Cosyntropin is a parenteral synthetic peptide containing the same first 24 amino acid sequence as natural corticotropin (ACTH). Cosyntropin is less potent and less allergenic than other exogenous ACTH preparations (i.e., corticotropin). It is used for diagnostic testing of adrenal function.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Injectable Administration
-Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
-Cosyntropin powder for injection may be administered intramuscularly or intravenously after reconstitution. Cosyntropin solution for injection may ONLY be administered intravenously.
Intravenous Administration
-May be administered by direct IV injection as a rapid screening test or as an IV infusion, over 4-8 hours, to provide a greater stimulus to the adrenal glands.
-Do not add to blood or plasma as this will inactivate cosyntropin.
IV injection:
-Dilute 1 mL (0.25 mg) in 2-5 mL of 0.9% Sodium Chloride Injection and infuse over 2 minutes.
IV infusion:
-Dilute 1 mL (0.25 mg) in an appropriate volume of either 5% Dextrose Injection or 0.9% Sodium Chloride Injection and administer at a rate of approximately 40 mcg/hour over 6 hours.
Intramuscular Administration
-Use Cosyntropin powder for injection only. Cosyntropin injection solution is NOT for IM use.
-Dilute 0.25 mg in 1 mL of 0.9% Sodium Chloride for Injection and inject IM.
Although cosyntropin does not contain animal protein and is less likely to cause hypersensitivity reactions than natural ACTH, rare hypersensitivity reactions, including anaphylactoid reactions and rash, have been reported. Such reactions are usually seen in patients with a pre-existing allergic disease and/or a previous reaction to natural ACTH. Most patients with a history of a hypersensitivity reaction to natural ACTH will tolerate cosyntropin.
Bradycardia, sinus tachycardia, hypertension, and peripheral edema have been reported after the administration of cosyntropin. A definitive correlation to the drug has not been established.
Cosyntropin is contraindicated in patients who have experienced a previous adverse reaction to the product. Although rare, hypersensitivity reactions including anaphylaxis have been reported and are usually seen in patients with a pre-existing allergic disease and/or a previous reaction to natural ACTH.
Cosyntropin should be given during pregnancy only if clearly needed. Animal reproduction studies have not been conducted with cosyntropin injection. It is also not known whether the drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Adrenocortical disease during pregnancy is relatively rare as most cases are diagnosed before a woman becomes pregnant, but ACTH stimulated normal cortisol values have been established for each trimester. Adrenal disease may cause significant maternal and fetal morbidity, so accurate and rapid diagnosis is important. The use of cosyntropin to confirm the diagnosis of adrenal insufficiency during pregnancy, when suspected, is described in the literature.
It is not known whether cosyntropin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when cosyntropin injection is administered during lactation to a woman who is breast-feeding.
For adrenocortical insufficiency diagnosis:
NOTE: See Therapeutic Drug Monitoring for further information regarding adrenocortical deficiency diagnosis.
NOTE: Patients taking cortisone, hydrocortisone, or spironolactone should omit pre-test doses.
Intravenous dosage:
Adults, Adolescents, and Children > 2 years: A single dose of 0.25 mg may be administered IV or via slow IV infusion over approximately 6 hours. NOTE: Doses of 0.25 to 0.75 mg have been used with a maximal response noted with the smallest dose.
Infants and Children <= 2 years: 0.125 mg IV or via slow IV infusion over 6 hours will often suffice.
Neonates: 0.015 mg/kg/dose IV for term neonates. A variety of dosage regimens are listed for premature neonates and include a 1 mcg/kg/dose regimen in premature neonates of low birth weight. Doses in premature neonates may range from 0.1 mcg/kg/dose to 3.5 mcg/kg/dose IV . It appears the IV route is preferred in premature neonates to ensure adequate dose-response.
Intramuscular dosage:
NOTE: Only Cosyntropin powder for reconstitution for injection may be given IM.
Adults, Adolescents, and Children > 2 years: A single dose of 0.25 mg may be administered IM. NOTE: Doses of 0.25 to 0.75 mg have been used with a maximal response noted with the smallest dose.
Infants and Children < 2 years: 0.125 mg IM will often suffice.
Neonates: 0.015 mg/kg/dose IM for term neonates. In premature neonates, dosing varies and the dose-response with IM dosing may not be adequate.
Therapeutic Drug Monitoring:
One method of testing adrenal function is a rapid screening test in which plasma cortisol concentrations are measured just before and 30 minutes after the IM administration of cosyntropin. Adrenal response also may be measured by determining urinary steroid excretion before and after IV injection of IV infusion or by measuring plasma cortisol concentrations before and at the end of administration. Plasma cortisol concentrations are generally preferred because the urinary steroid excretion does not always accurately reflect the adrenal response to cosyntropin. The usual normal response in most cases is roughly a doubling of the basal level, provided that the basal level does not exceed the normal range. If there is no increase in plasma cortisol concentrations, consider assessing cortisol concentration at later time points (e.g., 60 and/or 90 minutes).
The following criteria have been established to denote a normal response:
1. The control plasma cortisol level should exceed 5 mcg/100 ml.
2. The 30-minute level should show an increment of at least 7 mcg/100 ml above the basal level.
3. The 30-minute level should exceed 18 mcg/100 ml
The test may be performed at any time during the day but because of the physiological diurnal variation of plasma cortisol the criteria listed above cannot apply. It has been shown that basal plasma cortisol concentrations and the post cosyntropin increment exhibit diurnal changes. However, the 30-minute plasma cortisol concentration remains unchanged throughout the day so that only this single criterion should be used.
Maximum Dosage Limits:
-Adults
Usual maximum dose is 0.25 mg/test IV or IM. NOTE: 0.75 mg IV has been used in studies; however, maximal response is seen with 0.25 mg dose.
-Geriatric
Usual maximum dose is 0.25 mg/test IV or IM. NOTE: 0.75 mg IV has been used in studies; however, maximal response is seen with 0.25 mg dose.
-Adolescents
0.25 mg/test IV or IM.
-Children
Children > 2 years: 0.25 mg/dose IV or IM
Children <= 2 years: 0.125 mg/dose IV or IM.
-Infants
0.125 mg IV or IM.
-Neonates
0.015 mg/kg/dose IV or IM in term neonates. A variety of dosage regimens are used, up to 3.5 mcg/kg/dose IV in premature neonates. Optimal dosage not definitive for premature neonates.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
Aliskiren; Hydrochlorothiazide, HCTZ: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Amiloride: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Amiloride; Hydrochlorothiazide, HCTZ: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Amlodipine; Valsartan; Hydrochlorothiazide, HCTZ: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Atenolol; Chlorthalidone: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Azilsartan; Chlorthalidone: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Benazepril; Hydrochlorothiazide, HCTZ: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Bisoprolol; Hydrochlorothiazide, HCTZ: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Bumetanide: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Candesartan; Hydrochlorothiazide, HCTZ: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Captopril; Hydrochlorothiazide, HCTZ: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Chlorothiazide: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Chlorthalidone: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Conjugated Estrogens: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Conjugated Estrogens; Bazedoxifene: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Conjugated Estrogens; Medroxyprogesterone: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Cortisone: (Major) Patients receiving cortisone should omit their pre-test doses on the day selected for testing. Patients taking inadvertent doses of cortisone may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test. A paradoxical decrease in plasma cortisol concentrations may be seen in patients receiving cortisone following a stimulating dose of cosyntropin injection.
Desogestrel; Ethinyl Estradiol: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Dienogest; Estradiol valerate: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Drospirenone; Estetrol: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Drospirenone; Estradiol: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Drospirenone; Ethinyl Estradiol: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Drospirenone; Ethinyl Estradiol; Levomefolate: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Elagolix; Estradiol; Norethindrone acetate: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Enalapril; Hydrochlorothiazide, HCTZ: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Eprosartan; Hydrochlorothiazide, HCTZ: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Esterified Estrogens: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Esterified Estrogens; Methyltestosterone: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Estradiol: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Estradiol; Levonorgestrel: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Estradiol; Norethindrone: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Estradiol; Norgestimate: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Estradiol; Progesterone: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Estrogens: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Estropipate: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Ethacrynic Acid: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Ethinyl Estradiol; Norelgestromin: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Ethinyl Estradiol; Norethindrone Acetate: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Ethinyl Estradiol; Norgestrel: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Ethynodiol Diacetate; Ethinyl Estradiol: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Etonogestrel; Ethinyl Estradiol: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Fosinopril; Hydrochlorothiazide, HCTZ: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Furosemide: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Hydrochlorothiazide, HCTZ: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Hydrochlorothiazide, HCTZ; Moexipril: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Hydrocortisone: (Major) Patients receiving hydrocortisone should omit their pre-test doses on the day selected for testing. Patients taking inadvertent doses of hydrocortisone may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test. A paradoxical decrease in plasma cortisol concentrations may be seen in patients receiving hydrocortisone following a stimulating dose of cosyntropin injection.
Irbesartan; Hydrochlorothiazide, HCTZ: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Levonorgestrel; Ethinyl Estradiol: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Levonorgestrel; Ethinyl Estradiol; Ferrous Bisglycinate: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Levonorgestrel; Ethinyl Estradiol; Ferrous Fumarate: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Lisinopril; Hydrochlorothiazide, HCTZ: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Loop diuretics: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Losartan; Hydrochlorothiazide, HCTZ: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Metolazone: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Metoprolol; Hydrochlorothiazide, HCTZ: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Norethindrone Acetate; Ethinyl Estradiol; Ferrous fumarate: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Norethindrone; Ethinyl Estradiol: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Norethindrone; Ethinyl Estradiol; Ferrous fumarate: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Norgestimate; Ethinyl Estradiol: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Olmesartan; Amlodipine; Hydrochlorothiazide, HCTZ: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Olmesartan; Hydrochlorothiazide, HCTZ: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Quinapril; Hydrochlorothiazide, HCTZ: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Relugolix; Estradiol; Norethindrone acetate: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Segesterone Acetate; Ethinyl Estradiol: (Minor) Use cosyntropin cautiously in patients taking estrogens as these patients may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Spironolactone: (Major) Patients receiving spironolactone should omit their pre-test doses on the day selected for testing. Patients taking inadvertent doses of spironolactone may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test.
Spironolactone; Hydrochlorothiazide, HCTZ: (Major) Patients receiving spironolactone should omit their pre-test doses on the day selected for testing. Patients taking inadvertent doses of spironolactone may exhibit abnormally high basal plasma cortisol concentrations and a decreased response to the test. (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Telmisartan; Hydrochlorothiazide, HCTZ: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Thiazide diuretics: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Torsemide: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Triamterene: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Triamterene; Hydrochlorothiazide, HCTZ: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
Valsartan; Hydrochlorothiazide, HCTZ: (Moderate) Use cosyntropin cautiously in patients receiving diuretics. Cosyntropin may accentuate the electrolyte loss associated with diuretic therapy.
In patients with adrenal insufficiency, the administration of cosyntropin stimulates steroidogenesis and the release of cortisol, corticosterone, and androgens from the adrenal cortex. Cosyntropin exhibits the same corticosteroidogenic activity as natural corticotropin, ACTH, and the pharmacologic profile of the two compounds are similar. An injection of 0.25 mg cosyntropin will stimulate the adrenal cortex maximally and to the same extent as 25 Units of natural corticotropin, ACTH. Extra-adrenal effects of cosyntropin include melanotropic activity, increased growth hormone secretion, and an adipokinetic effect, all of which are considered clinically insignificant.
Cosyntropin is administered intramuscularly and intravenously. Specific pharmacokinetic data are not available from the manufacturer. Pharmacodynamically, the rapid effect on the adrenal cortex allows for quick (30-minute) testing procedures to assess adrenal function. Plasma cortisol levels usually peak about 45 to 60 minutes after an injection of cosyntropin. The usual normal response is an approximate doubling of the basal cortisol level.