vasopressin 20 [USP'U]/mL
Vasopressin · INJECTION · Medical Purchasing Solutions, LLC
vasopressin is a injection containing vasopressin at 20 [USP'U]/mL, taken intravenous. Manufactured by Medical Purchasing Solutions, LLC.
Key Facts
- Brand Name
- vasopressin
- Generic Name
- Vasopressin
- NDC Code (Product)
71872-7334- Manufacturer
- Medical Purchasing Solutions, LLC
- Strength
- 20 [USP'U]/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA213988
- Marketing Start
- 05/09/2024
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
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 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 10 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 71872-7334, listed by Medical Purchasing Solutions, LLC.
Other vasopressin Dosages
Other Vasopressin Brands
See all →- Vasopressin in 0.9% Sodium Chloride.2 [USP'U]/mL81298-8552
- Vasopressin in 0.9% Sodium Chloride.4 [USP'U]/mL81298-8554
- Vasopressin in 0.9% Sodium Chloride20 [USP'U]/100mL0338-9640
- VASOPRESSIN20 [USP'U]/mL71872-7306
- Vasopressin20 [USP'U]/mL0548-9701
- VASOPRESSIN20 [USP'U]/mL51662-1314
- Vasostrict20 [USP'U]/mL42023-164
- Vasostrict20 [USP'U]/mL42023-190
- VASOPRESSIN20 [USP'U]/mL51662-1623
- VASOPRESSIN20 [USP'U]/mL65219-039
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)