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RILUZOLE TABLETS(Riluzole)利鲁唑片

2015-06-22 12:36:06  作者:新特药房  来源:互联网  浏览次数:62  文字大小:【】【】【
简介: 英文药名:Rilutek(Riluzole Tablets) 中文药名:利鲁唑片 日文药名:リルゾール錠50mg「AA」 生产厂家:Daito Co., Ltd.类别名称肌萎缩性脊髓侧索硬化症用剤适应症:肌萎缩性脊髓侧索硬化症治疗(A ...

英文药名:Rilutek(Riluzole Tablets)

中文药名:利鲁唑片

日文药名:リルゾール錠50mg「AA」

生产厂家:Daito Co., Ltd.
类别名称
肌萎缩性脊髓侧索硬化症用剤
适应症:
肌萎缩性脊髓侧索硬化症治疗(ALS)
抑制肌萎缩侧索硬化症的病情进展(ALS)
用法用量:
推荐剂量为每次1片,每日两次(50mg每12小时一次)。
每日定时口服,如早晚各一片。
如漏服一次,按原计划服用下一片。
增加每日剂量并不能显著提高预期益处。
具有运动神经元病治疗经验的专科医师才可启用利魯唑治疗。
包装规格
片剂:50毫克“AA”
56片(14片×4)


生产商:大东有限公司[售]武田制药


完整资料附件:http://www.kegg.jp/medicus-bin/japic_med?japic_code=00062616
DESCRIPTION
RILUTEK (riluzole) is a member of the benzothiazole class. Chemically, riluzole is 2-amino-6-(trifluoromethoxy) benzothiazole. Its molecular formula is C8H5F3N2OS and its molecular weight is 234.2. Its structual formula is:
Riluzole is a white to slightly yellow powder that is very soluble in dimethylformamide, dimethylsulfoxide and methanol, freely soluble in dichloromethane, sparingly soluble in 0.1 NHCl and very slightly soluble in water and in 0.1 N NaOH. RILUTEK is available as a capsule-shaped, white, film-coated tablet for oral administration containing 50 mg of riluzole. Each tablet is engraved with RPR 202 on one side.
Inactive Ingredients: Core: anhydrous dibasic calcium phosphate, USP; microcrystalline cellulose, NF; anhydrous colloidal silica, NF; magnesium stearate, NF; croscarmellose sodium, NF. Film coating: hydroxypropyl methylcellulose, USP; polyethylene glycol 6000; titanium dioxide, USP.
INDICATIONS
RILUTEK is indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS). Riluzole extends survival and/or time to tracheostomy.
DOSAGE AND ADMINISTRATION
The recommended dose for RILUTEK is 50mg every 12 hours. No increased benefit can be expected from higher daily doses, but adverse events are increased.
RILUTEK tablets should be taken as least an hour before, or two hours after, a meal to avoid a food-related decrease in bioavailability.
Special Populations
Patients with Impaired Renal or Hepatic Function: Studies have not yet been completed in these populations (see WARNINGS, PRECAUTIONS, CLINICAL PHARMACOLOGY).
HOW SUPPLIED
RILUTEK 50mg tablets are white, film coated, capsule-shaped and engraved with RPR 202 on one side. RILUTEK is supplied in bottles of 60 tablets, NDC 0075-7700-60. These bottles are designed with a special dispensing flip cap to aid dispensing with minimum effort.

责任编辑:admin


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