals and risks for the individual woman.
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, 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 other 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 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, 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 do not experience severe side effects, and some may only have minor side effects. 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 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 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 other 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 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, 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 do not experience severe side effects, and some may only have minor side effects. 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 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 severe headache or migraine
- Sudden vision changes (e.g., partial or complete loss of vision)
- Sudden numbness or weakness in the face, arm, or leg (especially on one side of the body)
- Slurred speech or difficulty speaking
- Sudden chest pain, pressure, or discomfort
- Pain or swelling in one leg, especially the calf
- Shortness of breath, coughing up blood
- Abnormal vaginal bleeding (e.g., bleeding after menopause, heavy bleeding, prolonged spotting)
- New breast lump or changes in breasts
- Yellowing of the skin or eyes (jaundice)
- 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
+ Stroke
+ Tumors that are sensitive to estrogen
Unexplained vaginal bleeding
Pregnancy or potential pregnancy. Note: This medication should not be taken during pregnancy.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
A history of certain health conditions, including:
+ Bleeding disorders
+ Blood clots or an increased risk of blood clots
+ Breast cancer
+ Liver problems or liver tumors
+ Heart attack
+ Stroke
+ Tumors that are sensitive to estrogen
Unexplained vaginal bleeding
Pregnancy or potential pregnancy. Note: This medication should not be taken during pregnancy.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before certain surgical procedures, and will provide guidance on when to resume taking it after the surgery or procedure.
If you anticipate being inactive 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. 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, 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.
This medication can cause elevated triglyceride levels. If you have a history of high triglyceride levels, inform your doctor. Prolonged use of this drug may lead to the development of dark skin patches on your face, so it is essential to avoid sun exposure, sunlamps, and tanning beds, and to use sunscreen and protective clothing and eyewear.
This medication may affect certain laboratory test results, 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 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, 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.
If you are breastfeeding, consult 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, 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. 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, 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.
This medication can cause elevated triglyceride levels. If you have a history of high triglyceride levels, inform your doctor. Prolonged use of this drug may lead to the development of dark skin patches on your face, so it is essential to avoid sun exposure, sunlamps, and tanning beds, and to use sunscreen and protective clothing and eyewear.
This medication may affect certain laboratory test results, 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 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, 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.
If you are breastfeeding, consult your doctor to discuss any potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Breast tenderness
- Abdominal pain
- Drowsiness/fatigue
- Withdrawal bleeding (in women with a uterus)
What to Do:
Remove the patch immediately. There is no specific antidote. Treatment is symptomatic and supportive. Contact a poison control center or emergency services (e.g., call 911 in the US, or 1-800-222-1222 for Poison Control).
Drug Interactions
Major Interactions
- Aromatase inhibitors (e.g., anastrozole, letrozole, exemestane): Estrogens antagonize the effects of aromatase inhibitors.
- Fulvestrant: Estrogen receptor antagonist, may reduce efficacy of estradiol.
Moderate Interactions
- CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort): May decrease estrogen plasma concentrations, potentially reducing therapeutic effect. (Less significant for transdermal than oral).
- CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, ketoconazole, ritonavir, grapefruit juice): May increase estrogen plasma concentrations, potentially increasing adverse effects. (Less significant for transdermal than oral).
- Thyroid hormones (e.g., levothyroxine): Estrogens can increase thyroid-binding globulin (TBG), leading to increased bound thyroid hormone and potentially increased thyroid hormone requirements.
- Corticosteroids: Estrogens may decrease the clearance of corticosteroids, leading to increased corticosteroid effects.
- Warfarin: Estrogens may alter the effects of anticoagulants; monitor INR.
Minor Interactions
- Tricyclic antidepressants: Estrogens may increase plasma concentrations of TCAs.
Monitoring
Baseline Monitoring
Complete medical history and physical examination
Rationale: To identify contraindications, risk factors (e.g., cardiovascular disease, breast cancer), and establish baseline health status.
Timing: Prior to initiation of therapy
Blood pressure
Rationale: Estrogens can affect blood pressure.
Timing: Prior to initiation
Breast examination and mammography
Rationale: To screen for breast cancer, as estrogen therapy can increase risk.
Timing: Prior to initiation (within 12 months) and as clinically indicated
Pelvic examination and Pap test
Rationale: To screen for gynecological conditions and cervical cancer.
Timing: Prior to initiation (within 12 months) and as clinically indicated
Lipid profile
Rationale: Estrogens can affect lipid metabolism.
Timing: Prior to initiation (optional, but good practice)
Routine Monitoring
Annual physical examination, including breast and pelvic exams
Frequency: Annually
Target: Normal findings
Action Threshold: Any abnormal findings (e.g., new breast lump, abnormal bleeding) require immediate investigation.
Blood pressure
Frequency: Annually or as clinically indicated
Target: <130/80 mmHg (general guideline)
Action Threshold: Sustained elevation requires evaluation and potential intervention.
Mammography
Frequency: As recommended by national guidelines (e.g., every 1-2 years for women over 40-50)
Target: No suspicious findings
Action Threshold: Suspicious findings require further diagnostic workup.
Symptom assessment (e.g., hot flashes, vaginal dryness, mood, sleep)
Frequency: Regularly (e.g., every 3-6 months initially, then annually)
Target: Improved or resolved symptoms
Action Threshold: Persistent or worsening symptoms may indicate need for dose adjustment or alternative therapy.
Symptom Monitoring
- Abnormal vaginal bleeding (spotting, breakthrough bleeding, prolonged bleeding)
- Breast lumps or changes
- Signs of deep vein thrombosis (DVT) or pulmonary embolism (PE): leg pain, swelling, redness; sudden chest pain, shortness of breath, coughing up blood
- Signs of stroke: sudden severe headache, vision changes, slurred speech, weakness/numbness on one side of the body
- Signs of myocardial infarction (MI): chest pain, discomfort, pressure, pain radiating to arm/back/neck/jaw, shortness of breath, sweating, nausea
- Jaundice or signs of liver dysfunction (yellowing skin/eyes, dark urine, severe abdominal pain)
- Severe headache or migraine exacerbation
- Changes in vision
- Mood changes, depression
Special Patient Groups
Pregnancy
Contraindicated. Estrogen therapy is not indicated during pregnancy. There is no evidence of benefit from estrogen therapy during pregnancy, and there is an increased risk of birth defects (e.g., feminization of male fetuses) associated with in utero exposure to estrogens.
Trimester-Specific Risks:
First Trimester:
Potential for feminization of male fetuses; generally contraindicated.
Second Trimester:
Contraindicated.
Third Trimester:
Contraindicated.
Lactation
Contraindicated. Estrogens are known to be excreted in human milk and can reduce the quantity and quality of breast milk. Therefore, Climara should not be used by nursing mothers.
Infant Risk:
Potential for adverse effects on the infant (e.g., feminization, reduced milk supply).
Pediatric Use
Not indicated for use in pediatric patients. Safety and efficacy have not been established.
Geriatric Use
Women 65 years of age or older: Increased risk of probable dementia when initiating estrogen therapy (with or without progestin). Use with caution and consider alternative therapies if possible. The lowest effective dose for the shortest duration should be used.
Clinical Information
Clinical Pearls
- Transdermal estradiol bypasses first-pass hepatic metabolism, potentially leading to a more favorable lipid profile and lower risk of venous thromboembolism compared to oral estrogens, though risks still exist.
- Ensure patients understand the importance of weekly patch changes and proper site rotation to minimize skin irritation and ensure consistent drug delivery.
- Advise patients to apply the patch to a clean, dry, hairless area of the lower abdomen or buttocks, avoiding the breasts, waistline, or areas that may be rubbed by clothing.
- If a patch falls off, the patient should reapply it or 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 to reduce the risk of endometrial hyperplasia and cancer.
- Regular follow-up is crucial to assess symptom control, monitor for adverse effects, and re-evaluate the need for continued therapy, especially given the black box warnings.
Alternative Therapies
- Other transdermal estradiol patches (e.g., Vivelle-Dot, Minivelle, Dotti)
- Oral estrogens (e.g., conjugated estrogens, estradiol tablets)
- Vaginal estrogens (e.g., creams, rings, tablets for localized symptoms)
- Non-hormonal therapies for vasomotor symptoms (e.g., SSRIs/SNRIs like paroxetine, venlafaxine; gabapentin; clonidine)
- Bisphosphonates or other anti-resorptive agents for osteoporosis prevention (if HRT is contraindicated or not desired for bone health alone).
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 or Tier 2 (for generic)
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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.