NITHIODOTE
Details
- Status
- Prescription
- First Approved
- 2011-01-14
- Routes
- INTRAVENOUS, INTRAVENOUS
- Dosage Forms
- SOLUTION, SOLUTION
NITHIODOTE Approval History
What NITHIODOTE Treats
1 indicationsNITHIODOTE is approved for 1 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cyanide Poisoning
NITHIODOTE Boxed Warning
LIFE THREATENING HYPOTENSION AND METHEMOGLOBIN FORMATION Sodium nitrite can cause serious adverse reactions and death in humans, even at doses less than twice the recommended therapeutic dose. Sodium nitrite causes hypotension and methemoglobin formation, which diminishes oxygen carrying capacity. Hypotension and methemoglobin formation can occur concurrently or separately. Because of these risks, sodium nitrite should be used to treat acute life-threatening cyanide poisoning and be used with ca...
WARNING: LIFE THREATENING HYPOTENSION AND METHEMOGLOBIN FORMATION Sodium nitrite can cause serious adverse reactions and death in humans, even at doses less than twice the recommended therapeutic dose. Sodium nitrite causes hypotension and methemoglobin formation, which diminishes oxygen carrying capacity. Hypotension and methemoglobin formation can occur concurrently or separately. Because of these risks, sodium nitrite should be used to treat acute life-threatening cyanide poisoning and be used with caution in patients where the diagnosis of cyanide poisoning is uncertain . Patients should be closely monitored to ensure adequate perfusion and oxygenation during treatment with sodium nitrite. Alternative therapeutic approaches should be considered in patients known to have diminished oxygen or cardiovascular reserve (e.g. smoke inhalation victims, pre-existing anemia, cardiac or respiratory compromise), and those at higher risk of developing methemoglobinemia (e.g., congenital methemoglobin reductase deficiency) as they are at greater risk for potentially life-threatening adverse events related to the use of sodium nitrite . [See Warnings and Precautions (5.1 and 5.2) ] WARNING: LIFE-THREATENING HYPOTENSION AND METHEMOGLOBIN FORMATION See full prescribing information for complete boxed warning . Sodium nitrite can cause serious adverse reactions and death from: Hypotension ( 5.1 ) Methemoglobin formation ( 5.2 ) Patients should be closely monitored to ensure adequate perfusion and oxygenation during treatment with sodium nitrite.
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Active Pipeline
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Key Completed Trials
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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.
NITHIODOTE FDA Label Details
ProIndications & Usage
FDA Label (PDF)NITHIODOTE is indicated for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. When the diagnosis of cyanide poisoning is uncertain, carefully weigh the potentially life-threatening risks associated with NITHIODOTE against the potential benefits, especially if the patient is not in extremis. NITHIODOTE, an antidote, is indicated for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. Use with caution if the diagnosis of cyanide poisoning is uncertain.
WARNING: LIFE THREATENING HYPOTENSION AND METHEMOGLOBIN FORMATION Sodium nitrite can cause serious adverse reactions and death in humans, even at doses less than twice the recommended therapeutic dose. Sodium nitrite causes hypotension and methemoglobin formation, which diminishes oxygen carrying ca...
NITHIODOTE Patents & Exclusivity
Patents (9 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.