Vasopressin Injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.
Is Vasopressin Injection, USP an AP-rated Product?
Yes. Eagle Pharmaceuticals’ Vasopressin Injection, USP, 20 units/1 mL is therapeutically equivalent to the reference listed drug, and is assigned the TE Code “AP” in the Orange Book.
Can Vasopressin Injection, USP be stored at room temperature? (20°C to 25°C [68°F to 77°F])
Yes. Vasopressin Injection, USP, 20 units/1 mL can be stored unopened at room temperature for up to 12 months upon removal from refrigeration or until manufacturer expiration date, whichever is earlier.
How is Vasopressin Injection, USP supplied?
Vasopressin Injection, USP, 20 units/1 mL is supplied in a carton containing 25 x 1 mL multiple dose vials. [NDC 42367-570-87]
20 units/1 mL
1 mL Multiple Dose Vial
Carton containing 25 x 1 mL Multiple Dose Vials
|Strength||20 units/1 mL|
|Size||1 mL Multiple Dose Vial|
|Supplied As||Carton containing 25 x 1 mL Multiple Dose Vials|
Important Safety Information
INDICATIONVasopressin Injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.
CONTRAINDICATIONVasopressin Injection is contraindicated in patients with known allergy or hypersensitivity to 8-L-arginine vasopressin or chlorobutanol.
WARNINGS AND PRECAUTIONS
Worsening Cardiac FunctionA decrease in cardiac index may be observed with the use of vasopressin.
Reversible Diabetes InsipidusPatients may experience reversible diabetes insipidus, manifested by the development of polyuria, a diluted urine and hypernatremia, after cessation of treatment with vasopressin. Monitor serum electrolytes, fluid status and urine output after vasopressin discontinuation. Some patients may require readministration of vasopressin or administration of desmopressin to correct fluid and electrolyte shifts.
CatecholaminesUse with catecholamines is expected to result in an additive effect on mean arterial blood pressure and other hemodynamic parameters. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed.
IndomethacinUse with indomethacin may prolong the effect of Vasopressin Injection on cardiac index and systemic vascular resistance. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed.
Ganglionic Blocking AgentsUse with ganglionic blocking agents may increase the effect of Vasopressin Injection on mean arterial blood pressure. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed.
Drugs Suspected of Causing Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)Use with drugs suspected of causing SIADH (e.g., SSRIs, tricyclic antidepressants, haloperidol, chlorpropamide, enalapril, methyldopa, pentamidine, vincristine, cyclophosphamide, ifosfamide, felbamate) may increase the pressor effect in addition to the antidiuretic effect of Vasopressin Injection. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed.
Drugs Suspected of Causing Diabetes InsipidusUse with drugs suspected of causing diabetes insipidus (e.g., demeclocycline, lithium, foscarnet, clozapine) may decrease the pressor effect in addition to the antidiuretic effect of Vasopressin Injection. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed.
ADVERSE REACTIONSAdverse reactions associated with the use of vasopressin were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. The most common adverse reactions associated with the use of vasopressin include decreased cardiac output, bradycardia, tachyarrhythmias, hyponatremia and ischemia (coronary, mesenteric, skin, digital).
USE IN SPECIFIC PATIENT POPULATIONS
PregnancyThere are no available data on Vasopressin Injection use in pregnant women to inform a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted. Because of increased clearance of vasopressin in the second and third trimester, the dose of Vasopressin Injection may need to be increased. Vasopressin Injection may produce tonic uterine contractions that could threaten the continuation of pregnancy.
LactationThere are no data on the presence of vasopressin injection in either human or animal milk, the effects on the breastfed infant, or the effects on milk production.
Pediatric UseSafety and effectiveness of Vasopressin Injection in pediatric patients with vasodilatory shock have not been established.
Clinical studies of vasopressin did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.For safety and dosing guidelines for Vasopressin Injection, see complete Warnings and Precautions, Adverse Reactions, and Dosage and Administration sections in the full Prescribing Information.
To report SUSPECTED ADVERSE REACTIONS, contact Eagle Pharmaceuticals, Inc. at 1-855-318-2170 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
1. Vasopressin Injection, USP, 20 units/mL [Prescribing Information] Woodcliff Lake, NJ. Eagle Pharmaceuticals, Inc. 2021.