美国FDA批准雌二醇透皮喷雾剂上市
美国FDA批准VIVUS公司的雌二醇定量透皮喷雾剂（estradiol，EvaMist）上市，用于治疗绝经后妇女中度至严重的血管舒缩症状。本品是美国FDA批准的首个雌二醇透皮喷雾剂。此快速干燥的美国专利透皮喷雾剂由雌二醇、挥发性溶媒乙醇（溶解药物）和水杨酸乙基己酯（octisalate，一种在一些防晒用品中常用的皮肤渗透促进剂）组成。剂量规格：雌二醇1.53mg /90 μL/喷。
美国FDA批准本品代表VIVUS公司发展史上的一个重要里程碑：从产品构思至获准上市不到3年。据预测，本品2008年第一季度在美国上市后年销售峰值将达1.25亿美元。
本品为释放天然雌二醇的定量喷雾剂，每日应在相同的时间使用，喷于清洁、干燥和未破损的前臂至肘和手腕间的皮肤上。按一日1次的给药方案，药物被吸收进入血流可持续作用24小时。喷雾后在45秒内干燥形成“看不见的贴片”，但在皮肤上不留痕迹和残留物。临床研究显示，喷雾45秒后再搓擦和清洗不能去除已喷雾的用药剂量。此种透皮喷雾剂给药剂量较口服片低的多，而且较透皮贴片对皮肤无刺激性。本品的生产成本小，故价格低。
本品常见的不良反应是头痛、乳房痛、无规则阴道出血、胃/腹部痉挛、恶心、呕吐、掉发、水潴留及霉菌感染等.
EVAMIST - estradiol spray, metered
Ther-Rx Corporation
Evamist （雌二醇透皮喷）
适应症
Evamist为中度由于绝经在治疗重度血管舒缩症状表明雌激素
剂量与用法
一喷，每日一次，以前臂为起始剂量.
增加到每天两三个喷雾剂前臂根据临床反应.
剂型和规格
一喷提供90MCL含有1.53毫克雌二醇
EVAMIST Rx
Generic Name and Formulations:
Estradiol 1.53mg/spray; transdermal spray.
Company:
Ther-Rx Corporation
Indications for EVAMIST:
Moderate to severe vasomotor symptoms of menopause.
Adult Dose for EVAMIST:
Prime pump before 1st use. Apply to clean, dry, unbroken skin on the inside of the forearm between the elbow and wrist. Initially 1 spray daily; may increase to 2–3 sprays if needed; do not spray in the same area. Allow spray to dry before dressing; do not wash area for at least 30 minutes after application.
Children's Dose for EVAMIST:
Not applicable.
Pharmacological Class:
Estrogen.
Contraindications:
Breast or estrogen-dependent carcinoma. Undiagnosed abnormal vaginal bleeding. Thromboembolic disorders (eg, stroke or MI within one year, DVT, pulmonary embolism). Thrombophlebitis. Liver dysfunction or disease. Pregnancy (Cat.X).
Warnings/Precautions:
Use shortest duration and lowest dose consistent with treatment goals and risks. Not for prevention of cardiovascular disease (CVD) or dementia. Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Renal dysfunction. Gallbladder disease. Hypertriglyceridemia. Hypothyroidism. Hypercoagulability. Conditions aggravated by fluid retention. Bone disease associated with hypercalcemia. Do initial complete physical; repeat annually (include BP, mammogram, PAP smear). Discontinue if visual disturbances or jaundice occurs, and during immobilization, and at least 4–6 weeks before surgery associated with thromboembolism. Manage risk factors for CVD and VTE appropriately. May aggravate asthma, diabetes, epilepsy, migraine, porphyria, SLE, hepatic hemangiomas. May interfere with lab tests (eg, thyroid, PT, glucose tolerance, HDL-C/LDL-C). Product is flammable. Nursing mothers.
Interactions:
Avoid applying sunscreen 1 hr after (decreases estradiol absorption). May need higher doses of thyroid-replacement therapy. May be antagonized by CYP3A4 inducers. May be potentiated by CYP3A4 inhibitors.
Adverse Reactions:
Headache, breast/nipple pain, nausea, back pain, nasopharyngitis.
How Supplied:
Pump—8.1mL (56 sprays/pump)
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产地国家: 美国
原产地英文商品名:
EVAMIST 1.53MG/SPRAY 8.1ML/SPRAY
原产地英文药品名:
ESTRADIOL
中文参考商品译名:
EVAMIST 1.53毫克/喷 8.1毫升/喷雾器
中文参考药品译名:
雌二醇
生产厂家中文参考译名:
KV PHARM
生产厂家英文名:
KV PHARM