Levetiracetam

Depends on presentation or useFull monograph review pending

Historical dilution reference. Verify the preparation against the label for the product in hand.

Original GlobalRPh article: Keppra ® -levetiracetam (opens in a new tab)Original source URL: https://globalrph.com/dilution/keppra-levetiracetam/ Retrieved 2026-11-04

Historical source details

Original publication date: unavailable in the retrieved article.

Source location and file checksums

Original source URL: https://globalrph.com/dilution/keppra-levetiracetam/ (opens in a new tab)
Source date: Not established in the retrieved source
Retrieved: 2026-11-04T19:47:56.089983+00:00
Source location: div.post-content
Packaged content SHA-256: 050788abefe1db19eb1bb366ba3e0a1cef2c003066d0fc7b578de8f78ec1c200
Original response SHA-256: 0643dc3ef66b4445ebb772d3a8b4087a44ab307f66d9178d39aa3d8672dbd05e
Source body SHA-256: 1062b0e28a5b2b6f1fd9e6393afa3ad8a464a7f60bc333db1fc06887703c7da7

Levetiracetam (Keppra ®)

The authors make no claims of the accuracy of the information contained herein; and these suggested doses and/or guidelines are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this document shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.

Usual Diluents

NS, D5W, or LR

Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]

[Prescribed dose] [100ml] [ 15 minutes]

Examples:
[500 mg] [100ml] [15 minutes]
[1000 mg ] [100ml] [15 minutes]
[1500 mg ] [100ml] [15 minutes]

(Product with particulate matter or discoloration should not be used.)

Stability / Miscellaneous

Stability

Preparation and Administration Instructions
KEPPRA injection is for intravenous use only and should be diluted in 100 mL of a compatible diluent prior to administration. If a smaller volume is required (e.g. pediatric patients), the amount of diluent should be calculated to not exceed a maximum levetiracetam concentration of 15 mg per mL of diluted solution. Consideration should also be given to the total daily fluid intake of the patient. KEPPRA injection should be administered as a 15-minute IV infusion. One vial of KEPPRA injection contains 500 mg levetiracetam (500 mg/5 mL).

KEPPRA injection may be mixed with the following diluents and antiepileptic drugs and may be stored in polyvinyl chloride (PVC) bags. The diluted solution should not be stored for more than 4 hours at controlled room temperature [15-30°C (59-86°F)].

Compatible Diluents:
• Sodium chloride (0.9%) injection, USP
• Lactated Ringer's injection
• Dextrose 5% injection, USP

Depending on the packager /NDC, a recent revision increased the stabililty back to 24 hours from 4 hours. Timeline: Prior to ~ 2019, 24 hours was listed in all cases. After ~2019, the stability was reduced to 4 hours which is still the case in ~ 80-90% of the current package inserts. Example.

Revised: 5/2024 (PDF)
Packager: Hospira, Inc.
Levetiracetam injection was found to be physically compatible and chemically stable when mixed with the following diluents and antiepileptic drugs for at least 24 hours and stored in polyvinyl chloride (PVC) bags at controlled room temperature 15 to 30°C (59 to 86°F).

Indications: KEPPRA injection is indicated as adjunctive therapy in the treatment of partial onset seizures in ADULTS with epilepsy. KEPPRA injection is an alternative for patients when oral administration is temporarily not feasible.
(Safety and effectiveness of KEPPRA injection in patients below the age of 16 years have not been established.)

Dosage: KEPPRA injection is for intravenous use only and must be diluted prior to administration. Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open label studies with KEPPRA tablets for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

Note: dosage adjustments are necessary in patients with impaired renal function.

Separate renal reference: Open Renal Dosing Master

Impaired Renal Function:
First estimate the patient's creatinine clearance (ml/min):
Cockcroft and Gault equation:Separate renal reference: Open Renal Dosing Master

Creatinine clearance for males =Separate renal reference: Open Renal Dosing Master (opens in a new tab)	[140-age (years)]× [body wt (kg)] 72 × [serum creatinine (mg/dL)]
Creatinine clearance for females =Separate renal reference: Open Renal Dosing Master (opens in a new tab)	[140-age (years)]× [body wt (kg)]× 0.85 72 × [serum creatinine (mg/dL)]

CRCL (ml/min)Separate renal reference: Open Renal Dosing Master (opens in a new tab)	Dosage	Frequency
> 80 ml/min	500-1500 mg	q12h
50 - 80	500-1000 mg	q12h
30 - 50	250-750 mg	q12h
<30	250-550 mg	q12h
ESRD patients on dialysisSeparate renal reference: Open Renal Dosing Master (opens in a new tab)	500-1000 mg	q24h*
*Following dialysis, a 250 to 500mg supplemental dose is recommended

Replacement Therapy: When switching from oral KEPPRA, the initial total daily intravenous dosage of KEPPRA should be equivalent to the total daily dosage and frequency of oral KEPPRA . Any unused portion of the KEPPRA injection vial contents should be discarded.

Miscellaneous
Dilution:
Dilute prescribed dose in 100 ml of a compatible diluent and infuse over 15 minutes.

Compatible Diluents:
• Sodium chloride (0.9%) injection, USP
• Lactated Ringer's injection
• Dextrose 5% injection, USP

How Supplied
KEPPRA (levetiracetam) 500 mg/5 mL injection is a clear, colorless, sterile solution. It is supplied in single-use 5 mL vials, available in cartons of 10 vials (NDC 50474-002-63).

Storage
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Source: [package insert]

Open this historical article on its own

U.S. label preparation

Fresenius Kabi levetiracetam in sodium chloride, 100 mL single-dose bag · Depends on presentation or use

Preparation: Use the labeled 500 mg, 1,000 mg or 1,500 mg premixed bag. Each contains 100 mL. Do not further dilute these bags.
Administration and handling: Infuse intravenously over 15 minutes. Match the bag strength to the prescribed dose.
Precision Dose levetiracetam 500 mg/5 mL vial: For this vial, dilute the prescribed dose in 100 mL of 0.9% sodium chloride, 5% dextrose or lactated Ringer's, then infuse over 15 minutes. If a smaller volume is needed, keep the final concentration at or below 15 mg/mL. Vial label, section 2.6 (opens in a new tab)

Product and source details

Fresenius Kabi USA, LLC · ANDA208619

Product NDC: 65219-042, 65219-044, 65219-046

SPL effective 2026-02-05 | SPL version 4. 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.

Selected product identity

The selected product is identified for this preparation.

View product identifiers and primary-label provenance

Selected product scope: Fresenius Kabi levetiracetam in sodium chloride, 100 mL single-dose bag
Labeler: Fresenius Kabi USA, LLC
Application number(s): ANDA208619
NDC(s): 65219-042; 65219-044; 65219-046
DailyMed Set ID: da858849-1d18-4d38-b53d-d4dd1cd8fabc
SPL version: 4
Label printed revision date: Not established
SPL effective date: 2026-02-05
Retrieved: 2026-11-13
Downloaded XML SHA-256: c4f9f88faf1e024b84f0c675d8e8a457995e14e73d6fe0a2ba20534b5b17de7c

Selected label Fresenius Kabi levetiracetam in sodium chloride, 100 mL single-dose bag

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.

Open the original GlobalRPh site monograph (historical; not revalidated) (opens in a new tab)

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