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:

Par Pharmaceutical, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Vasostrict® is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. Vasostrict® 10 mL multiple dose vial is contraindicated in patients with known allergy or hypersensitivity to 8‑L-arginine vasopressin or chlorobutanol. The 1 mL single dose vial, 50 mL and 100 mL pre-mixed 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. Risk Summary There are no available data on Vasostrict® use in pregnant women to inform a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.  Animal reproduction studies have not been conducted with vasopressin. Clinical Considerations Dose adjustments during pregnancy and the postpartum period: Because of increased clearance of vasopressin in the second and third trimester, the dose of Vasostrict® may need to be increased [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)] . Maternal adverse reactions: Vasostrict® may produce tonic uterine contractions that could threaten the continuation of pregnancy. There are no data on the presence of vasopressin injection in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. Safety and effectiveness of Vasostrict® in pediatric patients with vasodilatory shock have not been established. Clinical studies of vasopressin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Warnings and Precautions (5), Adverse Reactions (6), and Clinical Pharmacology (12.3)] .

Product summary:

Vasostrict® (vasopressin injection, USP) is a clear, practically colorless solution for intravenous administration available as: NDC 42023-164-10: A carton of 10 single dose vials. Each vial contains vasopressin 1 mL at 20 units/mL. NDC 42023-164-25: A carton of 25 single dose vials. Each vial contains vasopressin 1 mL at 20 units/mL. NDC 42023-190-01: A carton of 1 multiple dose vial. Each vial contains vasopressin 10 mL at 200 units/10 mL (20 units/mL). NDC 42023-219-10: A carton of 10 single dose vials. Each vial contains vasopressin premixed in dextrose 100 mL at 40 units/100 mL (0.4 units/mL). NDC 42023-220-10: A carton of 10 single dose vials. Each vial contains vasopressin premixed in dextrose 100 mL at 60 units/100 mL (0.6 units/mL). NDC 42023-237-10: A carton of 10 single dose vials. Each vial contains vasopressin premixed in dextrose 100 mL at 20 units/100 mL (0.2 units/mL). NDC 42023-268-10: A carton of 10 single dose vials. Each vial contains vasopressin premixed in dextrose 50 mL at 50 units/50 mL (1 unit/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
PAR PHARMACEUTICAL, INC.
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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
VASOSTRICT (VASOPRESSIN IN DEXTROSE INJECTION) FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2014
INDICATIONS AND USAGE
Vasostrict
is indicated to increase blood pressure in adults with vasodilatory
shock who remain
hypotensive despite fluids and catecholamines. (1)
DOSAGE AND ADMINISTRATION
Dilute 20 units/mL single dose vial or 200 units/10 mL (20 units/mL)
multiple 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)
The 20 units/100 mL, 40 units/100 mL, 60 units/100 mL and 50 units/50
mL single dose vials do not
require further dilution prior to administration. (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/mL in a single dose vial. To be used after dilution.
200 units/10 mL (20 units/mL) in a multiple dose vial. To be used
after dilution.
20 units/100 mL (0.2 units/mL) premixed in dextrose in a single dose
vial. Ready to use.
40 units/100 mL (0.4 units/mL) premixed in dextrose in a single dose
vial. Ready to use.
60 units/100 mL (0.6 units/mL) premixed in dextrose in a single dose
vial. Ready to use.
50 units/50 mL (1 unit/mL) premixed in dextrose in a single dose vial.
Ready to use.
CONTRAINDICATIONS
Vasostrict
10 mL multiple dose vial is contraindicated in patients with known
allergy or hypersensitivity
to 8‑L-arginine vasopressin or chlorobutanol. The 1 mL single dose
vial, 50 mL and 100 mL pre-mixed
single dose vial does not contain chlorobutanol and is therefore
contraindicated only i