VASOPRESSIN injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

HF Acquisition Co LLC, DBA HealthFirst

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 8.1 Pregnancy 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. 8.2 Lactation 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. 8.4 Pediatric Use Safety and effectiveness of vasopressin in pediatric patients with vasodilatory shock have not been established. 8.5 Geriatric Use 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)].

Product summary:

Vasopressin injection, USP is a clear, practically colorless solution for intravenous administration available as: NDC 51662-1623-1 VASOPRESSIN INJECTION USP 20 UNITS PER mL 1mL VIAL NDC 51662-1623-2 VASOPRESSIN INJECTION USP 20 UNITS PER mL 1mL VIAL, IN A POUCH 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VASOPRESSIN- VASOPRESSIN INJECTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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VASOPRESSIN INJECTION USP 20 UNITS PER ML 1ML VIAL
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)
Post-cardiotomy shock: 0.03 to 0.1 units/minute (2)
Septic shock: 0.01 to 0.07 units/minute (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)
Reversible diabetes insipidus (5)
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 AuroMedics Pharma 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)
Indomethacin may prolong effects of vasopressin injection. (7)
Co-administration of ganglionic blockers or drugs causing SIADH may
increase the
pressor response. (7)
Co-administration of drugs causing diabetes insipidus may decrease the
pressor