CORTROSYN injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Cosyntropin (UNII: 72YY86EA29) (Cosyntropin - UNII:72YY86EA29)

Available from:

General Injectables & Vaccines, Inc

INN (International Name):

Cosyntropin

Composition:

Cosyntropin 0.25 mg in 1 mL

Administration route:

PARENTERAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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:

Product summary:

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

Authorization status:

New Drug Application

Summary of Product characteristics

CORTROSYN- CORTROSYN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
GENERAL INJECTABLES & VACCINES, INC
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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