Drugplain

Vasostrict 20 [USP'U]/mL

Vasopressin · INJECTION · Par Health USA, LLC

1 Recall on Record
Plain English

Vasostrict is a injection containing vasopressin at 20 [USP'U]/mL, taken intravenous. Manufactured by Par Health USA, LLC.

Key Facts

Brand Name
Vasostrict
Generic Name
Vasopressin
NDC Code (Product)
42023-164
Manufacturer
Par Health USA, LLC
Strength
20 [USP'U]/mL
Dosage Form
INJECTION
Route
INTRAVENOUS
Marketing Status
Application #
NDA204485
Marketing Start
11/12/2014

Recall History

1 Recall on Record
Class II01/11/2024

Par Sterile Products LLC

Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.

OngoingVoluntary: Firm initiated

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Vasostrict ® is indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines. Vasostrict ® is indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Dilute Vasostrict ® 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 Diluted Solutions Dilute Vasostrict ® 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 Vasostrict ® Diluent No 0.1 units/mL 2.5 mL (50 units) 500 mL Yes 1 unit/mL 5 mL (100 units) 100 mL Inspect parenteral drug products for particulate matter and discoloration prior to use, whenever solution and container permit. 2.2 Administration The goal of treatment is optimization of perfusion to critical organs, but aggressive treatment can compromise perfusion of organs, like the gastrointestinal tract, whose function is difficult to m…

Contraindications

4 CONTRAINDICATIONS Vasostrict ® is contraindicated in patients with known allergy or hypersensitivity to 8-L-arginine vasopressin or chlorobutanol. Vasostrict ® is contraindicated in patients with known allergy or hypersensitivity to 8-L-arginine vasopressin or chlorobutanol. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Pressor effects of catecholamines and Vasostrict ® are expected to be additive. ( 7.1 ) Indomethacin may prolong effects of Vasostrict ® . ( 7.2 ) Co-administration of ganglionic blockers or drugs causing SIADH may increase the pressor response. ( 7.3 , 7.5 ) Co-administration of drugs causing diabetes insipidus may decrease the pressor response. ( 7.6 ) 7.1 Catecholamines Use with catecholamines is expected to result in an additive effect on mean arterial blood pressure and other hemodynamic parameters. 7.2 Indomethacin Use with indomethacin may prolong the effect of Vasostrict ® on cardiac index and systemic vascular resistance [see Clinical Pharmacology (12.3) ]. 7.3 Ganglionic Blocking Agents Use with ganglionic blocking agents may increase the effect of Vasostrict ® on mean arterial blood pressure [see Clinical Pharmacology (12.3) ]. 7.4 Furosemide Use with furosemide increases the effect of Vasostrict ® on osmolar clearance and urine flow [see Clinical Pharmacology (12.3) ]. 7.5 Drugs Suspected of Causing SIADH Use with drugs suspected of causing SIADH (e.g., SSRIs, tricyclic antidepressants, haloperidol, chlorpropamide, enalapril, methyldopa, pentamidine,…

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 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 Par Pharmaceutical at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Frequently Asked Questions

What is Vasostrict used for?

Vasostrict contains Vasopressin. It is a injection taken intravenous. Consult your doctor for specific uses.

Is Vasostrict a controlled substance?

Vasostrict is not classified as a controlled substance by the DEA.

What is the generic name for Vasostrict?

The generic name for Vasostrict is Vasopressin. There are 10 other brand versions of Vasopressin.

What is the NDC code for Vasostrict 20 [USP'U]/mL?

The NDC (National Drug Code) for Vasostrict 20 [USP'U]/mL is 42023-164, listed by Par Health USA, LLC.

Product NDC

42023-164

Package NDC

42023-164-10

Other Vasostrict Dosages

Other Vasopressin Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)