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1. 1-24-acth
2. 1-24-corticotropin
3. Acth (1-24)
4. Acth 1-24
5. Acth, Synthetic
6. Corticotropin (1-24)-peptide
7. Corticotropin (1-24)-tetracosapeptide
8. Cortosyn
9. Cosyntropin
10. Synthetic Acth
11. Tetracosactide
12. Tetracosactrin
13. Tetracosapeptide
1. Cosyntropin
2. Tetracosactide
3. Cortrosyn (tn)
4. Tetracosactrin
5. 16960-16-0
6. Tetracosactide Acetate
7. Cosyntropin (usp)
8. Adrenocorticotropic Hormone Fragment 1-24 Human, Rat
9. Schembl720535
10. Gtpl6965
11. D00284
Molecular Weight | 2933.4 g/mol |
---|---|
Molecular Formula | C136H210N40O31S |
XLogP3 | -7.9 |
Hydrogen Bond Donor Count | 42 |
Hydrogen Bond Acceptor Count | 41 |
Rotatable Bond Count | 96 |
Exact Mass | 2932.5839961 g/mol |
Monoisotopic Mass | 2931.5806412 g/mol |
Topological Polar Surface Area | 1180 Ų |
Heavy Atom Count | 208 |
Formal Charge | 0 |
Complexity | 6500 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 21 |
Undefined Atom Stereocenter Count | 1 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Cosyntropin is used as an aid in the diagnosis of adrenocortical insufficiency. The 30-minute cosyntropin test provides a good method of screening for primary adrenocortical insufficiency (Addison's disease) and is preferable to corticotropin for rapid screening since it is less likely to cause allergic reactions. When a greater stimulus to the adrenal cortex is desired, corticotropin or cosyntropin may be administered by IV infusion. If subnormal increases in plasma cortisol concentrations occur following administration of corticotropin or cosyntropin, additional tests providing prolonged stimulation of the adrenal cortex are required before impaired adrenocortical function can be diagnosed precisely and differentiation between primary and secondary adrenocortical insufficiency can be established. /Included in US product label/
American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009)
Investigationally, long-acting IM depot cosyntropin preparations have been used as an aid in the diagnosis of adrenocortical insufficiency and, in patients with normal adrenocortical function, in the long-term management of chronic inflammatory and degenerative disorders that are responsive to glucocorticoids. /NOT included in US product label/
American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009)
/Experimental therapy/ ... The outcome of children with cryptogenic infantile spasms treated with high-dose synthetic adrenocorticotropic hormone (ACTH) and the relation between early treatment, within 1 month of onset, and outcome /were evaluated/. The long-term cognitive and seizure outcomes of 37 patients with cryptogenic infantile spasms (onset, age 3 to 9 months) receiving standardized treatment regimen of high-dose tetracosactide depot, 1 mg IM every 48 h for 2 weeks, with a subsequent 8- to 10-week slow taper and followed by oral prednisone, 10 mg/day for a month, with a subsequent slow taper for 5 months or until the infant reached the age of 1 year, whichever came later /were assessed/ . Development was assessed before treatment. Seizure outcomes were followed up prospectively. Cognitive outcomes were determined after 6 to 21 years and analyzed in relation to treatment lag and pretreatment regression. Twenty-two infants were treated within 1 month of onset of infantile spasms, and 15 after 1 to 6.5 months. Normal cognitive outcome was found in all 22 (100%) patients of the early-treatment group, and in 40% of the late-treatment group. Normal cognitive outcome was found in all 25 (100%) patients who had no or only mild mental deterioration at presentation, including four in the late-treatment group but in only three of the 12 patients who had had marked or severe deterioration before treatment. Early treatment of cryptogenic infantile spasms with a high-dose ACTH protocol is associated with favorable long-term cognitive outcomes. Once major developmental regression lasts for a month or more, the prognosis for normal cognitive outcome is poor. Further studies are needed on the optimal treatment regimen for this disorder.
PMID:15009227 Kivity S et al; Epilepsia 45 (3): 255-62 (2004).
Indications: Acute exacerbations in patients suffering from multiple sclerosis. Hypsarrhythmia, and or infantile spasms. /Tetracosactrin zinc phosphate complex - depot (NOT available in US)/
Prescribing Information for Synacthen Depot (tetracosactrin zinc phosphate complex); Novartis Pharmaceuticals Australia Pty Ltd (June 2005). Available from, as of March 22, 2010: https://www.novartis.com.au/PI_PDF/synd.pdf
Cosyntropin is less antigenic than corticotropin and is less likely to produce allergic reactions than is corticotropin; however, hypersensitivity reactions have occurred rarely. Patients known to be sensitized to corticotropin and who have markedly positive skin tests usually react negatively when tested intradermally with cosyntropin. Some patients who are hypersensitive to corticotropin preparations may be able to tolerate cosyntropin, but cross-sensitivity reactions may occur. The possibility of hypersensitivity reactions should be considered in all patients receiving cosyntropin, especially in those with preexisting allergic diseases and/or a history of allergic reactions to corticotropin. Patients should be carefully observed for hypersensitivity reactions during and after administration of cosyntropin.
American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009)
Since Cortrosyn (cosyntropin) for Injection is intended for diagnostic and not therapeutic use, adverse reactions other than a rare hypersensitivity reaction are not anticipated. A rare hypersensitivity reaction usually associated with a pre-existing allergic disease and/or a previous reaction to natural ACTH is possible. Symptoms may include slight whealing with splotchy erythema at the injection site. There have been rare reports of anaphylactic reaction. The following adverse reactions have been reported in patients after the administration of Cortrosyn and the association has been neither confirmed nor refuted: bradycardia, tachycardia, hypertension, peripheral, edema, rash.
US Natl Inst Health; DailyMed. Current Medication Information for CORTROSYN (cosyntropin) injection, powder, for solution (May 2006). Available from, as of February 24, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=3164
FDA Pregnancy Risk Category: C /RISK CANNOT BE RULED OUT. Adequate, well controlled human studies are lacking, and animal studies have shown risk to the fetus or are lacking as well. There is a chance of fetal harm if the drug is given during pregnancy; but the potential benefits may outweigh the potential risk./
US Natl Inst Health; DailyMed. Current Medication Information for CORTROSYN (cosyntropin) injection, powder, for solution (May 2006). Available from, as of February 24, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=3164
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Cortrosyn (cosyntropin) for Injection is administered to a nursing woman.
US Natl Inst Health; DailyMed. Current Medication Information for CORTROSYN (cosyntropin) injection, powder, for solution (May 2006). Available from, as of February 24, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=3164
For more Drug Warnings (Complete) data for Cosyntropin (15 total), please visit the HSDB record page.
Hormones
Chemical substances having a specific regulatory effect on the activity of a certain organ or organs. The term was originally applied to substances secreted by various ENDOCRINE GLANDS and transported in the bloodstream to the target organs. It is sometimes extended to include those substances that are not produced by the endocrine glands but that have similar effects. (See all compounds classified as Hormones.)
H - Systemic hormonal preparations, excl. sex hormones and insulins
H01 - Pituitary and hypothalamic hormones and analogues
H01A - Anterior pituitary lobe hormones and analogues
H01AA - Acth
H01AA02 - Tetracosactide
Cosyntropin is rapidly absorbed following IM administration.
American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009)
Adsorption of tetracosactrin on to zinc phosphate provides for sustained release of the active substance from the intramuscular injection site. After an injection of a mg Synacthen Depot IM, the radioimmunologically determined plasma concentrations of tetracosactrin lie for 12 hours between 200 and 300 pg/mL. Tetracosactrin has an apparent distribution volume of approximately 0.4 L/kg. /Tetracosactrin zinc phosphate complex - depot (NOT available in US)/
Prescribing Information for Synacthen Depot (tetracosactrin zinc phosphate complex); Novartis Pharmaceuticals Australia Pty Ltd (June 2005). Available from, as of March 22, 2010: https://www.novartis.com.au/PI_PDF/synd.pdf
The precise distribution and metabolic fate of cosyntropin is not known, but the drug is rapidly removed from the plasma by many tissues. Cosyntropin apparently does not cross the placenta.
American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009)
Cosyntropin elicits all the pharmacologic responses usually produced by endogenous corticotropin; however, cosyntropin is immunologically much less active than corticotropin since most of the antigenic activity of corticotropin has been attributed to the C-terminal portion of the molecule (i.e., the 22-39 amino acid residues). In patients with normal adrenocortical function, cosyntropin stimulates the adrenal cortex to secrete cortisol (hydrocortisone), corticosterone, several weakly androgenic substances, and to a very limited extent aldosterone. When cosyntropin is used diagnostically, the effect of the drug is usually measured by determining plasma cortisol concentrations prior to and following administration of the drug. In patients with primary adrenocortical insufficiency (Addison's disease), cosyntropin does not substantially increase plasma cortisol concentrations.
American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009)
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A Tetracosactide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tetracosactide, including repackagers and relabelers. The FDA regulates Tetracosactide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tetracosactide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Tetracosactide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tetracosactide supplier is an individual or a company that provides Tetracosactide active pharmaceutical ingredient (API) or Tetracosactide finished formulations upon request. The Tetracosactide suppliers may include Tetracosactide API manufacturers, exporters, distributors and traders.
click here to find a list of Tetracosactide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tetracosactide DMF (Drug Master File) is a document detailing the whole manufacturing process of Tetracosactide active pharmaceutical ingredient (API) in detail. Different forms of Tetracosactide DMFs exist exist since differing nations have different regulations, such as Tetracosactide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tetracosactide DMF submitted to regulatory agencies in the US is known as a USDMF. Tetracosactide USDMF includes data on Tetracosactide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tetracosactide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tetracosactide suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Tetracosactide Drug Master File in Japan (Tetracosactide JDMF) empowers Tetracosactide API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Tetracosactide JDMF during the approval evaluation for pharmaceutical products. At the time of Tetracosactide JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Tetracosactide suppliers with JDMF on PharmaCompass.
A Tetracosactide written confirmation (Tetracosactide WC) is an official document issued by a regulatory agency to a Tetracosactide manufacturer, verifying that the manufacturing facility of a Tetracosactide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tetracosactide APIs or Tetracosactide finished pharmaceutical products to another nation, regulatory agencies frequently require a Tetracosactide WC (written confirmation) as part of the regulatory process.
click here to find a list of Tetracosactide suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Tetracosactide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tetracosactide API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Tetracosactide as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Tetracosactide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tetracosactide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tetracosactide suppliers with NDC on PharmaCompass.
Tetracosactide Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Tetracosactide GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Tetracosactide GMP manufacturer or Tetracosactide GMP API supplier for your needs.
A Tetracosactide CoA (Certificate of Analysis) is a formal document that attests to Tetracosactide's compliance with Tetracosactide specifications and serves as a tool for batch-level quality control.
Tetracosactide CoA mostly includes findings from lab analyses of a specific batch. For each Tetracosactide CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Tetracosactide may be tested according to a variety of international standards, such as European Pharmacopoeia (Tetracosactide EP), Tetracosactide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tetracosactide USP).
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