Estradiol transdermal patch is a topical transdermal preparation for postmenopausal hormone replacement therapy (HRT), which continuously releases estradiol through the skin to directly supplement endogenous estrogen deficiency in postmenopausal women and avoid the first pass metabolic effects of oral estrogen on the liver. It is clinically used to alleviate symptoms related to postmenopausal estrogen deficiency and prevent high-risk postmenopausal osteoporosis. It is only suitable for women whose postmenopausal symptoms significantly affect their quality of life. The medication should strictly follow the principle of benefit risk assessment.

1、 Drug name

Estradiol transdermal patch (Estramon100), also known as ESTRAMON100 in English.

2、 Indications

For postmenopausal women (at least 12 months after the end of their last menstrual period):

1. Relieve postmenopausal symptoms (such as facial, neck, and chest hot flashes), only for situations that significantly affect daily quality of life.

2. Preventing osteoporosis: suitable for patients with high risk of fractures and other medications not suitable.

3、 Specifications and characteristics

1. Specification: Each patch covers an area of 40cm ² and contains 8.26mg of estradiol hemihydrate (equivalent to 8mg of estradiol), with an average daily release of 100 micrograms of estradiol.

2. Appearance: Transparent oval transdermal patch with protective film, self-adhesive substrate layer containing estradiol, and carrier film.

4、 Main components

1. Active ingredient: estradiol (present in the form of estradiol hemihydrate).

2. Other components: The matrix contains polyacrylate copolymer and RRR - α - tocopherol formulation (including soybean oil); The carrier film is polyethylene terephthalate; The protective film is polyethylene terephthalate (siliconized).

5、 Usage and dosage

1. Usage: For transdermal use, apply to skin areas below the waist that are wrinkle free, clean, dry, and undamaged (avoiding breasts and nearby areas). Replace twice a week, that is, replace one sticker every 3 or 4 days.

2. Medication method: It can be used continuously (without rest) or periodically (for 21 days, stopping for 7 days). Women with intact uterus must use progesterone in combination for at least 12-14 days in each 28 day cycle.

3. Start treatment: If HRT has not been used or has been used continuously, it can be started at any time; If it is a periodic treatment, it should start on the first day after the end of the previous cycle or discontinuation of medication.

4. Replacement method: Tear open the packaging, bend the patch along the incision line to separate the peeling film, apply the exposed adhesive surface to the skin, remove the remaining peeling film, and press with your palm for about 10 seconds.

6、 Dose adjustment

Doctors will use the lowest effective dose and shorten the treatment time as much as possible. Patients should not adjust the dosage on their own. If they feel that the effect is too strong or too weak, they should consult a doctor.

7、 Medication precautions

1. Before pasting: The skin needs to be clean, dry, oil-free, and undamaged.

2. After pasting: Avoid direct sunlight exposure. Bathing, showering, or exercising usually does not affect adhesion.

3. Missed use: If you forget to replace it after 3 or 4 days, you should replace it immediately and continue to replace it according to the original rules in the future. Double dosage is prohibited. Omission may increase the risk of breakthrough bleeding or spotting.

4. Patch detachment: If partially or completely detached in advance, a new patch should be replaced immediately.

5. Before surgery: If surgery is required, the doctor should be informed. Medication may need to be discontinued 4-6 weeks before surgery to reduce the risk of thrombosis.

6. Discontinuation of medication: Treatment should not be interrupted or stopped without the doctor's consent, as discontinuation of medication may result in withdrawal bleeding.

8、 Medication for special populations

1. Postmenopausal women: This product is only suitable for this population.

2. Women over 65 years old: Limited usage experience.

3. For those with intact uterus: combined treatment with progesterone is necessary.

4. Patients who have had their uterus removed usually do not require the addition of progesterone, except in cases of endometriosis.

5. Renal insufficiency: Close monitoring is necessary as severe renal insufficiency may result in elevated levels of estrogen in the blood.

6. Cardiac insufficiency: close monitoring is required. Estrogen may cause fluid retention.

7. Hypertriglyceridemia: Blood lipids need to be monitored during treatment, and in rare cases, it can cause a sharp increase in triglycerides and trigger pancreatitis.

8. Children: Not applicable.

9. Pregnancy and lactation: prohibited. If pregnant during medication, stop taking the medication immediately and seek medical attention.

9、 Adverse reactions

1. Common adverse reactions (with a higher incidence than non users) include:

Breast cancer, endometrial hyperplasia or endometrial cancer, ovarian cancer.

Venous thrombosis in the legs or lungs (venous thromboembolism).

Heart disease and stroke.

Cognitive impairment (possible dementia, limited to those over 65 years old who start HRT).

2. Serious symptoms that require immediate medical attention include:

Sudden chest pain, chest pain radiating to the arms or neck, and difficulty breathing.

Swelling, redness, and pain in the legs.

White eyes or yellow skin, dark urine color, itching (jaundice).

Abnormal vaginal bleeding or spotting after long-term medication or discontinuation.

Breast changes (skin indentation, nipple changes, palpable lumps).

Dysmenorrhea and unexplained migraine like headaches.

10、 Contraindications

1. This product is prohibited in the following situations:

Is or has been suffering from breast cancer, or suspected of breast cancer.

Estrogen dependent tumors (such as endometrial cancer) or suspected.

Vaginal bleeding of unknown cause.

Untreated endometrial hyperplasia.

Current or previous venous thrombosis (such as deep vein thrombosis, pulmonary embolism).

Coagulation dysfunction (such as protein C, protein S, antithrombin deficiency).

Current or previous arterial thrombotic diseases (such as myocardial infarction, stroke, angina pectoris).

Currently or previously suffering from liver disease and liver function has not returned to normal.

Blood porphyria.

Allergic to estradiol, soybeans, peanuts or any auxiliary materials of this product.

If the above situation occurs for the first time during use, the medication should be stopped immediately and medical attention should be sought.

11、 Drug interactions

1. Medications that can reduce the effectiveness of this product include antiepileptic drugs (phenobarbital, phenytoin, carbamazepine), anti tuberculosis drugs (rifampicin, rifampicin), some HIV drugs (nevirapine, efavirenz, ritonavir, nelfinavir), herbs containing St. John's wort, and some anti infective drugs (ketoconazole, erythromycin). These medications may cause irregular bleeding.

2. This product affects the efficacy of other drugs: it may increase the frequency of epileptic seizures with lamotrigine; The combination with hepatitis C treatment drugs (Obitavir/Paliravir/Letonavir ± Dasafvir, Gecarevir/Pirentavir) may increase ALT, but this product contains estradiol instead of ethinylestradiol, and the risk is unknown.

3. Laboratory examination: This product may affect some test results, and the doctor or testing personnel should be informed.

12、 Storage method

1. Storage conditions: Store below 30 ° C.

2. Storage requirements: Keep out of reach of children.

3. Validity period: Cannot be used after the expiration date of the "expiry date" or "useby" on the packaging or small bag.

4. Disposal: After use, the patch should be folded in half (with the adhesive side facing inward). Do not flush into the sewer, consult a pharmacy or refer to https://www.bfarm.de/arzneimittelentsorgung Carry out environmental protection disposal.

13、 Manufacturer

Hexal

Estramoninformation