TIMENTIN SUMMARY
TIMENTIN ®
(sterile ticarcillin disodium and clavulanate potassium)
for Intravenous Administration
TIMENTIN is a sterile injectable antibacterial combination consisting of the semisynthetic antibiotic ticarcillin disodium and the (beta)-lactamase inhibitor clavulanate potassium (the potassium salt of clavulanic acid) for intravenous administration. Ticarcillin is derived from the basic penicillin nucleus, 6-amino-penicillanic acid.
TIMENTIN is indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below: Septicemia (including bacteremia) caused by (beta)-lactamase-producing strains of Klebsiella spp. *, E. coli *, S. aureus *, or P. aeruginosa * (or other Pseudomonas species *)
Lower Respiratory Infections caused by (beta)-lactamase-producing strains of S. aureus, H. influenzae *, or Klebsiella spp. * Bone and Joint Infections caused by (beta)-lactamase-producing strains of S. aureus Skin and Skin Structure Infections caused by (beta)-lactamase-producing strains of S. aureus, Klebsiella spp. *, or E. coli * Urinary Tract Infections (complicated and uncomplicated) caused by (beta)-lactamase-producing strains of E. coli, Klebsiella spp., P. aeruginosa * (or other Pseudomonas spp. *), Citrobacter spp. *, Enterobacter cloacae *, S. marcescens *, or S. aureus * Gynecologic Infections endometritis caused by (beta)-lactamase-producing strains of P. melaninogenicus *, Enterobacter spp. (including E. cloacae *), E. coli, K. pneumoniae *, S. aureus, or S. epidermidis Intra-abdominal Infections peritonitis caused by (beta)-lactamase-producing strains of E. coli, K. pneumoniae, or B. fragilis * group
*Efficacy for this organism in this organ system was studied in fewer than 10 infections. NOTE: For information on use in pediatric patients (>/=3 months of age) see PRECAUTIONS -- Pediatric Use and CLINICAL STUDIES sections. There are insufficient data to support the use of TIMENTIN in pediatric patients under 3 months of age or for the treatment of septicemia and/or infections in the pediatric population where the suspected or proven pathogen is H. influenzae type b.
While TIMENTIN is indicated only for the conditions listed above, infections caused by ticarcillin-susceptible organisms are also amenable to treatment with TIMENTIN due to its ticarcillin content. Therefore, mixed infections caused by ticarcillin-susceptible organisms and (beta)-lactamase-producing organisms susceptible to ticarcillin/clavulanic acid should not require the addition of another antibiotic.
Due to its broad spectrum of bactericidal activity against gram-positive and gram-negative bacteria, TIMENTIN is particularly useful for the treatment of mixed infections and for presumptive therapy prior to the identification of the causative organisms. TIMENTIN has been shown to be effective as single drug therapy in the treatment of some serious infections where normally combination antibiotic therapy might be employed.
Based on the in vitro synergism between ticarcillin/clavulanic acid and aminoglycosides against certain strains of P. aeruginosa, combined therapy has been successful, especially in patients with impaired host defenses. Both drugs should be used in full therapeutic doses.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of TIMENTIN and other antibacterial drugs, TIMENTIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
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