SODIUM NITROPRUSSIDE injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Akorn

INN (International Name):

Sodium Nitroprusside

Composition:

Sodium Nitroprusside 50 mg in 2 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 17478-014-02 2 mL Single-dose vial Storage: 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. Akorn Manufactured for: Akorn, Inc. Lake Forest, IL 60045 PC4952C         Rev. 08/17

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SODIUM NITROPRUSSIDE- SODIUM NITROPRUSSIDE INJECTION, SOLUTION,
CONCENTRATE
AKORN
----------
SODIUM NITROPRUSSIDE INJECTION
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 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
2
5
2
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.
S