Nebcin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below:

Septicemia in the pediatric patient and adult caused by. P. aeruginosa, E. coli, and Klebsiella spp

Lower respiratory tract infections caused by P.aeruginosa, Klebsiella spp, Enterobacter spp, Serratia spp, E.coli, and S.aureus (penicillinase and non-penicillinase producing strains)

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 Nebcin, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity. Nebcin may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgment 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 wshow 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 Nebcin may be initiated before the results of susceptibility studies are obtained. The decision to continue therapy with Nebcin 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.

The patientγ¢††s pretreatment bodyweight 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).

Table 1

DOSAGE SCHEDULE GUIDE FOR ADULTS WITH NORMAL RENAL FUNCTION
(Dosage at 8-Hour Intervals)

*Applicable to all product forms except Nebcin, Pediatric, Injection (see How Supplied).

Pediatric patients (greater than 1 week of age): 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.

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 dosing 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 1mg/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 patientγ¢††s serum creatinine.

Normal dosage at prolonged intervals: If the creatinine clearance rate is not available and the patientγ¢††s condition is stable, a dosage frequency in hours for the dosage given in Table 1 can be determined by multiplying the patientγ¢††s serum creatinine by 6.

Dosage in Obese Patients

The appropriate dose may be calculated by using the patientγ¢††s estimated lean body weight plus 40% of the excess as the basic weight on which to figure mg/kg.

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).

Nebcin 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 wflow 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, entire contents of bulk vial should be dispensed within 24 hours.

Nebcin, Sterile, is supplied as a dry powder. The contents of the vial (No. 7040) 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.

Pharmacy Bulk Vial:

1.2 g* (Dry Powder) (40-mL size) (No.7040)γ¢††( Traypak of 6) NDC 0002-7040-16

Also Available:

Multiple-Dose Vials:

80 mg*/2 mL, 2 mL (No.781)γ¢††(Traypak of 25) NDC 0002-1499-25
Pediatric, 20 mg*/2 mL, 2mL (No.782)γ¢††(1s) NDC 0002-0501-01
40 mg*/mL, 1.2 g/30 mL (No.7090)γ¢††(Traypak of 6) NDC 0002-7090-16

ADD-Vantage Vials:

60 mg*/6 mL, 6 mL (No.7293)γ¢††(Traypak of 25) NDC 0002-7293-25
80 mg*/8 mL, 8 mL( No. 7294)γ¢††(Traypak of 25) NDC 0002-7294-25

The above ADD-Vantage vials are to be used only with Abbott Laboratoriesγ¢†† diluent containers.

Store at controlled room temperature 59°to 86° F (15°to 30°C).

*Equivalent to tobramycin

^γ¢†Â Traypak TM ( multivial carton, Lilly)

REFERENCES

1.National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disk Susceptibility Tests γ¢†† Sixth Edition. Approved Standard NCCLS Document M2-A6, Vol.17,No.1,NCCLS, Wayne, PA, 1997.

2.National Committee for Clinical Laboratory Standards, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically γ¢†† Fourth Edition. Approved Standard NCCLS Document M7-A4, Vol.17,No.2, NCCLS, Wayne, PA, 1997.

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