Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
Cosyntropin (UNII: 72YY86EA29) (Cosyntropin - UNII:72YY86EA29)
General Injectables & Vaccines, Inc
Cosyntropin
Cosyntropin 0.25 mg in 1 mL
PARENTERAL
PRESCRIPTION DRUG
FOR DIAGNOSTIC USE ONLY CORTROSYN™ (cosyntropin) for Injection is a sterile lyophilized 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 Injection, USP. Administration is by intravenous or intramuscular injection. Cosyntropin is a 1 – 24 corticotropin, a synthetic subunit of ACTH. It is an open chain polypeptide containing, from the N terminus, the first 24 of the 39 amino acids of natural ACTH. The sequence of amino acids in the 1 – 24 compound is as follows:
Box of 10 vials of CORTROSYN™ (cosyntropin) for Injection 0.25 mg NDC # 0548-5900-00 Storage Store at 15–30°C (59–86°F). CORTROSYN™ is intended as a single dose injection and contains no antimicrobial preservative. Any unused portion should be discarded. Rx only
New Drug Application
CORTROSYN- CORTROSYN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION GENERAL INJECTABLES & VACCINES, INC ---------- CORTROSYN (COSYNTROPIN) 0.25 MG INJECTION, USP 1ML VIAL DESCRIPTION FOR DIAGNOSTIC USE ONLY CORTROSYN™ (cosyntropin) for Injection is a sterile lyophilized 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 Injection, USP. Administration is by intravenous or intramuscular injection. Cosyntropin is a 1 – 24 corticotropin, a synthetic subunit of ACTH. It is an open chain polypeptide containing, from the N terminus, the first 24 of the 39 amino acids of natural ACTH. The sequence of amino acids in the 1 – 24 compound is as follows: Ser Tyr Ser Met Glu His Phe Arg Trp Gly Lys 1 2 3 4 5 6 7 8 9 10 11 Pro Val Gly Lys Lys Arg Arg Pro Val Lys Val 12 13 14 15 16 17 18 19 20 21 22 Tyr Pro 23 24 CLINICAL PHARMACOLOGY CORTROSYN™ (cosyntropin) for Injection exhibits the full corticosteroidogenic activity of natural ACTH. Various studies have shown that the biologic activity of ACTH resides in the N-terminal portion of the molecule and that the 1 – 20 amino acid residue is the minimal sequence retaining full activity. Partial or complete loss of activity is noted with progressive shortening of the chain beyond 20 amino acid residues. For example, the decrement from 20 to 19 results in a 70% loss of potency. The pharmacologic profile of CORTROSYN™ is similar to that of purified natural ACTH. It has been established that 0.25 mg of CORTROSYN™ will stimulate the adrenal cortex maximally and to the same extent as 25 units of natural ACTH. This dose of CORTROSYN™ will produce maximal secretion of 17-OH corticosteroids, 17- ketosteroids and / or 17 - ketogenic steroids. The extra-adrenal effects which natural ACTH and CORTROSYN™ have in common include increased melanotropic activity, increased growth hormone secretion and an adipokinetic effect. These are considered to be without physiological or clinical significance. Animal, hu Կարդացեք ամբողջական փաստաթուղթը