- Vial closure is not made with natural rubber latex
- Formulated, filled, and finished in our US-based manufacturing facilities
|Pack NDC#||Strength||Supplied As||Shelf Pack||Vial Opening Size||Product Info||Availability|
20 Units/mLSupplied As:
|25||13 mm||Product Label Full Prescribing Information Safety Data Sheet||Limited Availability|
Product Label Full Prescribing Information Safety Data Sheet
Contains 5 mg/mL chlorobutanol as a preservative
(8:00am–6pm Monday - Thursday and Friday 8:00am–4pm Eastern Time)
F: 610-650-0170E: firstname.lastname@example.org
Adverse Drug Events (ADEs) may be reported to the FDA:
P: 888-354-4859E: email@example.com
(9am–5pm Eastern Time, Monday - Friday)E: firstname.lastname@example.org
For drug information outside of normal business hours that cannot wait until the next day, please call:
American Regent, Inc.
5 Ramsey Road
Shirley, NY 11967
Vasopressin Injection, USP
For intravenous use. Dilute prior to administration.
INDICATIONS AND USAGE
Vasopressin injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.
IMPORTANT SAFETY INFORMATION
Vasopressin injection is contraindicated in patients with known allergy or hypersensitivity to 8-L-arginine vasopressin or chlorobutanol.
WARNINGS AND PRECAUTIONS
Can worsen cardiac function.
Patients may experience reversible diabetes insipidus.
The most common adverse reactions included decreased cardiac output, bradycardia, tachyarrhythmias, hyponatremia, and ischemia (coronary, mesenteric, skin, digital).
The following additional adverse reactions were identified:
Bleeding/lymphatic system disorders: Hemorrhagic shock, decreased platelets, intractable bleeding
Cardiac disorders: Right heart failure, atrial fibrillation, bradycardia, myocardial ischemia
Hepatobiliary: Increased bilirubin levels
Renal/urinary disorders: Acute renal insufficiency
Vascular disorders: Distal limb ischemia
Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed.
USE IN SPECIFIC POPULATIONS
Pregnancy: May induce tonic uterine contractions.
Pediatric Use: Safety and effectiveness have not been established.
Geriatric Use: Dose selection for an elderly patient should be cautious.
For additional safety information, please see Full Prescribing Information.
You are encouraged to report adverse drug events to American Regent, Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.