VASOPRESSIN injection

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

DR. REDDYS LABORATORIES INC

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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. 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 the continuation

Tuoteyhteenveto:

Vasopressin injection, USP is a clear, practically colorless solution for intravenous administration available as: NDC 43598-085-25: A carton of 25 single 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. The storage conditions and expiration periods are summarized in the following table. Unopened Refrigerated 2°C to 8°C (36°F to 46°F) Unopened Room Temperature 20°C to 25°C (68°F to 77°F) Do not store above 25°C (77°F)   Opened (After First Puncture) 1 mL Vial Until manufacturer expiration date 12 months or until manufacturer expiration date, whichever is earlier N/A

Valtuutuksen tilan:

New Drug Application

Valmisteyhteenveto

VASOPRESSIN- VASOPRESSIN INJECTION
DR. REDDYS LABORATORIES 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 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-administration of drugs causing diabetes insipidus may decrease the
pressor r