Cortrosyn
(Cosyntropin)Cortrosyn Prescribing Information
For Injection: 0.25 mg of cosyntropin as a lyophilized powder in a single-dose vial for reconstitution.
CORTROSYN is contraindicated in patients with a history of hypersensitivity to cosyntropin or to any excipients of CORTROSYN. Reactions have included anaphylaxis
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
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:
CORTROSYN (cosyntropin) for Injection is a sterile lyophilized powder in single-dose vials containing 0.25 mg of cosyntropin and 10 mg of mannitol. Sodium Hydroxide and Glacial acetic acid may be used to adjust pH.
CORTROSYN (cosyntropin) for injection 0.25 mg, in a single-dose vial for reconstitution.
Box contains 10 single-dose vials NDC 0548-5900-00
Store at 20º to 25ºC (68º to 77ºF); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
CORTROSYN injection is intended as a single-dose injection and contains no antimicrobial preservative. Any unused portion should be discarded.