Tobramycin In Sodium Chloride
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Questions & Answers
Side Effects & Adverse Reactions
See WARNINGS box above.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Tobramycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Tobramycin sulfate 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 neonate, child, and adult caused by P aeruginosa, E coli, and Klebsiella sp
Lower respiratory tract infections caused by P aeruginosa, Klebsiella sp, Enterobacter sp, Serratia sp, E coli, and S aureus (penicillinase and non-penicillinase-producing strains)
Serious central-nervous-system infections (meningitis) caused by susceptible organisms
Intra-abdominal infections, including peritonitis, caused by E coli, Klebsiella sp, and Enterobacter sp
Skin, bone, and skin-structure infections caused by P aeruginosa, Proteus sp, E coli, Klebsiella sp, Enterobacter sp, and S aureus
Complicated and recurrent urinary tract infections caused by P aeruginosa, Proteus sp (indole-positive and indole-negative), E coli, Klebsiella sp, Enterobacter sp, Serratia sp, S aureus, Providencia sp, and Citrobacter sp
Aminoglycosides, including tobramycin sulfate, 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 sulfate may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgment indicate its use.
Bacterial cultures should be obtained prior to and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. If susceptibility tests show that the causative organisms are resistant to tobramycin, other appropriate therapy should be instituted. In patients in whom a serious life-threatening gram-negative infection is suspected, including those in whom concurrent therapy with a penicillin or cephalosporin and an aminoglycoside may be indicated, treatment with tobramycin sulfate 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.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin and other antibacterial drugs, tobramycin 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 antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
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 in 0.9% Sodium Chloride Injection is a clear and colorless sterile aqueous solution for parenteral administration.
Each milliliter (mL) of the 50 mL size contains tobramycin sulfate equivalent to 1.2 mg tobramycin base with sodium chloride 9 mg in water for injection.
Each milliliter (mL) of the 100 mL size contains tobramycin sulfate equivalent to 0.8 mg tobramycin base with sodium chloride 9 mg in water for injection.
For the 50 and 100 mL sizes, the osmolar concentration is listed in the HOW SUPPLIED section; pH is 5.0 (3.0 to 6.5). Contains sulfuric acid and may contain sodium hydroxide for pH adjustment.
The solutions contain no bacteriostat, antimicrobial agent (except tobramycin) or buffer and are intended only for use as a single-dose infusion. When smaller doses are required the unused portion should be discarded.
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 1,425.39. The structural formula for tobramycin is as follows:
The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly.
Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.
Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.
Sources
Tobramycin In Sodium Chloride Manufacturers
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Hospira, Inc.
![Tobramycin In Sodium Chloride (Tobramycin Sulfate) Injection, Solution [Hospira, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Tobramycin In Sodium Chloride | Hospira, Inc.
Tobramycin sulfate injection may be given intramuscularly or intravenously. Recommended dosages are the same for both routes.
Tobramycin in 0.9% Sodium Chloride Injection is administered by intravenous infusion 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 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
(Total, 3 mg/kg/day)
(Total, 5 mg/kg/day)
kg lbmg/dose
mg/dose
120
264
120 mg
200 mg
115
253
115 mg
191 mg
110
242
110 mg
183 mg
105
231
105 mg
175 mg
100
220
100 mg
166 mg
95
209
95 mg
158 mg
90
198
90 mg
150 mg
85
187
85 mg
141 mg
80
176
80 mg
133 mg
75
165
75 mg
125 mg
70
154
70 mg
116 mg
65
143
65 mg
108 mg
60
132
60 mg
100 mg
55
121
55 mg
91 mg
50
110
50 mg
83 mg
45
99
45 mg
75 mg
40
88
40 mg
66 mg
NOTE: For information concerning the use of tobramycin in infants and children, see Pediatric tobramycin product information.
Children: 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.
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 children, 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 in 0.9% Sodium Chloride Injection should not be physically premixed with other drugs but should be administered separately according to the recommended dose and route.
The above schedules are not intended as rigid recommendations but are provided as guides to dosage when the measurement of tobramycin sulfate serum levels is not feasible.
A variety of methods are available to measure tobramycin concentrations in body fluids; these include microbiology, enzymatic and radioimmunoassay techniques.
Tobramycin in 0.9% Sodium Chloride Injection is a ready-to-use isotonic solution. NO DILUTION OR BUFFERING IS REQUIRED.
If the prescribed dose is exactly 60 or 80 mg, use the appropriate container. If the prescribed dose is higher or lower than that of the supplied containers, adjustments can be made in either container. If the dose is higher than the contents of the 80 mg container, the additional amount should be removed from a container of tobramycin and added to the 80 mg container. If the prescribed dose is less, decrements can be made by removing and discarding the appropriate amount from either unit.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See CONTRAINDICATIONS.
INSTRUCTIONS FOR USE
To Open
Tear outer wrap at notch and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.
Preparation for Administration
(Use aseptic technique)
Close flow control clamp of administration set.
Remove cover from outlet port at bottom of container.
Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: See full directions on administration set carton.
Suspend container from hanger.
Squeeze and release drip chamber to establish proper fluid level in chamber.
Open flow control clamp and clear air from set. Close clamp.
Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.
Regulate rate of administration with flow control clamp.
WARNING: Do not use flexible container in series connections.
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