NIPRIDE RTU IN SODIUM CHLORIDE 0.9% (sodium nitroprusside)
NIPRIDE RTU IN SODIUM CHLORIDE 0.9% is indicated for the treatment of Hypertension; Congestive Heart Failure.
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.
- Hypertension
- Congestive Heart Failure
NIPRIDE RTU IN SODIUM CHLORIDE 0.9% Boxed Warning
BOXED WARNING 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 con...
BOXED WARNING 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.
NIPRIDE RTU IN SODIUM CHLORIDE 0.9% Competitive Set
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Indication competitors
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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)NIPRIDE RTU IN SODIUM CHLORIDE 0.9% is indicated for the treatment of Hypertension; Congestive Heart Failure.
BOXED WARNING 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...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.