Cortrosyn

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Cortrosyn

Classes

ACTH and Analogs
Diagnostic Hormonal Agents

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.

Adverse Reactions
Severe

anaphylactoid reactions / Rapid / 0-1.0
bradycardia / Rapid / Incidence not known

Moderate

hypertension / Early / Incidence not known
sinus tachycardia / Rapid / Incidence not known
peripheral edema / Delayed / Incidence not known

Mild

rash / Early / 0-1.0

Common Brand Names

Cortrosyn

Dea Class

Rx

Description

Parenteral synthetic peptide of corticotropin (ACTH)
Used for diagnostic testing of adrenal function
Less potent and less allergenic than other exogenous ACTH preparations

Dosage And Indications
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.

Dosing Considerations
Hepatic Impairment

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Renal Impairment

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Drug Interactions

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.
Chlorthalidone; Clonidine: (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.
Diethylstilbestrol, DES: (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; Methyldopa: (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.
Methyclothiazide: (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.
Propranolol; 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.

How Supplied

Cortrosyn/Cosyntropin Intramuscular Inj Pwd F/Sol: 0.25mg
Cortrosyn/Cosyntropin Intravenous Inj Pwd F/Sol: 0.25mg
Cosyntropin Intravenous Inj Sol: 0.25mg, 1mL

Maximum Dosage
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.

Mechanism Of Action

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.

Pharmacokinetics

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.

Pregnancy And Lactation
Pregnancy

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.