NIPRIDE RTU IN SODIUM CHLORIDE 0.9% (sodium nitroprusside) · EXELA PHARMA
Sodium nitroprusside is a direct acting vasodilator indicated for: • Immediate reduction of blood pressure • Producing controlled hypotension to reduce bleeding during surgery. • Treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean arterial blood pressure.
Details
- Status
- Prescription
- First Approved
- 2017-03-08
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
NIPRIDE RTU IN SODIUM CHLORIDE 0.9% Approval History
What NIPRIDE RTU IN SODIUM CHLORIDE 0.9% Treats
2 indicationsNIPRIDE RTU IN SODIUM CHLORIDE 0.9% is approved for 2 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
NIPRIDE RTU IN SODIUM CHLORIDE 0.9% Boxed 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 les...
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 ).
NIPRIDE RTU IN SODIUM CHLORIDE 0.9% Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in NIPRIDE RTU IN SODIUM CHLORIDE 0.9%'s indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications NIPRIDE RTU IN SODIUM CHLORIDE 0.9% treats. First-in-class if their pivotal trials read out positive.
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Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03318094 | 162097 | Ph 1 | active not recruiting | Role of Sympathetic Vasoconstriction on Insulin-Mediated Microvascular Recruitment and Glucose Uptake in Obesity |
| NCT03953326 results posted | 00011271 | Ph 1, Ph 2 | terminated | HeartPhone Cancer Survivors Trial 2019 |
| NCT04986072 results posted | ALK3831-A309 | Ph 2 | terminated | Sodium Nitroprusside in Early Course Schizophrenia |
| NCT05277922 results posted | VP-C21-009 | Ph 1 | completed | Effect of C21 on Forearm Blood Flow |
| NCT03679780 | 2018-0648 | Ph 1 | completed | The Effect of Endothelin and L-Arginine on Racial Differences in Vasoconstriction |
| NCT03446612 results posted | 205767 2017-002268-42 | Ph 2 | terminated | Anemia Study in Chronic Kidney Disease (CKD) : Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat -Forearm Blood Flow (ASCEND-FBF) |
| NCT02767024 PRIORITY-ADHF | 2014-3586 | Ph 4 | withdrawn | Intravenous Vasodilator vs. Inotropic Therapy in Patients With Heart Failure |
| NCT02164981 results posted | 2014P001204 | Ph 2 | completed | A Proof of Concept Study of Intravenous Sodium Nitroprusside in Adults With Symptomatic Schizophrenia |
| NCT03680573 | 2017-0842 | Ph 1 | completed | The Effect of Antioxidants on Skin Blood Flow-BH4 |
| NCT00891696 | 08-306 R01AR049877 | Ph 1 | completed | Nutritional and Contractile Regulation of Muscle Growth |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NIPRIDE RTU IN SODIUM CHLORIDE 0.9% FDA Label Details
Indications & Usage
FDA Label (PDF)Sodium nitroprusside is a direct acting vasodilator indicated for: • Immediate reduction of blood pressure • Producing controlled hypotension to reduce bleeding during surgery. • Treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean arterial blood pressure. 1.1 Immediate Reduction of Blood Pressure Sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. 1.2 Induction and Maintenance of Controlled Hypotension So...
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....
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.