Tobramycin
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Questions & Answers
Side Effects & Adverse Reactions
See WARNINGS box above.
Tobramycin injection contains sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Serious allergic reactions including anaphylaxis and dermatologic reactions including exfoliative dermatitis, toxic epidermal necrolysis, erythema multiforme, and Stevens - Johnson syndrome have been reported rarely in patients on tobramycin therapy. Although rare, fatalities have been reported. (See CONTRAINDICATIONS.)
If an allergic reaction occurs, the drug should be discontinued and appropriate therapy instituted.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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 is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below:
Septicemia in the pediatric patient and adult caused by P. aeruginosa, E. coli., and Klebsiella spp
Lower respiratory tract infections caused by P. aeruginosa, Klebsiella spp, Enterobacter spp, Serratia spp, E. coli, and S. aureus (penicillinase and non-penicillinase-producing strains)
Serious central nervous system infections (meningitis) caused by susceptible organisms.
Intra-abdominal infections, including peritonitis, caused by E. coli, Klebsiella spp, and Enterobacter spp
Skin, bone, and skin-structure infections caused by P. aeruginosa, Proteus spp, E. coli, Klebsiella spp, Enterobacter spp, and S. aureus
Complicated and recurrent urinary tract infections caused by P. aeruginosa, Proteus spp (indole-positive and indole-negative), E. coli, Klebsiella spp, Enterobacter spp, Serratia spp, S. aureus, Providencia, and Citrobacter spp
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 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.
History
There is currently no drug history available for this drug.
Other Information
Tobramycin sulfate, a water-soluble antibiotic of the aminoglycoside group, is derived from the actinomycete Streptomyces tenebrarius. Tobramycin injection USP is a clear and colorless sterile aqueous solution for parenteral administration.
Tobramycin sulfate is O-3-amino-3-deoxy- α-D-glucopyranosyl-(1→4)-O-[2,6-diamino-2,3,6- trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy-L-streptamine sulfate (2:5) (salt) and has the chemical formula (C18H37N5O9)2•5H2SO4. The molecular weight is 1,425.45. The structural formula for tobramycin is as follows:
Each mL contains Active: tobramycin sulfate equivalent to 40 mg tobramycin; Preservative: phenol 5 mg; Inactives: 0.1 mg edetate disodium; sodium bisulfite 3.2 mg; sulfuric acid and/or sodium hydroxide may have been added to adjust the pH (3.0 to 6.5) and water for injection, q.s.
Sources
Tobramycin Manufacturers
-
Akorn – Strides, Llc
![Tobramycin (Tobramycin Sulfate) Injection [Akorn – Strides, Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Tobramycin | Akorn - Strides, Llc
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 FunctionAdults 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
WeighingUsual Dose for
Serious Infectionskg
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 mLFor
Patient
WeighingMaximum 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 mLPediatric 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 FibrosisIn 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 FunctionWhenever 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 PatientsThe 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 AdministrationTobramycin may be administered by withdrawing the appropriate dose directly from a vial.
Intravenous AdministrationFor 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.
-
App Pharmaceuticals, Llc
Tobramycin | App Pharmaceuticals, Llc
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 Infections3 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 PatientsThe 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 Infections3 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 PatientsThe 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.
-
Fresenius Kabi Usa, Llc
Tobramycin | Dolgencorp, Inc. (dollar General & Rexall)
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 -
Fresenius Kabi Usa, Llc
Tobramycin | Fresenius Kabi Usa, Llc
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 PatientsThe 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 AdministrationTobramycin 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 PatientsThe 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 AdministrationTobramycin 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.
-
Hospira, Inc.
Tobramycin | Hospira, Inc.
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
WeighingUsual Dose for
Serious InfectionsMaximum 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.
-
Hospira, Inc.
Tobramycin | Hospira, Inc.
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.
-
Fresenius Kabi Usa, Llc
Tobramycin | Fresenius Kabi Usa, Llc
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 PatientsThe 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 AdministrationTobramycin 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 PatientsThe 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 AdministrationTobramycin 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.
-
Mylan Institutional Llc
Tobramycin | Mylan Institutional Llc
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.
-
Mylan Institutional Llc
Tobramycin | Mylan Institutional Llc
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.
-
X-gen Pharmaceuticals, Inc.
Tobramycin | X-gen Pharmaceuticals, Inc.
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 mLPediatric 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.
-
X-gen Pharmaceuticals, Inc.
Tobramycin | X-gen Pharmaceuticals, Inc.
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.
-
Akorn, Inc.
Tobramycin | Akorn, Inc.
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 FunctionAdults 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 mLPediatric 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 FibrosisIn 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 FunctionWhenever 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 PatientsThe 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 AdministrationTobramycin may be administered by withdrawing the appropriate dose directly from a vial.
Intravenous AdministrationFor 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.
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