DOSAGE AND ADMINISTRATION
This package insert labeling is for a Pharmacy Bulk Package and is intended for preparing intravenous admixtures only. Dosage recommendations and/or references for the intramuscular route of administration are for informational purposes only
.
Tobramycin Injection, USP may be given intramuscularly or intravenously. Recommended dosages are the same for both routes. The patient’s pretreatment body weight should be obtained for calculation of correct dosage. It is desirable to measure both peak and trough serum concentrations (see
WARNINGS
box and
PRECAUTIONS
).
Administration for Patients with Normal Renal Function
Adults with Serious Infections:
3 mg/kg/day in 3 equal doses every 8 hours (see Table 1).
Adults With Life-Threatening Infections:
Up to 5 mg/kg/day may be administered in 3 or 4 equal doses (see Table 1). The dosage should be reduced to 3 mg/kg/day as soon as clinically indicated. To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored (see
WARNINGS
box and
PRECAUTIONS
).
Table 1
DOSAGE SCHEDULE GUIDE FOR ADULTS WITH
NORMAL RENAL FUNCTION
(Dosage at 8-Hour Intervals)
|
For
Patient
Weighing
|
Usual Dose for
Serious Infections
1 mg/kg q8h
(Total, 3 mg/kg/day)
|
kg
|
lb
|
mg/dose |
mL/dose* |
|
q8h
|
120
|
264
|
120 mg
|
3 mL
|
115
|
253
|
115 mg
|
2.9 mL
|
110
|
242
|
110 mg
|
2.75 mL
|
105
|
231
|
105 mg
|
2.6 mL
|
100
|
220
|
100 mg
|
2.5 mL
|
95
|
209
|
95 mg
|
2.4 mL
|
90
|
198
|
90 mg
|
2.25 mL
|
85
|
187
|
85 mg
|
2.1 mL
|
80
|
176
|
80 mg
|
2 mL
|
75
|
165
|
75 mg
|
1.9 mL
|
70
|
154
|
70 mg
|
1.75 mL
|
65
|
143
|
65 mg
|
1.6 mL
|
60
|
132
|
60 mg
|
1.5 mL
|
55
|
121
|
55 mg
|
1.4 mL
|
50
|
110
|
50 mg
|
1.25 mL
|
45
|
99
|
45 mg
|
1.1 mL
|
40
|
88
|
40 mg
|
1 mL
|
For
Patient
Weighing
|
Maximum Dose for Life-
Threatening Infections
(Reduce as soon as possible)
1.66 mg/kg q8h
(Total, 5 mg/kg/day)
|
kg
|
lb
|
mg/dose
|
mL/dose*
|
|
q8h
|
120
|
264
|
200 mg
|
5 mL
|
115
|
253
|
191 mg
|
4.75 mL
|
110
|
242
|
183 mg
|
4.5 mL
|
105
|
231
|
175 mg
|
4.4 mL
|
100
|
220
|
166 mg
|
4.2 mL
|
95
|
209
|
158 mg
|
4 mL
|
90
|
198
|
150 mg
|
3.75 mL
|
85
|
187
|
141 mg
|
3.5 mL
|
80
|
176
|
133 mg
|
3.3 mL
|
75
|
165
|
125 mg
|
3.1 mL
|
70
|
154
|
116 mg
|
2.9 mL
|
65
|
143
|
108 mg
|
2.7 mL
|
60
|
132
|
100 mg
|
2.5 mL
|
55
|
121
|
91 mg
|
2.25 mL
|
50
|
110
|
83 mg
|
2.1 mL
|
45
|
99
|
75 mg
|
1.9 mL
|
40
|
88
|
66 mg
|
1.6 mL
|
*Applicable to all product forms except the tobramycin injection for pediatric use, 10 mg/mL (see
HOW SUPPLIED
).
Pediatric Patients (greater than 1 week of age):
6 to 7.5 mg/kg/day in 3 or 4 equally divided doses (2 to 2.5 mg/kg every 8 hours or 1.5 to 1.89 mg/kg every 6 hours).
Premature or Full-Term Neonates 1 Week of Age or Less:
Up to 4 mg/kg/day may be administered in 2 equal doses every 12 hours.
It is desirable to limit treatment to a short term. The usual duration of treatment is 7 to 10 days. A longer course of therapy may be necessary in difficult and complicated infections. In such cases, monitoring of renal, auditory, and vestibular functions is advised, because neurotoxicity is more likely to occur when treatment is extended longer than 10 days.
Dosage in Patients with Cystic Fibrosis
In patients with cystic fibrosis, altered pharmacokinetics may result in reduced serum concentrations of aminoglycosides. Measurement of tobramycin serum concentration during treatment is especially important as a basis for determining appropriate dose. In patients with severe cystic fibrosis, an initial dosing regimen of 10 mg/kg/day in 4 equally divided doses is recommended. This dosing regimen is suggested only as a guide. The serum levels of tobramycin should be measured directly during treatment due to wide interpatient variability.
Administration for Patients with Impaired Renal Function
Whenever possible, serum tobramycin concentrations should be monitored during therapy.
Following a loading dose of 1 mg/kg, subsequent dosage in these patients must be adjusted, either with reduced doses administered at 8-hour intervals or with normal doses given at prolonged intervals. Both of these methods are suggested as guides to be used when serum levels of tobramycin cannot be measured directly. They are based on either the creatinine clearance level or the serum creatinine level of the patient because these values correlate with the half-life of tobramycin. The dosage schedule derived from either method should be used in conjunction with careful clinical and laboratory observations of the patient and should be modified as necessary. Neither method should be used when dialysis is being performed.
Reduced dosage at 8-hour intervals
: When the creatinine clearance rate is 70 mL or less per minute or when the serum creatinine value is known, the amount of the reduced dose can be determined by multiplying the normal dose from Table 1 by the percent of normal dose from the accompanying nomogram.
An alternate rough guide for determining reduced dosage at 8-hour intervals (for patients whose steady-state serum creatinine values are known) is to divide the normally recommended dose by the patient’s serum creatinine.
* Scales have been adjusted to facilitate dosage calculations.
Normal dosage at prolonged intervals
: If the creatinine clearance rate is not available and the patient’s condition is stable, a dosage frequency
in hours
for the dosage given in Table 1 can be determined by multiplying the patient’s serum creatinine by 6.
Dosage in Obese Patients
The appropriate dose may be calculated by using the patient’s estimated lean body weight plus 40% of the excess as the basic weight on which to figure mg/kg.
Intravenous Administration
For intravenous administration, the usual volume of diluent (0.9% Sodium Chloride Injection or 5% Dextrose Injection) is 50 to 100 mL for adult doses. For pediatric patients, the volume of diluent should be proportionately less than that for adults. The diluted solution usually should be infused over a period of 20 to 60 minutes. Infusion periods of less than 20 minutes are not recommended because peak serum levels may exceed 12 mcg/mL (see
WARNINGS
box).
Tobramycin injection, USP should not be physically premixed with other drugs but should be administered separately according to the recommended dose and route.
PREPARATION AND STORAGE
Directions for Proper Use of Pharmacy Bulk Package-Not for Direct Infusion
The Pharmacy Bulk Package is for use in a Pharmacy Admixture Service and only in a suitable work area, such as a laminar flow hood.
- For hanger use, grasp portion of the bottle label marked "LIFT HERE". Peel the laminated film (sling) away from the printed portion of the pressure sensitive label. Invert bottle and pull sling over the base of the bottle. Hang bottle using sling portion of the label.
- Remove cover from closure and cleanse with antiseptic.
- Using aseptic technique enter the vial only 1 time using a suitable sterile transfer device or dispensing set which allows measured dispensing of the contents. Use of a syringe and needle is not recommended as it may cause leakage. Transfer individual doses to appropriate intravenous infusion solutions without delay. AFTER INITIAL ENTRY USE ENTIRE CONTENTS OF VIAL PROMPTLY. ANY UNUSED PORTION MUST BE DISCARDED WITHIN
4 HOURS
.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
|