VasopressinInjection, USP

For intravenous infusion. Must be diluted prior to use.

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
	Strength: 20 Units/mL Supplied As: 1 mL Single-dose vial NDC#: 0517-1020-25	0517-1020-25	20 Units/mL	1 mL Single-dose vial	25	13 mm	Product Label Full Prescribing Information Safety Data Sheet	In-Stock Shipping Weekly
Shelf Pack 25 Availability In-Stock Shipping Weekly Product Label Full Prescribing Information Safety Data Sheet Contains 5 mg/mL chlorobutanol as a preservative Wholesaler Numbers ABC 10264598 Cardinal 1652452 McKesson 1613744 Morris & Dickson 198762 Case Information Unit of Sale NDC 0517-1020-25 Order Size 25 Case Size 24 Case Per Tier 110 View our list of Authorized Distributors Receive Availability Emails
	Strength: 20 Units/mL Supplied As: 10 mL Multiple-dose vial NDC#: 0517-1030-01	0517-1030-01	20 Units/mL	10 mL Multiple-dose vial	1	13 mm	Product Label Full Prescribing Information Safety Data Sheet	In-Stock Shipping Weekly
Shelf Pack 1 Availability In-Stock Shipping Weekly Product Label Full Prescribing Information Safety Data Sheet Contains 5 mg/mL chlorobutanol as a preservative Wholesaler Numbers ABC 10281147 Cardinal 5853239 McKesson 2829711 Morris & Dickson 294009 Case Information Unit of Sale NDC 0517-1030-01 Order Size 1 Case Size 84 Case Per Tier 80 View our list of Authorized Distributors Receive Availability Emails

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P: 800-734-9236
F: 610-650-0170

Adverse Drug Events (ADEs) may be reported to the FDA:
Phone: 1-800-FDA-1088
Web: www.fda.gov/medwatch
P: 888-354-4859
P: 888-354-4855
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American Regent, Inc.
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Shirley, NY 11967

P: 631-924-4000
F: 631-924-1731

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CONTRAINDICATIONS
Vasopressin injection is contraindicated in patients with known allergy or hypersensitivity to 8-L-arginine vasopressin or chlorobutanol.

WARNINGS AND PRECAUTIONS
Worsening Cardiac Function: – A decrease in cardiac index may be observed with the use of vasopressin.

Reversible Diabetes Insipidus: - Patients may experience reversible diabetes insipidus, manifested by the development of polyuria, a dilute urine, and hypernatremia after cessation of treatment with vasopressin.

ADVERSE REACTIONS
The following adverse 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:

Bleeding/lymphatic system disorders: Hemorrhagic shock, decreased platelets, intractable bleeding
Cardiac disorders: Right heart failure, atrial fibrillation, bradycardia, myocardial ischemia
Gastrointestinal disorders: Mesenteric ischemia
Hepatobiliary: Increased bilirubin levels
Renal/urinary disorders: Acute renal insufficiency
Vascular disorders: Distal limb ischemia
Metabolic: Hyponatremia
Skin: Ischemic lesions

DRUG INTERACTIONS
Pressor effects of catecholamines and vasopressin injection are expected to be additive.

Indomethacin may prolong the effects of vasopressin injection.

Use with ganglionic blocking agents may increase the effect of vasopressin injection on mean arterial blood pressure.

Use with drugs suspected of causing SIADH (Syndrome of Inappropriate Antidiuretic Hormone Secretion) may increase the pressor effect in addition to the antidiuretic effect of vasopressin injection.

Co-administration of drugs suspected of causing diabetes insipidus may decrease the pressor response in addition to the antidiuretic effect of vasopressin injection.

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.

OVERDOSAGE
Overdosage with vasopressin injection can be expected to manifest as consequences of vasoconstriction of various vascular beds (peripheral, mesenteric, and coronary) and as hyponatremia. In addition, overdosage may lead less commonly to ventricular tachyarrhythmias (including Torsade de Pointes), rhabdomyolysis, and non-specific gastrointestinal symptoms.

Direct effects will resolve within minutes of withdrawal of treatment.

INDICATIONS AND USAGE
Vasopressin injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.

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.

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