英文药名：Rhofade Cream 1%（oxymetazoline hydrochloride）

中文药名：盐酸羟甲唑啉霜 1%

生产商：Valeant公司
药品介绍
2017年1月，美国FDA批准RHOFADE™霜用于局部治疗 在成人中与红斑痤疮相关的持续性面部红斑（发红）。
RHOFADE（羟甲唑啉盐酸盐[oxymetazoline hydrochloride]）霜，用于局部使用
美国最初批准：1964年
作用机制
羟甲唑啉是α1A肾上腺素受体激动剂。 羟甲唑啉作为血管收缩剂。
适应症和用法
RHOFADE是一种alpha1A肾上腺素受体激动剂，用于局部治疗与成人红斑痤疮相关的持续性面部红斑。
剂量和给药
不适用于口服，眼科或阴道内使用。
在首次使用之前灌注泵瓶，并丢弃前三台泵的产品。
每天应用一次豌豆大小的量，覆盖整个面部（前额，鼻子，每个脸颊和下巴），避免眼睛和嘴唇。
应用后洗手。
剂型和强度
奶油，1％。每克乳膏含有10mg（1％）盐酸羟甲唑啉，相当于8.8mg（0.88％）羟甲唑啉游离碱。
禁忌症
没有。
警告和注意事项
作为一类的α-肾上腺素能激动剂可能会影响血压。建议患有心血管疾病，直立性低血压和/或不受控制的高血压或低血压的患者在情况恶化时寻求医疗护理。
在脑血管或冠状动脉功能不全，雷诺现象，闭塞性血栓性血管炎，硬皮病或干燥综合征患者中应谨慎使用，如果发生血管功能不全的症状和体征，建议患者寻求医疗护理。
如果出现急性窄角型青光眼的体征和症状，建议患者立即寻求医疗护理。
不良反应
最常见的不良反应（发生率≥1％）是应用部位皮炎，红斑痤疮的炎症病变恶化，应用部位瘙痒，应用部位红斑和应用部位疼痛。
包装提供/储存和处理
RHOFADE（羟甲唑啉盐酸盐）乳膏，1％，是一种白色至灰白色膏霜。 该产品可用于下列包装配置的层压管和无气泵聚丙烯瓶中，每种配有防儿童闭合装置：
NDC 0023-5300-30 30克管
NDC 0023-5300-60 60克管
NDC 0023-5300-35 30克泵
NDC 0023-5300-65 60克泵
储存：储存于20°C-25°C（68°F-77°F）; 允许15°C-30°C（59°F-86°F）的偏移[见USP受控室温]。

完整说明书附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ba1cc5b-4f7f-491b-a5af-a6a14fb5affd
llergan Announces FDA Approval Of RHOFADE™ (Oxymetazoline Hydrochloride) Cream, 1% For The Topical Treatment Of Persistent Facial Erythema Associated With Rosacea In Adults
"The FDA approval of RHOFADE™ exemplifies Allergan's commitment to continuing to address unmet patient needs through innovation in medical dermatology," said David Nicholson, Chief R&D Officer of Allergan plc. "We know persistent facial erythema associated with rosacea is a challenge for patients and physicians and having options can help in treating the disease.
RHOFADE™ is the first and only alpha1A adrenoceptor agonist approved for persistent facial erythema associated with rosacea in adults. The FDA approval of RHOFADE™ represents a new prescription treatment that can effectively help physicians and their patients manage this condition."  
The National Rosacea Society (NRS) estimates that approximately 16 million Americans are affected by rosacea.2 Persistent facial redness is cited as the most common sign of rosacea, and may resemble a flushing or sunburn that does not go away.3 Typical triggers include sun exposure, stress, weather, food, exercise and/or products.4 In an NRS survey, 65% of rosacea patients surveyed said their symptoms first appeared between 30-60 years of age.5
"Historically, there haven't been many options available to help physicians address persistent facial erythema and often we ended up just helping our patients identify and manage triggers, which can lead to frustration for both the doctor and patient," said Dr. Robert Weiss, Clinical Trial Investigator and Director of Maryland Laser, Skin & Vein Institute. "With the approval of RHOFADE™, doctors will now be able to provide their patients with an effective once-daily treatment option to help manage this condition."
In two clinical trials, a once-daily application of RHOFADE™ was proven to reduce persistent facial erythema associated with rosacea through 12 hours. The primary efficacy endpoint was at day 29 and defined as the proportion of patients with at least a 2-grade reduction in erythema (improvement) from baseline (pre-dose on day 1) on both the clinician erythema assessment (CEA) and subject self-assessment (SSA) (composite success) measured at hours 3, 6, 9 and 12 versus vehicle. CEA and SSA also measured at Days 1 and 15 at hours 3, 6, 9, and 12.1
The clinical trials were identical, multicentered, randomized, double-blind, parallel-group, and vehicle-controlled in moderate or severe patients, N=885, 18 years or older.
In both pivotal trials, the primary efficacy endpoint was met. The proportion of patients achieving composite success were as follows: at hours 3, 6, 9 and 12 results in study 1 were RHOFADE™ (N=222) 12%, 16%, 18%, 15% versus Vehicle (N=218) 6%, 8%, 6%, 6% and in study 2 were RHOFADE™ (N=224) 14%, 13%, 16% and 12% versus Vehicle (N=221) 7%, 5%, 9% and 6%. RHOFADE™ was proven more effective than vehicle in reducing persistent facial erythema associated with rosacea in adults.1
RHOFADE™ will be available for commercial supply starting May 2017 in the United States.
RHOFADETM (oxymetazoline hydrochloride) cream, 1% Indication and ISI
Indication
RHOFADETM (oxymetazoline hydrochloride) cream, 1% is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS"
Potential Impacts on Cardiovascular Disease
Alpha-adrenergic agonists may impact blood pressure. RHOFADETM should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension/hypotension. Advise patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension/hypotension to seek immediate medical care if their condition worsens.
Potentiation of Vascular Insufficiency
RHOFADETM should be used with caution in patients with cerebral or coronary insufficiency, Raynaud's phenomenon, thromboangiitis obliterans, scleroderma, or Sjögren's syndrome.  Advise patients to seek immediate medical care if signs and symptoms of potentiation of vascular insufficiency develop.
Risk of Angle Closure Glaucoma
RHOFADETM may increase the risk of angle closure glaucoma in patients with narrow-angle glaucoma. Advise patients to seek immediate medical care if signs and symptoms of acute angle closure glaucoma develop.
ADVERSE REACTIONS
The most commn adverse reactions for RHOFADETM were: application site dermatitis 2 %, worsening inflammatory lesions of rosacea 1%, application site pruritus 1%, application site erythema 1%, and application site pain 1%.
Please see accompanying RHOFADETM full Prescribing Information (pdf)