Climara 0.0375mg/day Patches 4s

Estradiol is the primary estrogen secreted by the human ovary. It binds to and activates nuclear estrogen receptors (ERα and ERβ) in target tissues, forming a 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 levels to alleviate symptoms like hot flashes and vaginal atrophy, and to prevent bone loss.

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 notice 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, pain, or soreness
Nipple discharge
Vaginal itching or discharge
Abnormal vaginal bleeding
Depression or mood changes
Memory problems or loss
Fever
Difficulty urinating or changes in urine output
Pain while urinating

This medication may cause fluid retention, leading to swelling or weight gain. If you experience any of these symptoms, 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
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 or seek medical help 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

Reporting Side Effects

If you have questions about side effects or experience any unusual symptoms, 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.

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 estrogen-dependent
Unexplained vaginal bleeding
Pregnancy or potential pregnancy. Note: This medication is contraindicated during pregnancy and should not be taken if you are pregnant.

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 the safety of taking this medication in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

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 immobility may increase your risk of developing blood clots. 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. Additionally, 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, 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. If you have a history of high triglyceride levels, inform your doctor. This medication may cause dark skin patches on your face, so it is essential to avoid sun exposure, sunlamps, and tanning beds, and to use sunscreen and protective clothing and eyewear when outdoors.

This drug may interfere with certain laboratory tests, so be sure to inform all your healthcare providers and lab personnel that you are taking this medication. 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.

For optimal effectiveness, use this medication in conjunction with calcium and vitamin D supplements and engage in weight-bearing exercises, such as walking or physical therapy, as directed by your doctor. Follow 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 with your doctor to discuss any potential risks to your baby.

• Aromatase inhibitors (e.g., anastrozole, letrozole, exemestane) - concurrent use may reduce efficacy of aromatase inhibitors.
• Tranexamic acid (increased risk of thrombosis).

• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenobarbital, phenytoin, St. John's Wort) - may decrease estradiol levels, reducing efficacy.
• CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir) - may increase estradiol levels, increasing risk of adverse effects.
• Thyroid hormone replacement therapy (e.g., levothyroxine) - estrogens can increase thyroid-binding globulin (TBG), potentially increasing thyroid hormone requirements.
• Corticosteroids (e.g., prednisone) - estrogens may decrease the clearance of corticosteroids, leading to increased effects.
• Warfarin - estrogens may alter the anticoagulant effect of warfarin; monitor INR closely.

• Grapefruit juice (oral estrogens, less relevant for transdermal but caution advised).
• Fluvoxamine (potential increase in estrogen levels).
• Lamotrigine (estrogens may decrease lamotrigine levels, leading to loss of seizure control).

• Not specifically identified for transdermal estradiol in a clinically significant minor category.

• Signs of thromboembolic events (e.g., sudden chest pain, shortness of breath, severe headache, sudden vision changes, pain/swelling in leg)
• Signs of myocardial infarction (e.g., chest pain, discomfort in other areas of upper body, shortness of breath, cold sweat, nausea, lightheadedness)
• Signs of stroke (e.g., sudden numbness or weakness, confusion, trouble speaking, trouble seeing, sudden severe headache, trouble walking)
• Abnormal vaginal bleeding (e.g., postmenopausal bleeding, irregular bleeding)
• Breast lumps or changes
• Jaundice or signs of liver dysfunction (e.g., dark urine, pale stools, persistent nausea/vomiting)
• Severe abdominal pain
• Mood changes or depression

Contraindicated in pregnancy. Estrogens are not indicated for use in pregnant women. There is no indication for estrogen therapy during pregnancy, and there is evidence of potential harm to the fetus (e.g., feminization of male fetuses, congenital anomalies).

Not recommended during lactation. Estrogens are known to be excreted in human milk and can reduce the quantity and quality of breast milk. Potential adverse effects on the nursing infant have not been fully established but are a concern.

Not indicated for use in pediatric patients. Safety and efficacy have not been established in this population. Estrogen therapy in children could affect bone maturation and sexual development.

Use with caution, especially 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. The lowest effective dose for the shortest duration should be used. Increased risk of stroke and venous thromboembolism may also be present in older women.

• Transdermal estradiol bypasses first-pass hepatic metabolism, resulting in a more favorable estrogen-to-estrone ratio and potentially fewer hepatic effects (e.g., on clotting factors, triglycerides) compared to oral estrogens.
• The patch should be applied to a clean, dry area of the trunk (e.g., lower abdomen, buttocks) and rotated to avoid irritation. Avoid applying to breasts or waistline.
• Adherence is crucial for efficacy; patients should be instructed on proper application and weekly replacement.
• For women with an intact uterus, a progestin must be co-administered to reduce the risk of endometrial hyperplasia and cancer.
• Regular re-evaluation (at least annually) of the need for continued therapy is essential, using the lowest effective dose for the shortest duration consistent with treatment goals and risks.
• Patients should be educated on the signs and symptoms of serious adverse events (e.g., blood clots, stroke, heart attack, breast cancer) and instructed to seek immediate medical attention if they occur.

• Other transdermal estradiol formulations (e.g., gels, sprays)
• Oral estrogens (e.g., conjugated estrogens, oral estradiol)
• Vaginal estrogens (e.g., creams, rings, tablets) for localized symptoms
• Selective Estrogen Receptor Modulators (SERMs) (e.g., ospemifene, bazedoxifene/conjugated estrogens)
• Non-hormonal therapies for vasomotor symptoms (e.g., SSRIs/SNRIs like paroxetine, venlafaxine; gabapentin; clonidine)
• Bisphosphonates, denosumab, teriparatide for osteoporosis prevention/treatment (if estrogen is contraindicated or not preferred for bone health)

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 details. 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 information about the medication taken, the amount, and the time it happened.