Vasopressin in 0.9% Sodium Chloride .2 [USP'U]/mL
Vasopressin · SOLUTION · Long Grove Pharmaceuticals, LLC
Vasopressin in 0.9% Sodium Chloride is a solution containing vasopressin at .2 [USP'U]/mL, taken intravenous. Manufactured by Long Grove Pharmaceuticals, LLC.
Key Facts
- Brand Name
- Vasopressin in 0.9% Sodium Chloride
- Generic Name
- Vasopressin
- NDC Code (Product)
81298-8552- Manufacturer
- Long Grove Pharmaceuticals, LLC
- Strength
- .2 [USP'U]/mL
- Dosage Form
- SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA217766
- Marketing Start
- 07/12/2024
Recall History
No Recall HistorySide 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 in Sodium Chloride Injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. Vasopressin in Sodium Chloride 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 • Post-cardiotomy shock: 0.03 units/minute to 0.1 units/minute by intravenous infusion. ( 2.1 ) • Septic shock: 0.01 units/minute to 0.07 units/minute by intravenous infusion. ( 2.1 ) 2.1 Administration This product does not require dilution prior to administration. In general, titrate to the lowest dose compatible with a clinically acceptable response. The recommended starting dose is: Post-cardiotomy shock: 0.03 units/minute by intravenous infusion Septic Shock: 0.01 units/minute by intravenous infusion Titrate up by 0.005 units/minute at 10- to 15-minute intervals until the target blood pressure is reached. There are limited data for doses above 0.1 units/minute for post-cardiotomy shock and 0.07 units/minute for septic shock. Adverse reactions are expected to increase with higher doses. After target blood pressure has been maintained for 8 hours without the use of catecholamines, taper vasopressin injection by 0.005 units/minute every hour as tolerated to maintain target blood pressure. Inspect visually for any particulate matter and discoloration prior to administration. Discard Unused Portion Do not add supplemental medication or additive
Contraindications
4 CONTRAINDICATIONS Vasopressin in Sodium Chloride Injection is contraindicated in patients with a known allergy or hypersensitivity to 8-L-arginine vasopressin. • Vasopressin in Sodium Chloride Injection is contraindicated in patients with known allergy or hypersensitivity to 8-L-arginine vasopressin. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS • Pressor effects of catecholamines and Vasopressin in Sodium Chloride Injection are expected to be additive. ( 7.1 ) • Indomethacin may prolong effects of Vasopressin in Sodium Chloride Injection. ( 7.2 ) • Co-administration of ganglionic blockers or drugs causing SIADH (syndrome of inappropriate antiduretic hormone secretion) 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 in Sodium Chloride 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 in Sodium Chloride Injection on mean arterial blood pressure. Hemodynamic monitoring i…
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 reliably their frequency or 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 Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Vasopressin in 0.9% Sodium Chloride used for?
Vasopressin in 0.9% Sodium Chloride contains Vasopressin. It is a solution taken intravenous. Consult your doctor for specific uses.
Is Vasopressin in 0.9% Sodium Chloride a controlled substance?
Vasopressin in 0.9% Sodium Chloride is not classified as a controlled substance by the DEA.
What is the generic name for Vasopressin in 0.9% Sodium Chloride?
The generic name for Vasopressin in 0.9% Sodium Chloride is Vasopressin. There are 9 other brand versions of Vasopressin.
What is the NDC code for Vasopressin in 0.9% Sodium Chloride .2 [USP'U]/mL?
The NDC (National Drug Code) for Vasopressin in 0.9% Sodium Chloride .2 [USP'U]/mL is 81298-8552, listed by Long Grove Pharmaceuticals, LLC.