Sodium nitroprusside

FDA label, EXELA PHARMA SCIENCES, LLC, intravenous, effective 2018-07-20. Full label on DailyMed

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Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Boxed warning

WARNING: (A) EXCESSIVE HYPOTENSION; (B) CYANIDE TOXICITY (A) EXCESSIVE HYPOTENSION: Sodium Nitroprusside can cause precipitous decreases in blood pressure which can lead to irreversible ischemic injuries or death. Use only with continuous blood pressure monitoring [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.1 ). (B) CYANIDE TOXICITY: Sodium nitroprusside metabolism produces dose-related cyanide, which can be lethal. A patient’s ability to buffer cyanide will be exceeded in less than one hour at the maximum dose rate (10 mcg/kg/min); limit infusions at the maximum rate to as short a duration as possible [see Warnings and Precautions ( 5.2 )].

WARNING: (A) EXCESSIVE HYPOTENSION; (B) CYANIDE TOXICITY (A) Sodium Nitroprusside can cause precipitous decreases in blood pressure which can lead to irreversible ischemic injuries or death. Use only with continuous blood pressure monitoring. ( 2.2 , 5.1 ) (B) Sodium nitroprusside metabolism produces dose-related cyanide, which can be lethal. A patient’s ability to buffer cyanide will be exceeded in less than one hour at the maximum dose rate (10 mcg/kg/min); limit infusion at the maximum rate to as short a duration as possible ( 5.2 ).

Dosing in kidney impairment

the maximum recommended infusion rate of 10 mcg/kg/min has been reached, whichever occurs first. In patients with eGFR <30 mL/min/1.73 m 2 , limit the mean infusion rate to less than 3 mcg/kg/min. In anuric patients, limit the mean infusion rate to 1 mcg/kg/min. 2.3 Administration Do not administer other drugs in the same solution with sodium nitroprusside.

Preparation and administration

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Basis

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Inspection Inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Sodium nitroprusside should be a clear colorless to red/brown color; do not use if solution is blue, green, or bright red.

Dosing Continuously monitor blood pressure in patients receiving sodium nitroprusside. Start infusion of sodium nitroprusside at a rate of 0.3 mcg/kg/min. Evaluate blood pressure for at least 5 minutes before titrating to a higher or lower dose to achieve the desired blood pressure. The dose may be titrated upward until:

the desired effect is achieved,

systemic blood pressure cannot be further reduced without compromising the perfusion of vital organs, or

the maximum recommended infusion rate of 10 mcg/kg/min has been reached, whichever occurs first. In patients with eGFR <30 mL/min/1.73 m 2 , limit the mean infusion rate to less than 3 mcg/kg/min. In anuric patients, limit the mean infusion rate to 1 mcg/kg/min.

Administration Do not administer other drugs in the same solution with sodium nitroprusside. Sodium nitroprusside must be delivered by a volumetric infusion pump because small variations in infusion rate can lead to wide, undesirable variations in blood pressure [see Clinical Pharmacology] .

Contraindications

4 CONTRAINDICATIONS • Diseases with compensatory hypertension (e.g., coarctation of the aorta, arteriovenous shunting). • 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. • Acute heart failure associated with reduced peripheral vascular resistance. • Concomitant use with sildenafil, tadalafil, vardenifil, or riociguat. • Diseases with compensatory hypertension (e.g. coarctation of the aorta, arteriovenous shunting) ( 4 ). • Inadequate cerebral circulation or moribund patients (A.S.A. Class 5E) coming to emergency surgery ( 4 ).

• Congenital (Leber’s) optic atrophy or tobacco amblyopia ( 4 ). • Acute heart failure with reduced peripheral vascular resistance ( 4 ). • Concomitant use with sildenafil, tadalafil, vardenifil, or riociguat ( 4 )

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