Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cosyntropin
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 0781-3440-95
Cosyntropin for Injection
0.25 mg/vial
Rx Only
FOR DIAGNOSTIC USE ONLY
For IV or IM Use
Lyophilized and Must be diluted
Discard unused portion
10 x 0.25 mg Single Dose Vial
SANDOZ
DESCRIPTION SECTION
11 DESCRIPTION
Cosyntropin is an adrenocorticotropic hormone (ACTH). Cosyntropin is synthetic beta 1 - 24 corticotropin, a synthetic subunit of ACTH. It is an open chain polypeptide containing, the first 24 of the 39 amino acids of natural ACTH in sequence from N terminal. The sequence of amino acids in the 1 - 24 compound is as follows:
Molecular Formula: C136H210N40O31S
Molecular Weight: 2933 g/mol.
Cosyntropin for injection is a sterile lyophilized powder in single-dose vials containing 0.25 mg of cosyntropin and 10 mg of mannitol.
INDICATIONS & USAGE SECTION
Highlight: Cosyntropin for injection is an adrenocorticotropin hormone indicated, in combination with other diagnostic tests, for use as a diagnostic agent in the screening of adrenocortical insufficiency in adults and pediatric patients. (1)
1 INDICATIONS AND USAGE
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.
DOSAGE & ADMINISTRATION SECTION
Highlight: •
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)
•
For adults, the recommended dose is 0.25 mg to be administered by intravenous or intramuscular injection. (2.2)
•
For pediatric patients, the recommended dose to be administered by intravenous or intramuscular injection is (2.3):
o
0.125 mg for patients birth to less than 2 years of age
o
0.25 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)
•
See Full Prescribing Information for reconstitution and interpretation of cortisol levels information. (2.4, 2.6)
2 DOSAGE AND ADMINISTRATION
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 [seeWarnings and Precautions (5.2), Drug Interactions (7)].
•
Stop estrogen-containing drugs four to six weeks before cosyntropin for injection testing [see Warnings andPrecautions (5.2), Drug Interactions (7)].
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.
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 |
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.
2.5 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.
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 (5.2)].
DOSAGE FORMS & STRENGTHS SECTION
Highlight: •
For injection: 0.25 mg of cosyntropin as a lyophilized powder in single-dose vial for reconstitution (3)
3 DOSAGE FORMS AND STRENGTHS
For Injection: 0.25 mg of cosyntropin as a lyophilized powder in a single-dose vial for reconstitution.
ADVERSE REACTIONS SECTION
Highlight: Most common adverse reactions are: anaphylactic reaction, bradycardia, tachycardia, hypertension, peripheral edema, and rash (6)
**To report SUSPECTED ADVERSE REACTIONS, contactSandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or **www.fda.gov/medwatch.
6 ADVERSE REACTIONS
Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during post approval use of cosyntropin for injection:
•
anaphylactic reaction
•
bradycardia
•
tachycardia
•
hypertension
•
peripheral edema
•
rash
NONCLINICAL TOXICOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term carcinogenicity studies in animals to evaluate the carcinogenic potential of cosyntropin have not been conducted. Studies to evaluate mutagenic potential or impairment of fertility in animals have not been conducted.
HOW SUPPLIED SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
Cosyntropin for injection 0.25 mg, in a single-dose vial for reconstitution.
Box contains 10 single-dose vials NDC 0781-3440-95
Storage and Handling
Store at 20º to 25ºC (68º to 77ºF); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Cosyntropin for injection is intended as a single-dose injection and contains no antimicrobial preservative. Any unused
portion should be discarded.