SODIUM NITROPRUSSIDE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

sodium nitroprusside (UNII: EAO03PE1TC) (Nitroprusside - UNII:169D1260KM)

Available from:

Nexus Pharmaceuticals Inc

INN (International Name):

Sodium Nitroprusside

Composition:

Sodium Nitroprusside 25 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Sodium Nitroprusside Injection is supplied in amber-colored, single-dose 50 mg /2 mL Fliptop Vials (NDC 14789 -012-02). Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] To protect Sodium Nitroprusside from light, it should be stored in its carton until it is used. The container closure is not made with natural rubber latex. To report SUSPECTED ADVERSE REACTIONS contact Lambda Therapeutics Limited (Toll Free Number: 1-855-642-2594 or by email: [e-mail]) or the FDA (Toll Free Number: 1-800-FDA-1088 or by the MedWatch website at www.fda.gov/safety/MedWatch/). Revised: 09/2021 Manufactured by: Nexus Pharmaceuticals, Inc. Lincolnshire, Illinois 60069 NEXUS PHARMACEUTICALS SNPPIR002

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SODIUM NITROPRUSSIDE- SODIUM NITROPRUSSIDE INJECTION
NEXUS PHARMACEUTICALS INC
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SODIUM NITROPRUSSIDE INJECTION
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 0.5-10 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] • 2H O, and whose
molecular weight is
2
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 i