CORTROSYN™ (cosyntropin) for Injection is a sterile Iyophilized powder in vials containing 0.25 mg of CORTROSYN™ and 10 mg of mannitol to be reconstituted with 1 mL of 0.9% Sodium Chloride Injec-tion, USP. Administration is by intravenous or intramuscular injection. Cosyntropin is ⓫ - 24 corticotropin, a synthetic subunit of ACTH.

INDICATIONS

CORTROSYN™ (cosyntropin) for Injection is intended for use as a diagnostic agent in the screening of patients presumed to have ad-renocortical insufficiency. Because of its rapid effect on the adrenal cortex it may be utilized to perform a 30-minute test of adrenal func-tion (plasma cortisol response) as an office or outpatient procedure, using only 2 venipunctures (see DOSAGE AND ADMINISTRATION section).

Severe hypofunction of the pituitary - adrenal axis is usually associ-ated with subnormal plasma cortisol values but a low basal level is not per se evidence of adrenal insufficiency and does not suffice to make the diagnosis. Many patients with proven insufficiency will have normal basal levels and will develop signs of insufficiency only when stressed. For this reason a criterion which should be used in estab-lishing the diagnosis is the failure to respond to adequate corticotropin stimulation. When presumptive adrenal insufficiency is diagnosed by a subnormal CORTROSYN™ test, further studies are indicated to determine if it is primary or secondary.

Primary adrenal insufficiency (Addison's disease) is the result of an intrinsic disease process, such as tuberculosis within the gland. The production of adrenocortical hormones is deficient despite high ACTH levels (feedback mechanism). Secondary or relative insufficiency arises as the result of defective production of ACTH leading in turn to disuse atrophy of the adrenal cortex. It is commonly seen, for ex-ample, as result of corticosteroid therapy, Sheehan's syndrome and pituitary tumors or ablation.

The differentiation of both types is based on the premise that a primarily defective gland cannot be stimulated by ACTH whereas a secondarily defective gland is potentially functional and will respond to adequate stimulation with ACTH. Patients selected for further study as the result of a subnormal CORTROSYN™ test should be given a 3 or 4 day course of treatment with Repository Corticotropin Injection USP and then retested. Suggested doses are 40 USP units twice daily for 4 days or 60 USP units twice daily for 3 days. Under these conditions little or no increase in plasma cortisol levels will be seen in Addison's disease whereas higher or even normal levels will be seen in cases with secondary adrenal insufficiency.

SIDE EFFECTS

Since CORTROSYN™ (cosyntropin) for Injection is intended for diag-nostic and not therapeutic use, adverse reactions other than a rare hypersensitivity reaction are not anticipated. A rare hypersensitivity reaction usually associated with a pre-existing allergic disease and/or a previous reaction to natural ACTH is possible. Symptoms may include slight whealing with splotchy erythema at the injection site. There have been rare reports of anaphylactic reaction. The following adverse reactions have been reported in patients after the admin-istration of CORTROSYN™ and the association has been neither confirmed nor refuted:

  * bradycardia
  * tachycardia
  * hypertension
  * peripheral edema
  * rash

DRUG INTERACTIONS

Corticotropin may accentuate the electrolyte loss associated with diuretic therapy. 

替可克肽 [tetracosactide]
适应症
        参见用法用量。
适应症/成人常用量
        静脉/肌肉注射 肾上腺皮质机能不全诊断普通制剂：250 mcg。在注射前即刻和注射后30分钟准时取血测量血浆皮质醇浓度。醋酸盐缓释剂：1 mg，肌注。在注射前即刻和注射后30分钟、1、2、3、4和5小时准时取血测定血浆皮质醇浓度。肌肉注射 皮质类固醇激素治疗；类风湿性关节炎和骨关节炎辅助治疗 1 mg/天。急性期：1 mg，12小时一次。维持剂量：1 mg，2-3天一次。反应良好的患者：0.5 mg，2-3天一次或 1 mg/周。
肾上腺皮质功能低下诊断试验
成人: 普通制剂：250 mcg，肌注/静注。在注射前即刻和注射后30分钟准时取血测量血浆皮质醇浓度。如果肾上腺皮质功能正常，注射后血浆皮质醇浓度升高应≥200 nmol/L（70 mcg/L）。醋酸替可克肽控释剂（如果注射普通制剂后未能明确诊断）：1 mg，肌注。分别在注射前即刻和注射后30分钟、1、2、3、4和5小时准时取血测定血浆皮质醇浓度。如果注射后血浆皮质醇浓度在1小时升高2倍，并持续平稳增加，说明肾上腺皮质功能正常。预期1小时水平：600-1,250 nmol/L，5小时时缓慢增加至1000-1800 nmol/L。
儿童: 250 mcg/1.73 m2体表面积，静注。
禁忌
        未控制的急性感染, 活动期或静止期结核，变态反应疾病史如哮喘，妊娠和哺乳期妇女 (治疗用途)禁用。用药期间不要接种活疫苗。
注意事项
        下列情况慎用：心力衰竭, 近期心梗, 青光眼, 甲状腺机能低下, 肝衰竭, 肾损害, 高血压, 癫痫, 偏头痛, 骨质疏松症, 精神病/严重情绪异常，消化性溃疡, 非特异性溃疡性结肠炎，憩室炎，糖尿病，易发生血栓栓塞的患者，重症肌无力，存在发生水痘/严重带状疱疹危险的患者。长期用药时，监测儿童生长发育，进行心脏超声检查。突然停药会引发垂体功能低下的症状。
不良反应
        钠水潴留, 钾丢失增加。过敏反应如呼吸困难、荨麻疹。
严重不良反应: 全身过敏反应。
药物相互作用
        增加降糖药和抗高血压药的需求量。与排钾利尿剂、两性霉素B或支气管扩张剂如黄嘌呤类或β2-激动剂合用，发生低钾血症的风险增加。影响抗凝剂的作用。拮抗治疗重症肌无力的抗毒蕈碱药的作用。巴比妥酸盐、卡马西平、苯妥英、扑米酮或利福平会导致本药作用降低。口服避孕药或利托那韦会导致本药血浓度增加。与非甾体类抗炎药合用，增加胃肠道出血和溃疡的发生率。
替可克肽： ：增强下列药物的毒性：卡介苗

程度分级:    

严重 - 这些药物之间的相互作用有生命危险或可能导致永久性残疾。这些药物通常不能合用，需要给予医学干预。

文献证据分级:
有充分研究资料证实 - 尽管无关于药物相互作用的临床对照研究，但数个病例报道已经证实了它们之间的相互作用，并获得其它证据的有力支持。

可能的作用机制:
全身大剂量使用皮质激素的患者会发生免疫抑制，对这样的患者使用减毒活疫苗有引起严重的、全身性感染的风险。促肾上腺皮质激素与减毒活疫苗的相互作用与皮质激素类似。同样，也需要在停止促肾上腺皮质激素治疗至少3个月后才能接种减毒活疫苗。

处理措施:
1. 两药间转换需要间隔一段时间（参考医学文献）。
2. 禁止合用。

替可克肽 属于一种 垂体促肾上腺皮质激素
合成的类固醇激素，可替代内源性促肾上腺皮质激素。
       
C级: 动物研究证明药物对胎儿有危害性（致畸或胚胎死亡等），或尚无设对照的妊娠妇女研究，或尚未对妊娠妇女及动物进行研究。本类药物只有在权衡对孕妇的益处大于对胎儿的危害之后，方可使用。
       
贮藏/有效期

        肠道外给药: 2-8°C贮存。避光。
药理作用

        替可克肽是合成的多肽，能诱导肾上腺增生，刺激肾上腺皮质激素，尤其是氢化可的松（皮质醇）和某些盐皮质激素如皮质酮的分泌，也能刺激雄激素的分泌，但作用较弱。对醛固酮的分泌几无影响。
分布: 快速从血浆清除，大部分分布于肾上腺和肾脏。
代谢: 被血清肽链内切酶代谢为无活性的寡肽，然后被氨基肽酶代谢为自由氨基酸。
排泄: 通过尿液排泄。终末半衰期：3小时。
MIMS药物分类

        肾上腺皮质激素 (Corticosteroid Hormones)

 1 Australia Synacthen Depot 1 mg/1 mL
 
2 Austria synacthen depot amp.
 
3 Belgium Synacthen
 
4 Denmark Synacthen
 
5 France SYNACTHENE 0,25 MG/1 ML, SOLUTION INJECTABLE
6  SYNACTHENE RETARD 1 MG/1 ML, SUSPENSION INJECTABLE IM
 
7 Germany SYNACTHEN DEPOT 1MG
8  Synacthene
9  Synacthene 0.25mg
10  Synacthene Depot 1mg Ampullen 
 
11 Italy Synacthen
12  SYNACTHEN 1F 0,25MG/1ML
13  SYNACTHEN IM 1F 1MG 1ML R.P.
 
14 Japan Acetate Tetorakosakuchido
15  KOTOROSHIN
16  Tetracosactide acetate
 
17 New Zealand Synacthen
18  Synacthen Depot 
 
19 Spain NUVACTHEN DEPOT 0,5MG 3 AMPOLLAS 1ML SOLUCION INYECTABLE
20  NUVACTHEN DEPOT 1MG/1ML 3 AMPOLLAS 1ML SOLUC INYEC
21  NUVACTHEN DEPOT 2MG 1 VIAL 2ML
22  NUVACTHEN DEPOT 2MG 1 VIAL 2ML SOLUCION INYECTABLE
 
23 Sweden Synacthen
24  Synacthen Depot 
 
25 Turkey SYNACTHEN DEPOT 1 MG 1 AMPUL
 
26 United Kingdom Synacthen 250micrograms/1ml solution for injection ampoules
27  Synacthen Depot 1mg/1ml suspension for injection ampoules