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VANCOMYCIN BAXTER (Baxter Healthcare Pty Ltd)

Product name
VANCOMYCIN BAXTER
Date registered
Evaluation commenced
Decision date
Approval time
126 (255 working days)
Active ingredients
vancomycin hydrochloride
Registration type
New generic medicine
Indication

VANCOMYCIN BAXTER is indicated for potentially life threatening infections which cannot be treated with another effective, less toxic antimicrobial drug, including the penicillins and cephalosporins.

VANCOMYCIN BAXTER is useful in therapy of severe staphylococcal (including methicillin-resistant staphylococcal) infections in patients who cannot receive or who have failed to respond to the penicillins and cephalosporins or who have infections with staphylococci that are resistant to other antibiotics. Once sensitivity data are available, therapy should be adjusted accordingly.

VANCOMYCIN BAXTER is effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., S. faecalis), vancomycin is effective only in combination with an aminoglycoside. Vancomycin is effective for the treatment of diphtheroid endocarditis. VANCOMYCIN BAXTER is used in combination with rifampicin, an aminoglycoside, or both in early onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids.

The effectiveness of vancomycin has been documented in other infections due to staphylococci including osteomyelitis, pneumonia, septicaemia and, skin and skin structure infections. When staphylococcal infections are localised and purulent, antibiotics are used as adjuncts to appropriate surgical measures.

Specimens for bacteriological cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin.

Vancomycin should be administered orally for the treatment of staphylococcal enterocolitis and antibiotic associated pseudomembranous colitis (produced by C. difficile). Parenteral administration of vancomycin alone is inappropriate for this indication. Vancomycin is not effective by the oral route for other types of infections. For oral administration the parenteral formulation may be used. Some systemic absorption may occur following oral administration in patients with pseudomembranous colitis.

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