SODIUM NITROPRUSSIDE injection, solution, concentrate

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

Sodium Nitroprusside (UNII: EAO03PE1TC) (Nitroprusside - UNII:169D1260KM)

Tilgængelig fra:

Sagent Pharmaceuticals

INN (International Name):

Sodium Nitroprusside

Sammensætning:

Sodium Nitroprusside 25 mg in 1 mL

Indgivelsesvej:

INTRAVENOUS

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

Sodium Nitroprusside Injection is supplied in an amber-colored vial as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Discard solution 24 hours after dilution. Protect from light. Retain in carton until time of use. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. SAGENT® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 Made in USA ©2016 Sagent Pharmaceuticals, Inc. May 2016

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

SODIUM NITROPRUSSIDE- SODIUM NITROPRUSSIDE INJECTION, SOLUTION,
CONCENTRATE
SAGENT PHARMACEUTICALS
----------
SODIUM NITROPRUSSIDE INJECTION
SAGENT
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 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 Na [Fe(CN) NO] • 2H
O, 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.
Sodium Nit