CORTROSYN- cosyntropin injection, powder, lyophilized, for solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Amphastar Pharmaceuticals, Inc.

INN (Mezinárodní Name):

Cosyntropin

Složení:

Cosyntropin 0.25 mg in 1 mL

Podání:

INTRAMUSCULAR

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

CORTROSYN® (cosyntropin) for Injection is intended for use as a diagnostic agent in the screening of patients presumed to have adrenocortical insufficiency. Because of its rapid effect on the adrenal cortex it may be utilized to perform a 30-minute test of adrenal function (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 associated 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 establishing 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 example, 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. The only contraindication to CORTROSYN® (cosyntropin) for Injection is a history of a previous adverse reaction to it.

Přehled produktů:

Box of 10 vials of CORTROSYN® (cosyntropin) for Injection 0.25 mg                                         NDC # 0548-5900-00 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 REFERENCES 1. Wood, J.B. et al. LANCET 1.243, 1965. 2. Greig, W.R. et al. J. ENDOCR 34.411, 1966. 3. McGill, P.E. et al. ANN RHEUM DIS 26.123, 1967. Amphastar Pharmaceuticals, Inc. Rancho Cucamonga, CA 91730 U.S.A.             REV. 6-21

Stav Autorizace:

New Drug Application

Charakteristika produktu

CORTROSYN - COSYNTROPIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
AMPHASTAR PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CORTROSYN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CORTROSYN .
CORTROSYN (COSYNTROPIN) FOR INJECTION, FOR INTRAVENOUS OR
INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 2008
INDICATIONS AND USAGE
CORTROSYN is an adrenocorticotropin hormone indicated, in combination
with other diagnostic tests, for
use as a diagnostic agent in the screening of adrenocortical
insufficiency in adults and pediatric patients.
(1)
DOSAGE AND ADMINISTRATION
In general, stop glucocorticoids and spironolactone on the day of
CORTROSYN testing. For long-acting
glucocorticoids, stop for a longer period before CORTROSYN testing.
(2.1)
For adults, the recommended dose is 0.25 mg to be administered by
intravenous or intramuscular
injection. (2.2)
For pediatric patients, the recommended dose to be administered by
intravenous or intramuscular
injection is (2.3):
o 0.125 mg for patients birth to less than 2 years of age
o 0.25 mg for patients 2 to 17 years of age (2)
Obtain blood samples for serum cortisol level at baseline and exactly
30 and 60 minutes after
CORTROSYN administration. (2.5)
See Full Prescribing Information for reconstitution and interpretation
of cortisol levels information. (2.4,
2.6)
DOSAGE FORMS AND STRENGTHS
For injection: 0.25 mg of cosyntropin as a lyophilized powder in
single-dose vial for reconstitution (3)
CONTRAINDICATIONS
CORTROSYN is contraindicated in patients with a history of
hypersensitivity to cosyntropin or to any
excipients of CORTROSYN. Reactions have included anaphylaxis. (4, 5.1)
WARNINGS AND PRECAUTIONS
• _Hypersensitivity:_ reactions including anaphylaxis have been
reported. Monitor patients for
hypersensitivity reactions and treat as needed. (5.1)
• _Diagnostic Inaccuracies:_ Cortisol levels and subsequent
diagnosis of adrenocortical insufficiency following
CORTROSYN administra