Frozen Premix Vancomycin Injection, USP

Vancomycin Injection, USP
Indications and Important Risk Information

Indications

Vancomycin is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci.  It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs.

Vancomycin is effective in the treatment of:

• Infective Endocarditis
   - staphylococcal endocarditis
  - endocarditis caused by Streptococcus viridans or S. bovis, alone or in combination with an aminoglycoside
  - endocarditis caused by enterococci (e.g., E. faecalis), only in combination with an aminoglycoside
  - diphtheroid endocarditis
  - early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids in combination with either rifampin, an aminoglycoside, or both
• Septicemia
• Skin and Skin Structure Infection
• Bone Infections
• Lower Respiratory Tract Infections

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

Important Risk Information

• Contraindications:  Vancomycin is contraindicated in patients with known hypersensitivity to this antibiotic. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.
• Infusion Reactions:  Rapid bolus administration (e.g., over several minutes) may be associated with exaggerated hypotension, including shock, and, rarely, cardiac arrest.
  During or soon after rapid infusion of vancomycin, patients may develop anaphylactoid reactions, including hypotension, wheezing, dyspnea, urticaria, or pruritus.  Rapid infusion may also cause flushing of the upper body (“vancomycin infusion reaction”) or pain and muscle spasm of the chest and back. 
  Vancomycin should be administered over a period of not less than 60 minutes. Stopping the infusion usually results in prompt cessation of these reactions.
• Nephrotoxicity:  Systemic vancomycin exposure may result in acute kidney injury (AKI). The risk of AKI increases as systemic exposure/serum levels increase.  Monitor renal function in all patients; especially with underlying renal impairment, with co-morbidities, and receiving concomitant therapy with a known nephrotoxic drug.
• Ototoxicity:  It may be transient or permanent.  It has been reported mostly in patients who have been given excessive doses, who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent, such as an aminoglycoside.  Vancomycin should be used with caution in patients with renal insufficiency.
• Severe Dermatologic Reactions:  Toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear IgA bullous dermatosis (LABD) have been reported.  Cutaneous signs or symptoms reported include skin rashes, mucosal lesions, and blisters.  Discontinue Vancomycin Injection at the first appearance of signs and symptoms of TEN, SJS, DRESS, AGEP, or LABD.  Dosage of vancomycin must be adjusted for patients with renal dysfunction.
• Clostridioides difficile associated diarrhea (CDAD):  May range in severity from mild diarrhea to fatal colitis.  CDAD must be considered in all patients who present with diarrhea following antibiotic use.  If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.  Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
• Hemorrhagic Occlusive Retinal Vasculitis:  Including permanent loss of vision, occurred in patients receiving intracameral or intravitreal administration of vancomycin during or after cataract surgery.  The safety and efficacy of vancomycin administered by the intracameral or the intravitreal route have not been established.
• Adverse Reactions:  Not already mentioned above, patients have been reported to have neutropenia, phlebitis, drug fever, nausea, chills, and vasculitis in association with administration of vancomycin.
• Drug Interactions:
   - Anesthetic Agents:  Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing and anaphylactoid reactions.
  - Monitor renal function in patients receiving vancomycin and concurrent and/or sequential systemic or topical use of other potentially neurotoxic and/or nephrotoxic drugs, such as amphotericin B, aminoglycosides, bacitracin, polymyxin B, colistin, viomycin, or cisplatin.

Please see accompanying full Prescribing Information for Vancomycin Injection, USP.