Cortrosyn .25 mg/mL
Cosyntropin · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Amphastar Pharmaceuticals, Inc.
Cortrosyn is a injection, powder, lyophilized, for solution containing cosyntropin at .25 mg/mL, taken intramuscular. Manufactured by Amphastar Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Cortrosyn
- Generic Name
- Cosyntropin
- NDC Code (Product)
0548-5900- Manufacturer
- Amphastar Pharmaceuticals, Inc.
- Strength
- .25 mg/mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- NDA016750
- Drug Class
- Adrenocorticotropic Hormone [EPC]
- Marketing Start
- 08/01/2003
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 Indications and Usage CORTROSYN 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. CORTROSYN 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)
Dosage & Administration
2 Dosage and Administration 2.1 Important Information Before Conducting CORTROSYN TESTING In general, stop glucocorticoids and spironolactone on the day of CORTROSYN testing. However, long-acting glucocorticoids may need to be stopped for a longer period before CORTROSYN testing [see Warnings and Precautions (5.2), Drug Interactions (7)]. Stop estrogen-containing drugs four to six weeks before CORTROSYN testing [see Warnings and Precautions (5.2), Drug Interactions (7)]. 2.2 Recommended Dose for Adults The recommended dose of CORTROSYN 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 CORTROSYN in pediatric patients, aged birth to 17 years, to be administered by intravenous or intramuscular injection is presented in Table 1. 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 CORTROSYN reconstituted solution is 0.25 mg/mL. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to adm…
Contraindications
4 Contraindications CORTROSYN is contraindicated in patients with a history of hypersensitivity to cosyntropin or to any excipients of CORTROSYN. Reactions have included anaphylaxis [see Warnings and Precautions (5.1)]. CORTROSYN is contraindicated in patients with a history of hypersensitivity to cosyntropin or to any excipients of CORTROSYN. Reactions have included anaphylaxis. (4, 5.1)
Drug Interactions
7 Drug Interactions 7.1 Drug Effects on Plasma Cortisol Levels Accuracy of the test results can be affected by concomitant medications. Plasma cortisol levels and subsequent diagnosis of adrenocortical insufficiency following CORTROSYN administration may be inaccurate if patients are on certain medications because of their effect on cortisol or cortisol binding globulin levels [see Dosage and Administration (2.1) and Warnings and Precautions (5.2)]. Glucocorticoids and spironolactone: May falsely elevate plasma cortisol levels. Stop these drugs on the day of CORTROSYN testing. Long-acting glucocorticoids may need to be stopped for a longer period before CORTROSYN testing. Estrogen: May elevate plasma total cortisol levels. Stop estrogen containing drugs 4 to 6 weeks before CORTROSYN testing to allow cortisol binding globulin levels to return to levels within the reference range. Alternatively, concomitant measurement of cortisol binding globulin at the time of testing can be done; if cortisol binding globulin levels are elevated, plasma total cortisol levels are considered inaccurate. Drug effects on plasma cortisol levels: ◦ Accuracy of the test results can be affected by concomit…
Adverse Reactions
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 CORTROSYN: anaphylactic reaction bradycardia tachycardia hypertension peripheral edema rash Most common adverse reactions are: anaphylactic reaction, bradycardia, tachycardia, hypertension, peripheral edema, and rash (6) To report SUSPECTED ADVERSE REACTIONS, contact Amphastar Pharmaceuticals, Inc. at 1-800-423-4136 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Cortrosyn used for?
Cortrosyn contains Cosyntropin. It is a injection, powder, lyophilized, for solution taken intramuscular. Consult your doctor for specific uses.
Is Cortrosyn a controlled substance?
Cortrosyn is not classified as a controlled substance by the DEA.
What is the generic name for Cortrosyn?
The generic name for Cortrosyn is Cosyntropin. There are 3 other brand versions of Cosyntropin.
What is the NDC code for Cortrosyn .25 mg/mL?
The NDC (National Drug Code) for Cortrosyn .25 mg/mL is 0548-5900, listed by Amphastar Pharmaceuticals, Inc..