英文药名：PROTECADIN OD tablet（Lafutidine）

中文药名：拉呋替丁口腔崩解片

生产厂家：大鹏药业有限公司
药品介绍
拉呋替丁是日本富士（ Fujirebio）公司和大鹏（Taiho）公司联合开发的一种抗溃疡药，该产品为强效、长效的第二代组胺H2受体拮抗剂，具有独特的胃保护作用。已于2000年4月在日本上市。
本品为第二代H2受体拮抗剂，主要用于治疗消化性溃疡，本品可减少胃酸的基础分泌量，抑制组胺、胃泌素、乌拉坦刺激的胃酸分泌。相比其它同类药物（如西咪替丁和法莫替丁），本品对H2受体的阻断作用更有效、持久，所以具有抗胃酸分泌作用更加持续的优点。 胃溃疡和十二指肠溃疡 。
药理作用
拉呋替丁能持续地抑制人胃酸、胃蛋白酶的基础分泌、夜间分泌及四肽胃泌素等刺激因子引起的分泌，对胃酸的抑制作用与法莫替丁和西咪替丁相比，作用更有效、更持久。拉呋替丁还具有很强的黏膜保护作用，在低于抗胃酸分泌剂量下就可产生抗溃疡活性。而法莫替丁和西咪替丁只有在高于抗分泌剂量下才能发挥抗溃疡活性。动物实验中，拉呋替丁可使胃黏膜损伤加速愈合，包括恢复变薄的胃黏膜厚度和减少的壁细胞数量，而法莫替丁和西咪替丁在产生相同程度的抗胃酸分泌作用的同时没有这些形态学作用。以奥美拉唑为代表的现有的质子泵抑制剂也无胃黏膜保护作用。另外，接受拉呋替丁治疗后的复发率低。与法莫替丁和雷尼替丁在实验性胃溃疡愈合率相当的剂量下，三者的溃疡复发率分别为4%、40.9%和31.3%，拉呋替丁与后二者差异有显着性。
临床作用
1) 治疗消化性溃疡
临床试验中，采用多中心、随机、双盲、阳性药物平行对照的临床研究。对不同中心进行区组随机分配，分为两组，一组为试验药拉呋替丁片，另一组为对照药法莫替丁片。本试验共入组患者207例，拉呋替丁组103例，法莫替丁组104例，全部患者均使用了研究药物并进行了至少一次安全性评价和有效性评价，202例被纳入PPS分析，其中拉呋替丁组102例，法莫替丁组100例，所有入组患者被纳入FAS分析与安全性分析数据集（SS）分析；试验中有5例患者脱落，脱落率为2.42%。无剔除病例。内镜检查溃疡愈合率：PPS人群中拉呋替丁组溃疡愈合率为85.1%,法莫替丁组溃疡愈合率为75%，两组溃疡治愈率差异无显着性（P>0.05）。总有效率：PPS人群中拉呋替丁组溃疡总有效率为93.1%,法莫替丁组溃疡总有效率为82%，两组总有效率差异有显着性（P<0.05）。
2) 治疗急性胃炎
临床报道，在治疗急性胃炎时，服用拉呋替丁10mg/次，2次/d，连续用药6天，结果治愈率为96.8%。机制：胃炎急性期胃黏膜充血、水肿、胃酸分泌过多等造成一系列临床刺激症状，应用拉呋替丁将H2受体阻断，减少胃酸分泌，控制和改善黏膜充血、水肿，使疼痛、恶心及呕吐症状消失。
3) 在胃泌素瘤中的应用
胃泌素瘤好发于十二指肠和胰腺，亦可见于脾门、胃或肝脏，高胃泌素血症是诊断胃泌素瘤有价值的依据之一。大多数胃泌素瘤病人未刺激胃酸分泌超过18mmol/L。拉呋替丁是被证明治疗胃泌素瘤有效的H2受体阻断剂，可缓解症状、减少酸分泌和治疗溃疡。拉呋替丁经安全性评价，均未证明有致癌性、致突变性和致畸性。
根据临床观察，本药不良反应甚微，少数患者有口干、头晕、失眠、便秘、腹泻等症状。
包装规格
口腔崩解片
5mg
PTP包装：100片（10片×10），1000片（10片×10×10）
10mg
PTP包装：100片（10片×10），1000片（10片×10×10）

制造厂商
大鹏药业有限公司
原研药品资料附件：http://www.info.pmda.go.jp/go/pack/2325006F3020_1_03/
Notice of New Release of H2 Receptor Antagonist Procaskin® OD Tablet'(Orally Disintegrating Tablets)Taiho Pharmaceutical Co. Ltd.(Headquarters: Tokyo, President: Masayuki Kobayashi)has announced the release of H2 receptor antagonist "Procaskin® Tablets (Generic name: lafutidine)), we will inform you that the orally disintegrating tablets "Protectazin ® OD tablet 5" and "Protectazin®OOD tablet 10" were listed on the price today of Friday, June 22.
Release is scheduled for July 24 (Tue).
"Protectazine®tablets" has been confirmed to be useful for gastric ulcer, duodenal ulcer and others, and 5 mg tablets and 10 mg tablets were released in April 2000.
In March 2010, we acquired additional indications of efficacy and effect of reflux esophagitis.
"Protectazine ® OOD tablets" can be taken without water, so it is useful for patients who have deteriorated swallowing function, elderly people, patients with restricted intake of water, etc. Meanwhile, it is also suitable for taking medication under circumstances where water can not be drunk on the go, it is a drug that can respond to various needs
Product overview Product name Procaskin® OD tablet 5
Protectin® ® OD Tablet 10
Common name Lafutidine
Indication/effect
○ gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux esophagitis
○ Improvement of gastric mucosal lesions (erosion, bleeding, redness, edema) of the following diseases
Acute gastritis, acute exacerbation phase of chronic gastritis
○ Pre-anesthesia medication
Dosage regimen
○ Gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux esophagitis
Usually for adults, 10 mg once a day as lafutidine twice a day (after breakfast, after dinner or before going to bed)
Orally. Incidentally, it increases and decreases according to age and symptoms as appropriate.
○ Improvement of gastric mucosal lesions (erosion, bleeding, redness, edema) of the following diseases
Acute gastritis, acute exacerbation phase of chronic gastritis
Ordinarily, for adults, 10 mg once a day (once after dinner or before going to bed) is orally administered as lafutidine
. Incidentally, it increases and decreases according to age and symptoms as appropriate.
○ Pre-anesthesia medication
Normally, 10 mg of lafutidine is administered once a day to the adult before bedtime before surgery and on the day of surgery introduction
Two doses 2 hours before oral administration.
Manufacture and sale approval date February 15, 2012
Drug Price List Date 22nd June 2012
Expected release date July 24, 2012
Packing Proteacadin® OD tablet 5: PTP packaging 100 tablets (10 tablets × 10) 1000 tablets (10 tablets × 10 × 10)
Protectazin® OD tablet 10: PTP packing 100 tablets (10 tablets × 10) 1000 tablets (10 tablets × 10 × 10)
Manufacturer Distributor Taiho Pharmaceutical Co., Ltd.