NAMZARIC (memantine hydrochloride extended-release and donepezil hydrochloride) capsules
——FDA批准固定剂量美金刚-多奈哌齐复方制剂Namzaric-预防患老年性痴呆症
美国食品药品监督管理局(FDA)批准固定剂量复方制剂的盐酸美金刚延长释放制剂(XR)和盐酸多奈哌齐(Namzaric,阿特维斯制药 /Adamas Pharm)治疗中度到重度老年痴呆症，患者接受稳定的两种药物剂量。
美金刚XR(Namenda XR, 阿特维斯制药)是一个由N-甲基-D-天门冬氨酸抑制剂，和多奈哌齐(安理申,辉瑞)一种乙酰胆碱酯酶抑制剂(AChEI)。“在一个胶囊里Namzaric组合两个互补疗效的药剂，通常共同规定大约70%使用盐酸美金刚的患者也使用AchEI的治疗”，阿特维斯全球品牌研发部门高级副总裁大卫•尼科尔森，在一次新闻发布会上指出。盐酸美金刚XR和多奈哌齐都证实了其疗效和安全性，用于治疗中度至重度的阿尔茨海默氏症患者。此外，数据显示，盐酸美金刚XR和AchEI的联合疗法对认知上显示了较大的改善，以及全功能的改善相对于单独使用AChEI”，尼克尔森表示。
Namzaric(先前MDX-8704)目前是每日一粒服用的胶囊剂，含有美金刚胺(10毫克每日两次或28毫克XR每日一次)再加上多奈哌齐10毫克。胶囊可以打开，撒在食物上用于有吞咽困难的病人服用。
Namzaric可以采用两方面的特点:28/10毫克(美金刚/多奈哌齐)和14/10毫克(美金刚/多奈哌齐)用于有严重肾功能损害的患者。
“在对阿尔茨海默病的中度到重度的阶段病人做治疗决定时，我会考虑治疗的有效性、安全性及其易于管理的特点，”加州科斯塔梅萨ATP临床研究神经精神病学家和医学主任医学博士Gustavo Alva和加州大学志愿者教员欧文在新闻发布会上说。“FDA批准Namzaric提供新的治疗选择，这为病人提供了一个固定剂量组合的药剂，这种药剂在一个胶囊中实现了两种治疗效果”他补充道。
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use NAMZARIC capsules safely and effectively. See full prescribing information for NAMZARIC capsules.
NAMZARIC (memantine hydrochloride extended-release and donepezil hydrochloride) capsules, for oral use
Initial U.S. Approval: 2014
INDICATIONS AND USAGE
NAMZARIC is a combination of memantine hydrochloride extended-release, a NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor, indicated for the treatment of moderate to severe dementia of the Alzheimer's type in patients stabilized on:
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memantine hydrochloride (10 mg twice daily or 28 mg extended-release once daily) and donepezil hydrochloride 10 mg (1), or
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memantine hydrochloride (5 mg twice daily or 14 mg extended-release once daily) and donepezil hydrochloride 10 mg (1)
DOSAGE AND ADMINISTRATION
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Patients on memantine hydrochloride (10 mg twice daily or 28 mg extended-release once daily) and donepezil hydrochloride 10 mg can be switched to NAMZARIC 28 mg/10 mg, taken once a day in the evening (2.1)
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NAMZARIC can be taken with or without food, whole or sprinkled on applesauce; do not divide, chew, or crush (2.2)
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Severe renal impairment: patients on memantine hydrochloride (5 mg twice daily or 14 mg extended-release once daily) and donepezil hydrochloride 10 mg can be switched to NAMZARIC 14 mg/10 mg (2.3)
DOSAGE FORMS AND STRENGTHS
NAMZARIC capsules:
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14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (3)
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28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (3)
CONTRAINDICATIONS
NAMZARIC is contraindicated in patients with known hypersensitivity to memantine hydrochloride, donepezil hydrochloride, piperidine derivatives, or to any excipients used in the formulation (4)
WARNINGS AND PRECAUTIONS
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NAMZARIC is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia (5.1)
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NAMZARIC may have vagotonic effects on the sinoatrial and atrioventricular nodes manifesting as bradycardia or heart block (5.2)
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Monitor patients for symptoms of active or occult gastrointestinal bleeding, especially those at increased risk for developing ulcers (5.3)
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NAMZARIC can cause diarrhea, nausea, and vomiting (5.4)
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NAMZARIC may cause bladder outflow obstructions (5.5)
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Conditions that raise urine pH may decrease the urinary elimination of memantine, resulting in increased plasma levels of memantine (5.5, 7.1)
ADVERSE REACTIONS
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The most common adverse reactions occurring at a frequency of at least 5% and greater than placebo with memantine hydrochloride extended-release 28 mg/day were headache, diarrhea, and dizziness (6.1)
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The most common adverse reactions occurring at a frequency of at least 5% in patients receiving donepezil and at twice or more the placebo rate, include diarrhea, anorexia, vomiting, nausea, and ecchymosis (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Forest Laboratories, LLC. at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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Combined use with NMDA antagonists: use with caution (7.2)
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NAMZARIC may interfere with anticholinergic medications (7.4)
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Concomitant administration of succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists may lead to synergistic effect (7.5)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 12/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
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