CombiPatch Information:
CombiPatch is a hormonal medication used to prevent or reduce the symptoms of menopause, or when ovaries have either been removed or have stopped working. CombiPatch is a combination of estradiol and norethindrone. Estradiol is a form of estrogen that works by binding to nuclear receptors in estrogen-responsive tissues. It then modulates the pituitary secretion of the gonadotropins, luteinizing hormone (LH), and follicle stimulating hormone (FSH) through a negative feedback mechanism. Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women. Norethindrone is a form of progestin that works by diffusing into the female reproductive tract, the mammary gland, the hypothalamus, and the pituitary, and binding to the progesterone receptor. Once bound to the receptor, progestins slow the frequency of release of gonadotropin releasing hormone (GnRH) from the hypothalamus and blunt the pre-ovulatory LH surge. Before using this medication, tell your doctor if you have unusual vaginal bleeding, liver disease, a bleeding disorder, a history of heart attack, stroke, or blood clots, or a history of hormone related cancer, or cancer of the breast, uterus, or vagina.
Side Effects
Commonly reported side effects include application site reactions (redness, itching, or irritation), headache, breast tenderness or pain, nausea, and abdominal bloating or gas. You may also experience breakthrough bleeding or spotting, weight gain, and mood changes like irritability or depression.
Contact your doctor immediately if you develop any of the serious medical conditions associated with CombiPatch, including:
• Gallbladder Disease
• Hypercalcemia: Increased risk of high calcium levels in patients with breast cancer and bone metastases.
• Cardiovascular Risks: Increased risk of blood clots (including deep vein thrombosis and pulmonary embolism), stroke, and heart attack.
• Probable Dementia: Increased risk of cognitive decline, especially in women 65 years of age and older.
• Malignant Neoplasms: Increased risk of invasive breast cancer and, if estrogen is used without progestin, endometrial cancer.
• Visual Abnormalities: Such as partial or complete loss of vision, or retinal vascular thrombosis.
Seek emergency medical attention immediately if you experience:
• Sudden leg pain, swelling, or warmth
• Severe chest pain, coughing up blood, or sudden shortness of breath
• A sudden, severe headache or sudden confusion
• Sudden changes in or loss of vision
• A new lump in the breast or under the arm
Consult your doctor before stopping CombiPatch; discontinuing therapy abruptly can cause a rapid return of menopausal symptoms or irregular vaginal bleeding.
Precautions:
Do not use CombiPatch if you have a known hypersensitivity (allergy) to estradiol, norethindrone acetate, or any ingredients in the patch adhesive.
Tell your doctor about your medical history, especially if you have:
o Active or past blood clots (DVT or pulmonary embolism).
o A history of heart attack or stroke.
o Known, suspected, or a history of breast cancer or other estrogen-dependent tumors.
o Liver disease or liver tumors.
o Known or suspected pregnancy.
o Undiagnosed abnormal vaginal bleeding.
CombiPatch may interact with medications that induce liver enzymes, such as carbamazepine, rifampin, phenobarbital, and St. John’s Wort, which can decrease hormone levels and reduce the patch's effectiveness.
It may also interact with caffeine and certain thyroid replacement therapies, the latter of which may require your doctor to adjust your thyroid medication dosage.
CombiPatch is contraindicated during pregnancy as it may harm an unborn baby. Speak to your doctor immediately if you become pregnant or are planning a pregnancy. It is generally not recommended during breastfeeding as estrogens pass into human milk and may reduce milk quality and quantity.
This combination patch is specifically intended for women with a uterus to protect against endometrial hyperplasia (thickening of the uterine lining). Women without a uterus (who have had a hysterectomy) should typically use estrogen-only therapy.
Store CombiPatch in the refrigerator (2°C to 8°C or 36°F to 46°F) before dispensing or use. After opening the pouch, individual patches may be stored at room temperature (below 25°C or 77°F) for up to 6 months. Do not store patches outside of their protective pouches. Keep out of reach of children and pets.
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