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Tobramycin (Tobramycin Sulfate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tobramycin Injection, USP and other antibacterial drugs, Tobramycin 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.

Tobramycin injection 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 sp

Lower respiratory tract infections caused by P. aeruginos a, Klebsiella sp, Enterobacter sp, Serratia sp, 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 sp, and Enterobacter sp

Skin, bone, and skin structure infections caused by P. aeruginosa , Proteus sp, E. coli , Klebsiella sp, Enterobacter sp, and S. aureus

Complicated and recurrent urinary tract infections caused by P. aeruginosa , Proteus sp, (indole-positive and indole-negative), E. coli , Klebsiella sp, Enterobacter sp, Serratia sp, S. aureus , Providencia sp, and Citrobacter sp.

Aminoglycosides, including tobramycin, 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 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 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 may be initiated before the results of susceptibility studies are obtained.  The decision to continue therapy with tobramycin 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.

DOSAGE AND ADMINISTRATION

This package insert labeling is for a Pharmacy Bulk Package and is intended for preparing intravenous admixtures only.  Dosage recommendations and/or references for the intramuscular route of administration are for informational purposes only .

Tobramycin Injection, USP 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 ).

Table 1  

DOSAGE SCHEDULE GUIDE FOR ADULTS WITH

NORMAL RENAL FUNCTION

(Dosage at 8-Hour Intervals)

For

Patient

Weighing  

Usual Dose for

Serious Infections

1 mg/kg q8h

(Total, 3 mg/kg/day)

   kg    lb   mg/dose   mL/dose*

q8h

120

264

120 mg

3 mL

115

253

115 mg

2.9 mL

110

242

110 mg

2.75 mL

105

231

105 mg

2.6 mL

100

220

100 mg

2.5 mL

95

209

95 mg

2.4 mL

90

198

90 mg

2.25 mL

85

187

85 mg

2.1 mL

80

176

80 mg

2 mL

75

165

75 mg

1.9 mL

70

154

70 mg

1.75 mL

65

143

65 mg

1.6 mL

60

132

60 mg

1.5 mL

55

121

55 mg

1.4 mL

50

110

50 mg

1.25 mL

45

99

45 mg

1.1 mL

40

88

40 mg

1 mL


For

Patient

Weighing

Maximum Dose for Life-

Threatening Infections

(Reduce as soon as possible)

1.66 mg/kg q8h

(Total, 5 mg/kg/day)  

  kg   lb mg/dose 
mL/dose* 

q8h

120

264

200 mg

5 mL

115

253

191 mg

4.75 mL

110

242

183 mg

4.5 mL

105

231

175 mg

4.4 mL

100

220

166 mg

4.2 mL

95

209

158 mg

4 mL

90

198

150 mg

3.75 mL

85

187

141 mg

3.5 mL

80

176

133 mg

3.3 mL

75

165

125 mg

3.1 mL

70

154

116 mg

2.9 mL

65

143

108 mg

2.7 mL

60

132

100 mg

2.5 mL

55

121

91 mg

2.25 mL

50

110

83 mg

2.1 mL

45

99

75 mg

1.9 mL

40

88

66 mg

1.6 mL

*Applicable to all product forms except the tobramycin injection for pediatric use, 10 mg/mL (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 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.

 

 

* Scales have been adjusted to facilitate dosage calculations.

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.

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 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 a Pharmacy Admixture Service and only in a suitable work area, such as a laminar flow hood. 

  1. For hanger use, grasp portion of the bottle label marked "LIFT HERE".  Peel the laminated film (sling) away from the printed portion of the pressure sensitive label.  Invert bottle and pull sling over the base of the bottle.  Hang bottle using sling portion of the label.
  2. Remove cover from closure and cleanse with antiseptic.
  3. Using aseptic technique enter the vial only 1 time 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.  Transfer individual doses to appropriate intravenous infusion solutions without delay.  AFTER INITIAL ENTRY USE ENTIRE CONTENTS OF VIAL PROMPTLY.  ANY UNUSED PORTION MUST BE DISCARDED WITHIN 4 HOURS .

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED

Tobramycin Injection USP, in the Pharmacy Bulk Package, is supplied as follows:

Product  

No.

NDC

No.

Strength

Fill Volume

300751

63323-307-51    

40 mg/mL        

50 mL in a 60 mL vial, packaged individually.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Vial stoppers do not contain natural rubber latex.



Tobramycin Injection, USP, is also available in multiple dose vials:

Product

No.

NDC

No.

Strength

Fill Volume

300502

63323-305-02

10 mg/mL     

2 mL in a 2 mL vial, packaged in 25.

300602

63323-306-02

40 mg/mL

2 mL in a 2 mL  vial, packaged in 25.

300630

63323-306-30

40 mg/mL

30 mL in a 30 mL vial, packaged in 10.


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