US Home - VANCO READY® - Sepsis - Antimicrobial Lead Time

Is your antimicrobial
lead time (ALT)
sufficient?

Click here to see full
Prescribing Information
including BOXED WARNING.

When treating sepsis, every minute counts

The Surviving Sepsis guidelines call for early intervention with antimicrobial therapy within 1 hour from recognition of sepsis to antibiotic administration.1

 

Yet, in a clinical study of sepsis patients, 
57% of patients received antimicrobials greater
than 1 hour after order placement.2

†ALT measures the difference in hours, between the first electronic antimicrobial order timestamp and initiation of the administration of the first antimicrobial.


  • Antimicrobial lead time (ALT) had a significant impact on mortality. Increasing ALT demonstrated a progressive increase in mortality.2

  • The pharmacy can facilitate decreases in ALT through coordinated preparation and ready-to-use access of antimicrobials specifically for sepsis.2

Surviving Sepsis guidelines call for antibiotics in <1 hour
from recognition of sepsis to antibiotic administration.1

I was lying there , waiting for them to get vancomycin on
board. VANCO READY® would have made a big difference.

- Tim, patient and former pharmacist, who suffered from sepsis

VANCO READY® , Vancomycin Injection could help reduce antimicrobial lead time (ALT) in the hospital2*


  • Storage of common antimicrobials in the
    patient care area have led to a significant
    reduction in ALT. 3
  • Average time from order entry to pharmacist verification is 9-10 minutes.3

  • The average time from order
    verification to antibiotic administration
    was 87-113 minutes.3
  • Dose availability is among the most common sources of delay in ALT. 3

*Vanco READY® is presented as an example antimicrobial that can be stored on patient units.

Standardized across your institution

VANCO READY® streamlines complex delivery systems.

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Risk mitigation

VANCO READY® may help reduce the potential risk for errors associated with compounding drugs.

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VANCO READY® Vancomycin Injection, USP is available in 7 different dose amounts to cover most of your patients' vancomycin needs.

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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use VANCOMYCIN INJECTION, safely and effectively. See full prescribing information for VANCOMYCIN INJECTION.

VANCOMYCIN injection, for intravenous use
Initial U.S. Approval: 1958

RECENT MAJOR CHANGES

Boxed Warning 10/2021
Warnings and Precautions, Severe Dermatologic Reactions (5.5) 5/2021
Warnings and Precautions, Potential Risk of Exposure to Excipients During the First or Second Trimester of Pregnancy (5.1) 10/2021

WARNING: POTENTIAL RISK OF EXPOSURE TO EXCIPIENTS DURING THE FIRST OR SECOND TRIMESTER OF PREGNANCY

See full prescribing information for complete boxed warning.

If use of vancomycin is needed during the first or second trimester of pregnancy, use other available formulations of vancomycin. This formulation of vancomycin injection contains the excipients polyethylene glycol (PEG 400) and N-acetyl D-alanine (NADA), which resulted in fetal malformations in animal reproduction studies at dose exposures approximately 8 and 32 times, respectively, higher than the exposures at the human equivalent dose (5.1, 8.1).


INDICATIONS AND USAGE
Vancomycin Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (1 month and older) for the treatment of:
  • Septicemia (1.1)
  • Infective Endocarditis (1.2)
  • Skin and Skin Structure Infections (1.3)
  • Bone Infections (1.4)
  • Lower Respiratory Tract Infections (1.5)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Injection and other antibacterial drugs, Vancomycin Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.6)

DOSAGE AND ADMINISTRATION
  • Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with Vancomycin Injection. [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1,8.3)].
  • Use this formulation of Vancomycin Injection only in patients who require the entire (500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g) dose and not any fraction thereof. (2.1)
  • For intravenous use only. Do Not administer orally.
  • Administer Vancomycin Injection by intravenous infusion over 60 minutes or greater to reduce the risk of infusion reactions. (2.1)
  • Adult Patients:2 g divided either as 0.5 grams (g) every 6 hours or 1 g every 12 hours. (2.2)
  • Pediatric Patients (1 Month and Older):10 mg/kg per dose given every 6 hours. (2.3)
  • Patients with Renal Impairment: See full prescribing information for recommended doses in patients with renal impairment. (2.4)
  • See full prescribing information for further important administration and preparation instructions. (2.1, 2.5)

DOSAGE FORMS AND STRENGTHS
Vancomycin Injection, USP: Single-dose flexible bags containing 500 mg vancomycin in 100 mL, 750 mg vancomycin in 150 mL, 1 g vancomycin in 200 mL, 1.25 g vancomycin in 250 mL, 1.5 g vancomycin in 300 mL, 1.75 g vancomycin in 350 mL and 2 g vancomycin in 400 mL of liquid. (3)

CONTRAINDICATIONS

Hypersensitivity to vancomycin (4)

WARNINGS AND PRECAUTIONS
  • Infusion Reactions: Hypotension, including shock and cardiac arrest, wheezing, dyspnea, urticaria, muscular and chest pain and “red man syndrome” which manifests as pruritus and erythema that involves the face, neck and upper torso may occur with rapid intravenous administration. To reduce the risk of infusion reactions, administer Vancomycin Injection over a period of 60 minutes or greater and also prior to intravenous anesthetic agents. (2.1, 5.2)
  • Nephrotoxicity: Systemic vancomycin exposure may result in acute kidney injury (AKI) including acute renal failure, mainly due to interstitial nephritis or less commonly acute tubular necrosis. Monitor serum vancomycin concentrations and renal function. (5.3)
  • Ototoxicity: Ototoxicity has occurred in patients receiving vancomycin. Monitor for signs and symptoms of ototoxicity during therapy. Monitor serum vancomycin concentrations and renal function. Assessment of auditory function may be appropriate in some instances. (5.4)
  • Severe Dermatologic reactions: Discontinue Vancomycin Injection at the first appearance of skin rashes, mucosal lesions, or blisters. (5.5)
  • Clostridioides difficile-Associated Diarrhea: Evaluate patients if diarrhea occurs. (5.6)
  • Neutropenia: Periodically monitor leukocyte count. (5.8)
  • Phlebitis: To reduce the risk of local irritation and phlebitis administer Vancomycin Injection by a secure intravenous route of administration. (5.9)
  • Development of Drug-Resistant Bacteria: Prescribing Vancomycin Injection in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria. (5.10)

ADVERSE REACTIONS
The common adverse reactions are anaphylaxis, “red man syndrome”, acute kidney injury, hearing loss, neutropenia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Xellia Pharmaceuticals USA, LLC at 1-833-295-6953 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS
  • Anesthetic Agents: Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing. (2.1, 7.1)
  • Piperacillin/Tazobactam: Increased incidence of acute kidney injury in patients receiving concomitant piperacillin/tazobactam and vancomycin as compared to vancomycin alone. Monitor kidney function in patients. (7.2)
Revised: 10/2021  Download Complete Prescribing Information

References:
1. Weiss SL, Peters MJ, Alhazzani W, et al. Surviving sepsis campaign international guidelines for the management of septic shock and sepsis-associated organ dysfunction in children. Pediatr. Crit. Care Med. 2020;21(2):52-106.
2. Kashiouris MG, Zemore Z, Kimball Z, et al. Supply chain delays in antimicrobial administration after the initial clinician order and mortality in patients with sepsis. J Clin Invest. 2019;47(10):1388-1395.
3. Carroll D, Popa A, Hejal R, et al. 1601: Evaluation of timing of first-dose antibiotic administration in patients with sepsis or septic shock. Crit Care Med. 2019;47(1):776.