Compound estradiol patch ( patch )

Number

YT120-3

Product description

Instructions for estradiol sustained release patch

Please read the instructions carefully and use them under the guidance of the doctor

[ Drug Name ]

Common name: estradiol sustained-release patch

Product name: il

English Name: Estradiol Sustained - Release Patches

Chinese pinyin: ci' er chun huanshi tie Pian

【 Ingredients 】 The main ingredient of this product is estradiol.

Chemical name: Estrogen - 1,3,5 ( 10 ) - triene - 3,17 β - diol.

Molecular formula: C 18 H 24 O 2

Molecular weight: 272.39

[ Character ]

This product is a sticky film coated on aluminum-plastic film, and the drug surface is colorless, transparent or slightly milky white.

【 Indications 】 This product is suitable for the following symptoms caused by estrogen deficiency due to various reasons: hot flashes, sweating, sleep disorders, dizziness, genital atrophy, atrophic vaginitis, vaginal dryness, etc.

【 Specification 】 2.5 mg ( 4.0 cm× 2.6 cm )

[ Usage and Dosage ]

External use: Immediately after removing the protective film from the patch, apply it to the clean and dry skin of the lower abdomen or buttocks without trauma. One tablet a week, three weeks in a row, stop for one week. On the last 5 days of using the patch, medroxyprogesterone acetate 4mg was added once a day for 5 consecutive days. The position of the patch should be changed frequently, and the same part of the skin should not be pasted twice in a row, and should not be pasted on the breast.

[ Adverse Reactions ]

The skin on the patch may show mild redness or itching, with occasional rashes. Also can appear dizziness, headache, nausea, vomiting, breast pain, vaginal bleeding and lower body edema.

[ Taboo ]

Patients suspected of or suffering from breast tumors, patients suspected of or suffering from estrogen-dependent tumors, patients with unexplained irregular vaginal bleeding, active thrombophlebitis or thromboembolism, patients with a history of thrombophlebitis or thrombosis due to estrogen use, patients with endometriosis, and severe liver damage are prohibited.

[ Precautions ]

( 1 ) Regular physical examination should be conducted before and during medication: including blood pressure, breast, abdominal and pelvic organs and cervical smear.

( 2 ) Patients with family history of breast cancer, or breast nodules, cystic fibrosis of breast and abnormal X - ray images of breast, severe hypertension and cardiac and renal insufficiency, patients with cerebrovascular or coronary artery disease, asthma, skin allergy, epilepsy, migraine, diabetes or depression should be cautious.

[ Medication for pregnant and lactating women ] is prohibited.

[ Children's medication ] is not clear.

[ Medication for the Elderly ] is not yet clear.

[ Drug Interaction ]

1. When used with anticoagulants, anticoagulants can be reduced. When used with anticoagulants, the dosage of anticoagulants should be adjusted.

2. When used together with carbamazepine, phenobarbital, phenytoin sodium, paracetamol and rifampicin, the effect of estrogen can be reduced, which is due to the induction of liver microsomal enzymes and the acceleration of estrogen metabolism.

3. When used together with tricyclic antidepressants, a large amount of estrogen can increase the adverse reactions of antidepressants and reduce their proper effects.

4. Use with antihypertensive drugs can reduce the effect of antihypertensive drugs.

5. Reduce the therapeutic effect of tamoxifen.

6. Increase the absorption of calcium.

[ Drug overdose ] is not clear.

[ Pharmacology and Toxicology ]

Pharmacological action

Estradiol is an estrogen with high receptor level activity secreted by ovaries in women of childbearing age. After menopause, ovarian failure and estradiol production almost stopped, resulting in vascular dyskinesia and unstable body temperature regulation. Clinical manifestations include hot flashes, sweating, sleep disorders, atrophy of the genitourinary system and osteoporosis. After estradiol is absorbed into the blood, the concentration of estradiol in the blood rises to the early level of follicle and acts on the target organ, thus obviously alleviating or eliminating the above symptoms.

[ Pharmacokinetics ]

After the patch was applied, the serum estradiol level increased, the peak time ( tmax ) was 22 hours, and the maximum blood concentration ( Cmax ) was 43.8pg/ml. Maintain an effective and stable blood drug level within 7 days. The serum estradiol level returned to the pre-administration level 24 hours after discontinuation of the drug. The average penetration of human skin is 50ug per day. Mainly metabolized by the liver, the main metabolites are estriol, estrone and their conjugates, which are excreted by the kidney in the form of glucuronic acid salt and sulfate conjugates.

[ Storage ]

Sealed and stored in a cool place ( no more than 20 ℃ ).

" Packaging" aluminum plastic bag packaging, ( 1 ) 1 piece / bag, 1 bag / box; ( 2 ) 1 piece / bag, 2 bags / box; ( 3 ) 1 piece / bag, 3 bags / box

[ Effective Period ] 24 Months

[ Implementation Standard ] Part II, 2010 Edition of Chinese Pharmacopoeia

[ approval number ] national medicine standard word H10950258

[ Production Enterprise ]

Enterprise name: Zhejiang Asia Pacific Pharmaceutical Co., Ltd.

Address: No. 1152, Jiji Road, Shaoxing County, Zhejiang Province

Postal Code: 312303

Phone number: ( 0575 ) 84816742 ( Sales ) ( 0575 ) 84810110 ( Consulting ) ( 0575 ) 84810115 ( Quality )

Compound estradiol patch ( patch )