MIRVASO (brimonidine tartrate) gel
[Galderma Laboratories, L.P.]
Galderma公司的药物Mirvaso已成功获得美国食品及药物管理局认定，用于酒糟鼻的治疗。其主要成分为0.33%酒石酸溴莫尼定，一种α-2肾上腺素受体激动剂（alpha-2 adrenergic agonist）。mirvaso是外用凝胶，可以通过压缩面部扩张血管减少酒渣鼻发红。mirvaso使用豌豆大小的量，每日一次，每次脸上的五个区域可以使用：额头，下巴，鼻子和两颊。
据称，每日使用一次，mirvaso可迅速减少酒渣鼻的发红，并持续12小时。
该药物的验证采取了常规的对比验证，基于超过550例患者的样本，在一个月的时间内对两个3期小组（一为实验组，一为对照组）临床研究中所收集的数据。
研究的结果表明，使用mirvaso凝胶的患者表现出比使用vehicle gel（嘛玩意？不知道什么药物）的患者面部发红有更大的改善。此外，还进行了长期的药物使用研究，有276名受试者使用mirvaso长达12个月。
副作用：在临床试验中，最常见的不良反应包括红斑（≥1%），皮肤烧灼感和接触性皮炎。抑郁症患者注意，该药物可造成脑或冠状动脉供血不足，雷诺氏现象，体位性低血压，血栓闭塞性脉管炎，硬皮病，或öSJ干燥综合征。α-2肾上腺素能药物可降低血压。严重或不稳定或不受控制的心血管疾病患者慎用。
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use MIRVASO® safely and effectively. See full prescribing information for MIRVASO.
MIRVASO (brimonidine) topical gel, for topical use
Initial U.S. Approval: 1996
INDICATIONS AND USAGE
MIRVASO (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older. (1)
DOSAGE AND ADMINISTRATION
Not for oral, ophthalmic, or intravaginal use. (2)
Apply a pea-size amount once daily to each of the five areas of the face (forehead, chin, nose, each cheek) avoiding the eyes and lips. (2)
Hands should be washed immediately after applying MIRVASO topical gel. (2)
DOSAGE FORMS AND STRENGTHS
Gel, 0.33%; Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Potentiation of Vascular Insufficiency (5.1)
Severe Cardiovascular Disease (5.2)
Serious Adverse Reactions Following Ingestion of MIRVASO topical gel (5.3)
Erythema and Flushing (5.4)
ADVERSE REACTIONS
In controlled clinical trials with MIRVASO topical gel the most common adverse reactions (incidence > 1%) included erythema, flushing, skin burning sensation, and contact dermatitis. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. (6)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 08/2013
Back to Highlights and Tabs
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Potentiation of Vascular Insufficiency
5.2 Severe Cardiovascular Disease
5.3 Serious Adverse Reactions Following Ingestion of MIRVASO topical gel
5.4 Erythema and Flushing
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
7.1 Anti-hypertensives/Cardiac Glycosides
7.2 CNS Depressants
7.3 Monoamine Oxidase Inhibitors
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*
Sections or subsections omitted from the full prescribing inf
