Climara 0.05mg/day Patches 4s
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; Hormone Replacement Therapy (HRT)
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 skin patch that delivers the hormone estrogen (estradiol) through your skin. It's used to relieve symptoms of menopause, such as 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 to ensure safe and effective treatment.
Administration
Do not take this medication by mouth. It is for topical use on your skin only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning.
Apply the patch at the same time every day to maintain a consistent routine.
Preparation and Application
Wash your hands before and after handling the patch to prevent the spread of infection.
Choose a clean, dry, and healthy area of skin on your lower belly or upper buttocks for patch application.
Rotate the patch site with each new application to avoid skin irritation. Do not apply a patch to the same site for at least 7 days.
Avoid applying the patch to skin with problems, such as cuts, wounds, or irritation.
Do not apply the patch to the breast or skin 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 to ensure better adhesion.
Avoid applying the patch to your waistline or areas that may cause the patch to come off when sitting.
Patch Handling and Disposal
Do not cut or divide the patches, as this may affect their effectiveness.
Do not use damaged patches, as they may not work correctly.
If the patch falls off, reapply it to the same site. If you cannot reapply the patch, apply a new one to a different area.
Wear only one patch at a time to avoid overdose or increased side effects.
After removing a used patch, fold the sticky sides together and dispose of it in a secure location where children and pets cannot access it.
Storage and Disposal
Store the medication at room temperature in a dry place, away from bathrooms and areas prone to moisture.
Keep used patches out of reach of children and pets to prevent accidental ingestion or exposure.
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 to ensure safe and effective treatment.
Administration
Do not take this medication by mouth. It is for topical use on your skin only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning.
Apply the patch at the same time every day to maintain a consistent routine.
Preparation and Application
Wash your hands before and after handling the patch to prevent the spread of infection.
Choose a clean, dry, and healthy area of skin on your lower belly or upper buttocks for patch application.
Rotate the patch site with each new application to avoid skin irritation. Do not apply a patch to the same site for at least 7 days.
Avoid applying the patch to skin with problems, such as cuts, wounds, or irritation.
Do not apply the patch to the breast or skin 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 to ensure better adhesion.
Avoid applying the patch to your waistline or areas that may cause the patch to come off when sitting.
Patch Handling and Disposal
Do not cut or divide the patches, as this may affect their effectiveness.
Do not use damaged patches, as they may not work correctly.
If the patch falls off, reapply it to the same site. If you cannot reapply the patch, apply a new one to a different area.
Wear only one patch at a time to avoid overdose or increased side effects.
After removing a used patch, fold the sticky sides together and dispose of it in a secure location where children and pets cannot access it.
Storage and Disposal
Store the medication at room temperature in a dry place, away from bathrooms and areas prone to moisture.
Keep used patches out of reach of children and pets to prevent accidental ingestion or exposure.
Missed Dose
If you miss a dose, apply a new patch as soon as you remember, after removing the old one.
Lifestyle & Tips
- Do not smoke, as smoking significantly increases the risk of blood clots, heart attack, and stroke when taking estrogen.
- Maintain a healthy diet and engage in regular physical activity to support overall health and bone density.
- Limit alcohol intake.
- Discuss any concerns about diet, exercise, or smoking with your healthcare provider.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One Climara 0.05 mg/day transdermal patch applied to the lower abdomen or buttocks once weekly (changed every 7 days).
Dose Range:
0.025 - 0.1 mg
Condition-Specific Dosing:
vasomotorSymptoms:
Initial dose typically 0.025 mg/day or 0.0375 mg/day, titrated based on response. 0.05 mg/day is a common effective dose.
preventionOfPostmenopausalOsteoporosis:
0.025 mg/day or 0.05 mg/day, depending on individual patient needs and risk factors.
vulvarAndVaginalAtrophy:
0.025 mg/day or 0.0375 mg/day, titrated as needed. Local estrogen products are often preferred for isolated symptoms.
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, use with caution.
Moderate:
No specific dose adjustment recommended, use with caution.
Severe:
No specific dose adjustment recommended, use with caution.
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; monitor for adverse effects. Estrogens are extensively metabolized by the liver.
Severe:
Contraindicated in patients with severe liver dysfunction or disease.
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, including the reproductive tract, breast, bone, and brain. This binding leads to the formation of a hormone-receptor complex that interacts with DNA to regulate gene transcription, resulting in the expression of estrogen-responsive genes and the physiological effects of estrogen.
Pharmacokinetics
Absorption:
Bioavailability:
High (transdermal route bypasses first-pass hepatic metabolism, leading to a more favorable estradiol-to-estrone ratio compared to oral administration).
Tmax:
Steady-state estradiol concentrations are generally achieved within 2-3 weeks of continuous patch application. Peak concentrations are typically seen within 24-48 hours after patch application, with sustained release over 7 days.
FoodEffect:
Not applicable for transdermal patch.
Distribution:
Vd:
Approximately 1 L/kg (for estradiol).
ProteinBinding:
>95% (primarily to sex hormone-binding globulin (SHBG) and albumin).
CnssPenetration:
Limited for therapeutic effects, but estrogens can influence CNS function (e.g., mood, cognition).
Elimination:
HalfLife:
Estradiol: Approximately 1-2 hours (systemic circulation), but the transdermal patch provides sustained release over 7 days due to a reservoir effect.
Clearance:
Not readily quantifiable for transdermal delivery due to continuous absorption.
ExcretionRoute:
Renal (primarily as glucuronide and sulfate conjugates of metabolites).
Unchanged:
<1% (of estradiol excreted unchanged in urine).
Pharmacodynamics
OnsetOfAction:
Symptomatic relief (e.g., hot flashes) may begin within a few days to weeks, with full effect often seen after several weeks of consistent use.
PeakEffect:
Sustained throughout the 7-day patch application period.
DurationOfAction:
7 days (due to continuous release from the transdermal patch).
Safety & Warnings
BLACK BOX WARNING
Estrogens and progestins should not be used for the prevention of cardiovascular disease or dementia. The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50-79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 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 (CE 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 CE plus MPA and in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily oral CE alone, relative to placebo. Estrogen-alone therapy should not be used in women with a uterus because of the increased risk of endometrial cancer. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which can be a precursor to endometrial cancer.
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 notice any of the following symptoms, contact your doctor immediately or seek medical attention:
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 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
Signs of high calcium levels, including:
+ Weakness
+ Confusion
+ Fatigue
+ Headache
+ Upset stomach or vomiting
+ Constipation
+ Bone pain
Other Side Effects
Most people do not experience severe side effects, but some may occur. If you notice any of the following side effects, contact your doctor 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
Signs of a common cold
Nose or throat irritation
Weight gain or loss
Joint pain
Leg cramps
Changes in sex interest
Irritation at the site of application
Reporting Side Effects
This is not an exhaustive list of potential side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek medical attention:
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 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
Signs of high calcium levels, including:
+ Weakness
+ Confusion
+ Fatigue
+ Headache
+ Upset stomach or vomiting
+ Constipation
+ Bone pain
Other Side Effects
Most people do not experience severe side effects, but some may occur. If you notice any of the following side effects, contact your doctor 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
Signs of a common cold
Nose or throat irritation
Weight gain or loss
Joint pain
Leg cramps
Changes in sex interest
Irritation at the site of application
Reporting Side Effects
This is not an exhaustive list of potential side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Sudden severe headache or migraine
- Sudden vision changes (e.g., partial or complete loss of vision)
- Sudden numbness or weakness in your face, arm, or leg, especially on one side of the body
- Trouble speaking or understanding speech
- Sudden chest pain, discomfort, or pressure
- Pain, swelling, or tenderness in one or both legs (especially in the calf)
- Sudden shortness of breath
- Yellowing of the skin or eyes (jaundice)
- Severe abdominal pain
- New breast lump or changes
- Unusual vaginal bleeding (e.g., spotting, breakthrough bleeding, or prolonged bleeding after menopause)
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 you experienced, including any 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. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any 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. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before certain surgical procedures, and if so, will instruct you 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 while taking this medication.
Regular blood pressure checks are necessary, as this medication can cause high blood pressure. Your doctor will also recommend regular blood tests and bone density checks to monitor your health. Furthermore, it is vital to maintain regular breast exams, 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.
Be aware that this medication can cause elevated triglyceride levels. If you have a history of high triglyceride levels, inform your doctor. This medication may also lead to the development of dark skin patches on your face, so it is essential to avoid sun exposure, sunlamps, and tanning beds, and use protective measures like sunscreen, clothing, and eyewear when going outside.
As this medication may affect certain laboratory tests, notify all your healthcare providers and lab personnel that you are taking this drug. It is also crucial to 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, as it may interact with the medication.
To maximize the effectiveness of this medication, follow the diet and exercise plan recommended by your doctor, and engage in weight-bearing activities like walking or physical therapy, along with calcium and vitamin D supplements. In some cases, this medication may affect growth in children and teenagers, so regular growth checks may be necessary. Discuss any concerns with your doctor.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Finally, 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 while taking this medication.
Regular blood pressure checks are necessary, as this medication can cause high blood pressure. Your doctor will also recommend regular blood tests and bone density checks to monitor your health. Furthermore, it is vital to maintain regular breast exams, 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.
Be aware that this medication can cause elevated triglyceride levels. If you have a history of high triglyceride levels, inform your doctor. This medication may also lead to the development of dark skin patches on your face, so it is essential to avoid sun exposure, sunlamps, and tanning beds, and use protective measures like sunscreen, clothing, and eyewear when going outside.
As this medication may affect certain laboratory tests, notify all your healthcare providers and lab personnel that you are taking this drug. It is also crucial to 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, as it may interact with the medication.
To maximize the effectiveness of this medication, follow the diet and exercise plan recommended by your doctor, and engage in weight-bearing activities like walking or physical therapy, along with calcium and vitamin D supplements. In some cases, this medication may affect growth in children and teenagers, so regular growth checks may be necessary. Discuss any concerns with your doctor.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Finally, 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)
What to Do:
Remove the patch. Treatment is symptomatic and supportive. There is no specific antidote. Call a poison control center (1-800-222-1222) or seek immediate medical attention if overdose is suspected or symptoms are severe.
Drug Interactions
Major Interactions
- Aromatase inhibitors (e.g., anastrozole, letrozole, exemestane) - concurrent use with estrogens will counteract their therapeutic effect.
- Tamoxifen - concurrent use may reduce tamoxifen's effectiveness and increase risk of endometrial abnormalities.
- Tranexamic acid - increased risk of thrombosis.
Moderate Interactions
- CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort) - may decrease estradiol plasma concentrations, reducing efficacy.
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin, grapefruit juice) - may increase estradiol plasma concentrations, increasing risk of adverse effects.
- Thyroid hormone replacement therapy (e.g., levothyroxine) - estrogens can increase thyroid-binding globulin (TBG), potentially increasing the need for thyroid hormone.
- Warfarin - estrogens may alter the anticoagulant effect of warfarin; monitor INR.
- Corticosteroids - estrogens may decrease the clearance of corticosteroids, leading to increased effects.
Minor Interactions
- Folic acid - may increase folate levels.
- Vitamin B6 - may increase B6 levels.
Monitoring
Baseline Monitoring
Complete medical history and physical examination
Rationale: To identify contraindications, risk factors, and establish baseline health status.
Timing: Prior to initiation of therapy.
Blood pressure
Rationale: Estrogens can affect blood pressure.
Timing: Prior to initiation of therapy.
Breast examination and mammography
Rationale: To screen for breast cancer and establish baseline breast health.
Timing: Prior to initiation of therapy, as appropriate for age and risk.
Pelvic examination and Pap test
Rationale: To screen for gynecological conditions, including cervical and endometrial cancer.
Timing: Prior to initiation of therapy, as appropriate for age and risk.
Lipid profile
Rationale: Estrogens can affect lipid metabolism.
Timing: Prior to initiation of therapy.
Liver function tests (LFTs)
Rationale: To assess hepatic function, as estrogens are metabolized by the liver.
Timing: Prior to initiation of therapy, especially if hepatic impairment is suspected.
Bone mineral density (BMD) scan
Rationale: If therapy is for osteoporosis prevention, to establish baseline bone health.
Timing: Prior to initiation of therapy, if indicated.
Routine Monitoring
Annual physical examination
Frequency: Annually
Target: N/A
Action Threshold: Any significant change or new symptom.
Blood pressure
Frequency: Annually, or more frequently if clinically indicated.
Target: Normal range for age.
Action Threshold: Sustained elevation (e.g., >140/90 mmHg) or significant increase from baseline.
Breast examination and mammography
Frequency: Annually (breast exam); mammography per age-appropriate screening guidelines.
Target: N/A
Action Threshold: New lumps, pain, discharge, or abnormal mammogram findings.
Pelvic examination and Pap test
Frequency: Annually (pelvic exam); Pap test per age-appropriate screening guidelines.
Target: N/A
Action Threshold: Abnormal bleeding, pain, or abnormal Pap test results.
Lipid profile
Frequency: Periodically, as clinically indicated.
Target: Individualized based on cardiovascular risk.
Action Threshold: Significant adverse changes in lipid levels.
Symptom Monitoring
- Abnormal vaginal bleeding (spotting, breakthrough bleeding, prolonged or recurrent bleeding)
- Breast lumps or changes
- Leg pain, swelling, or tenderness (signs of deep vein thrombosis)
- Sudden shortness of breath or chest pain (signs of pulmonary embolism)
- Sudden severe headache, vision changes, slurred speech, weakness or numbness in an arm or leg (signs of stroke)
- Chest pain, discomfort, or pressure (signs of myocardial infarction)
- Jaundice (yellowing of skin or eyes)
- Severe abdominal pain
- Mood changes, depression
Special Patient Groups
Pregnancy
Contraindicated. Estrogen therapy during pregnancy is associated with an increased risk of birth defects and should not be used.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on fetal development, including cardiovascular and limb defects.
Second Trimester:
Not indicated; continued exposure may lead to adverse effects.
Third Trimester:
Not indicated; continued exposure may lead to adverse effects.
Lactation
Not recommended. Estrogens are excreted in human milk and may decrease the quantity and quality of breast milk. Potential adverse effects on the nursing infant have not been fully established but could include feminization.
Infant Risk:
L4 (Possibly Hazardous) - Potential for adverse effects on milk production and infant exposure to hormones.
Pediatric Use
Not indicated for use in pediatric patients. Safety and efficacy have not been established.
Geriatric Use
Use with caution. Women 65 years of age or older may have an increased risk of probable dementia with estrogen-alone or estrogen plus progestin therapy. Use the lowest effective dose for the shortest duration consistent with treatment goals. Closely monitor for adverse cardiovascular events and cognitive changes.
Clinical Information
Clinical Pearls
- Climara patches should be applied to a clean, dry, hairless area of the lower abdomen or buttocks. Avoid the waistline, breasts, or areas that may be rubbed by clothing.
- Rotate application sites to prevent skin irritation. Do not apply to the same site more than once every week.
- If a patch falls off, reapply it or apply a new patch to a different site. If it's close to the time for the next scheduled patch change, wait and apply a new patch at the regularly scheduled time.
- For women with an intact uterus, a progestin must be added to estrogen therapy to reduce the risk of endometrial hyperplasia and cancer.
- Regularly assess the need for continued therapy. HRT should be used for the shortest duration consistent with treatment goals, especially for vasomotor symptoms.
- Counsel patients on the black box warnings regarding cardiovascular risks, stroke, and endometrial cancer.
Alternative Therapies
- Selective Estrogen Receptor Modulators (SERMs) (e.g., bazedoxifene/conjugated estrogens, ospemifene, tamoxifen, raloxifene) for specific indications like osteoporosis or dyspareunia.
- Non-hormonal therapies for vasomotor symptoms (e.g., SSRIs/SNRIs like paroxetine, venlafaxine; gabapentin; clonidine; fezolinetant).
- Lifestyle modifications (e.g., diet, exercise, stress reduction, avoiding triggers for hot flashes).
Cost & Coverage
Average Cost:
$100 - $250 per 4 patches (1 month supply)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (Brand name); Tier 1 (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 emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.