VASOPRESSIN IN 0.9% SODIUM CHLORIDE injection

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Baxter Healthcare Corporation

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Vasopressin in Sodium Chloride Injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. Vasopressin in Sodium Chloride Injection is contraindicated in patients with a known allergy or hypersensitivity to 8-L-arginine vasopressin. Risk Summary There are no available data on Vasopressin in Sodium Chloride 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 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 Vasopressin in Sodium Chloride Injection 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)].

Prehľad produktov:

Vasopressin in Sodium Chloride Injection is supplied as a clear, practically colorless solution for intravenous administration in single-dose 100 mL ready-to-use containers available as: Product Code Product Description NDC Number 2G3498 20 units vasopressin (0.2 units/mL) Supplied as 12 bags per carton 0338-9640-12 2G3499 40 units vasopressin (0.4 units/mL) Supplied as 12 bags per carton 0338-9647-12 Store in the refrigerator (2°C to 8°C [36°F to 46°F]). Protect from freezing. If needed, Vasopressin in Sodium Chloride Injection may be stored at room temperature up to 25°C (77°F) for up to 6 months. Discard after 6 months if stored at room temperature or until the expiration date printed on the carton and container label, whichever is earlier. Once stored at room temperature, do not place back in the refrigerator. The drug product must be stored in its light protective carton during storage. Manufactured by, Packed by, Distributed by: Baxter Healthcare Corporation Deerfield, IL 60015 USA Printed in USA 07-19-06-884 Baxter and Galaxy are trademarks of Baxter International Inc.

Stav Autorizácia:

New Drug Application

Súhrn charakteristických

VASOPRESSIN IN 0.9% SODIUM CHLORIDE- VASOPRESSIN IN 0.9% SODIUM
CHLORIDE INJECTION
BAXTER HEALTHCARE CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VASOPRESSIN IN SODIUM
CHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
VASOPRESSIN IN SODIUM CHLORIDE INJECTION.
VASOPRESSIN IN SODIUM CHLORIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2014
INDICATIONS AND USAGE
Vasopressin in Sodium Chloride Injection is indicated to increase
blood pressure in adults with vasodilatory
shock who remain hypotensive despite fluids and catecholamines. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Injection: 100-mL single dose, ready-to-use containers with (3)
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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 BAXTER HEALTHCARE AT
1-866-888-2472 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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REVISED: 2/2024
Post-cardiotomy shock: 0.03 units/minute to 0.1 units/minute by
intravenous infusion. (2.1)
Septic shock: 0.01 units/minute to 0.07 units/minute by intravenous
infusion. (2.1)
20 units vasopressin (0.2 units/mL) in 0.9% sodium chloride.
40 units vasopressin (0.4 units/mL) in 0.9% sodium chloride.
Vasopressin in Sodium Chloride Injection is contraindicated in
patients with known allergy or
hypersensitivity to 8-L-arginine vasopressin. (4)
Can worsen cardiac function (5.1)
Reversible diabetes insipidus (5.2)
Pressor effects of catecholamines and Vasopressin in Sodium Chloride
Injection are expected to be
additive. (7.1)
Indomethacin may prolong effects of Vasopressin in Sodium Chloride
Injection. (7.2)
Co-administration of ganglionic blockers or drugs causing SIADH
(syndrome of ina