VASOPRESSIN injection

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

VASOPRESSIN (UNII: Y4907O6MFD) (VASOPRESSIN - UNII:Y4907O6MFD)

Tersedia dari:

Eagle Pharmaceuticals, Inc.

Rute administrasi :

PARENTERAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Vasopressin Injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. Vasopressin Injection is contraindicated in patients with known allergy or hypersensitivity to 8-L-arginine vasopressin or chlorobutanol. 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 see Clinical Pharmacology (12.3) ]. Maternal adverse reactions: Vasopressin Injection may produce tonic uterine contractions that could threaten the continuation of pregnancy. There are no data on the pres

Ringkasan produk:

Vasopressin Injection, USP is a clear, colorless to practically colorless solution for intravenous administration available as: NDC 42367-570-87: A carton containing 25 x 1 mL multiple dose vials. 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. Discard vial after 48 hours after first puncture. The storage conditions and expiration periods are summarized in the following table.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

VASOPRESSIN - VASOPRESSIN INJECTION
EAGLE PHARMACEUTICALS, INC.
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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 multiple dose vial content with normal saline (0.9%
sodium chloride) or 5% dextrose
in water (D5W) to either 0.1 units per mL or 1 unit per 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 in a multiple dose vial. To be used after
dilution. (3)
CONTRAINDICATIONS
Vasopressin Injection 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)
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 EAGLE PHARMACEUTICALS,
INC. AT 1-855-
318-2170 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, 7.4)
Co-administration of drugs causing diabetes insipidus may decrease the
pressor response. (7.5)
USE IN