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  药店国别: 欧洲共同体药房
产地国家: 比利时
所属类别: 心血管系统药物->心脏病
处方药:处方药
包装规格: 40 mg/vial, 3 vials/pack
计价单位:
  点击放大  
生产厂家英文名:
Pfizer Manufacturing Belgium NV/SA
该药品相关信息网址1:
https://www.pfizer.co.uk/prescription-medicines/solu-medrone
该药品相关信息网址2:
https://www.drugs.com/methylprednisolone.html
该药品相关信息网址3:
https://en.wikipedia.org/wiki/Methylprednisolone
原产地英文商品名:
Solu-Medrol(methylprednisolone Sodium Succinate Act-O-Vials) injection vial x 40mg (minimum order: 20)
原产地英文药品名:
Methylprednisolone Sodium Succinate for Injection
原产地英文化合物名称:
11β, 17α, 21-trihydroxy-6α-methylpregnant-1,4-diene-3,20-dione- 21-sodium succinate.
中文参考商品译名:
SOLU-MEDRONE含溶剂(甲基吡咯烷酮SO SUC)注射液×40毫克 (最低订单:20)
中文参考药品译名:
甲泼尼龙琥珀酸钠注射剂
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
First aid for critical illness
英文适应病症2:
endocrine disorders
英文适应病症3:
rheumatic diseases
英文适应病症4:
allergic reactions
临床试验期:
完成
中文适应病症参考翻译1:
危重疾病的急救
中文适应病症参考翻译2:
内分泌失调
中文适应病症参考翻译3:
风湿性疾病
中文适应病症参考翻译4:
过敏反应
药品信息:

---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件(201811623285122.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------
部分中文甲泼尼龙琥珀酸钠注射剂处方资料(仅供参考)

英文药名: Solu-Medrol(methylprednisolone Sodium Succinate Act-O-Vials)

中文药名: 甲泼尼龙琥珀酸钠注射剂

品牌药生产厂家: Pfizer

药品名称

通用名称:注射用甲泼尼龙琥珀酸钠

商品名称:米乐松

英文名称:Methylprednisolone Sodium Succinate for Injection

成份: 本品主要成份为甲泼尼龙琥珀酸钠,化学名称:11β,17α,21-三羟基 -6α- 甲基孕甾-1,4-二烯-3,20-二酮-21-琥珀酸钠。

性状: 本品为白色或类白色的疏松块状物。

生产厂家:Pfizer 辉瑞

药理毒理

药理作用

本品为人工合成的、抗炎作用强的注射用类固醇。除了具有糖皮质激素的药理作用外,与泼尼松龙相比,有更强的抗炎作用和较弱的水、钠潴留作用。 毒理研究

某些动物试验表明,妊娠期间服用大剂量皮质类固醇可能引起胎儿畸形。

药代动力学

据国外文献资料报道: 在体内,胆碱酯酶迅速将甲泼尼龙琥珀酸钠水解为游离的甲泼尼龙。 在体内,甲泼尼龙与白蛋白及皮质激素转运蛋白形成弱的、可解离的结合,结合型甲泼尼龙约为40~90%。

以20分钟静脉滴注甲泼尼龙30mg/kg,或以30分钟至60分钟静脉滴注甲泼尼龙1g,约15分钟后血浆峰浓度近20μg/ml。静脉推注甲泼尼龙40mg,约25分钟后血浆峰浓度达到42~47μg/100ml。肌肉推注甲泼尼龙40mg,约120分钟后血浆峰浓度达到34μg/100ml。肌肉注射后的血浆峰浓度低于静脉注射,但肌肉注射后血浆药物水平持续时间较长,因此两种给药方法可给予等量的甲泼尼龙。考虑到糖皮质激素的作用机制,两种给药方法间这些细小的差异在临床上无重要意义。通常在给药 4~6 小时后可以观察到临床反应;而在治疗哮喘时,给药1或2小时后即可观察到第一个有效的结果。甲泼尼龙琥珀酸钠的血浆半衰期为2.3~4小时,并且与给药方法无关。

甲泼尼龙属中效糖皮质激素,其生物半衰期为12~36小时。糖皮质激素的细胞内活性使得它们的血浆半衰期与药理半衰期有显著差异。即使在血浆中已检测不到糖皮质激素,其药理活性仍持续存在。糖皮质激素抗炎活性的持续时间与下丘脑-垂体-肾上腺(HPA)轴被抑制的时间相同。

甲泼尼龙与可的松同样经肝脏代谢。主要代谢产物为20β-羟基甲泼尼龙和20β-羟基-6α-甲基泼尼松。这些代谢产物以葡萄糖醛酸盐、硫酸盐和非结合型化合物的形式随尿液排出。

静脉注射14C标记的甲泼尼龙,96小时后在尿液中可回收75%总放射活性,5天后在粪便中可回收9%,20%的放射活性存在于胆汁内。

适应症

除非用于某些内分泌失调的疾病的替代治疗,糖皮质激素仅仅是一种对症治疗的药物。

1、抗炎治疗:

-风湿性疾病:作为短期使用的辅助药物(帮助患者渡过急性期或危重期),用于:创伤后骨关节炎;骨关节炎引发的滑膜炎;类风湿性关节炎,包括幼年型类风湿性关节炎(个别患者可能需要低剂量维持治疗);急性或亚急性滑囊炎;上踝炎;急性非特异性踺鞘炎;急性痛风性关节炎;银屑病关节炎;强直性脊柱炎。 -胶原疾病(免疫复合物疾病):用于下列疾病危重期或维持治疗:系统性红斑狼疮(和狼疮性肾炎);急性风湿性心肌炎;全身性皮肌炎(多发性肌炎);结节性多动脉炎;古德帕斯彻综合征(Good pasture′s Syndrome)。 -皮肤疾病:天疱疮;严重的多形红斑(Stevens-Johnson 综合征);剥脱性皮炎;大疱疱疹性皮炎;严重的脂溢性皮炎;严重的银屑病;蕈样真菌病;荨麻疹。 -过敏状态:用于控制如下以常规疗法难以处理的严重的或造成机能损伤的过敏性疾病;支气管哮喘;接触性皮炎;异位性皮炎;血清病;季节性或全年性过敏性鼻炎; 药物过敏反应;荨麻疹样输血反应;急性非感染性喉头水肿(肾上腺素为首选药物)。

-眼部疾病:严重的眼部急慢性过敏和炎症,例如:眼部带状疱疹;虹膜炎、虹膜睫状体炎;脉络膜视网膜炎;扩散型后房色素层炎和脉络膜炎;视神经炎;交感性眼炎。

-胃肠道疾病:帮助患者渡过以下疾病的危重期;溃疡性结肠炎(全身治疗);局限性回肠炎(全身治疗)。

-呼吸道疾病:肺部肉瘤病;铍中毒;与适当的抗结核化疗法合用于暴发性或扩散型肺结核;其它方法不能控制的吕弗勒氏综合症(Loffler’s Syndrome);吸入性肺炎。

-水肿状态:用于无尿毒症的自发性或狼疮性肾病综合征的利尿及缓解蛋白尿。

2、免疫抑制治疗:

-器官移植。

3、治疗血液疾病及肿瘤:

-血液疾病:获得性(自身免疫性)溶血性贫血;成人自发性血小板减少性紫癜(仅允许静脉注射,禁忌肌内注射);成人继发性血小板减少;成红细胞减少(红细胞性贫血);先天性(红细胞)再生不良性贫血。

-肿瘤:用于下列疾病的姑息治疗;成人白血病和淋巴瘤;儿童急性白血病。

4、治疗休克:

-肾上腺皮质机能不全诱发的休克,或因肾上腺皮质机能不全而使休克对常规治疗无反应(氢化可的松为常用药;若不希望有盐皮质激素活性,可使用甲基强的松龙)。 对常规治疗无反应的失血性、创伤性及手术性休克。尽管没有完善的(双盲对照)临床研究,但动物实验的资料显示甲泼尼龙可能对常规疗法(例如:补液)无效的休克有效。同时请参见“注意事项”中的“感染性休克”部分。

5、其它:

-神经系统:由原发性或转移性肿瘤、和(或)手术及放疗引起的脑水肿;多发性硬化症急性危重期;急性脊髓损伤。治疗应在创伤后8小时内开始。 -与适当的抗结核化疗法合用,用于伴有蛛网膜下腔阻塞或趋于阻塞的结核性脑膜炎。 -累及神经或心肌的旋毛虫病。 -预防癌症化疗引起的恶心、呕吐。

6、内分泌失调:

原发性或继发性肾上腺皮质机能不全;急性肾上腺皮质机能不全;(以上疾病氢化可的松或可的松为首选药物,如有需要,合成的糖皮质激素可与盐皮质激素合用。)

已知患有或可能患有肾上腺皮质机能不全的患者,在手术前和发生严重创伤或疾病时给药。先天性肾上腺增生;非化脓性甲状腺炎;癌症引起的高钙血症。

用法用量

本品必须遵医嘱用药。

*作为对生命构成威胁的情况的辅助药物时:推荐剂量为15~30mg/kg体重, 应至少30分钟作静脉注射。根据临床需要,此剂量可在医院内于48小时内每隔 4~6 小时重复一次(参见“注意事项”)。

*冲击疗法:用于疾病严重恶化和(或)对常规治疗(如:非甾体类药,金盐及青霉胺)无反应的疾病。

建议方案:

-类风湿性关节炎:一日1g,静脉注射,用1、2、3或4日;或一月1g,静脉注射,用6个月。因大剂量皮质类固醇能引起心律失常,因此仅限在医院内使用本治疗方法,以便及时作心电图及除颤。每次应至少用30分钟给药,如果治疗后一周内病情无好转, 或因病情需要,本治疗方案可重复。 *预防肿瘤化疗引起的恶心及呕吐;

建议方案:

-关于化疗引起的轻至中度致吐:在化疗前1小时、以至少5分钟静脉注射250mg 甲泼尼龙。在给予首剂甲泼尼龙时,可同时给予氯化酚噻嗪以增强效果。

-关于化疗引起的重度致吐:化疗前1小时、化疗开始时及化疗结束后,以至少5分钟静脉注射甲泼尼龙,同时给予适量的灭吐灵或丁酰苯类药物,随后在化疗开始时及结束时分别静脉注射250mg甲泼尼龙。

*急性脊髓损伤:

治疗应在损伤后8小时内开始。初始剂量为30mg/kg体重甲泼尼龙,在持续的医疗监护下,以15分钟静脉注射。 仅此适应症能以此速度进行大剂量注射,并且要在心电监护并能提供除颤器的情况下进行。 短时间内静脉注射大剂量甲泼尼龙(以少于10分钟的时间给予大于500mg的甲泼尼龙)可能引起心律失常、循环性虚脱及心脏停搏。 大剂量注射后暂停45分钟,随后以每小时5.4mg/kg体重的速度持续静脉滴注23小时。应选择与大剂量注射不同的注射部位安置输液泵。

*其它适应症的初始剂量从10mg到500mg不等,以临床疾病而变化。大剂量甲基强的松龙可用于短期内控制某些急性重症疾病,如:支气管哮喘、血清病、荨麻疹样输血反应及多发性硬化症急性恶化期。小于等于250mg的初始剂量应至少用5分钟静脉注射;大于250mg的初始剂量应至少用30分钟静脉注射。根据患者的反应及临床需要,间隔一段时间后可静脉注射或肌内注射下一剂量。皮质类固醇只可辅助,不可替代常规疗法。婴儿和儿童可减量,但依据应是疾病的严重程度及患者的反应,而不是年龄和体型。每24小时的总量不应少于0.5mg/kg。

用药数天后,必须逐步递减用药剂量或逐步停药。如果慢性疾病自发缓解,应停止治疗。长期治疗的患者应定期作常规实验室检查,如:尿常规,饭后2小时血糖,血压和体重,胸部X线检查。有溃疡史或明显消化不良的患者应作上消化道X线检查,中断长期治疗的患者也需要作医疗监护。

甲泼尼龙溶液可静脉注射或肌内注射给药,或静脉滴注给药,紧急情况的治疗应使用静脉注射。溶液的制备:临用前用灭菌注射用水或5%葡萄糖注射液或0.9%氯化钠注射液溶解。起始治疗方法可能是用至少5分钟(剂量小于或等于250mg)或至少30分钟(剂量大于250mg)静脉注射甲泼尼龙;下一剂量可能减少并用同样方法给药。如果需要,该药可稀释后给药,方法为将已溶解的药品与5%葡萄糖注射液或0.9%氯化钠注射液混合,混合后立即使用。

不良反应

据国外研究资料报道: 可能会观察到全身性不良反应。 尽管在短期时很少出现,但仍应仔细随访,这是类固醇治疗的随访工作的一部分,并不针对某一药物。糖皮质激素(如甲泼尼龙)可能的不良反应为:

*体液与电解质紊乱:

相当于可的松和氢化可的松,合成的衍生物(如甲泼尼龙)较少发生盐皮质激素作用。限钠、补钾的饮食可能是必要的。所有皮质类固醇都会增加钙离子的丧失。 钠潴留;体液潴留;某些敏感患者的充血性心力衰竭;钾离子丧失;低钾性碱中毒;高血压。

*肌肉骨骼系统:

肌无力;类固醇性肌病;骨质疏松;压迫性脊椎骨折;无菌性坏死;病理性骨折; *胃肠道: 可能发生穿孔或出血的消化道溃疡;消化道出血;胰腺炎;食管炎;肠穿孔;

*皮肤病:

妨碍伤口愈合;皮肤变薄脆弱;瘀点和瘀斑;反复局部皮下注射可能引起局部皮肤萎缩。

*神经病:

颅内压升高;假性脑肿瘤;癫痫发作;眩晕; 服用皮质类固醇可能出现下列精神紊乱的症状:欣快感、失眠、情绪变化、个性改变及重度抑郁直至明显的精神病表现。

*内分泌:

月经失调;出现柯兴氏体态;抑制儿童生长;抑制垂体-肾上腺皮质轴;糖耐量降低;引发潜在的糖尿病;增加糖尿病患者对胰岛素和口服降糖药的需求。

*眼部:

长期使用糖皮质激素可能引起后房囊下白内障、青光眼(可能累及视神经),并增加眼部继发性真菌或病毒感染的机会。为防止角膜穿孔,糖皮质激素应慎用于眼部单纯疱疹患者;眼内压增高;眼球突出。

*代谢方面:

因蛋白质分解造成的负氮平衡。

*免疫系统:

掩盖感染;潜在感染发作;机会性感染;过敏反应;可能抑制皮试反应。 *以下不良反应与胃肠道外给予皮质类固醇激素有关: 过敏反应,伴有或不伴有循环性虚脱;心脏停搏;支气管痉挛;低血压或高血压;心律不齐。 据报道,短时间内静脉注射大剂量甲泼尼龙(10分钟内所给的量超过0.5g)会引起心律不齐和(或)循环性虚脱和(或)心脏停搏。也有报道大剂量甲基强的松龙会引起心动过缓,但与给药速度或滴注时间可能无关。

禁忌

全身性霉菌感染及已知对药物成分过敏者禁用。

特殊危险人群:

对属于下列特殊危险人群的患者应采取严密的医疗监护并应尽可能缩短疗程(同时参见“注意事项”和“不良反应”);儿童;糖尿病患者;高血压患者;有精神病史者;有明显症状的某些感染性疾病,如结核病;或有明显症状的某些病毒性疾病,如波及眼部的疱疹及带状疱疹。

注意事项

-特殊危险人群:

对属于下列特殊危险人群的患者应采取严密的医疗监护并应尽可能缩短疗程:

-儿童:长期每天服用分次给予糖皮质激素会抑制儿童的生长,这种治疗方法只可用于非常危重的情况。

-糖尿病患者:引发潜在的糖尿病或增加糖尿病患者对胰岛素和口服降糖药的需求。

-高血压患者:使动脉性高血压病情恶化。

-有精神病史者:已有的情绪不稳和精神病倾向可能会因服用皮质类固醇而加重。

-因糖皮质激素治疗的并发症与用药的剂量和时间有关,对每个病例均需就剂量、疗程及每日给药还是隔日给药来权衡利弊。

-采用皮质类固醇治疗异常紧急状况的患者,在紧急状况发生前、发生时和发生后需加大速效皮质类固醇的剂量。

-皮质类固醇可能会掩盖感染的若干症状,治疗期间亦可能发生新的感染。皮质类固醇可能会减弱抵抗力而无法使感染局限。

-一项为明确甲泼尼龙对感染性休克的有效性所作的研究发现,参加研究时已有血清肌酐水平升高或激素治疗开始后有继发感染的病人死亡率较高。

-甲泼尼龙用于结核活动期患者时,应仅限于暴发性或扩散型结核病,皮质激素可与适当的抗结核病药物联用以控制病情,如皮质类固醇用于结核病潜伏期或结核菌素试验阳性的患者时,必须小心观察以防病情复发。此类患者长期服用皮质类固醇期间应接受化学预防治疗。

-由于极少数经胃肠道外接受类固醇治疗的患者发生过过敏反应(如支气管痉挛),因此在给药前应采取适当的预防措施,特别对有药物过敏史的患者。

-逐量递减用药量可减少因用药而产生的肾上腺皮质机能不全现象。这种相对机能不全现象可在停药后持续数月,因而在此期间一旦出现紧急情况应恢复服药;由于盐皮质激素的分泌也可能被抑制,应同时补充盐份和(或)给与盐皮质激素。

-甲状腺功能减退和肝硬化会增强皮质类固醇的作用。

-皮质类固醇应慎用于眼部单纯疱疹患者,以免引起角膜穿孔。

-糖皮质激素应慎用于非特异性溃疡性结肠炎的患者。

-应注意观察长期接受类固醇激素治疗的婴儿及儿童的生长发育情况。

-某些制剂中含苯甲醇。据报道苯甲醇与致命的早产儿“喘息综合症”(以持续喘息为特征的呼吸紊乱)有关。

-在解释整套生物学检查和数据时(如:皮试,甲状腺素水平),应将类固醇治疗因素考虑在内。

-通常情况下应尽量缩短疗程(同时参见“用法用量”)。长期治疗后停药也应在医疗监护下进行(逐量递减,评估肾上腺皮质功能)。肾上腺皮质机能不全最重要的症状为无力、体位性低血压及抑郁。

-避免在三角肌注射,因为此部位皮下萎缩发病率高。

-尽管视力障碍属极少见的不良反应,但仍建议患者小心驾驶汽车和操作机器。

-配伍禁忌:

静脉注射甲泼尼龙溶液时的相容性与稳定性,及它与静脉输注液中其他药物的相容性与稳定性取决于混合液的pH、浓度、放置时间、温度及甲泼尼龙自身的溶解性。 为了避免相容性和稳定性问题,建议无论用静脉注射、还是静脉滴注均应尽可能将甲泼尼龙溶液与其他药物分开给药。

-甲泼尼龙琥珀酸钠不应作为颅脑损伤的常规治疗。

孕妇及哺乳期妇女用药

一些动物试验表明,妊娠期间服用大剂量皮质类固醇可能引起胎儿畸形。 因未作过足够的人类生殖研究,因而当皮质类固醇用于孕妇、哺乳妇女或准备生育的妇女时,应仔细权衡其益处与它对母亲和胚胎或胎儿的潜在威胁之间的关系。只有当确实需要时,皮质类固醇才可用于孕妇。如果在怀孕期间必须停用已长期服用的皮质类固醇(与其它长期疗法相同),停药过程必须逐步进行(同时参见“用法用量”)。然而某些疾病的治疗(如肾上腺皮质机能不全的替代治疗)可能需要继续,甚至增加剂量。因皮质类固醇很容易透过胎盘,对怀孕期间用过大剂量皮质类固醇的母亲生育的婴儿,应仔细观察和评价是否有肾上腺皮质机能减退的迹象。 甲基强的松龙对分娩的影响还未知。 皮质类固醇随乳汁分泌。

儿童用药

长期每天分次服用给予糖皮质激素会抑制儿童的生长, 这种治疗方法只可用于非常严重的情况。婴儿和儿童可减量,但依据应是疾病的严重程度及患者的反应,而不是年龄和体型。每24小时的总量不应少于0.5mg/kg。

老年用药

遵医嘱慎用。

药物相互作用

有益的药物相互作用:

-预防肿瘤化疗引起的恶心和呕吐;轻至中度致吐的化疗方案;

-氯化酚噻嗪可与首剂甲泼尼龙(化疗前1小时)合用以增强效果。

中度致吐的化疗方案:

灭吐灵或丁酰苯类药物可与首剂甲泼尼龙(化疗前1小时)合用以增强效果。

-甲泼尼龙与其他抗结核化疗联合,可用于治疗暴发性或扩散型肺结核及伴有蛛网膜下腔阻塞或趋于阻塞的结核性脑膜炎。

-甲泼尼龙经常与烷化剂、抗代谢类药物及长春花碱类药物联合用于肿瘤疾病,如白血病及淋巴瘤。

有害的药物相互作用: ,/br>-糖皮质激素与致溃疡药物(如水杨酸盐和甾体抗炎药)合用,会增加发生消化道并发症的危险。糖皮质激素与噻嗪类利尿药合用,会增加糖耐量异常危险。糖皮质激素会增加糖尿病患者对胰岛素和口服降糖药的需求。 -服用皮质类固醇的患者不可接种牛痘,也不可接受其它免疫措施,特别是大剂量服用的患者,因为有出现神经系统并发症和(或)缺乏抗体反应的危险。

-皮质类固醇与乙酰水杨酸联合用于凝血酶原过少的患者时应谨慎。

-有报道同时服用甲泼尼龙和环胞菌素会引起惊厥。因为上述两种药物会相互抑制对方的代谢,所以服用任一药物时引起的惊厥和其它不良反应在同时服用两种药物时更易发生。

药物过量

未发现甲泼尼龙急性过量引起的综合征。长期过量会引起典型的柯兴氏症状。甲泼尼龙可经透析排出。

English name: Solu-Medrol (methylprednisolone Sodium Succinate Act-O-Vials)

Chinese medicine name: methylprednisolone sodium succinate injection

Branded drug manufacturer: Pfizer

Drug name

Common name: methylprednisolone sodium succinate for injection

Product Name: Milesson

English name: Methylprednisolone Sodium Succinate for Injection

Ingredients: The main ingredient of this product is methylprednisolone sodium succinate, chemical name: 11β, 17α, 21-trihydroxy-6α-methylpregnant-1,4-diene-3,20-dione- 21-sodium succinate.

Characteristics: This product is a white or off-white loose mass.

Manufacturer: Pfizer Pfizer

Pharmacology and Toxicology

Pharmacological action

This product is a synthetic, anti-inflammatory and strong steroid for injection. In addition to the pharmacological effects of glucocorticoids, it has stronger anti-inflammatory effects and weaker water and sodium retention than prednisolone. Toxicological research

Some animal tests have shown that taking large doses of corticosteroids during pregnancy may cause fetal malformations.

Pharmacokinetics

According to foreign literature reports: In vivo, cholinesterase rapidly hydrolyzes methylprednisolone sodium succinate to free methylprednisolone. In vivo, methylprednisolone forms a weak, dissociable bond with albumin and corticosteroid transporters, and the bound methylprednisolone is about 40-90%.

Intravenous infusion of methylprednisolone 30 mg/kg for 20 minutes, or intravenous infusion of 1 g of methylprednisolone for 30 minutes to 60 minutes, and the plasma peak concentration was approximately 20 μg/ml after about 15 minutes. Intravenous injection of methylprednisolone 40mg, peak plasma concentration of 42 ~ 47μg / 100ml after about 25 minutes. The muscle was injected with 40 mg of methylprednisolone, and the peak plasma concentration reached 34 μg/100 ml after about 120 minutes. The peak plasma concentration after intramuscular injection is lower than that of intravenous injection, but the plasma drug level lasts longer after intramuscular injection, so the two administration methods can be given the same amount of methylprednisolone. Given the mechanism of action of glucocorticoids, these small differences between the two administration methods are clinically insignificant. The clinical response is usually observed after 4 to 6 hours of administration; in the treatment of asthma, the first effective result can be observed after 1 or 2 hours of administration. The plasma half-life of methylprednisolone sodium succinate is 2.3 to 4 hours and is independent of the method of administration.

Methylprednisolone is a medium-acting glucocorticoid with a biological half-life of 12 to 36 hours. The intracellular activity of glucocorticoids makes their plasma half-life and pharmacological half-life significantly different. Even if glucocorticoids have not been detected in plasma, their pharmacological activities persist. The duration of glucocorticoid anti-inflammatory activity is the same as the time at which the hypothalamic-pituitary-adrenal (HPA) axis is inhibited.

Methylprednisolone is metabolized by the liver as well as cortisone. The main metabolites are 20β-hydroxymethylprednisolone and 20β-hydroxy-6α-methylprednisone. These metabolites are excreted in the urine in the form of glucuronates, sulfates and unbound compounds.

Intravenous injection of 14C-labeled methylprednisolone, 75% of total radioactivity can be recovered in urine after 96 hours, and 9% can be recovered in feces after 5 days, 20% of which is present in bile.

Indications

Unless it is used as an alternative treatment for certain endocrine disorders, glucocorticoids are only a symptomatic treatment.

1, anti-inflammatory treatment:

- rheumatic diseases: as a short-term use of adjuvant drugs (to help patients through the acute or critical phase), for: post-traumatic osteoarthritis; synovitis caused by osteoarthritis; rheumatoid arthritis, including juvenile Rheumatoid arthritis (individual patients may require low-dose maintenance therapy); acute or subacute bursitis; blepharospasm; acute nonspecific tenosynovitis; acute gouty arthritis; psoriatic arthritis; ankylosing spine inflammation. - Collagen disease (immune complex disease): for critical illness or maintenance treatment of systemic lupus erythematosus (and lupus nephritis); acute rheumatic myocarditis; systemic dermatomyositis (polymyositis); nodules Polyarteritis; Good pasture's Syndrome. - skin diseases: pemphigus; severe polymorphous erythema (Stevens-Johnson syndrome); exfoliative dermatitis; herpes simplex dermatitis; severe seborrheic dermatitis; severe psoriasis; mycosis fungoides; measles. - Allergic condition: used to control severe or functional allergic diseases that are difficult to treat with conventional therapies; bronchial asthma; contact dermatitis; atopic dermatitis; serum disease; seasonal or year-round allergic rhinitis; Drug allergic reaction; urticaria-like transfusion reaction; acute non-infectious laryngeal edema (adrenalin is the drug of choice).

-Eye diseases: severe acute and chronic eye allergies and inflammation, such as: ocular herpes zoster; iritis, iridocyclitis; chorioretinitis; diffuse posterior uveitis and choroiditis; Optic neuritis; sympathetic ophthalmia.

- Gastrointestinal disease: a critical period that helps patients to survive the following diseases; ulcerative colitis (systemic therapy); Crohn's disease (systemic therapy).

-Respiratory diseases: pulmonary sarcoma; sputum poisoning; combined with appropriate anti-tuberculosis therapy for fulminant or proliferative tuberculosis; Loffler's Syndrome, which cannot be controlled by other methods; aspiration pneumonia .

- Edema state: diuretic and proteinuria for spontaneous or lupus nephrotic syndrome without uremia.

2, immunosuppressive therapy:

- Organ transplantation.

3, treatment of blood diseases and tumors:

- blood disease: acquired (autoimmune) hemolytic anemia; adult spontaneous thrombocytopenic purpura (only intravenous, contraindications for intramuscular injection); adult secondary thrombocytopenia; erythropoiesis (erythrocyte anemia); Congenital (red blood cells) aplastic anemia.

-Tumor: palliative treatment for the following diseases; adult leukemia and lymphoma; childhood acute leukemia.

4, treatment shock:

- Adrenal insufficiency induced shock, or due to adrenal insufficiency, shock does not respond to conventional treatment (hydrocortisone is a commonly used drug; if mineralocorticoid activity is not desired, methylprednisolone can be used) . Hemorrhagic, traumatic, and operative shock that does not respond to conventional therapy. Although there are no well-established (double-blind control) clinical studies, data from animal studies suggest that methylprednisolone may be effective in shocks that are not effective for conventional therapies (eg, fluid replacement). Also see the "Septic Shock" section of the "Precautions".

5, other:

- Nervous system: cerebral edema caused by primary or metastatic tumors, and/or surgery and radiotherapy; acute critical stage of multiple sclerosis; acute spinal cord injury. Treatment should begin within 8 hours of the trauma. - In combination with appropriate anti-tuberculosis therapy for tuberculous meningitis with subarachnoid obstruction or occlusion. - Trichinosis involving the nerve or heart muscle. - Prevent nausea and vomiting caused by cancer chemotherapy.

6, endocrine disorders:

primary or secondary adrenal insufficiency; acute adrenal insufficiency; (the above diseases hydrocortisone or cortisone is the drug of choice, if necessary, synthetic Glucocorticoids can be combined with mineralocorticoids.)

A patient known to have or may have adrenal insufficiency is administered prior to surgery and when a severe trauma or disease occurs. Congenital adrenal hyperplasia; non-suppurative thyroiditis; hypercalcemia caused by cancer.

Usage and Usage

This product must be prescribed according to the doctor's advice.

* When it is an adjunct to life-threatening conditions: The recommended dose is 15~30mg/kg body weight, and intravenous injection should be given for at least 30 minutes. This dose can be repeated every 4 to 6 hours within 48 hours of the hospital according to clinical needs (see "Precautions").

* Shock therapy: A disease that is used for severe disease progression and/or non-responsive to conventional treatments such as non-steroidal drugs, gold salts and penicillamine.

Suggestions:

- Rheumatoid arthritis: 1 g per day, intravenous, with 1, 2, 3 or 4 days; or 1 g in January, intravenously for 6 months. Because high-dose corticosteroids can cause arrhythmias, this treatment is only used in hospitals for ECG and defibrillation. The drug should be administered at least 30 minutes each time. If the condition does not improve within one week after treatment, or because of the condition, the treatment plan can be repeated. * Prevent nausea and vomiting caused by chemotherapy;

Suggestions:

- Regarding mild to moderate vomiting caused by chemotherapy: 250 mg of methylprednisolone is administered intravenously for at least 5 minutes 1 hour before chemotherapy. When the first dose of methylprednisolone is administered, chlorinated phenothiazine can be administered simultaneously to enhance the effect.

-About severe vomiting caused by chemotherapy: 1 hour before chemotherapy, at the beginning of chemotherapy, and after chemotherapy, intravenous injection of methylprednisolone for at least 5 minutes, while administering an appropriate amount of metoclopramide or butyrylbenzene, followed by At the beginning and at the end of chemotherapy, 250 mg of methylprednisolone was injected intravenously.

*Acute spinal cord injury:

Treatment should begin within 8 hours of the injury. The initial dose was 30 mg/kg body weight of methylprednisolone, administered intravenously for 15 minutes under continuous medical monitoring. Only this indication can be administered in large doses at this rate and should be performed with ECG monitoring and a defibrillator. Intravenous injection of large doses of methylprednisolone (giving more than 500 mg of methylprednisolone in less than 10 minutes) may cause arrhythmia, circulatory collapse, and cardiac arrest. The high-dose injection was suspended for 45 minutes, followed by continuous intravenous infusion for 23 hours at a rate of 5.4 mg/kg body weight per hour. The infusion pump should be placed at a different injection site than the high-dose injection.

*The initial dose for other indications ranges from 10 mg to 500 mg and varies with clinical disease. High-dose methylprednisolone can be used to control certain acute severe diseases in a short period of time, such as bronchial asthma, serum disease, urticaria-like transfusion reaction, and acute exacerbation of multiple sclerosis. An initial dose of 250 mg or less should be administered intravenously for at least 5 minutes; an initial dose greater than 250 mg should be administered intravenously for at least 30 minutes. Depending on the patient's response and clinical needs, the next dose can be administered intravenously or intramuscularly at intervals. Corticosteroids can only be used as an aid and are not a substitute for conventional therapies. Infants and children can be reduced, but it should be based on the severity of the disease and the patient's response, not the age and size. The total amount per 24 hours should not be less than 0.5 mg/kg.

After a few days of medication, the dose must be gradually reduced or phased out. If the chronic disease is spontaneously relieved, treatment should be discontinued. Patients with long-term treatment should be routinely tested routinely, such as: urine routine, 2 hours postprandial blood glucose, blood pressure and weight, chest X-ray examination. Patients with a history of ulcers or significant dyspepsia should be treated with a digestive tract X-ray, and patients who discontinue long-term treatment also need medical monitoring.

Methylprednisolone solution can be administered intravenously or intramuscularly, or intravenously, and intravenous treatment should be used for emergency treatment. Preparation of the solution: Dissolve with sterile water for injection or 5% dextrose injection or 0.9% sodium chloride injection before use. The initial treatment may be intravenous injection of methylprednisolone for at least 5 minutes (dose less than or equal to 250 mg) or at least 30 minutes (dose greater than 250 mg); the next dose may be reduced and administered in the same manner. If necessary, the drug can be administered after dilution by mixing the dissolved drug with 5% dextrose injection or 0.9% sodium chloride injection, and mixing immediately after use.

Adverse reactions

According to foreign research data: Systemic adverse reactions may be observed. Although rarely seen in the short term, it should be followed carefully, which is part of the follow-up of steroid therapy and does not target a drug. Possible adverse effects of glucocorticoids (such as methylprednisolone) are:

*Human fluid and electrolyte disorders:

is equivalent to cortisone and hydrocortisone, and synthetic derivatives (such as methylprednisolone) are less likely to act as mineralocorticoids. A diet that limits sodium and potassium may be necessary. All corticosteroids increase the loss of calcium ions. Sodium retention; fluid retention; congestive heart failure in some sensitive patients; loss of potassium ions; hypokalemic alkalosis; hypertension.

* Musculoskeletal system:

Myasthenia gravis; steroidal myopathy; osteoporosis; compression spinal fracture; aseptic necrosis; pathological fracture; * Gastrointestinal: Peptic ulcers that may have perforation or bleeding; gastrointestinal bleeding; pancreatitis; esophagitis; intestinal perforation;

*Skin disease:

Prevents wound healing; skin becomes thin and fragile; blemishes and ecchymoses; repeated local subcutaneous injections may cause local skin atrophy.

*neuropathy:

increased intracranial pressure; pseudo-brain tumor; seizure; dizziness; Taking corticosteroids may present symptoms of the following mental disorders: euphoria, insomnia, mood changes, personality changes, and major depression until significant psychotic manifestations.

*Endocrine:

menstrual disorders; Cushing's posture; inhibits growth in children; inhibits pituitary-adrenal axis; impaired glucose tolerance; triggers potential diabetes; increases demand for insulin and oral hypoglycemic agents in diabetic patients .

*Eye:

Long-term use of glucocorticoids may cause cataracts under the posterior capsule, glaucoma (which may involve the optic nerve), and increase the chance of secondary fungal or viral infections in the eye. In order to prevent corneal perforation, glucocorticoids should be used with caution in patients with ocular herpes simplex; intraocular pressure is increased; eyeballs are prominent.

* Metabolic aspects:

Negative nitrogen balance due to protein breakdown.

*Immune system:

cover infection; potential infection episode; opportunistic infection; allergic reaction; may inhibit skin test response. *The following adverse reactions are related to parenteral administration of corticosteroids: Allergic reactions, with or without circulatory collapse; cardiac arrest; bronchospasm; hypotension or hypertension; arrhythmia. It has been reported that intravenous injection of large doses of methylprednisolone (more than 0.5 g in 10 minutes) can cause arrhythmia and/or circulatory collapse and/or cardiac arrest. It has also been reported that high-dose methylprednisolone causes bradycardia, but may not be related to the rate of administration or the time of instillation.

Contraindications

Systemic fungal infections and those known to be allergic to pharmaceutical ingredients are prohibited.

Special risk groups:

Patients with the following special risk groups should be treated with strict medical supervision and should be treated as short as possible (see also "Precautions" and "Adverse Reactions"); Children; Diabetes; Hypertensive Patients; Those with a history of mental illness; Symptoms of certain infectious diseases, such as tuberculosis; or certain viral diseases with obvious symptoms, such as herpes and herpes zoster.

Notes

-Specially dangerous people:

Patients with the following special risk groups should be treated with strict medical supervision and should be treated as short as possible:

-Children: Long-term daily administration of glucocorticoids in divided doses inhibits the growth of children. This treatment can only be used in very critical situations.

-Diabetes: triggers potential diabetes or increases the demand for insulin and oral hypoglycemic agents in diabetic patients.

-Hypertension patients: worsen the condition of arterial hypertension.

-Psychotic history: Existing emotional instability and mental illness may be exacerbated by taking corticosteroids.

-The complications of glucocorticoid therapy are related to the dose and timing of the drug. For each case, the pros and cons need to be weighed in terms of dose, duration of treatment, and daily or intermittent administration.

- Patients with abnormal emergencies treated with corticosteroids need to increase the dose of fast-acting corticosteroids before, during, and after an emergency.

-Corticosteroids may mask some of the symptoms of infection and new infections may occur during treatment. Corticosteroids may reduce resistance and not limit infection.

-A study to determine the effectiveness of methylprednisolone in septic shock found that patients who had elevated serum creatinine levels or had secondary infections after hormone therapy started had a higher mortality rate.

- When methylprednisolone is used in patients with active tuberculosis, it should be limited to fulminant or diffuse tuberculosis. Corticosteroids can be combined with appropriate anti-tuberculosis drugs to control the condition, such as corticosteroids for tuberculosis latency or tuberculin test positive. Patients must be carefully observed to prevent recurrence. Such patients should receive chemoprevention during long-term use of corticosteroids.

-Because there are very few allergic reactions (such as bronchospasm) in patients treated with steroids outside the gastrointestinal tract, appropriate precautions should be taken before administration, especially in patients with a history of drug allergy.

- Decrease the dose to reduce the adrenal insufficiency caused by medication. This phenomenon of relative insufficiency can last for several months after stopping the drug. Therefore, in the event of an emergency, the drug should be resumed during this period; since the secretion of mineralocorticoid may also be inhibited, the salt and/or salt should be supplemented at the same time. Corticosteroids.

- Hypothyroidism and cirrhosis enhance corticosteroids.

- Corticosteroids should be used with caution in patients with herpes simplex in the eye to avoid corneal perforation.

-Glucocorticoids should be used with caution in patients with non-specific ulcerative colitis.

- Care should be taken to observe the growth and development of infants and children who have been treated with steroids for a long time.

- Some formulations contain benzyl alcohol. It is reported that benzyl alcohol is associated with a fatal premature infant "wheezing syndrome" (a respiratory disorder characterized by persistent wheezing).

- When interpreting the entire set of biological tests and data (eg skin test, thyroxine levels), steroid treatment factors should be taken into account.

-In general, the course of treatment should be as short as possible (see also "Usage and Dosage"). Drug withdrawal after long-term treatment should also be performed under medical supervision (decreasing by volume, assessing adrenal function). The most important symptoms of adrenal insufficiency are weakness, orthostatic hypotension, and depression.

- Avoid injections in the deltoid muscle because of the high incidence of subcutaneous atrophy in this area.

- Although visual impairment is a rare adverse reaction, patients are advised to drive the car carefully and operate the machine.

-Incompatibility:

The compatibility and stability of intravenous methylprednisolone solution, and its compatibility and stability with other drugs in intravenous infusion solution depend on the pH, concentration, settling time, temperature of the mixture and methylprednisolone itself. Solubility. In order to avoid compatibility and stability problems, it is recommended that the methylprednisolone solution be administered separately from other drugs, whether intravenous or intravenous.

-Methylprednisolone sodium succinate should not be used as a routine treatment for craniocerebral injury.

Pregnant women and lactating women

Some animal studies have shown that taking large doses of corticosteroids during pregnancy may cause fetal malformations. Because there is not enough human reproduction research, when corticosteroids are used in pregnant women, breastfeeding women or women who are ready to give birth, the relationship between its benefits and its potential threat to the mother and the embryo or fetus should be carefully weighed. Corticosteroids are only available to pregnant women when they are really needed. If long-term use of corticosteroids (as in other long-term therapies) must be discontinued during pregnancy, the withdrawal procedure must be carried out step by step (see also “Usage and Dosage”). However, treatment of certain diseases (such as replacement therapy for adrenal insufficiency) may require continued or even increased doses. Because corticosteroids are easily transmitted through the placenta, infants born to mothers who have used high doses of corticosteroids during pregnancy should be carefully observed and evaluated for signs of adrenal insufficiency. The effect of methylprednisolone on childbirth is unknown. Corticosteroids are secreted with milk.

Child medication

Long-term daily administration of glucocorticoids can inhibit the growth of children, and this treatment can only be used in very serious situations. Infants and children can be reduced, but it should be based on the severity of the disease and the patient's response, not the age and size. The total amount per 24 hours should not be less than 0.5 mg/kg.

Geriatric Use

Use it with caution.

Drug interaction

Beneficial drug interactions:

-Preventing nausea and vomiting caused by chemotherapy for chemotherapy; chemotherapy regimen for mild to moderate vomiting;

- Chlorophenothiazine can be combined with the first dose of methylprednisolone (1 hour before chemotherapy) to enhance the effect.

Medium vomiting chemotherapy regimen:

Metoclopramide or butyrylbenzene can be combined with the first dose of methylprednisolone (1 hour before chemotherapy) to enhance the effect.

-Methylprednisolone combined with other anti-tuberculosis chemotherapy can be used to treat fulminant or diffuse tuberculosis and tuberculous meningitis with subarachnoid obstruction or occlusion.

- Methylprednisolone is often used in combination with alkylating agents, antimetabolites, and vinblastine drugs for oncological diseases such as leukemia and lymphoma.

Harmful drug interactions: , /br>-Glucocorticoids combined with ulcerative drugs (such as salicylates and steroidal anti-inflammatory drugs) increase the risk of gastrointestinal complications. The combination of glucocorticoids and thiazide diuretics increases the risk of impaired glucose tolerance. Glucocorticoids increase the demand for insulin and oral hypoglycemic agents in diabetic patients. - Patients taking corticosteroids should not be vaccinated against vaccinia, nor can they receive other immunizations, especially in high-dose patients, due to neurological complications and/or lack of antibody response.

- Corticosteroids should be used with acetylsalicylic acid in patients with too little prothrombin.

-It has been reported that taking methylprednisolone and cyclosporin at the same time can cause convulsions. Because the above two drugs inhibit each other's metabolism, the convulsions and other adverse reactions caused by taking any of the drugs are more likely to occur when taking both drugs at the same time.

Overdose

No syndrome caused by acute overdose of methylprednisolone was found. Long-term overdose can cause typical Cushing's symptoms. Methylprednisolone can be discharged by dialysis.

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 详细处方信息以本药内容附件PDF文件(201811623285122.pdf)的“原文Priscribing Information”为准
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更新日期: 2018-11-06
附件:
201811623285122.pdf    

 
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