DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Cortrosyn (Cosyntropin) - Summary




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.

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 (seeDOSAGE 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.

See all Cortrosyn indications & dosage >>


Published Studies Related to Cortrosyn (Cosyntropin)

Cosyntropin for prophylaxis against postdural puncture headache after accidental dural puncture. [2010.08]
BACKGROUND: The aim of the current study was to investigate the effect of administration of cosyntropin after accidental dural puncture (ADP) on the incidence of postdural puncture headache (PDPH) and the need for therapeutic epidural blood patch (EBP)... CONCLUSIONS: Administration of cosyntropin after ADP in parturients was associated with significant reduction in the incidence of PDPH and need for EBP and significant prolongation of the time from ADP to occurrence of PDPH.

Basal and cosyntropin-stimulated plasma cortisol concentrations, as measured by high-performance liquid chromatography, in children aged 5 months to younger than 6 years. [2007.06]
CONTEXT: Topical corticosteroids are the recommended first-line treatment for all severities of persistent asthma and moderate to severe allergic rhinitis. Potential adrenal suppression resulting from corticosteroid administration necessitates monitoring of children participating in clinical studies. Measurement of pretreatment cortisol concentrations is necessary to assess effects on adrenal function. OBJECTIVE: Plasma cortisol concentrations are assay dependent; normal reference range values must be obtained for each assay. Our objective is to provide these values for children as determined by HPLC... CONCLUSIONS: Basal and cosyntropin-stimulated morning plasma cortisol concentrations of children aged 5 to younger than 12 months and 2 to younger than 6 yr were consistently measurable, with the large majority similar among the age groups examined, and comparable with those reported elsewhere for adults.

Comparison of low-dose and high-dose cosyntropin stimulation testing in children. [2011.04]
BACKGROUND: There is no consensus among pediatric endocrinologists in using low-dose (LD) versus high-dose (HD) cosyntropin to test for secondary/tertiary adrenal insufficiency. This paper compares LD and HD cosyntropin stimulation testing in children for evaluation of hypothalamic-pituitary-adrenal axis (HPAA) and suggests a new peak cortisol cut-off value for LD stimulation testing to avoid false positivity... CONCLUSIONS: LD cosyntropin stimulation testing results should be interpreted cautiously when used alone to prevent unnecessary long-term treatment. Using a lower cut-off for LD (>/=14 microg/dL) seems to avoid false positive results and still detects most cases of impaired HPAA. (c) 2011 The Authors.Pediatrics International (c) 2011 Japan Pediatric Society.

Cortisol and aldosterone response to various doses of cosyntropin in healthy cats. [2011.01.15]
OBJECTIVE: To determine the lowest dose of cosyntropin on a per body weight basis that would produce maximal cortisol and aldosterone secretion and the ideal timing of blood sample collection after ACTH stimulation in healthy cats... CONCLUSIONS AND CLINICAL RELEVANCE: Low-dose ACTH stimulation testing with IV administration of cosyntropin at 5 mug/kg followed by blood sample collection at 60 to 75 minutes resulted in concurrent peak serum cortisol and aldosterone concentrations that were equivalent to those achieved following administration of cosyntropin at 125 mug/cat, the standard dose currently used.

Is the cosyntropin test redundant in the acutely ill patient suspected of adrenal insufficiency? A case report and literature review. [2010.09]
Relative adrenal insufficiency is an increasingly documented phenomenon in acute illness.We recommend that clinicians managing acutely ill patients have a low threshold for initiating glucocorticoid replacement in the presence of hypoglycemia and shock regardless of the peak cortisol values.

more studies >>

Clinical Trials Related to Cortrosyn (Cosyntropin)

Value of 25 mcg Cortrosyn Stimulation Test [Recruiting]
The diagnosis of secondary AI is vital to prevent catastrophic events in patients. An optimal test should have a very low margin of error with high sensitivity and specificity, be easy and safe to administer, and have distinct cut off values. Both 1 ug and 250 ug doses have their limitations. Based on our experience over the past six years, we hypothesize that 25 ug ACTH stimulation test may eliminate some of the shortcomings of the LDST (1 ug) and SDST (250 ug). This is supported by our preliminary data and the study by Oelkers et al, which looked at ACTH levels following various doses of cortrosyn injections. Therefore we propose a head to head comparison of 25 ug, 250 ug and 1 ug dose using ITT as gold standard.

Cosyntropin Versus Epidural Blood Patch (EBP) for Treatment of Treatment of Post Dural Puncture Headache [Completed]
PDPH is a common problem after either intentional or unintentional Dural puncture. It is especially common in young female patients and in patients undergoing Lumbar Puncture using the typical kit containing large 20 gauge needles (1). Hypothesis is that Cosyntropin therapy is at least as effective as current conservative therapy (caffeine/fluid) and/or Epidural Blood Patch. Patients will be randomly assigned to undergo either: (1) EBP with IVF therapy or (2)Cosyntropin IV with IVF therapy. Endpoints will be a pain score that is given prior to the procedure, Emergency Department (ED) discharge pain score and post procedural day (PPD) day 1, day 3 and day 7 pain and functional levels. Patients in Cosyntropin arm of the study may request crossover to EBP at anytime after a 24 hour assessment period is completed per Standard of Care for treatment of PDPH, in order to ensure no undue distress is placed on the patient in order to complete this study. Current treatments consist primarily of non-invasive treatment with intravenous fluids and caffeine therapy and invasive treatment by Epidural Blood Patch. Efficacy of Caffeine 300mg IV BID x 1d doses is approximately 70% (2). However this therapy has been linked to post-treatment seizures. EBP was originally thought to be 90% effective with repeat treatment efficacy approaching >96%. However more recent studies by Taivainen et al (3) have shown only a 61% rate of permanent cure. Additionally, EBP are contraindicated in patients with signs of increased intra-cranial pressure (ICP), coagulation issues, signs/symptoms of Central Nervous System (CNS) /systemic infection or local infection at the site of the EBP, thus resulting in decreased utility. Complications are also quite serious ranging from meningitis, spinal hematoma, repeat dural puncture, localized infection and vagal response to the procedure. EBP are not typically performed until after conservative measures have failed which leads to further prolongation of the patients decreased functional status and pain. Additionally, the cost of both treatments is substantial considering prolonged ED visits for conservative treatments often followed by the time and expense of an EBP. The goal of this investigation is to aid in the confirmation of case reports advocating the economy, efficacy and safety of synthetic Adrenal CorticTropin Hormone (ACTH) as a treatment of PDPH (4,5,6,7,8,9).

Stress and the Nervous System [Recruiting]
Models of stress such as hypoglycemia have identified that stress results the next day in decreased baroreflex sensitivity. This project will test the hypothesis that these delayed changes in autonomic nervous system function are secondary to a rise in ACTH. The investigators will infuse cosyntropin versus placebo in a double-blind, crossover study in healthy adults and measure the delayed effects on the autonomic system as measured by cardiovagal baroreflex sensitivity.

Treatment With Synthetic ACTH in High Risk Patients With Membranous Nephropathy [Completed]
The purpose of this study is to determine whether treatment with long-acting synthetic adrenocorticotropic hormone is in the treatment of patients with idiopathic membranous nephropathy and high for renal failure.

Adrenocorticotropic Hormone Stimulation in Postural Orthostatic Tachycardia Syndrome (POTS) [Recruiting]
This study is to determine different chemical levels in the blood during a low salt diet. This study will compare normal volunteers to those with Postural Tachycardia Syndrome (POTS)

more trials >>

Page last updated: 2011-12-09

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017