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LABEL. HIGHLIGHTS OF PRESCRIBING INFORMATION. These highlights do not include all the information needed to use for NIPRIDE RTU safely and effectively. See full prescribing information. for...
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Sodium Nitroprusside (Nexus Pharmaceuticals Inc): FDA Package Insert. Nexus Pharmaceuticals Inc 9 May 2022. SODIUM NITROPRUSSIDE- sodium nitroprusside injection. Nexus Pharmaceuticals Inc. Rx only. Sodium Nitroprusside Injection is not suitable for direct injection.
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- Overview
- Highlights of Prescribing Information
- See full prescribing information for complete boxed warning.
- Indications and Usage for Sodium Nitroprusside
- Sodium Nitroprusside Dosage and Administration
- Dosage Forms and Strengths
- Contraindications
- Warnings and Precautions
- Adverse Reactions/Side Effects
- Full Prescribing Information
These highlights do not include all the information needed to use SODIUM NITROPRUSSIDE in 0.9% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for SODIUM NITROPRUSSIDE in 0.9% SODIUM CHLORIDE INJECTION.
SODIUM NITROPRUSSIDE in SODIUM CHLORIDE injection, for intravenous use
(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).
Sodium nitroprusside is a direct acting vasodilator indicated for:
•Immediate reduction of blood pressure ( 1.1)
•Producing controlled hypotension to reduce bleeding during surgery ( 1.2)
•Treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean arterial blood pressure ( 1.3)
Initiate infusion of sodium nitroprusside at a rate of 0.3 mcg/kg/min, and titrate every few minutes until the desired effect is achieved OR the maximum recommended infusion rate of 10 mcg/kg/min has been reached ( 2.2).
Injection: 50 mg of sodium nitroprusside in 100 mL of 0.9% sodium chloride (0.5 mg/mL) in 100 mL single-dose vials, 20 mg of sodium nitroprusside in 100 mL of 0.9% sodium chloride (0.2 mg/mL) in 100 mL single-dose vials and 10 mg of sodium nitroprusside in 50 mL of 0.9% sodium chloride (0.2 mg/mL) in 50 mL single-dose vials ( 3).
•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).
•Thiocynate toxicity ( 5.3)
•Methemoglobinemia ( 5.4)
•Increases in intracranial pressure ( 5.5)
•Diminished capacity to compensate for anemia and hypovolemia with anesthesia during surgery ( 5.6)
Most common adverse reactions are hypotension and cyanide toxicity ( 6).
To report SUSPECTED ADVERSE REACTIONS, contactSlate Run Pharmaceuticals, LLC at 1-888-341-9214or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 10/2023
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 infusion at the maximum rate to as short a duration as possible [see Warnings and Precautions( 5.2) ].
Jan 11, 2024 · Package insert / product label. Generic name: sodium nitroprusside. Dosage form: injection, solution, concentrate. Drug classes: Agents for hypertensive emergencies, Vasodilators. Medically reviewed by Drugs.com. Last updated on Jan 11, 2024.
Jan 9, 2020 · SODIUM NITROPRUSSIDE (Micro Labs Limited): FDA Package Insert, Page 2. SODIUM NITROPRUSSIDE (Page 2 of 4) Micro Labs Limited 9 January 2020. INDICATIONS AND USAGE. Sodium nitroprusside injection is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises.
