VASOPRESSIN 20 [USP'U]/mL
VASOPRESSIN · INJECTION, SOLUTION · Fresenius Kabi USA, LLC
VASOPRESSIN is a injection, solution containing vasopressin at 20 [USP'U]/mL, taken intravenous. Manufactured by Fresenius Kabi USA, LLC.
Key Facts
- Brand Name
- VASOPRESSIN
- Generic Name
- VASOPRESSIN
- NDC Code (Product)
65219-039- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 20 [USP'U]/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA213206
- Marketing Start
- 05/26/2023
Recall History
Central Admixture Pharmacy Services, Inc.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
IntegraDose Compounding Services LLC
Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
Central Admixture Pharmacy Services, Inc.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Par Sterile Products LLC
Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
SCA Pharmaceuticals, Inc.
Subpotent drug.
American Regent, Inc.
Subpotent product in addition to having out-of-specification results for impurities.
Pharmedium Services, LLC
cGMP deviations
Central Admixture Pharmacy Services, Inc.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
IntegraDose Compounding Services LLC
Subpotent Drug
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Vasopressin injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. • Vasopressin injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Dilute 20 units/mL single dose vial contents with normal saline (0.9% sodium chloride) or 5% dextrose in water (D5W) to either 0.1 units/mL or 1 unit/mL for intravenous administration. Discard unused diluted solution after 18 hours at room temperature or 24 hours under refrigeration. ( 2.1 ) • Post-cardiotomy shock: 0.03 to 0.1 units/minute ( 2.2 ) • Septic shock: 0.01 to 0.07 units/minute ( 2.2 ) 2.1 Preparation of Solution Inspect parenteral drug products for particulate matter and discoloration prior to use, whenever solution and container permit. Vasopressin Injection Solution for Dilution, 20 units/mL Dilute Vasopressin injection in normal saline (0.9% sodium chloride) or 5% dextrose in water (D5W) prior to use for intravenous administration. Discard unused diluted solution after 18 hours at room temperature or 24 hours under refrigeration. Table 1 Preparation of diluted solutions Fluid restriction? Final concentration Mix Vasopressin injection Diluent No 0.1 units/mL 2.5 mL (50 units) 500 mL Yes 1 unit/mL 5 mL (100 units) 100 mL 2.2 Administration In general, titrate to the lowest dose compatible with a clinically acceptable response. The recomme…
Contraindications
4 CONTRAINDICATIONS Vasopressin injection 1 mL single dose vial does not contain chlorobutanol and is therefore contraindicated only in patients with a known allergy or hypersensitivity to 8-L-arginine vasopressin. • Vasopressin injection 1 mL single dose vial does not contain chlorobutanol and is therefore contraindicated only in patients with a known allergy or hypersensitivity to 8-L-arginine vasopressin. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS • Pressor effects of catecholamines and Vasopressin injection are expected to be additive. ( 7.1 ) • Indomethacin may prolong effects of Vasopressin injection. ( 7.2 ) • Co-administration of ganglionic blockers or drugs causing SIADH may increase the pressor response. ( 7.3 , 7.4 ) • Co-administration of drugs causing diabetes insipidus may decrease the pressor response. ( 7.5 ) 7.1 Catecholamines Use 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. 7.2 Indomethacin Use 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 [see Clinical Pharmacology ( 12.3 )]. 7.3 Ganglionic Blocking Agents Use 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 [see Clinical Pharmacology ( 12.3 )]. 7.4 Drugs Suspected of Causing SIADH Use …
Adverse Reactions
6 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 Postmarketing Experience Reversible diabetes insipidus [see Warnings and Precautions ( 5.2 )]. The most common adverse reactions include decreased cardiac output, bradycardia, tachyarrhythmias, hyponatremia and ischemia (coronary, mesenteric, skin, digital). ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is VASOPRESSIN used for?
VASOPRESSIN contains VASOPRESSIN. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is VASOPRESSIN a controlled substance?
VASOPRESSIN is not classified as a controlled substance by the DEA.
What is the generic name for VASOPRESSIN?
The generic name for VASOPRESSIN is VASOPRESSIN. There are 8 other brand versions of VASOPRESSIN.
What is the NDC code for VASOPRESSIN 20 [USP'U]/mL?
The NDC (National Drug Code) for VASOPRESSIN 20 [USP'U]/mL is 65219-039, listed by Fresenius Kabi USA, LLC.
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)