NITROPRESS- sodium nitroprusside injection, solution, concentrate

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

SODIUM NITROPRUSSIDE (UNII: EAO03PE1TC) (NITROPRUSSIDE - UNII:169D1260KM)

Disponible depuis:

Bausch Health US, LLC

DCI (Dénomination commune internationale):

SODIUM NITROPRUSSIDE

Composition:

SODIUM NITROPRUSSIDE 50 mg in 2 mL

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with sodium nitroprusside can be minimized. Sodium nitroprusside is also indicated for producing controlled hypotension in order to reduce bleeding during surgery. Sodium nitroprusside is also indicated for the treatment of acute congestive heart failure. Sodium nitroprusside should not be used in the treatment of compensatory hypertension, where the primary hemodynamic lesion is aortic coarctation or arteriovenous shunting. Sodium nitroprusside should not be used to produce hypotension during surgery in patients with known inadequate cerebral circulation, or in moribund patients (A.S.A. Class 5E) coming to emergency surgery. Patients with congenital (Leber’s) optic atrophy or with tobacco amblyopia have unusually high cyanide/thiocyanate ratios. These rare condition

Descriptif du produit:

NITROPRESS (sodium nitroprusside injection) is supplied in amber-colored, single-dose 50 mg/2 mL Flip-top Vials NDC 0187-4302-02. STORAGE Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] To protect NITROPRESS from light, it should be stored in its carton until it is used. Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA Manufactured by: Hospira, Inc., McPherson, KS 67460 USA Nitropress is a registered trademark of Hospira, Inc. used under license. ©Valeant Pharmaceuticals North America LLC 9444501 EN-4446 Revised: 10/2016

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

NITROPRESS- SODIUM NITROPRUSSIDE INJECTION, SOLUTION, CONCENTRATE
BAUSCH HEALTH US, LLC
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NITROPRES S
(SODIUM NITROPRUSSIDE INJECTION)
FLIP-TOP VIAL
RX ONLY
NITROPRESS® (SODIUM NITROPRUSSIDE INJECTION) IS NOT SUITABLE FOR
DIRECT INJECTION. THE
SOLUTION MUST BE FURTHER DILUTED IN STERILE 5% DEXTROSE INJECTION
BEFORE INFUSION.
NITROPRESS CAN CAUSE PRECIPITOUS DECREASES IN BLOOD PRESSURE (SEE
_DOSAGE AND_
_ADMINISTRATION_). IN PATIENTS NOT PROPERLY MONITORED, THESE DECREASES
CAN LEAD TO
IRREVERSIBLE ISCHEMIC INJURIES OR DEATH. SODIUM NITROPRUSSIDE SHOULD
BE USED ONLY WHEN
AVAILABLE EQUIPMENT AND PERSONNEL ALLOW BLOOD PRESSURE TO BE
CONTINUOUSLY MONITORED.
EXCEPT WHEN USED BRIEFLY OR AT LOW (< 2 MCG/KG/MIN) INFUSION RATES,
SODIUM NITROPRUSSIDE
GIVES RISE TO IMPORTANT QUANTITIES OF CYANIDE ION, WHICH CAN REACH
TOXIC, POTENTIALLY LETHAL
LEVELS (SEE _WARNINGS_). THE USUAL DOSE RATE IS 0.5-10 MCG/KG/MIN, BUT
INFUSION AT THE
MAXIMUM DOSE RATE SHOULD NEVER LAST MORE THAN 10 MINUTES. IF BLOOD
PRESSURE HAS NOT BEEN
ADEQUATELY CONTROLLED AFTER 10 MINUTES OF INFUSION AT THE MAXIMUM
RATE, ADMINISTRATION OF
SODIUM NITROPRUSSIDE SHOULD BE TERMINATED IMMEDIATELY.
ALTHOUGH ACID-BASE BALANCE AND VENOUS OXYGEN CONCENTRATION SHOULD BE
MONITORED AND
MAY INDICATE CYANIDE TOXICITY, THESE LABORATORY TESTS PROVIDE
IMPERFECT GUIDANCE.
DESCRIPTION
Sodium nitroprusside is disodium pentacyanonitrosylferrate(2-)
dihydrate, a hypotensive agent whose
structural formula is
®
whose molecular formula is Na2[Fe(CN)5NO] • 2H2O, and whose
molecular weight is 297.95. Dry
sodium nitroprusside is a reddish-brown powder, soluble in water. In
an aqueous solution infused
intravenously, sodium nitroprusside is a rapid-acting vasodilator,
active on both arteries and veins.
Sodium nitroprusside solution is rapidly degraded by trace
contaminants, often with resulting color
changes. (See _DOSAGE AND ADMINISTRATION_ section.) The solution is
also sensitive to certain
wavelengths of light, and it must be protected from light in clinical
use.
NITROPRESS