Cosyntropin is a man-made form of a hormone called adrenocorticotropic hormone (ACTH). ACTH is a hormone that is normally produced by the pituitary gland in the brain. ACTH stimulates the adrenal glands to release the hormones cortisol and adrenaline. These hormones help your body respond to stress and also support many systems of the body including circulation, metabolism, immunity, and the nervous system.

Cosyntropin is used as part of a medical test called an ACTH stimulation test. This test can help your doctor diagnose adrenal gland disorders such as Addison's disease, Cushing syndrome, or hypopituitarism (failure of the pituitary gland to produce hormones correctly).

Cosyntropin may also be used for purposes not listed in this medication guide.

Before you receive cosyntropin, tell your doctor about all your medical conditions or allergies, and all the medicines you are using.

Cosyntropin is given as an infusion into a vein. A healthcare provider will give you this injection.

Before you receive cosyntropin, your blood will be drawn to measure your "baseline" level of certain hormones.

Your blood will be drawn again 30 to 60 minutes after cosyntropin was injected, to measure your hormone levels and compare them to the baseline levels. This will help your doctor determine if your pituitary and adrenal functions are normal.

You may need additional medical tests to help your doctor diagnose your condition and determine how best to treat it.

Usual Adult Dose for Adrenocortical Insufficiency:

Rapid Screening Test for Adrenal Function: 0.25 mg IV or IM once
-Dose range of 0.25 to 0.75 mg has been used in clinical studies; maximal response occurred with 0.25 mg dose
-At 30 minutes post-dose, a rise of at least 7 mcg/100 mL is expected; stimulated plasma cortisol levels less than 18 to 20 mcg/dL at 30 to 60 minutes post dose are suggestive of adrenocortical insufficiency.

Comments:
-Patients should omit pre-test doses of cortisone, hydrocortisone, or spironolactone to avoid diagnostic inaccuracies.
-An IV infusion has also been used to provide a greater stimulus to the adrenal glands; same dose infused over 4 to 8 hours with adrenal response measured by urinary steroid excretion before and after treatment or measuring plasma cortisol levels before and at the end of the infusion (preferred).
-Test results can be affected by concomitant medications and certain medical conditions.

Use: As a diagnostic drug in screening patients presumed to have adrenocortical insufficiency.

Usual Pediatric Dose for Adrenocortical Insufficiency:

Rapid Screening Test for Adrenal Function:

0 to 2 years: 0.125 mg IV or IM once

3 years or older: 0.25 mg IV or IM once
-Dose range of 0.25 to 0.75 mg has been used in clinical studies; maximal response occurred with 0.25 mg dose

At 30 minutes post-dose, a rise of at least 7 mcg/100 mL is expected; stimulated plasma cortisol levels less than 18 to 20 mcg/dL at 30 to 60 minutes post dose are suggestive of adrenocortical insufficiency.

Comments:
-Patients should omit pre-test doses of cortisone, hydrocortisone, or spironolactone to avoid diagnostic inaccuracies.
-An IV infusion has also been used to provide a greater stimulus to the adrenal glands; same dose infused over 4 to 8 hours with adrenal response measured by urinary steroid excretion before and after treatment or measuring plasma cortisol levels before and at the end of the infusion (preferred).
-Test results can be affected by concomitant medications and certain medical conditions.

Use: As a diagnostic drug in screening patients presumed to have adrenocortical insufficiency.

You should not be treated with cosyntropin if you are allergic to it.

Tell your doctor if you have ever had:

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or

• an allergic reaction during any prior ACTH stimulation test.

It is not known whether cosyntropin will harm an unborn baby. Tell your doctor if you are pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Because you will receive cosyntropin in a clinical setting, you are not likely to miss a dose.

Since cosyntropin is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers right away if you have redness, swelling, or hives where the medicine was injected.

Common side effects of cosyntropin may include:

• an allergic reaction;

• fast or slow heartbeats;

• increased blood pressure;

• rash; or

• swelling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines, especially a diuretic or "water pill."

Other drugs may affect cosyntropin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.