药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(20127601213633.PDF)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文Alora处方资料(仅供参考)
英文药名: Alora (Estradiol Transdermal Patch)
中文药名: 雌二醇贴剂
FDA批准雌二醇缓释经皮给药系统安全标示的修改 2005年5月19日,FDA批准修改雌二醇缓释经皮给药系统(estradiol,Alora)标签中的禁忌证和警告事项内容,以警示:本品可能增加痴呆、脑卒中、肺栓塞和深度静脉栓塞的风险。 本品禁用于肝功能不全、患有肝病或对本品所含成分过敏的患者。尽管早期妊娠女性意外地使用了雌激素或孕激素后,几乎没有增加出生缺陷的风险,但妊娠女性或疑似妊娠的女性仍应避免服用本品。 雌激素和(或)孕激素不应用于预防痴呆或心血管疾病。此项警告基于女性健康倡导行动(WHI)的一项研究的结果得出。此项安慰剂对照临床研究显示,结合雌激素+醋酸甲羟孕酮(medroxyprogesterone acetate)疗法使65岁及以上女性在4年中诊断为可能痴呆的比率显著增高。WHI研究的5年结果显示,与安慰剂组相比,结合雌激素+醋酸甲羟孕酮疗法用于50~79岁绝经后女性,导致脑卒中、肺栓塞和深度静脉栓塞的比例显著增加。 本品由Watson Laboratories公司生产,适用于治疗绝经相关的中重度血管收缩症状和外阴阴道萎缩症状。
Generic Name for ALORA Estradiol 0.025mg/day, 0.05 mg/day, 0.075 mg/day, 0.1 mg/day; transdermal patch.
Legal Classification: Rx
Pharmacological Class for ALORA Estrogen.
Manufacturer of ALORA Watson Pharmaceuticals, Inc. Indications for ALORA Moderate to severe vasomotor symptoms of menopause. Vulval and vaginal atrophy. Postmenopausal osteoporosis prevention. Hypoestrogenism.
Adult dose for ALORA Apply to clean, dry area on lower abdomen, hips, or buttocks (avoid breasts, waistline). Osteoporosis: initially one 0.025mg/day patch twice weekly. Others: initially one 0.05 mg/day patch twice weekly. Maintenance: use lowest effective dose. Patients without intact uterus may use continuous schedule; otherwise use cyclically (3 weeks on, 1 week off). Transferring from other topical therapy: may start immediately or if from oral estrogens: apply 1st patch up to 1 week after last oral dose. Rotate application sites. Reevaluate periodically.
Children's dosing for ALORA Not applicable.
Contraindications for ALORA Undiagnosed abnormal genital bleeding. Thromboembolic disorders. Thrombophlebitis. Breast or estrogen-dependent carcinoma. Pregnancy (Cat.X).
Warnings/Precautions for ALORA Patients with intact uterus should receive a progestin to avoid endometrial hyperplasia. Familial hyperlipoproteinemia or history of breast cancer. Hypercoagulability. Hepatic insufficiency. Conditions aggravated by fluid retention. Endometriosis. Gallbladder disease. Bone disease associated with hypercalcemia. Do initial complete physical and repeat annually (include Pap smear, mammogram, and BP). Discontinue if hypertension or jaundice occurs and during immobilization, or at least 2 weeks before surgery associated with increased risk of thromboembolism. Nursing mothers.
Adverse Reactions for ALORA See literature. Increased risk of endometrial cancer or hyperplasia, thromboembolic disorders. Headache, local irritation, fluid retention, breakthrough bleeding, mastodynia, nausea, abdominal cramps, migraine, dizziness; vaginal bleeding (at 0.1mg/day dose).
How is ALORA supplied? Patch 0.05 mg/day—8, 24 0.025mg/day, 0.075 mg/day, 0.1 mg/day—8
Related Disease: Menopausal disorders Osteoporosis~estrogens
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