VASOPRESSIN injection

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

VASOPRESSIN (UNII: Y87Y826H08) (VASOPRESSIN - UNII:Y87Y826H08)

Dostupné z:

Eugia US LLC

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 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 vasopressin may need to be increased [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)] . Maternal adverse reactions: Vasopressin  may produce tonic uterine contractions that could threaten the continuation of pregnancy. There are no data on the presence of vasopressin injec

Prehľad produktov:

Vasopressin injection, USP is a clear, practically colorless solution for intravenous administration available as: 1 mL Multiple-Dose Vial Packaged Individually              NDC 55150-370-01 1 mL Multiple-Dose Vials in a Carton of 25                               NDC 55150-370-25 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], see 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, USP beyond the manufacturer’s expiration date stamped on the vial. After initial entry into the vial, the remaining contents must be refrigerated. Discard the refrigerated vial after 48 hours after first puncture. The storage conditions and expiration periods are summarized in the following table. The vial stopper is not made with natural rubber latex. Distributed by: Eugia US LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

VASOPRESSIN - VASOPRESSIN INJECTION
EUGIA US LLC
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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 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)
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 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 EUGIA US LLC AT
1-866-850-2876 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-administration of drugs causing diabetes insipidus may decrease the
pressor response. (7.6)
USE IN SPECIFIC POPULATIONS
PREGNANCY: May induce