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Tobramycin for injection USP is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below:
Serious central-nervous-system infections (meningitis) caused by susceptible organisms
Intra-abdominal infections, including peritonitis, caused by E. coli, Klebsiella spp, and Enterobacter spp
Skin, bone, and skin structure infections caused by P. aeruginosa, Proteus spp, E. coli, Klebsiella spp, Enterobacter spp, and S. aureus
Complicated and recurrent urinary tract infections caused by P. aeruginosa, Proteus spp (indole-positive and indole-negative), E. coli, Klebsiella spp, Enterobacter spp, Serratia spp, S. aureus, Providencia spp, and Citrobacter spp
Aminoglycosides, including tobramycin for injection USP, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity. Tobramycin for injection USP may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgement indicate its use.
Bacterial cultures should be obtained prior to and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. If susceptibility tests show that the causative organisms are resistant to tobramycin, other appropriate therapy should be instituted. In patients in whom a serious life-threatening gram-negative infection is suspected, including those in whom concurrent therapy with a penicillin or cephalosporin and an aminoglycoside may be indicated, treatment with tobramycin for injection USP may be initiated before the results of susceptibility studies are obtained. The decision to continue therapy with tobramycin for injection USP should be based on the results of susceptibility studies, the severity of the infection, and the important additional concepts discussed in the Warnings box above.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin and other antibacterial drugs, Tobramycin for Injection USP 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
This insert is for a Pharmacy Bulk Package and is intended for preparing intravenous admixtures only. Dosage recommendations and/or references to the intramuscular route of administration are for informational purposes only.
Tobramycin for Injection may be given intramuscularly or intravenously. Recommended dosages are the same for both routes. The patient's pretreatment body weight should be obtained for calculation of correct dosage. It is desirable to measure both peak and trough serum concentrations (see WARNINGS BOX and PRECAUTIONS).
Administration for Patients With Normal Renal Function – Adults With Serious Infections: 3 mg/kg/day in 3 equal doses every 8 hours (see Table 1).
Adults With Life-Threatening Infections: Up to 5 mg/kg/day may be administered in 3 or 4 equal doses (see Table 1). The dosage should be reduced to 3 mg/kg/day as soon as clinically indicated. To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored (see WARNINGS BOX and PRECAUTIONS).
Pediatric patients: 6 to 7.5 mg/kg/day in 3 or 4 equally divided doses (2 to 2.5 mg/kg every 8 hours or 1.5 to 1.89 mg/kg every 6 hours).
Premature or Full-Term Neonates 1 Week of Age or Less: Up to 4 mg/kg/day may be administered in 2 equal doses every 12 hours.
It is desirable to limit treatment to a short term. The usual duration of treatment is 7 to 10 days. A longer course of therapy may be necessary in difficult and complicated infections. In such cases, monitoring of renal, auditory, and vestibular functions is advised, because neurotoxicity is more likely to occur when treatment is extended longer than 10 days.
Table 1 - DOSAGE SCHEDULE GUIDE FOR ADULTS WITH NORMAL RENAL
(Dosage at 8-Hour Intervals)
|Usual Dose for Serious Infections
1 mg/kg q8h
(Total, 3 mg/kg/day)
|Maximum Dose for Life-
(Reduce as soon as possible)
1.66 mg/kg q8h
(Total, 5 mg/kg/day)
|120||264||120 mg||3 mL||200 mg||5 mL|
|115||253||115 mg||2.9 mL||191 mg||4.75 mL|
|110||242||110 mg||2.75 mL||183 mg||4.5 mL|
|105||231||105 mg||2.6 mL||175 mg||4.4 mL|
|100||220||100 mg||2.5 mL||166 mg||4.2 mL|
|95||209||95 mg||2.4 mL||158 mg||4 mL|
|90||198||90 mg||2.25 mL||150 mg||3.75 mL|
|85||187||85 mg||2.1 mL||141 mg||3.5 mL|
|80||176||80 mg||2 mL||133 mg||3.3 mL|
|75||165||75 mg||1.9 mL||125 mg||3.1 mL|
|70||154||70 mg||1.75 mL||116 mg||2.9 mL|
|65||143||65 mg||1.6 mL||108 mg||2.7 mL|
|60||132||60 mg||1.5 mL||100 mg||2.5 mL|
|55||121||55 mg||1.4 mL||91 mg||2.25 mL|
|50||110||50 mg||1.25 mL||83 mg||2.1 mL|
|45||99||45 mg||1.1 mL||75 mg||1.9 mL|
|40||88||40 mg||1 mL||66 mg||1.6 mL|
Dosage in Patients with Cystic Fibrosis – In patients with cystic fibrosis, altered pharmacokinetics may result in reduced serum concentrations of aminoglycosides. Measurement of tobramycin serum concentration during treatment is especially important as a basis for determining appropriate dose. In patients with severe cystic fibrosis, an initial dosage regimen of 10 mg/kg/day in 4 equally divided doses is recommended. This dosing regimen is suggested only as a guide. The serum levels of tobramycin should be measured directly during treatment due to wide interpatient variability.
Administration for Patients With Impaired Renal Function – Whenever possible, serum tobramycin concentrations should be monitored during therapy.
Following a loading dose of 1 mg/kg, subsequent dosage in these patients must be adjusted, either with reduced doses administered at 8-hour intervals or with normal doses given at prolonged intervals. Both of these methods are suggested as guides to be used when serum levels of tobramycin cannot be measured directly. They are based on either the creatinine clearance level or the serum creatinine level of the patient because these values correlate with the half-life of tobramycin. The dosage schedule derived from either method should be used in conjunction with careful clinical and laboratory observations of the patient and should be modified as necessary. Neither method should be used when dialysis is being performed.
Reduced dosage at 8-hour intervals: When the creatinine clearance rate is 70 mL or less per minute or when the serum creatinine value is known, the amount of the reduced dose can be determined by multiplying the normal dose from Table 1 by the percent of normal dose from the accompanying nomogram.
An alternate rough guide for determining reduced dosage at 8-hour intervals (for patients whose steady-state serum creatinine values are known) is to divide the normally recommended dose by the patient's serum creatinine.
Normal dosage at prolonged intervals: If the creatinine clearance rate is not available and the patient's condition is stable, a dosage frequency in hours for the dosage given in Table 1 can be determined by multiplying the patient's serum creatinine by 6.
Dosage in Obese Patients – The appropriate dose may be calculated by using the patient's estimated lean body weight plus 40% of the excess as the basic weight on which to figure mg/kg.
Intramuscular Administration – Tobramycin for Injection may be administered by withdrawing the appropriate dose directly from a vial or by using a prefilled syringe. The Pharmacy Bulk Package is not intended for intramuscular administration.
Intravenous Administration – For intravenous administration, the usual volume of diluent (0.9% Sodium Chloride Injection or 5% Dextrose Injection) is 50 to 100 mL for adult doses. For pediatric patients, the volume of diluent should be proportionately less than that for adults. The diluted solution usually should be infused over a period of 20 to 60 minutes. Infusion periods of less than 20 minutes are not recommended because peak serum levels may exceed 12 mcg/mL (see WARNINGS BOX).
Tobramycin for injection USP should not be physically premixed with other drugs but should be administered separately according to the recommended dose and route.
Preparation and Storage
Directions for Proper Use of Pharmacy Bulk Package – Not for direct infusion. The pharmacy bulk package is for use in the Hospital Pharmacy Admixture Service and only in a suitable work area, such as a laminar flow hood. Using aseptic technique, the closure may be penetrated only 1 time after reconstitution using a suitable sterile transfer device or dispensing set, which allows measured dispensing of the contents. Use of a syringe and needle is not recommended as it may cause leakage. After entry, enter contents of bulk vial should be dispensed within 24 hours.
Sterile tobramycin sulfate is supplied as a dry powder. The contents of the vial should be diluted with 30 mL of Sterile Water for Injection, USP, to provide a solution containing 40 mg of tobramycin per mL. Prior to reconstitution, the vial should be stored at controlled room temperature, 59°to 86°F (15°to 30°C). After reconstitution, the solution should be kept in a refrigerator and used within 96 hours. If kept at room temperature, the solution must be used within 24 hours.
Prior to administration, parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.
Tobramycin for Injection USP (Pharmacy Bulk Package), containing tobramycin sulfate equivalent to 1.2 gm† of tobramycin (Dry Powder in 50 mL size vial). (Single vial 39822-0412-1 and Six Pak 39822-0412-6)
Store at controlled room temperature 59° to 86°F (15°to 30°C).
Manufactured for: X-Gen Pharmaceuticals Inc., Northport, NY 11768. Revised February 2004. FDA revision date: 12/9/2002
Last reviewed on RxList: 11/13/2008
This monograph has been modified to include the generic and brand name in many instances.
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