(cosyntropin) for Injection
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 α 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 (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.
Media Articles Related to Cortrosyn (Cosyntropin)
APA Leaders Defend New Diagnostic Guide
Source: MedPage Today Cardiovascular [2013.05.18]
SAN FRANCISCO (MedPage Today) -- The fifth edition of the "psychiatrist's bible" was officially released here in all its 947-page glory, with its developers offering a spirited rebuttal to their critics.
Topol on Using Smartphones for Complex Diagnostic Challenges
Source: Medscape Allergy & Clinical Immunology Headlines [2013.05.15]
Eric J. Topol, MD, describes how smartphones and supercomputers will partner to help clinicians with challenging medical diagnoses and treatments.
FDA Approves New Lung Cancer Diagnostic "Cobas EGFR Mutation Test"
Source: Cancer / Oncology News From Medical News Today [2013.05.15]
The U.S. Food and Drug Administration (FDA) has approved the cobas EGFR Mutation Test, a companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10 percent of non-small cell lung cancers (NSCLC)...
Medical Diagnostic Device Employs Wireless Signals To Identify Brain Swelling Or Bleeding
Source: Medical Devices / Diagnostics News From Medical News Today [2013.05.15]
New technology developed at the University of California, Berkeley, is using wireless signals to provide real-time, non-invasive diagnoses of brain swelling or bleeding. The device analyzes data from low energy, electromagnetic waves, similar to the kind used to transmit radio and mobile signals...
FDA Approves Companion Genetic Diagnostic Test for Tarceva
Source: Medscape Today Headlines [2013.05.14]
The FDA has approved the first companion diagnostic test that can detect EGFR mutations in non-small cell lung cancer.
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.
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
Treatment With Synthetic ACTH in High Risk Patients With Membranous Nephropathy [Recruiting]
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)
Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures [Not yet recruiting]
Cortisol is a stress hormone that can be measured in saliva. This has provided a convenient
way to evaluate the biological impact of day-to-day stressors that people encounter as they
go about their lives, since saliva is so easy to collect. However, the biological meaning
of saliva cortisol measures has never been carefully examined. The goal of this study is to
collect saliva from a large group of people as they go about their every-day lives, to
measure their cortisol levels, and then study them in the laboratory where Investigators can
learn more about how their stress response system (which produces cortisol) is really
functioning. Investigators can then determine much more precisely what saliva cortisol
levels really mean in terms of stress system biology. This will allow investigators to
obtain much more useful information from the next decade of research on naturalistic stress
and its biological impact using saliva cortisol measures, helping investigators to
understand how stress undermines health and how to combat this effect.
Evaluation of Adrenal Androgens in Normal and Obese Girls After Suppression and Stimulation [Recruiting]
Women with Polycystic Ovary Syndrome (PCOS) often have irregular menstrual periods, too much
facial and body hair, and weight gain. Women with PCOS also have a hard time becoming
pregnant. Girls with high levels of the male hormone testosterone often develop PCOS as
adults. Some girls with high levels of male hormone will develop normal hormone levels as
they grow up, but most girls continue to have high levels of male hormone as adults. The
purpose of this study is to understand where the male and female hormones come from in girls
as they get older. The investigators think the adrenal gland, makes most of the hormones in
young girls and that the ovary and the adrenal gland make these hormones in older girls.
The investigators would like to find out whether an overactive adrenal gland makes these
hormones higher in girls who are overweight, compared to those who are not overweight.