METHOHEXITAL SODIUM
Details
- Status
- Prescription
- First Approved
- 2024-10-03
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
METHOHEXITAL SODIUM Approval History
What METHOHEXITAL SODIUM Treats
1 FDA approvalsOriginally approved for its first indication in 2024 .
- Other (1)
Other
(1 approval)- • Approved indication (Oct 2024)
METHOHEXITAL SODIUM Boxed Warning
WARNING Methohexital Sodium for Injection should be used only in hospital or ambulatory care settings that provide for continuous monitoring of respiratory (e.g. pulse oximetry) and cardiac function. Immediate availability of resuscitative drugs and age- and size-appropriate equipment for bag/valve/mask ventilation and intubation and personnel trained in their use and skilled in airway management should be assured. For deeply sedated patients, a designated individual other than the practitioner ...
WARNING Methohexital Sodium for Injection should be used only in hospital or ambulatory care settings that provide for continuous monitoring of respiratory (e.g. pulse oximetry) and cardiac function. Immediate availability of resuscitative drugs and age- and size-appropriate equipment for bag/valve/mask ventilation and intubation and personnel trained in their use and skilled in airway management should be assured. For deeply sedated patients, a designated individual other than the practitioner performing the procedure should be present to continuously monitor the patient. (See WARNINGS.)
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.
METHOHEXITAL SODIUM FDA Label Details
ProIndications & Usage
Methohexital Sodium for Injection can be used in adults as follows: 1.For intravenous induction of anesthesia prior to the use of other general anesthetic agents. 2.For intravenous induction of anesthesia and as an adjunct to subpotent inhalational anesthetic agents (such as nitrous oxide in oxygen) for short surgical procedures; Methohexital Sodium for Injection may be given by infusion or intermittent injection. 3.For use along with other parenteral agents, usually narcotic analgesics, to supplement subpotent inhalational anesthetic agents (such as nitrous oxide in oxygen) for longer surgica...
WARNING Methohexital Sodium for Injection should be used only in hospital or ambulatory care settings that provide for continuous monitoring of respiratory (e.g. pulse oximetry) and cardiac function. Immediate availability of resuscitative drugs and age- and size-appropriate equipment for bag/valve/...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.