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 ?-lactamase–producing strains of Klebsiella spp.*, E. coli*, S.

aureus*, or P.

aeruginosa* (or other Pseudomonas species*)Lower Respiratory Infections caused by ?-lactamase–producing strains of S.

aureus, H. influenzae*, or Klebsiella spp.*Bone and Joint Infections caused by ?-lactamase–producing strains of S.

aureusSkin and Skin Structure Infections caused by ?-lactamase–producing strains of S.

aureus, Klebsiella spp.*, or E. coli*Urinary Tract Infections (complicated and uncomplicated) caused by ?-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 ?-lactamase–producing strains of P. melaninogenicus*, Enterobacter spp.

(including E. cloacae*), E.

coli, K.

pneumoniae*, S. aureus, or S.

epidermidisIntra-abdominal Infections peritonitis caused by ?-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.

influenzaetype 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 ?-lactamase–producing organisms susceptible to ticarcillin/clavulanic acid should not require the addition of another antibiotic.

Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ticarcillin/clavulanic acid.

Because of 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.

Therapy with TIMENTIN may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the ?-lactamase–producing organisms listed above.

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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Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Septicemia -- systemic disease associated with presence and persistance of pathogenic microorganisms or their toxins in the blood.

BACTEREMIA -- The presence of viable bacteria circulating in the blood. Fever, chills, tachycardia, and tachypnea are common acute manifestations of bacteremia. The majority of cases are seen in already hospitalized patients, most of whom have underlying diseases or procedures which render their bloodstreams susceptible to invasion.

respiratory infection -- Invasion of the host RESPIRATORY SYSTEM by microorganisms, usually leading to pathological processes or diseases.

Arthropathy associated with infection --

skin infection -- Skin diseases caused by bacteria, fungi, parasites, or viruses.

Urinary tract infection -- Inflammatory responses of the epithelium of the URINARY TRACT to microbial invasions. They are often bacterial infections with associated BACTERIURIA and PYURIA.

Escherichia coli infections -- Infections with bacteria of the species ESCHERICHIA COLI.

Endometritis -- Inflammation of the ENDOMETRIUM, usually caused by intrauterine infections. Endometritis is the most common cause of postpartum fever.

Pneumonia -- Inflammation of any part, segment or lobe, of the lung parenchyma.

Peritonitis -- INFLAMMATION of the PERITONEUM lining the ABDOMINAL CAVITY as the result of infectious, autoimmune, or chemical processes. Primary peritonitis is due to infection of the PERITONEAL CAVITY via hematogenous or lymphatic spread and without intra-abdominal source. Secondary peritonitis arises from the ABDOMINAL CAVITY itself through RUPTURE or ABSCESS of intra-abdominal organs.

Communicable Diseases -- broad class of diseases whose causative agents may be passed between individuals in many different ways.

TIMENTIN is contraindicated in patients with a history of hypersensitivity reactions to any of the penicillins.

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Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY.

THESE REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY AND/OR A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS.

THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS. BEFORE INITIATING THERAPY WITH TIMENTIN, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS.

IF AN ALLERGIC REACTION OCCURS, TIMENTIN SHOULD BE DISCONTINUED AND THE APPROPRIATE THERAPY INSTITUTED.

SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE.

OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE PROVIDED AS INDICATED.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including TIMENTIN, and may range in severity from mild diarrhea to fatal colitis.

Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use.

Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.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.

When very high doses of TIMENTIN are administered, especially in the presence of impaired renal function, patients may experience convulsions.

(See ADVERSE REACTIONS and OVERDOSAGE.)