Tobramycin Sulfate
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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 Sulfate Manufacturers
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Pfizer Laboratories Div Pfizer Inc
![Tobramycin Sulfate Injection [Pfizer Laboratories Div Pfizer Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Tobramycin Sulfate | Pfizer Laboratories Div Pfizer 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 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 INJECTION IN ADULTS WITH NORMAL RENAL FUNCTION (Dosage at 8-Hour Intervals) * Applicable to all product forms except tobramycin pediatric injection (see HOW SUPPLIED) For Patient Weighing Usual Dose for Serious Infections kg lb 1 mg/kg q8h
(Total, 3 mg/kg/day) mg/dose mL/dose* q8h 120 264 120 mg 3 mL 115 253 115 mg 2.9 mL 110 242 110 mg 2.75 mL 105 231 105 mg 2.6 mL 100 220 100 mg 2.5 mL 95 209 95 mg 2.4 mL 90 198 90 mg 2.25 mL 85 187 85 mg 2.1 mL 80 176 80 mg 2 mL 75 165 75 mg 1.9 mL 70 154 70 mg 1.75 mL 65 143 65 mg 1.6 mL 60 132 60 mg 1.5 mL 55 121 55 mg 1.4 mL 50 110 50 mg 1.25 mL 45 99 45 mg 1.1 mL 40 88 40 mg 1 mL For Patient Weighing Maximum Dose for Life-Threatening Infections
(Reduce as soon as possible) kg lb 1.66 mg/kg q8h
(Total, 5 mg/kg/day) mg/dose mL/dose* q8h 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 intervalsWhen 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 REDUCED DOSAGE 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 IntervalsIf 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.
-
Pfizer Laboratories Div Pfizer Inc
Tobramycin Sulfate | Pfizer Laboratories Div Pfizer 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 Function Adults with Serious Infections3 mg/kg/day in 3 equal doses every 8 hours. (See Table 1).
Adults with Life-Threatening InfectionsUp 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 INJECTION IN ADULTS WITH NORMAL RENAL FUNCTION (Dosage at 8-Hour Intervals) * Applicable to all product forms except tobramycin pediatric injection (see HOW SUPPLIED) For Patient Weighing Usual Dose for Serious Infections kg lb 1 mg/kg q8h
(Total, 3 mg/kg/day) mg/dose mL/dose* q8h 120 264 120 mg 3 mL 115 253 115 mg 2.9 mL 110 242 110 mg 2.75 mL 105 231 105 mg 2.6 mL 100 220 100 mg 2.5 mL 95 209 95 mg 2.4 mL 90 198 90 mg 2.25 mL 85 187 85 mg 2.1 mL 80 176 80 mg 2 mL 75 165 75 mg 1.9 mL 70 154 70 mg 1.75 mL 65 143 65 mg 1.6 mL 60 132 60 mg 1.5 mL 55 121 55 mg 1.4 mL 50 110 50 mg 1.25 mL 45 99 45 mg 1.1 mL 40 88 40 mg 1 mL For Patient Weighing Maximum Dose for Life-Threatening Infections
(Reduce as soon as possible) kg lb 1.66 mg/kg q8h
(Total, 5 mg/kg/day) mg/dose mL/dose* q8h 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 LessUp 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 intervalsWhen 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 REDUCED DOSAGE 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 IntervalsIf 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.
![Tobramycin Sulfate Injection [Pfizer Laboratories Div Pfizer Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=86681c94-58dd-46a2-bb6c-239223a585bf&name=tobramycin-04.jpg)
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