VASOPRESSIN injection

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

HF Acquisition Co LLC, DBA HealthFirst

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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. 8.1 Pregnancy 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 ( 12-12.3)]. 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 shock. Vasostrict® may produce tonic uterine contractions that could threaten the continuatio

Prehľad produktov:

VASOSTRICT(TM) (VASOPRESSIN INJECTION, USP) is supplied in the following dosage forms. NDC 51662-1314-1 VASOSTRICT(TM) (VASOPRESSIN INJECTION, USP) 20 UNITS PER mL 1mL VIAL NDC 51662-1314-2 VASOSTRICT(TM) (VASOPRESSIN INJECTION, USP) 20 UNITS PER mL 1mL VIAL in 1 pouch HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms 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.

Stav Autorizácia:

New Drug Application

Súhrn charakteristických

VASOPRESSIN- VASOPRESSIN INJECTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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VASOSTRICT(TM) (VASOPRESSIN INJECTION, USP) 20 UNITS PER ML
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. ( 2-2.1)
Post-cardiotomy shock: 0.03 to 0.1 units/minute ( 2-2.2)
Septic shock: 0.01 to 0.07 units/minute ( 2-2.2)
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. ( 5-5.1)
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. ( 7-7.1)
Indomethacin may prolong effects of Vasostrict®. ( 7-7.2)
Co-administration of ganglionic blockers or drugs causing SIADH may
increase the
pressor response. ( 7-7.3, 7-7.5)
Co-administration of drugs causing diabetes insipidus may decrease the
pressor
response. ( 7-7.6)
USE IN SPECIFIC POPULATIONS
Pregnancy: M