Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
SODIUM NITROPRUSSIDE (UNII: EAO03PE1TC) (NITROPRUSSIDE - UNII:169D1260KM)
Bausch Health US, LLC
SODIUM NITROPRUSSIDE
SODIUM NITROPRUSSIDE 50 mg in 2 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
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
Abbreviated New Drug Application
NITROPRESS- SODIUM NITROPRUSSIDE INJECTION, SOLUTION, CONCENTRATE BAUSCH HEALTH US, LLC ---------- 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 Leggi il documento completo