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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 β-lactamase–producing strains of Klebsiella spp.*, E. coli*, S. aureus*, or P. aeruginosa* (or other Pseudomonas species*)
Lower Respiratory Infections caused by β-lactamase–producing strains of S. aureus, H. influenzae*, or Klebsiella spp.*
Bone and Joint Infections caused by β-lactamase–producing strains of S. aureus
Skin and Skin Structure Infections caused by β-lactamase–producing strains of S. aureus, Klebsiella spp.*, or E. coli*
Urinary Tract Infections (complicated and uncomplicated) caused by β-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 β-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 β-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 β-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 β-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.
DOSAGE AND ADMINISTRATION
TIMENTIN should be administered by intravenous infusion (30 min.).
Adults: The usual recommended dosage for systemic and urinary tract infections for average (60 kg) adults is 3.1 grams of TIMENTIN (3.1-gram vial containing 3 grams ticarcillin and 100 mg clavulanic acid) given every 4 to 6 hours. For gynecologic infections, TIMENTIN should be administered as follows: Moderate infections, 200 mg/kg/day in divided doses every 6 hours, and for severe infections, 300 mg/kg/day in divided doses every 4 hours. For patients weighing less than 60 kg, the recommended dosage is 200 to 300 mg/kg/day, based on ticarcillin content, given in divided doses every 4 to 6 hours.
Pediatric Patients ( ≥ 3 months): For patients < 60 kg: In patients < 60 kg, TIMENTIN is dosed at 50 mg/kg/dose based on the ticarcillin component. TIMENTIN should be administered as follows: Mild to moderate infections, 200 mg/kg/day in divided doses every 6 hours; for severe infections, 300 mg/kg/day in divided doses every 4 hours.
For patients ≥ 60 kg: For mild to moderate infections, 3.1 grams of TIMENTIN (3 grams of ticarcillin and 100 mg of clavulanic acid) administered every 6 hours; for severe infections, 3.1 grams every 4 hours. Renal Impairment: For infections complicated by renal insufficiency†, an initial loading dose of 3.1 grams should be followed by doses based on creatinine clearance and type of dialysis as indicated below:
|Creatinine clearance mL/min.||Dosage|
|over 60||3.1 grams every 4 hrs.|
|30 to 60||2 grams every 4 hrs.|
|10 to 30||2 grams every 8 hrs.|
|less than 10||2 grams every 12 hrs.|
|less than 10 with hepatic dysfunction||2 grams every 24 hrs.|
|patients on peritoneal dialysis||3.1 grams every 12 hrs.|
|patients on hemodialysis||2 grams every 12 hrs. supplemented with 3.1 grams after each dialysis|
|†The half-life of ticarcillin in patients with renal failure is approximately 13 hours|
|To calculate creatinine clearance‡ from a serum creatinine value use the following formula:|
|Ccr=||(140-Age) (wt. in kg)|
|72 x Scr (mg/100 mL)|
|This is the calculated creatinine clearance for adult males; for females it is 15% less.|
|‡Cockcroft, D.W., et al: Prediction of Creatinine Clearance from Serum Creatinine. Nephron 16:31-41, 1976.|
Dosage for any individual patient must take into consideration the site and severity of infection, the susceptibility of the organisms causing infection, and the status of the patient's host defense mechanisms.
The duration of therapy depends upon the severity of infection. Generally, TIMENTIN should be continued for at least 2 days after the signs and symptoms of infection have disappeared. The usual duration is 10 to 14 days; however, in difficult and complicated infections, more prolonged therapy may be required.
Frequent bacteriologic and clinical appraisals are necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed. Persistent infections may require treatment for several weeks, and doses smaller than those indicated above should not be used.
In certain infections, involving abscess formation, appropriate surgical drainage should be performed in conjunction with antimicrobial therapy.
Directions For Use
The 3.1-gram vial should be reconstituted by adding approximately 13 mL of Sterile Water for Injection, USP, or Sodium Chloride Injection, USP, and shaking well. When dissolved, the concentration of ticarcillin will be approximately 200 mg/mL with a corresponding concentration of 6.7 mg/mL for clavulanic acid. Conversely, each 5.0 mL of the 3.1-gram dose reconstituted with approximately 13 mL of diluent will contain approximately 1 gram of ticarcillin and 33 mg of clavulanic acid.
Intravenous Infusion: The dissolved drug should be further diluted to desired volume using the recommended solution listed in the COMPATIBILITY AND STABILITY Section (STABILITY PERIOD) to a concentration between 10 mg/mL to 100 mg/mL. The solution of reconstituted drug may then be administered over a period of 30 minutes by direct infusion or through a Y-type intravenous infusion set. If this method of administration is used, it is advisable to discontinue temporarily the administration of any other solutions during the infusion of TIMENTIN.
Stability: For I.V. solutions, see STABILITY PERIOD below.
When TIMENTIN is given in combination with another antimicrobial, such as an aminoglycoside, each drug should be given separately in accordance with the recommended dosage and routes of administration for each drug.
After reconstitution and prior to administration, TIMENTIN, as with other parenteral drugs, should be inspected visually for particulate matter. If this condition is evident, the solution should be discarded.
The color of reconstituted solutions of TIMENTIN normally ranges from light to dark yellow, depending on concentration, duration, and temperature of storage while maintaining label claim characteristics.
Compatibility And Stability
(Dilutions Derived From A Stock Solution Of 200 Mg/Ml)
The concentrated stock solution at 200 mg/mL is stable for up to 6 hours at room temperature 21° to 24°C (70° to 75°F) or up to 72 hours under refrigeration 4°C (40°F).
If the concentrated stock solution (200 mg/mL) is held for up to 6 hours at room temperature 21° to 24°C (70° to 75°F) or up to 72 hours under refrigeration 4°C (40°F) and further diluted to a concentration between 10 mg/mL and 100 mg/mL with any of the diluents listed below, then the following stability periods apply.
Stability Period (3.1-gram Vials)
|Intravenous Solution (ticarcillin concentrations of 10 mg/mL to 100 mg/mL)||Room Temperature 21° to 24°C (70° to 75°F)||Refrigerated 4°C (40°F)|
|Dextrose Injection 5%, USP||24 hours||3 days|
|Sodium Chloride Injection, USP||24 hours||7 days|
|Lactated Ringer's Injection, USP||24 hours||7 days|
If the concentrated stock solution (200 mg/mL) is stored for up to 6 hours at room temperature and then further diluted to a concentration between 10 mg/mL and 100 mg/mL, solutions of Sodium Chloride Injection, USP, and Lactated Ringer's Injection, USP, may be stored frozen –18°C (0°F) for up to 30 days. Solutions prepared with Dextrose Injection 5%, USP, may be stored frozen –18°C (0°F) for up to 7 days. All thawed solutions should be used within 8 hours or discarded. Once thawed, solutions should not be refrozen.
NOTE: TIMENTIN is incompatible with Sodium Bicarbonate.
Unused solutions must be discarded after the time periods listed above.
Each 3.1-gram vial of TIMENTIN contains sterile ticarcillin disodium equivalent to 3 grams ticarcillin and sterile clavulanate potassium equivalent to 0.1 gram clavulanic acid.
NDC 0029-6571-26 3.1-gram Vial
TIMENTIN is also supplied as:
NDC 0029-6571-40 3.1-gram ADD-Vantage® Antibiotic Vial
Each 31 gram Pharmacy Bulk Package contains sterile ticarcillin disodium equivalent to 30 grams ticarcillin and sterile clavulanate potassium equivalent to 1 gram clavulanic acid.
NDC 0029-6579-21 31 gram Pharmacy Bulk Package
Vials of TIMENTIN should be stored at or below 24°C (75°F).
NDC 0029-6571-31 TIMENTIN as an iso-osmotic, sterile, nonpyrogenic, frozen solution in GALAXY® (PL 2040) Plastic Containers - supplied in 100 mL single-dose containers equivalent to 3 grams ticarcillin and clavulanate potassium equivalent to 0.1 gram clavulanic acid.
GlaxoSmithKline, Research Triangle Park, NC 27709
Last reviewed on RxList: 6/28/2011
This monograph has been modified to include the generic and brand name in many instances.
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