VASOSTRICT- vasopressin injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VASOPRESSIN, UNSPECIFIED (UNII: Y87Y826H08) (VASOPRESSIN, UNSPECIFIED - UNII:Y87Y826H08)

Available from:

Medical Purchasin Solutions, LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 contraindicated in patients with known allergy or hypersensitivity to 8-L-arginine vasopressin or chlorobutanol. Pregnancy Category C Risk Summary: There are no adequate or well-controlled studies of Vasostrict ® in pregnant women. It is not known whether vasopressin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Animal reproduction studies have not been conducted with vasopressin [see Clinical Pharmacology (12.3)]. Clinical Considerations: Because of increased clearance of vasopressin in the second and third trimester, the dose of Vasostrict ® may need to be up-titrated to doses exceeding 0.1 units/minute in post-cardiotomy shock and 0.07 units/minute in septic

Product summary:

Vasostrict ® (vasopressin injection, USP) is a clear, practically colorless solution for intravenous administration available as: NDC 42023-164-25: A carton of 25 single dose vials each containing vasopressin 1 mL at 20 units/mL. NDC 42023-190-01: A carton of 1 multiple dose vial containing vasopressin 10 mL at 200 units/10 mL (20 units/mL). Store between 2°C and 8°C (36°F and 46°F). Do not freeze. Vials may be held up to 12 months upon removal from refrigeration to room temperature storage conditions (20°C to 25°C [68°F to 77°F], USP Controlled Room Temperature), anytime within the labeled shelf life. Once removed from refrigeration, unopened vial should be marked to indicate the revised 12 month expiration date. If the manufacturer’s original expiration date is shorter than the revised expiration date, then the shorter date must be used. Do not use Vasostrict ® beyond the manufacturer’s expiration date stamped on the vial. After initial entry into the 10 mL vial, the remaining contents must be refrigerated. Discard the refrigerated 10 mL vial after 30 days after first puncture. The storage conditions and expiration periods are summarized in the following table. Unopened Refrigerated 2°C to 8°C (36°F to 46°F) Unopened Room Temperature 20°C to 25°C (68°F to 77°F) Do not store above 25°C (77°F)   Opened (After First Puncture) 1 mL Vial Until manufacturer expiration date 12 months or until manufacturer expiration date, whichever is earlier N/A  10 mL Vial Until manufacturer expiration date 12 months or until manufacturer expiration date, whichever is earlier 30 days

Authorization status:

New Drug Application

Summary of Product characteristics

VASOSTRICT- VASOPRESSIN INJECTION
MEDICAL PURCHASIN SOLUTIONS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VASOSTRICT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VASOSTRICT
.
VASOSTRICT (VASOPRESSIN INJECTION) FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2014
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. ( 1)
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)
DOSAGE FORMS AND STRENGTHS
Injection: 20 units per mL ( 3)
CONTRAINDICATIONS
Vasostrict
is contraindicated in patients with known allergy or hypersensitivity
to 8-L-arginine
vasopressin or chlorobutanol. ( 4)
WARNINGS AND PRECAUTIONS
Can worsen cardiac function. ( 5.1)
ADVERSE REACTIONS
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.
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)
USE IN SPECIFIC POPULATIONS
PREGNANCY: May induce uterine contractions. ( 8.1)
PEDIATRIC USE: Safety and effectiveness have not been establishe