Cosyntropin - Cosyntropin injection, Powder, Lyophilized, For Solution (Cosyntropin)

Cosyntropin for injection is indicated, in combination with other diagnostic tests, for use as a diagnostic agent in the screening of adrenocortical insufficiency in adults and pediatric patients.

• •In general, stop glucocorticoids and spironolactone on the day of cosyntropin for injection testing. For long-acting glucocorticoids, stop for a longer period before cosyntropin for injection testing. (
  2.1 Important Information Before Conducting Cosyntropin for Injection Testing

  • •In general, stop glucocorticoids and spironolactone on the day of cosyntropin for injection testing. However, long-acting glucocorticoids may need to be stopped for a longer period before cosyntropin for injection testing
    [see
    Warnings and Precautions , Drug Interactions ]
    .
  • •Stop estrogen-containing drugs four to six weeks before cosyntropin for injection testing
    [see Warnings and
    Precautions , Drug Interactions ]
    .
  )
• •For adults, the recommended dose is 0.25 mg to be administered by intravenous or intramuscular injection. (
  2.2 Recommended Dose for Adults

  • •The recommended dose of cosyntropin for injection in adults is 0.25 mg to be administered by intravenous or intramuscular injection.
  )
• •For pediatric patients, the recommended dose to be administered by intravenous or intramuscular injection is (
  2.3 Recommended Dose for Pediatric Patients

  • •The recommended dose of cosyntropin for injection in pediatric patients, aged birth to 17 years, to be administered by intravenous or intramuscular injection is presented in
    Table 1
    .

  Table 1. Recommended Cosyntropin for Injection Dose for Pediatric Patients

  Age	Recommended Dose	Volume of Reconstituted Solution
  Birth to less than 2 years	0.125 mg	0.5 mL
  2 to 17 years	0.25 mg	1 mL
  ):
• o0.125 mg for patients birth to less than 2 years of age
• o0.25 mg for patients 2 to 17 years of age
• •Obtain blood samples for serum cortisol level at baseline and exactly 30 and 60 minutes after cosyntropin for injection administration. (
  2.5 Administration Information

  • •Cosyntropin for injection may be administered by intramuscular or intravenous injection.
  • •Obtain blood sample for baseline serum cortisol. Obtain blood samples again for assessment of cortisol levels exactly 30 minutes and 60 minutes after administration of cosyntropin for injection.
  )
• •See Full Prescribing Information for reconstitution and interpretation of cortisol levels information. (
  2.4 Reconstitution Instructions

  • •Aseptically reconstitute the lyophilized powder in the vial using 1 mL of 0.9% Sodium Chloride Injection, USP and gently swirl.
  • •After reconstitution, the final concentration of cosyntropin for injection reconstituted solution is 0.25 mg/mL.
  • •Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The reconstituted cosyntropin for injection solution should be clear and colorless, and free of particulates. If cosyntropin for injection solution is cloudy or contains particulates, do not administer.
  • •If the cosyntropin for injection reconstituted solution is not used immediately, discard the unused cosyntropin for injection reconstituted solution.
  ,
  2.6 Interpretation of Plasma Cortisol Levels after Cosyntropin for Injection

  • •Stimulated plasma cortisol levels of less than 18 mcg/dL at 30- or 60-minutes post cosyntropin for injection are suggestive of adrenocortical insufficiency. Cutoff values for exclusion of adrenocortical insufficiency may vary according to the assay used. Test results can be affected by concomitant medications and certain medical conditions
    [see Warnings and Precautions ]
    .
  )

For Injection: 0.25 mg of cosyntropin as a lyophilized powder in a single-dose vial for reconstitution.

Available data from case reports over decades of use with cosyntropin during pregnancy have not identified an increased

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk for major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Unidentified adrenal insufficiency during pregnancy can result in maternal and/or fetal death; therefore, the diagnosis of suspected adrenal insufficiency during pregnancy should not be delayed.

Cortisol levels and subsequent diagnosis of adrenocortical insufficiency following cosyntropin for injection administration may be inaccurate if patients are on certain medications because of their effect on cortisol or cortisol binding globulin levels.

Glucocorticoids and spironolactone may result in falsely elevated cortisol levels. Stop these drugs on the day of cosyntropin for injection testing. Long-acting glucocorticoids may need to be stopped for a longer period before cosyntropin for injection testing

Estrogen-containing drugs increase cortisol binding globulin levels which can increase plasma total cortisol levels. To obtain accurate plasma total cortisol levels, stop estrogen containing drugs four to six weeks before cosyntropin for injection testing to allow cortisol binding globulin levels to return to levels within the reference range

Any condition that elevates or lowers cortisol binding globulin levels may increase or decrease plasma total cortisol levels, respectively. Cortisol binding globulin levels can be low in cirrhosis or nephrotic syndrome. Measure cortisol binding globulin levels as necessary to ensure accuracy of interpretation of plasma total cortisol levels.