VASOPRESSIN injection

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

HF Acquisition Co LLC, DBA HealthFirst

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Vasopressin injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. Vasopressin injection 1 mL 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. 8.1 Pregnancy Risk Summary There are no available data on vasopressin injection 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. 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 vasopressin injection may need to be increased [see DOSAGE AND ADMINISTRATION (2.2) and CLINICAL PHARMACOLOGY (12.3)]. Maternal adverse reactions: Vasopressin injection may produce tonic uterine contractions that could threaten

Descriptif du produit:

Vasopressin injection, USP is a clear, practically colorless solution for intravenous administration available as: NDC 51662-1607-1 VASOPRESSIN INJECTION, USP 20 UNITS PER mL 1mL VIAL. Each vial contains vasopressin 1 mL at 20 units/mL. NDC 51662-1607-2 VASOPRESSIN INJECTION, USP 20 UNITS PER mL 1mL VIAL, IN A POUCH, Each vial contains vasopressin 1 mL at 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 vasopressin injection beyond the manufacturer’s expiration date stamped on the vial. The storage conditions and expiration periods are summarized in the following table.

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

VASOPRESSIN- VASOPRESSIN INJECTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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VASOPRESSIN INJECTION, USP 20 UNITS PER ML
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
VASOPRESSIN
INJECTION safely and effectively. See full prescribing information for
VASOPRESSIN
INJECTION.
VASOPRESSIN injection, for intravenous use
Initial U.S. Approval: 2014
INDICATIONS AND USAGE
Vasopressin injection 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 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/mL in a single dose vial. To be used after
dilution. ( 3)
CONTRAINDICATIONS
Vasopressin injection 1 mL 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. ( 4)
WARNINGS AND PRECAUTIONS
Can worsen cardiac function. ( 5.1)
Reversible diabetes insipidus ( 5.2)
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 vasopressin injection are
expected to be additive.
( 7.1)
Indomethacin may prolong effects of vasopressin injection. ( 7.2)
Co-administration of ganglionic blockers or drugs causing SIADH may
increase the
pressor response. ( 7.3, 7.5)
Co-administra