SODIUM NITROPRUSSIDE- sodium nitroprusside injection

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Amphastar Pharmaceuticals, Inc.

Администрация маршрут:

INTRAVENOUS

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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

Обзор продуктов:

Sodium nitroprusside injection is supplied in amber-colored, single-dose 50 mg/2 mL vials (NDC 0548-9401-00). 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. Amphastar Pharmaceuticals, Inc. Rancho Cucamonga, CA 91730 USA Rev. 10/16

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

SODIUM NITROPRUSSIDE- SODIUM NITROPRUSSIDE INJECTION
AMPHASTAR PHARMACEUTICALS, INC.
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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 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 nitroprusside injection is available as:
50 mg Vial –