Ketamine
Depends on presentation or useFull monograph review pending
U.S. label preparation
Ketalar · Depends on presentation or use
- Preparation
- For IV induction, dilute the 100 mg/mL vial with an equal volume of sterile water for injection, 0.9% sodium chloride or 5% dextrose to make 50 mg/mL. The 10 and 50 mg/mL strengths may be used undiluted for IV induction.
- Administration and handling
- Administer induction slowly, generally over 60 seconds, with airway and ventilation capability. Continuous maintenance infusions use a separate dilution in section 2.3.
- Manufacturer's storage limits
- Use the diluted 100 mg/mL induction preparation immediately. A compounding beyond-use date requires a separate assessment.
Product and source details
Par Health USA, LLC · NDA016812
Product NDC: 42023-113, 42023-114, 42023-115
SPL effective 2026-03-27 | SPL version 33. Checked 2026-11-13.
Source for this summary: U.S. prescribing information. Use the full label for dose selection, contraindications, preparation tables and monitoring.
Product identifiers and clinical review status
U.S. label preparation available. Full monograph review pending.
Exact formulation, concentration, container, manufacturer, regulatory identifiers, and a reproducible label snapshot have not all been reconciled.
What remains to be completed
- Obtain independent corroboration of the label preparation where available.
- Complete indication- and age-specific dosing, incompatibility, monitoring and stability review.
- Assess any proposed compounding BUD for the exact formulation, concentration, container and conditions.