SODIUM NITROPRUSSIDE- sodium nitroprusside injection 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:

Xiromed, LLC.

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:

Sodium Nitroprusside Injection is supplied in amber-colored, single-dose 50 mg/2 mL Fliptop Vials (NDC 70700-126-92). Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] To protect Sodium Nitroprusside Injection from light, it should be stored in its carton until it is used. Revised: 02/2021 Manufactured for: Xiromed, LLC., Florham Park, NJ 07932 Made in Germany PI-126-00

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

SODIUM NITROPRUSSIDE- SODIUM NITROPRUSSIDE INJECTION INJECTION,
SOLUTION, CONCENTRATE
XIROMED, LLC.
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SODIUM NITROPRUSSIDE INJECTION, 50 MG/2ML (25MG/ML)
FLIPTOP VIAL
RX ONLY
SODIUM NITROPRUSSIDE INJECTION IS NOT SUITABLE FOR DIRECT INJECTION.
THE SOLUTION MUST BE
FURTHER DILUTED IN STERILE 5% DEXTROSE INJECTION BEFORE INFUSION.
SODIUM NITROPRUSSIDE INJECTION 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 TO 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
Sodium Nitroprusside
whose molecular formula is Na2[Fe(CN)5NO] • 2H2O, and whose
molecular weight is 297.95. Dry
sodium nitroprusside is a reddish-brown crystals or powder, freely
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,