Tobramycin

Tobramycin 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 TOBRAMYCIN INJECTIONIN ADULTS WITH NORMAL RENAL FUNCTION(Dosage at 8-Hour Intervals)

For Patient
Weighing

Usual Dose for
Serious Infections

kg

Lb

1 mg/kg q8h
(Total, 3 mg/kg/day)

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)

kg

Lb

1.66 mg/kg q8h
(Total, 5 mg/kg/day)

mg/dose

mL/dose*

q8h

* Applicable to all product forms except tobramycin pediatric injection (see HOW SUPPLIED ) 120 264 200 mg 5 mL 115 253 191 mg 4.75 mL 95 242 183 mg 4.5 mL 75 231 175 mg 4.4 mL 55 220 166 mg 4.2 mL 115 209 158 mg 4 mL 95 198 150 mg 3.75 mL 75 187 141 mg 3.5 mL 55 176 133 mg 3.3 mL 115 165 125 mg 3.1 mL 95 154 116 mg 2.9 mL 75 143 108 mg 2.7 mL 55 132 100 mg 2.5 mL 115 121 91 mg 2.25 mL 95 110 83 mg 2.1 mL 75 99 75 mg 1.9 mL 55 88 66 mg 1.6 mL

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.

                             * Scales have been adjusted to facilitate dosage calculations

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 may be administered by withdrawing the appropriate dose directly from a vial.

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 should not be physically premixed with other drugs but should be administered separately according to the recommended dose and route.

Prior to the administration, parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

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, USP, (Pediatric).

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.

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 should not be physically premixed with other drugs but should be administered separately according to the recommended dose and route.

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, USP, (Pediatric).

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.

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 should not be physically premixed with other drugs but should be administered separately according to the recommended dose and route.

take every 4 hours do not take more than 6 doses in 24 hours  adults and children 12 years of age and older  take 1 tablet  children 6 to under 12 years of age  take 1/2 tablet  children under 6 years of age  consult a doctor  children under 4 years of age  do not use

Tobramycin 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 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 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.

 

 

* Scales have been adjusted to facilitate dosage calculations.

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 may be administered by withdrawing the approriate dose directly from a vial.

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 should not be physically premixed with other drugs but should be administered separately according to the recommended dose and route.

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

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 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 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.

 

 

* Scales have been adjusted to facilitate dosage calculations.

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 may be administered by withdrawing the approriate dose directly from a vial.

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 should not be physically premixed with other drugs but should be administered separately according to the recommended dose and route.

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

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 3).

Adults with Life-Threatening Infections: Up to 5 mg/kg/day may be administered in 3 or 4 equal doses (see Table 3). 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 3. Dosage Schedule Guide for Tobramycin Injection, USP in Adults with Normal Renal Function (Dosage at 8-Hour Intervals)

For
Patient
Weighing

Usual Dose for
Serious Infections

Maximum Dose for Life-
Threatening Infections
(Reduce as soon as possible)

1 mg/kg q8h
(Total, 3 mg/kg/day)

1.66 mg/kg q8h
(Total, 5 mg/kg/day)

mg/dose

mL/dose*

mg/dose

mL/dose*

kg

lb

q8h

q8h

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

*   Applicable to all product forms except Tobramycin Injection, USP, 10 mg/mL (Pediatric). 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 concentration 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 a 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 or the serum creatinine of the patient, because these values correlate with the half-life of tobramycin. The dosage schedules 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 3 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 3 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 Injection, USP may be administered by withdrawing the appropriate dose directly from a vial. Tobramycin Sulfate in 0.9% Sodium Chloride 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 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.

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

This insert is for a Pharmacy Bulk Package and is intended for preparing I.V. admixtures only. 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 3).

Adults with Life-Threatening Infections: Up to 5 mg/kg/day may be administered in 3 or 4 equal doses (see Table 3). 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 3. Dosage Schedule Guide for Tobramycin Injection, USP in Adults with Normal Renal Function (Dosage at 8-Hour Intervals) For Patient
Weighing Usual Dose for
Serious Infections Maximum Dose for
Life-Threatening Infections
(Reduce as soon as possible) 1 mg/kg q8h
(Total, 3 mg/kg/day) 1.66 mg/kg q8h
(Total, 5 mg/kg/day) mg/dose mL/dose* mg/dose mL/dose* kg lb q8h q8h 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

*Applicable to all product forms except Tobramycin Injection, USP, 10 mg/mL (Pediatric).

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 or the serum creatinine of the patient, because these values correlate with the half-life of tobramycin. The dosage schedules 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 3 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 3 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 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.

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

Directions for Proper Use of Pharmacy Bulk Package

Use Aseptic Technique – Not for Direct Infusion

The pharmacy bulk package is for use in a Pharmacy Admixture Service only.

For hanger application, peel off the paper liner from both ends of the tape hanger to expose 3/4 in. long adhesive portions. Adhere each end to the label on the bottle. During use, container must be stored and all manipulations performed in an appropriate laminar flow hood. Remove cover from container and cleanse closure with antiseptic. Using aseptic technique, a single entry through the pharmacy bulk package bottle closure should be made with a sterile dispensing set which allows measured dispensing of the contents. Transfer individual dose(s) to appropriate intravenous infusion solutions without delay. Use of a syringe with needle is not recommended as it may cause leakage. Multiple entries will also increase the potential of microbial and particulate contamination. The above process should be carried out under a laminar flow hood using aseptic technique. 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.

Tobramycin 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 3).

Adults With Life-Threatening Infections:  Up to 5 mg/kg/day may be administered in 3 or 4 equal doses (see Table 3).  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 3

DOSAGE SCHEDULE GUIDE FOR ADULTS WITH NORMAL RENAL FUNCTION

(Dosage at 8-Hour Intervals)

For

Patient Weighing

Usual Dose for Serious Infections

Maximum Dose for Life-Threatening Infections

(Reduce as soon as possible)

1 mg/kg q8h

1.66 mg/kg q8h

kg

lb

(Total, 3 mg/kg/day)

(Total, 5 mg/kg/day)

 

 

mg/dose

 

mL/dose*

mg/dose

 

mL/dose*

 

 

 

q8h

 

 

q8h

 

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

*Applicable to all product forms except the tobramycin 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 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 3 by the percent of normal dose from the accompanying nomogram.

 

 

 

* Scales have been adjusted to facilitate dosage calculations.

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 3 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 may be administered by withdrawing the approriate dose directly from a vial.

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 should not be physically premixed with other drugs but should be administered separately according to the recommended dose and route.

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

Administration for Patients with Normal Renal Function

Adults with Serious Infections:  3 mg/kg/day in 3 equal doses every 8 hours (see Table 3).

Adults With Life-Threatening Infections:  Up to 5 mg/kg/day may be administered in 3 or 4 equal doses (see Table 3).  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 3

DOSAGE SCHEDULE GUIDE FOR ADULTS WITH NORMAL RENAL FUNCTION

(Dosage at 8-Hour Intervals)

For

Patient Weighing

Usual Dose for Serious Infections

Maximum Dose for Life-Threatening Infections

(Reduce as soon as possible)

1 mg/kg q8h

1.66 mg/kg q8h

kg

lb

(Total, 3 mg/kg/day)

(Total, 5 mg/kg/day)

 

 

mg/dose

 

mL/dose*

mg/dose

 

mL/dose*

 

 

 

q8h

 

 

q8h

 

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

*Applicable to all product forms except the tobramycin 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 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 3 by the percent of normal dose from the accompanying nomogram.

 

 

 

* Scales have been adjusted to facilitate dosage calculations.

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 3 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 may be administered by withdrawing the approriate dose directly from a vial.

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 should not be physically premixed with other drugs but should be administered separately according to the recommended dose and route.

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

Tobramycin 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 3).

Adults With Life-Threatening Infections: Up to 5 mg/kg/day may be administered in 3 or 4 equal doses (see Table 3). 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 3 DOSAGE SCHEDULE GUIDE FOR TOBRAMYCIN INJECTION ADULTS WITH NORMAL RENAL FUNCTION(Dosage at 8-Hour Intervals)

(continued)

For Patient Weighing
Usual Dose for Serious Infections
kg
lb
1mg/kg q 8h (Total, 3mg/kg/day)


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
Table 3DOSAGE SCHEDULE GUIDE FOR TOBRAMYCIN INJECTION ADULTS WITH NORMAL RENAL FUNCTION(Dosage at 8-Hour Intervals)

*Applicable to all product forms except Tobramycin Injection Pediatric, 10 mg/mL. See HOW SUPPLIED.

For Patient Weighing
Maximum Dose for Life-Threatening Infections (Reduce as soon as possible)
kg
lb
1.66mg/kg 8h (Total, 5mg/kg/day)


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

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 3 by the percent of normal dose from the accompanying nomogram.

* Scales have been adjusted to facilitate dosage calculations.

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 3 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 may be administered by withdrawing the appropriate dose directly from a vial.

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 should not be physically premixed with other drugs but should be administered separately according to the recommended dose and route.

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

Tobramycin 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 3).

Adults With Life-Threatening Infections: Up to 5 mg/kg/day may be administered in 3 or 4 equal doses (see Table 3). 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 3 DOSAGE SCHEDULE GUIDE FOR ADULTS WITH NORMAL RENAL FUNCTION (Dosage at 8-Hour Intervals)

(continued)

For Patient Weighing
Usual Dose for Serious Infections
kg
lb
1mg/kg q 8h (Total, 3mg/kg/day)


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

*Applicable to all product forms except Tobramycin Injection Pediatric, 10 mg/mL. See HOW SUPPLIED.

For Patient Weighing
Maximum Dose for Life-Threatening Infections (Reduce as soon as possible)
kg
lb
1.66mg/kg 8h (Total, 5mg/kg/day)


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

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 3 by the percent of normal dose from the accompanying nomogram.

* Scales have been adjusted to facilitate dosage calculations.

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 3 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 may be administered by withdrawing the appropriate dose directly from a vial.

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 should not be physically premixed with other drugs but should be administered separately according to the recommended dose and route.

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

This insert is for a Pharmacy Bulk Package and is intended for preparing intravenous admixtures only.

Tobramycin for Injection may be given intravenously.  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(seeTable 1).

Adults With Life-Threatening Infections: Up to 5 mg/kg/day may be administered in 3 or 4 equal doses (seeTable 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) Usual Dose for Maximum Dose for Life- Serious Infections Threatening Infections For (Reduce as soon as possible) Patient Weighing 1 mg/kg q8h 1.66 mg/kg q8h kg lb (Total, 3 mg/kg/day) (Total, 5 mg/kg/day)      mg/dose    mL/dose  mg/dose    mL/dose        q8h      q8h    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

 

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.

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.

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, entire contents of Pharmacy Bulk Package bottle should be dispensed within 24 hours.

Tobramycin for Injection is supplied as a dry powder. The contents of the Pharmacy Bulk Package bottle 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 Pharmacy Bulk Package bottle should be stored at controlled room temperature, 20º to 25ºC (68º to 77ºF). 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.

This insert is for a Pharmacy Bulk Package and is intended for preparing intravenous admixtures only.

Tobramycin for Injection may be given intravenously.  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 (seeTable 1).

Adults With Life-Threatening Infections: Up to 5 mg/kg/day may be administered in 3 or 4 equal doses (seeTable 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)

table 1

  

 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.

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.

figure

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.

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, entire contents of Pharmacy Bulk Package bottle should be dispensed within 24 hours.

Tobramycin for Injection is supplied as a dry powder. The contents of the Pharmacy Bulk Package bottle 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 Pharmacy Bulk Package bottle should be stored at controlled room temperature, 20º to 25ºC (68º to 77ºF). 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 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 3).

Adults With Life-Threatening Infections: Up to 5 mg/kg/day may be administered in 3 or 4 equal doses (see Table 3). 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 3 DOSAGE SCHEDULE GUIDE FOR ADULT 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

* Applicable to all product forms except Tobramycin Injection Pediatric, 10 mg/mL.

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

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 3 by the percent of normal dose from the accompanying nomogram.

*Scales have been adjusted to facilitate dosage calculations.

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 3 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 may be administered by withdrawing the appropriate dose directly from a vial.

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 should not be physically premixed with other drugs but should be administered separately according to the recommended dose and route.

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