Climara Pro 0.045mg/day Patches 4's
Overview
What is this medicine?
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and read all the information provided. Apply the patch to clean, dry, healthy skin on either the lower belly or upper buttocks. Each time you apply a new patch, choose a different site to avoid skin irritation.
Applying the Patch: Important Guidelines
- Do not apply the patch to your breast.
- Avoid placing the patch on your waistline.
- Choose a site where the patch won't be dislodged by sitting.
- Do not apply to irritated, damaged, or sensitive skin.
- Avoid areas with skin folds or where tight clothing may rub against the patch.
- Do not apply the patch to skin that has recently been treated with creams, oils, lotions, powder, or other skin products, as this may affect how well the patch adheres.
Patch Maintenance and Replacement
- If the patch starts to loosen at the edges, press them firmly to secure it.
- If the patch falls off, reapply it. If you're unable to reapply the same patch, use a new one in a different area.
- After removing a patch, fold the sticky sides together and dispose of it in a way that prevents children and pets from accessing it.
Water Exposure and Patch Use
Exposure to water through swimming, bathing, showering, or using a sauna may cause the patch to detach. While it's unclear how water exposure affects the medication's efficacy, it's essential to be aware of this potential issue.
Storage and Disposal
Store your medication patches at room temperature, keeping them in their pouches until you're ready to use them.
Missed Dose
If you miss applying a patch, put on a new one as soon as you remember, after removing the old patch if it's still in place. Do not apply more than one patch at a time.
Lifestyle & Tips
- Apply the patch to a clean, dry area of your lower abdomen or buttock. Avoid areas with cuts, rashes, or irritation.
- Rotate the application site each week to prevent skin irritation.
- Do not apply the patch to your breasts or waistline.
- Avoid exposing the patch to direct sunlight or heat for prolonged periods.
- If a patch falls off, try to reapply it. If it doesn't stick, apply a new patch and continue your regular schedule.
- Discuss any concerns about diet, exercise, or smoking with your doctor, as these can impact your health while on HRT.
- Attend all scheduled doctor appointments and screenings (e.g., mammograms, Pap tests).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat.
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades, yellow skin or eyes, fever with chills, bloating, or severe upset stomach or vomiting.
Signs of high blood pressure: severe headache or dizziness, passing out, or changes in eyesight.
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe upset stomach or vomiting.
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred eyesight.
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel.
Breast-related symptoms: lump in the breast, breast pain or soreness, or nipple discharge.
Vaginal symptoms: itching or discharge, or abnormal vaginal bleeding.
Depression or other mood changes, or memory problems or loss.
Fluid Retention and Swelling
This medication may cause fluid retention or swelling in the body. Inform your doctor if you experience swelling, weight gain, or trouble breathing.
Blood Clots and High Calcium Levels
Seek medical help 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 have been reported in some people with cancer taking this medication. Contact your doctor right away if you experience:
Weakness
Confusion
Feeling tired
Headache
Upset stomach or vomiting
Constipation
Bone pain
Other Side Effects
Most people do not experience serious side effects, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Headache
Hair loss
Back pain
Upset stomach or vomiting
Cramps
Bloating
Tender breasts
Vaginal bleeding or spotting
Irritation at the site of administration
Signs of a common cold
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 chest pain or shortness of breath (possible blood clot in lungs or heart attack)
- Sudden severe headache, vision changes, or weakness/numbness on one side of the body (possible stroke)
- Swelling, redness, or pain in your leg (possible deep vein thrombosis)
- New breast lump or changes in your breasts
- Unusual vaginal bleeding or spotting after menopause
- Yellowing of your skin or eyes (jaundice)
- Severe abdominal pain
- Memory loss or confusion (especially if over 65)
Before Using This Medicine
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
Previous removal of the uterus (hysterectomy)
Pregnancy or suspected pregnancy. Do not take this medication if you are pregnant.
Additionally, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
Any existing health problems
This information is crucial to ensure your safety while taking this medication. Do not start, stop, or modify the dosage of any medication without consulting your doctor first. It is your responsibility to verify that it is safe to take this medication in combination with your other medications and health conditions.
Precautions & Cautions
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment. Your doctor may advise you to stop taking this medication before certain surgical procedures, and will provide guidance on when to resume treatment after the surgery or procedure.
If you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as prolonged inactivity may increase your risk of developing blood clots.
If you have diabetes, closely monitor your blood sugar levels, as this medication may affect them. Additionally, inform your doctor if you have a history of high triglyceride levels, as this medication may cause an increase in triglyceride levels.
Regularly undergo blood tests and bone density checks as directed by your doctor. This medication may also increase your blood pressure, so have your blood pressure checked regularly.
It is crucial to maintain regular breast exams and gynecology check-ups, and perform breast self-exams as instructed by your doctor. This medication may interfere with certain laboratory tests, so inform all your healthcare providers and lab personnel about your treatment.
To minimize the risk of heart disease, refrain from smoking, and limit your alcohol consumption. If you consume grapefruit juice or eat grapefruit regularly, consult your doctor. Protect the patch from sunlight to minimize the risk of side effects.
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 treatment, whether it is taken with or without a progestin, and other individual factors. Discuss the benefits and risks of this medication 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.
Osteoporosis
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.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Breast tenderness
- Abdominal pain
- Drowsiness/fatigue
- Withdrawal bleeding (in females)
What to Do:
Remove the patch immediately. Seek medical attention or call a poison control center. Call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Aromatase inhibitors (e.g., anastrozole, letrozole, exemestane) - concurrent use would counteract the effect of the aromatase inhibitor.
- Drugs for which estrogen exposure is a contraindication (e.g., certain breast cancers, estrogen-dependent tumors).
Major Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenobarbital, phenytoin, St. John's Wort) - may decrease estrogen and progestin plasma concentrations, potentially reducing therapeutic effects and increasing risk of breakthrough bleeding.
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin, grapefruit juice) - may increase estrogen and progestin plasma concentrations, potentially increasing adverse effects.
- Thyroid hormone replacement therapy - estrogens can increase thyroid-binding globulin (TBG), leading to increased circulating TBG and decreased free thyroid hormone. Patients on thyroid hormone replacement may require increased doses of thyroid hormone.
Moderate Interactions
- Corticosteroids - estrogens may decrease the clearance of corticosteroids, leading to increased corticosteroid effects.
- Oral anticoagulants (e.g., warfarin) - estrogens may affect coagulation parameters; close monitoring of INR is recommended.
- Lamotrigine - estrogens may decrease lamotrigine plasma concentrations, potentially leading to loss of seizure control.
Minor Interactions
- Folic acid - may enhance estrogen metabolism.
- Vitamin C - may inhibit estrogen metabolism.
Monitoring
Baseline Monitoring
Rationale: To identify contraindications, risk factors for cardiovascular disease, breast cancer, and other conditions.
Timing: Prior to initiation of therapy.
Rationale: To establish baseline and monitor for hypertension.
Timing: Prior to initiation of therapy.
Rationale: To screen for breast cancer.
Timing: Prior to initiation of therapy and as clinically indicated.
Rationale: To screen for gynecological conditions and cervical cancer.
Timing: Prior to initiation of therapy and as clinically indicated.
Rationale: To assess cardiovascular risk factors.
Timing: Prior to initiation of therapy, if indicated.
Routine Monitoring
Frequency: Annually
Target: N/A
Action Threshold: N/A
Frequency: Annually or more frequently if indicated
Target: <130/80 mmHg (general guideline)
Action Threshold: Sustained elevation requiring intervention.
Frequency: Annually (breast exam), biennially or as per guidelines (mammography)
Target: N/A
Action Threshold: New lumps, pain, or suspicious findings requiring further investigation.
Frequency: As per current screening guidelines (e.g., every 3-5 years for Pap test)
Target: N/A
Action Threshold: Abnormal findings requiring further investigation.
Frequency: Ongoing patient education and self-monitoring
Target: Absence of symptoms
Action Threshold: Immediate medical attention for new or worsening symptoms (e.g., chest pain, shortness of breath, leg swelling, abnormal vaginal bleeding, breast lump).
Symptom Monitoring
- Unusual vaginal bleeding or spotting
- Breast lumps or changes
- Chest pain or discomfort
- Shortness of breath
- Sudden severe headache
- Sudden vision changes
- Weakness or numbness in an arm or leg
- Speech difficulties
- Swelling, redness, or pain in a leg (especially calf)
- Yellowing of skin or eyes (jaundice)
- Severe abdominal pain
Special Patient Groups
Pregnancy
Climara Pro is contraindicated during pregnancy. There is no indication for use in pregnancy, and there is evidence of fetal harm.
Trimester-Specific Risks:
Lactation
Climara Pro is contraindicated during lactation. Estrogens and progestins are excreted in breast milk and may reduce the quantity and quality of breast milk. Potential adverse effects on the breastfed infant are also a concern.
Pediatric Use
Climara Pro is not indicated for use in pediatric patients. Safety and efficacy have not been established in this population.
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 combined estrogen plus progestin therapy. Increased risk of stroke and VTE has also been observed in this age group. Individualize therapy and consider alternative non-hormonal treatments.
Clinical Information
Clinical Pearls
- Climara Pro is a continuous combined HRT, meaning both estrogen and progestin are delivered continuously, which typically results in amenorrhea (no monthly bleeding) in most women after several months of use.
- It is crucial to adhere to the weekly application schedule and rotate patch sites to maintain consistent hormone levels and minimize skin irritation.
- Patients should be thoroughly counseled on the Black Box Warnings regarding cardiovascular events, breast cancer, and dementia, and the decision to use HRT should be individualized based on symptoms, risk factors, and patient preference.
- Regular follow-up appointments, including physical exams and screenings (mammograms, Pap tests), are essential to monitor for potential adverse effects.
- Transdermal delivery bypasses first-pass hepatic metabolism, which may be advantageous for some patients compared to oral HRT, potentially leading to a more favorable lipid profile and less impact on clotting factors, though cardiovascular risks still exist.
Alternative Therapies
- Estrogen-only therapy (for women without a uterus, or with progestin separately)
- Selective Estrogen Receptor Modulators (SERMs) (e.g., bazedoxifene/conjugated estrogens, ospemifene, tamoxifen, raloxifene)
- Non-hormonal therapies for vasomotor symptoms (e.g., SSRIs/SNRIs like paroxetine, venlafaxine; gabapentin; clonidine)
- Lifestyle modifications (e.g., diet, exercise, stress reduction, avoiding triggers for hot flashes)