Cosyntropin

2933.47

2931.580566

241-031-1

H - Systemic hormonal preparations, excl. sex hormones and insulins

2937220000

1184.02000

-3.27

1.47±0.1 g/cm3(Predicted)

1.681

Soluble in water

−20°C

NONH for all modes of transport

3

GM7915000

SRP: Expired or waste pharmaceuticals shall carefully take into consideration applicable DEA, EPA, and FDA regulations. It is not appropriate to dispose by flushing the pharmaceutical down the toilet or discarding to trash. If possible return the pharmaceutical to the manufacturer for proper disposal being careful to properly label and securely package the material. Alternatively, the waste pharmaceutical shall be labeled, securely packaged and transported by a state licensed medical waste contractor to dispose by burial in a licensed hazardous or toxic waste landfill or incinerator.|SRP: At the time of review, regulatory criteria for small quantity disposal are subject to significant revision, however, household quantities of waste pharmaceuticals may be managed as follows: Mix with wet cat litter or coffee grounds, double bag in plastic, discard in trash.

The Approved Drug Products with Therapeutic Equivalence Evaluations List identifies currently marketed prescription drug products, including cosyntropin, approved on the basis of safety and effectiveness by FDA under sections 505 of the Federal Food, Drug, and Cosmetic Act.

|Danger|H317 (100%): May cause an allergic skin reaction [Warning Sensitization, Skin]|P261, P271, P272, P280, P285, P302+P352, P304+P312, P304+P340, P304+P341, P312, P321, P333+P313, P342+P311, P363, and P501|Aggregated GHS information provided by 17 companies from 1 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.

NIOSH (NOES Survey 1981-1983) has statistically estimated that 1,071 workers (546 of these were female) were potentially exposed to cosyntropin in the US(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/|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/|/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.|Indications: Acute exacerbations in patients suffering from multiple sclerosis. Hypsarrhythmia, and or infantile spasms. /Tetracosactrin zinc phosphate complex - depot (NOT available in US)/

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.|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.|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./|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.|For more Drug Warnings (Complete) data for Cosyntropin (15 total), please visit the HSDB record page.

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.)

Cosyntropin is rapidly absorbed following IM administration.|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)/|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.

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.

/SRP:/ Immediate first aid: Ensure that adequate decontamination has been carried out. If patient is not breathing, start artificial respiration, preferably with a demand valve resuscitator, bag-valve-mask device, or pocket mask, as trained. Perform CPR if necessary. Immediately flush contaminated eyes with gently flowing water. Do not induce vomiting. If vomiting occurs, lean patient forward or place on the left side (head-down position, if possible) to maintain an open airway and prevent aspiration. Keep patient quiet and maintain normal body temperature. Obtain medical attention. /Poisons A and B/|/SRP:/ Basic treatment: Establish a patent airway (oropharyngeal or nasopharyngeal airway, if needed). Suction if necessary. Watch for signs of respiratory insufficiency and assist ventilations if needed. Administer oxygen by nonrebreather mask at 10 to 15 L/min. Monitor for pulmonary edema and treat if necessary ... . Monitor for shock and treat if necessary ... . Anticipate seizures and treat if necessary ... . For eye contamination, flush eyes immediately with water. Irrigate each eye continuously with 0.9% saline (NS) during transport ... . Do not use emetics. For ingestion, rinse mouth and administer 5 mL/kg up to 200 mL of water for dilution if the patient can swallow, has a strong gag reflex, and does not drool ... . Cover skin burns with dry sterile dressings after decontamination ... . /Poisons A and B/|/SRP:/ Advanced treatment: Consider orotracheal or nasotracheal intubation for airway control in the patient who is unconscious, has severe pulmonary edema, or is in severe respiratory distress. Positive-pressure ventilation techniques with a bag valve mask device may be beneficial. Consider drug therapy for pulmonary edema ... . Consider administering a beta agonist such as albuterol for severe bronchospasm ... . Monitor cardiac rhythm and treat arrhythmias as necessary ... . Start IV administration of D5W /SRP: "To keep open", minimal flow rate/. Use 0.9% saline (NS) or lactated Ringer's if signs of hypovolemia are present. For hypotension with signs of hypovolemia, administer fluid cautiously. Watch for signs of fluid overload ... . Treat seizures with diazepam or lorazepam ... . Use proparacaine hydrochloride to assist eye irrigation ... . /Poisons A and B/

/CASE REPORTS/ Synthetic 1-24adrenocorticotrophin (tetracosactid, Synacthen) is used in clinical medicine for diagnostic and therapeutic purposes. Side effects may occur due to unphysiological stimulation of endogenous adrenocortical hormone production. Allergic reactions to tetracosactid are rare. Anaphylactic shock leading to death was observed after intravenous injection of tetracosactid in a 14-year-old girl with bronchial asthma. Adrenocorticotrophin antibodies could be demonstrated after death in serum and ascitic fluid using the double antibody method.|/CASE REPORTS/ Some patients with diabetes mellitus are at increased risk for the development of hyperkalemia. Included in this group are patients with glucose-induced hyperkalemia who may have renal insufficiency, hyporeninemic hypoaldosteronism, or other impediments to the release or action of aldosterone. In an unusual demonstration of this abnormality, two patients with diabetes, who form the basis of our report, became markedly hyperglycemic and hyperkalemic after cosyntropin administration. To our knowledge, this complication of adrenocorticotropic hormone (ACTH) stimulation testing has not been previously reported. It should therefore be emphasized that the use of cosyntropin as a diagnostic agent can provoke severe hyperglycemia and hyperkalemia in a susceptible subgroup of patients with diabetes mellitus.

1-24-ACTH

Parenteral: for injection 0.25 mg Cortrosyn (with mannitol) (Organon).|IM injection: 1 mg/mL, 1 mL ampoules; containers of 1, Synacthen Depot (Novartis Pharmaceuticals Australia Pty Ltd)

Synthetic polypeptide corresponding to the first 24 amino acids of ACTH

Human drugs -> Rare disease (orphan)|Human Drugs -> FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) -> Active Ingredients