Climara 0.06mg/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 ligand-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 those on the reproductive system, bone, cardiovascular system, and central nervous system. In the context of menopause, it replaces declining endogenous estrogen levels to alleviate vasomotor symptoms and 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 experience any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of gallbladder problems, such as:
+ Pain in the upper right belly area, right shoulder area, or between the shoulder blades
+ Yellow skin or eyes
+ Fever with chills
+ Bloating
+ Severe upset stomach or vomiting
Signs of pancreatitis (pancreas problem), including:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
Eyesight changes or loss
Bulging eyes
Changes in how contact lenses feel
Breast changes, including:
+ Lump in the breast
+ Breast pain or soreness
+ Nipple discharge
Vaginal changes, including:
+ Itching or discharge
+ Abnormal vaginal bleeding
Depression or other mood changes
Memory problems or loss
Fever
Urination problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Pain when passing urine
Swelling or fluid retention in the body, including:
+ Weight gain
+ Trouble breathing
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, which can cause:
+ Weakness
+ Confusion
+ Fatigue
+ Headache
+ Upset stomach or vomiting
+ Constipation
+ Bone pain

Other Possible Side Effects

Most people do not experience serious side effects, and many have only minor or no side effects at all. However, if you experience 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
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 administration

This is not a comprehensive list of all 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.

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 or stroke
+ Tumors that are sensitive to estrogen
Any instances of unexplained vaginal bleeding
If you are pregnant or think you might be pregnant. Do not take this medication 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 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 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 will be 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, 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.

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 use sunscreen and protective clothing and eyewear when going outside.

This drug may interfere with certain laboratory tests, so 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 like walking or physical therapy. 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 your doctor to discuss potential risks to your baby.

• CYP3A4 Inducers (e.g., Carbamazepine, Phenobarbital, Phenytoin, Rifampin, St. John's Wort): May significantly decrease estradiol plasma concentrations, leading to reduced therapeutic effect and potential for breakthrough bleeding.
• Aromatase Inhibitors (e.g., Anastrozole, Letrozole, Exemestane): Estrogens are contraindicated with aromatase inhibitors as they counteract their mechanism of action in breast cancer treatment.

• CYP3A4 Inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir, Clarithromycin, Grapefruit Juice): May increase estradiol plasma concentrations, potentially leading to increased adverse effects.
• Thyroid Hormone Replacement Therapy (e.g., Levothyroxine): Estrogens can increase thyroid-binding globulin (TBG) levels, leading to a decrease in free thyroid hormone. Patients on thyroid replacement therapy may require an increased dose of thyroid hormone.
• Corticosteroids (e.g., Prednisolone): Estrogens may decrease the clearance of corticosteroids, leading to increased corticosteroid effects and toxicity.
• Anticoagulants (e.g., Warfarin): Estrogens may diminish the anticoagulant effect of warfarin. Close monitoring of INR is recommended.
• Lamotrigine: Estrogens may decrease lamotrigine plasma concentrations, potentially leading to loss of seizure control.

• Folic Acid: Estrogens may increase the need for folic acid.
• Vitamin B6: Estrogens may increase the need for vitamin B6.

• Abnormal vaginal bleeding (spotting, breakthrough bleeding, prolonged bleeding)
• Breast lumps or tenderness
• Swelling, pain, or redness in a leg (DVT symptoms)
• Sudden chest pain, shortness of breath, coughing up blood (PE symptoms)
• Sudden severe headache, vision changes, slurred speech, weakness/numbness on one side of the body (Stroke symptoms)
• Chest pain, discomfort, shortness of breath, pain radiating to arm/jaw (MI symptoms)
• Jaundice or yellowing of skin/eyes
• Severe abdominal pain
• Mood changes, depression

Climara is contraindicated during pregnancy. There is no indication for estrogen therapy in pregnancy. Estrogen exposure during pregnancy has been associated with an increased risk of birth defects in the reproductive organs of female fetuses.

Climara is not recommended during lactation. Estrogens are excreted in human milk and may decrease the quantity and quality of breast milk. Potential adverse effects on the nursing infant are unknown but generally considered undesirable.

Climara is 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 pubertal development.

Use with caution in women 65 years of age or older. The WHIMS study showed an increased risk of probable dementia in women 65 years of age or older receiving estrogen-alone or estrogen plus progestin therapy. Consider the lowest effective dose for the shortest duration consistent with treatment goals. Closely monitor for adverse events, particularly cardiovascular and cognitive effects.

• Transdermal estradiol bypasses first-pass hepatic metabolism, resulting in a more favorable estradiol-to-estrone ratio and potentially lower risk of certain adverse effects (e.g., VTE) compared to oral estrogens, though risks still exist.
• Always assess for the presence of a uterus. If the patient has an intact uterus, a progestin must be co-administered with estrogen to reduce the risk of endometrial hyperplasia and cancer.
• Rotate application sites weekly to avoid skin irritation. Apply to a clean, dry area on the lower abdomen or buttocks, avoiding the waistline, breasts, or irritated skin.
• The lowest effective dose for the shortest duration consistent with treatment goals should be used for menopausal hormone therapy.
• Regular monitoring, including annual physical exams, breast exams, and mammograms, is crucial.
• Educate patients thoroughly on the Black Box Warnings, especially regarding cardiovascular risks and the importance of reporting any unusual symptoms immediately.

• Other transdermal estradiol patches (e.g., Vivelle-Dot, Minivelle, Dotti)
• Oral estrogens (e.g., Estrace, Premarin)
• Vaginal rings (e.g., Estring, Femring)
• Estrogen gels/sprays (e.g., Divigel, Elestrin, Evamist)
• Non-hormonal therapies for vasomotor symptoms (e.g., SSRIs/SNRIs like paroxetine, venlafaxine; gabapentin; clonidine)
• Bisphosphonates or other anti-resorptive agents for osteoporosis prevention/treatment (if HRT is contraindicated or not preferred for bone health)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.