Estraderm

The active ingredient in Minivelle is estradiol, which is an estrogen replacement. It supplements the natural estrogen that the body loses during menopause. Replacing estrogen reduces bone loss and alleviates vasomotor menopausal symptoms such as hot flashes and night sweats.

Follow all directions provided by your doctor and read all documents carefully, including the full Prescribing Information, FDA-approved Product Labeling, Instructions for Use, and Medication Guide, before using Minivelle. However, the following is a synopsis of the general guidelines for the use of Minivelle:

• Use the skin patch on clean, dry skin on your stomach or buttocks. Hold the patch firmly in place for at least 10 seconds. Do not apply to the same skin region twice in 7 days. Avoid skin that is inflamed or injured.
• Do not use a skin patch on your breasts. Do not place a patch where it could be rubbed off by tight clothing, such as under an elastic waistband. Never cut a skin patch.
• If a patch falls off, try gluing it back in place. If it does not stay well, apply a new patch to a different skin location and leave it on for the remainder of your wear period.
• Remove the patch and apply a new one on the same day(s) each week to maintain your once- or twice-weekly regimen.
• Estradiol may raise your risk of getting a condition that can progress to uterine cancer. Your doctor may prescribe a progestin to reduce this risk. If you see any odd vaginal bleeding, report it right away.
• If you need significant surgery or will be on long-term bed rest, you may need to discontinue using Minivelle for a brief period. Any doctor or surgeon who treats you should be aware that you are on estradiol.
• Your doctor should monitor your development on a regular basis to determine if you should continue receiving this treatment. Self-examine your breasts for lumps every month, and have regular mammograms while taking Minivelle.

Some common side effects of Minivelle include:

• Breast tenderness.
• Fluid retention.
• Breast pain.
• Vaginal dryness.
• Weight gain.
• Common cold symptoms or sinus issues.
• Depression.
• Joint pain.
• Increased triglyceride levels.

Some individuals may experience serious side effects while using Minivelle. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Heart attack symptoms include chest pain or tightness that extends to your shoulder, arm, neck, or jaw.
• Stroke symptoms include difficulty speaking, walking, numbness on one side of the body or face, a severe headache, and confusion.
• A blood clot in the leg (deep vein thrombosis or DVT) causes leg cramping, swelling, pain, and muscle tightness.
• Cough, chest pain, difficulty breathing, and a racing heart are symptoms of a pulmonary embolism (a blood clot in the lungs).
• Cancer symptoms include lumps, pain, swelling, or changes in the breasts; swollen lymph nodes; unusual or copious vaginal flow; bloating; extreme weariness; and stomach pain.
• Gallbladder disorders include stomach pain, persistent nausea or vomiting, fever, and yellowing of the skin and eyes (jaundice).
• Severe allergic reactions include hives, swelling in the face or throat, difficulty breathing, stomach pain, and vomiting.

These are not all of the possible side effects of Minivelle. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Minivelle, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Unusual vaginal bleeding that has not been evaluated by a physician.
• Coronary artery disease or heart disease.
• A bleeding condition.
• A history of heart attack, stroke, or blood clots.
• High blood pressure.
• A history of hormone-related cancer, such as breast cancer, uterine/cervical/ovarian cancer, or vaginal/endometrial cancer.
• Pregnancy and hormone use might induce liver issues or jaundice.
• A thyroid condition.
• Gallbladder disease.
• Kidney disease.
• Asthma.
• Epilepsy or another seizure disease.
• Migraine headaches.
• Lupus.
• Porphyria (a genetic enzyme condition characterised by skin and neurological system symptoms).
• Endometriosis, or uterine fibroid tumours.
• High blood calcium levels.
• Hereditary angioedema.
• High triglyceride or cholesterol levels.

Boxed Warning

The boxed warnings emphasize significant dangers associated with estrogen therapy. Estrogen-alone therapy raises the risk of endometrial cancer; thus, adding progestin and monitoring irregular bleeding is critical. Estrogens, with or without progestins, should not be used to prevent cardiovascular disease or dementia, as studies reveal an increased risk of stroke, heart attack, blood clots, breast cancer, and probable dementia in postmenopausal women, particularly those over the age of 65. These concerns were identified in the WHI and WHIMS investigations, but their significance for lower doses, different products, or methods is unknown. Estrogen therapy should be provided at the lowest effective dose for the shortest possible time, and transdermal preparations should be used with caution due to instances of inadvertent secondary exposure producing hormonal changes in youngsters.

• Abnormal vaginal bleeding.
• A history of breast cancer.
• Cancer that relies on estrogen to flourish.
• Blood clots or clotting-related conditions.
• History of a stroke or heart attack.
• Liver issues.

Minivelle begins releasing estradiol into the bloodstream within hours and achieves consistent levels in 24-48 hours. Symptom improvement, such as fewer hot flashes or night sweats, typically appears after 2-4 weeks, although advantages for bone health require several months of ongoing treatment.

When Minivelle is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions.

Your dosage will be determined by the reason you are taking Minivelle (estradiol patch). Apply one patch to the skin of your lower stomach or buttocks twice a week, or every 3 to 4 days.

Symptoms of menopause: The typical initial dose is one 0.0375 mg/day patch administered twice a week. Your prescriber may increase your dose based on how well it works for you.

Postmenopausal osteoporosis: The typical starting dose is a 0.025 mg/day patch used twice a week.

Store at room temperature and keep out of reach of children.

Noven Pharmaceuticals is the company that manufactures Minivelle.

There is no generic version of Minivelle available.

You should not discontinue Minivelle abruptly; it is normally tapered down under a doctor's supervision to reduce the recurrence of symptoms such as hot flashes or mood disturbances.

If you are pregnant, do not use Minivelle. If you become pregnant during treatment, contact your doctor right away.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.