Gentamicin Sulfate In Sodium Chloride
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Questions & Answers
Side Effects & Adverse Reactions
WARNINGS: (See WARNINGS box on first page).
Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycoside antibiotics cross the placenta, and there have been several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Animal reproduction studies conducted on rats and rabbits did not reveal evidence of impaired fertility or harm to the fetus due to gentamicin sulfate. It is also not known whether gentamicin sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Serious side effects to mother, fetus, or newborn have not been reported in the treatment of pregnant women with other aminoglycosides. If gentamicin is used during pregnancy or if the patient becomes pregnant while taking gentamicin, she should be apprised of the potential hazard to the fetus.
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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 gentamicin and other antibacterial drugs, gentamicin 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.
Gentamicin Sulfate in 0.9% Sodium Chloride Injection is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: Pseudomonas aeruginosa, Proteus species (indole-positive and indole-negative), Escherichia coli, Klebsiella-Enterobacter-Serratia species, Citrobacter species, and Staphylococcus species (coagulase-positive and coagulase-negative).
Clinical studies have shown gentamicin sulfate to be effective in bacterial neonatal sepsis; bacterial septicemia; and serious bacterial infections of the central nervous system (meningitis), urinary tract, respiratory tract, gastrointestinal tract (including peritonitis), skin, bone and soft tissue (including burns).
Aminoglycosides, including gentamicin, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are susceptible to these antibiotics and are not susceptible to antibiotics having less potential for toxicity.
Specimens for bacterial culture should be obtained to isolate and identify causative organisms and to determine their susceptibility to gentamicin.
Gentamicin may be considered as initial therapy in suspected or confirmed gram-negative infections, and therapy may be instituted before obtaining results of susceptibility testing. The decision to continue therapy with this drug should be based on the results of susceptibility tests, the severity of the infection, and the important additional concepts contained in the “WARNINGS box”. If the causative organisms are resistant to gentamicin, other appropriate therapy should be instituted.
In serious infections when the causative organisms are unknown, gentamicin may be administered as initial therapy in conjunction with a penicillin-type or cephalosporin-type drug before obtaining results of susceptibility testing. If anaerobic organisms are suspected as etiologic agents, consideration should be given to using other suitable antimicrobial therapy in conjunction with gentamicin. Following identification of the organism and its susceptibility, appropriate antibiotic therapy should then be continued.
Gentamicin has been used effectively in combination with carbenicillin for the treatment of life-threatening infections caused by Pseudomonas aeruginosa. It has also been found effective when used in conjunction with a penicillin-type drug for the treatment of endocarditis caused by group D streptococci.
Gentamicin has also been shown to be effective in the treatment of serious staphylococcal infections. While not the antibiotic of first choice, gentamicin may be considered when penicillins or other less potentially toxic drugs are contraindicated and bacterial susceptibility tests and clinical judgment indicate its use. It may also be considered in mixed infections caused by susceptible strains of staphylococci and gram-negative organisms.
In the neonate with suspected bacterial sepsis or staphylococcal pneumonia, a penicillin-type drug is also usually indicated as concomitant therapy with gentamicin.
History
There is currently no drug history available for this drug.
Other Information
Gentamicin Sulfate in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic solution of gentamicin sulfate in 0.9% sodium chloride injection. It is administered by the intravenous route as an antibiotic infusion.
Each milliliter (mL) of the 50 mL size contains gentamicin sulfate equivalent to 1.2, 1.4, 1.6 or 2 mg gentamicin base with sodium chloride 9 mg in water for injection.
Each milliliter (mL) of the 100 mL size contains gentamicin sulfate equivalent to 0.6, 0.8, 0.9 or 1 mg gentamicin base with sodium chloride 9 mg in water for injection.
For the 50 and 100 mL sizes, the osmolar concentration is 317 mOsmol/liter (calc.); pH is 3.8 (3.0 to 5.5). May contain sulfuric acid and/or sodium hydroxide for pH adjustment.
The solutions contain no bacteriostat, antimicrobial agent (except gentamicin) or buffer and are intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded.
Gentamicin is classified as an aminoglycoside antibiotic and is derived from Micromonospora purpurea, an actinomycete.
The chemical name for gentamicin C1A is: 0-3-Deoxy-4-C-methyl-3-(methylamino)-β-L-arabinopyranosyl-(1→ 6)-0-[2,6-diamino-2,3,4,6-tetradeoxy-α-D-erythro-hexopyranosyl-(1 → 4)]-2-deoxy-D-streptamine.
Gentamicin Sulfate, USP is chemically designated gentamicin sulfate, a white to buff powder soluble in water. It has the following structural formula:
Sources
Gentamicin Sulfate In Sodium Chloride Manufacturers
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Hospira, Inc.
![Gentamicin Sulfate In Sodium Chloride (Gentamicin Sulfate) Injection, Solution [Hospira, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Gentamicin Sulfate In Sodium Chloride | Hospira, Inc.
Gentamicin Sulfate 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. The dosage of aminoglycosides in obese patients should be based on an estimate of the lean body mass. It is desirable to limit the duration of treatment with aminoglycosides to short term.
Patients with Normal Renal Function
Adults: The recommended dosage of gentamicin sulfate for patients with serious infections and normal renal function is 3 mg/kg/day, administered in three equal doses every eight hours (Table 1).
For patients with life-threatening infections, dosages up to 5 mg/kg/day may be administered in three or four equal doses. The dosage should be reduced to 3 mg/kg/day as soon as clinically indicated (Table 1).
It is desirable to measure both peak and trough serum concentrations of gentamicin to determine the adequacy and safety of the dosage. When such measurements are feasible, they should be carried out periodically during therapy to assure adequate but not excessive drug levels. For example, the peak concentration (at 30 to 60 minutes following cessation of infusion) is expected to be in the range of 4 to 6 mcg/mL. When monitoring peak concentrations, dosage should be adjusted so that prolonged levels above 12 mcg/mL are avoided. When monitoring trough concentrations (just prior to the next dose), dosage should be adjusted so that levels above 2 mcg/mL are avoided. Determination of the adequacy of a serum level for a particular patient must take into consideration the susceptibility of the causative organism, the severity of the infection, and the status of the patient’s host-defense mechanisms. In patients with extensive burns, altered pharmacokinetics may result in reduced serum concentrations of aminoglycosides. In such patients treated with gentamicin, measurement of serum concentrations is recommended as a basis for dosage adjustment.
Table 1 Dosage Schedule Guide For Adults With Normal Renal Function (Dosage at Eight-Hour Intervals)Patient’s
Weight*
kg (lb)
Usual Dose
for Serious
Infections
1 mg/kg q8h
(3 mg/kg/day)
Dose for Life-Threatening
Infections (Reduce as Soon
as Clinically Indicated)
1.7 mg/kg q8h**
(5 mg/kg/day)
mg/dose
q8h
mg/dose
q8h
40 ( 88) 40 6645
( 99)
45
75
50
(110)
50
83
55
(121)
55
91
60
(132)
60
100
65
(143)
65
108
70
(154)
70
116
75
(165)
75
125
80
(176)
80
133
85
(187)
85
141
90
(198)
90
150
95
(209)
95
158
100
(220)
100
166
* The dosage of aminoglycosides in obese patients should be based on an estimate of the lean body mass.
** For q6h schedules, dosage should be recalculated.
NOTE: For information concerning the use of gentamicin in infants and children, see Pediatric Gentamicin Sulfate Injection product information.
The usual duration of treatment for all patients is seven to ten days. In difficult and complicated infections, a longer course of therapy may be necessary. In such cases monitoring of renal, auditory, and vestibular functions is recommended, since toxicity is more apt to occur with treatment extended for more than ten days. Dosage should be reduced if clinically indicated.
The intravenous administration of gentamicin may be particularly useful for treating patients with bacterial septicemia or those in shock. It may also be the preferred route of administration for some patients with congestive heart failure, hematologic disorders, severe burns, or those with reduced muscle mass. For multiple intravenous administration in adults, a single dose of Gentamicin Sulfate in 0.9% Sodium Chloride Injection may be administered according to individual patient requirements from a premixed flexible bag. The solution may be infused over a period of one-half to two hours.
Gentamicin sulfate should not be physically premixed with other drugs, but should be administered separately in accordance with the recommended route of administration and dosage schedule.
Patients with Impaired Renal Function
Dosage must be adjusted in patients with impaired renal function to assure therapeutically adequate, but not excessive blood levels. Whenever possible, serum concentrations of gentamicin should be monitored. One method of dosage adjustment is to increase the interval between administration of the usual doses. Since the serum creatinine concentration has a high correlation with the serum half-life of gentamicin, this laboratory test may provide guidance for adjustment of the interval between doses. The interval between doses (in hours) may be approximated by multiplying the serum creatinine level (mg/100 mL) by 8. For example, a patient weighing 60 kg with a serum creatinine level of 2 mg/100 mL could be given 60 mg (1 mg/kg) every 16 hours (2 x 8).
In patients with serious systemic infections and renal impairment, it may be desirable to administer the antibiotic more frequently but in reduced dosage. In such patients, serum concentrations of gentamicin should be measured so that adequate, but not excessive levels result. A peak and trough concentration measured intermittently during therapy will provide optimal guidance for adjusting dosage. After the usual initial dose, a rough guide for determining reduced dosage at eight-hour intervals is to divide the normally recommended dose by the serum creatinine level (Table 2). For example, after an initial dose of 60 mg (1 mg/kg), a patient weighing 60 kg with a serum creatinine level of 2 mg/100 mL could be given 30 mg every eight hours (60 ÷ 2). It should be noted that the status of renal function may be changing over the course of the infectious process.
It is important to recognize that deteriorating renal function may require a greater reduction in dosage than that specified in the above guidelines for patients with stable renal impairment.
Table 2 Dosage Adjustment Guide for Patients with Renal Impairment (Dosage at Eight-Hour Intervals After the Usual Initial Dose)Serum
Creatinine
(mg %)
Approximate
Creatinine
Clearance
(mL/min/1.73M2)
Percent of
Usual Doses
Shown in
Table 1
≤1.0
>100
100
1.1 - 1.3
70 - 100
80
1.4 - 1.6
55 - 70
65
1.7 - 1.9
45 - 55
55
2.0 - 2.2
40 - 45
50
2.3 - 2.5
35 - 40
40
2.6 - 3.0
30 - 35
35
3.1 - 3.5
25 - 30
30
3.6 - 4.0
20 - 25
25
4.1 - 5.1
15 - 20
20
5.2 - 6.6
10 - 15
15
6.7 - 8.0
<10
10
In adults with renal failure undergoing hemodialysis, the amount of gentamicin removed from the blood may vary depending upon several factors including the dialysis method used. An eight-hour hemodialysis may reduce serum concentrations of gentamicin by approximately 50%. The recommended dose at the end of each dialysis period is 1 to 1.7 mg/kg depending upon the severity of infection.
The above dosage schedules are not intended as rigid recommendations but are provided as guides to dosage when the measurement of gentamicin serum levels is not feasible.
A variety of methods are available to measure gentamicin concentrations in body fluids; these include microbiologic, enzymatic and radioimmunoassay techniques.
Gentamicin Sulfate Injection is a ready-to-use isotonic solution. NO DILUTION OR BUFFERING IS REQUIRED.
If the prescribed dose is exactly 60, 70, 80, 90 or 100 mg, use the appropriate container. If the prescribed dose is higher or lower than that of the supplied container, adjustments can be made in either container. If the dose is higher than the contents of the 100 mg container, the additional amount should be removed from a container of gentamicin sulfate (40 mg/mL) and added to the 100 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. If supplemental medication is desired, follow directions below before preparing for administration. 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.
-
Baxter Healthcare Corporation
Gentamicin Sulfate In Sodium Chloride | Baxter Healthcare Corporation
Gentamicin Sulfate in 0.9% Sodium Chloride Injection is for intravenous use only.
The patient’s pretreatment body weight should be obtained for calculation of correct dosage. The dosage of aminoglycosides in obese patients should be based on an estimate of the lean body mass. It is desirable to limit the duration of treatment with aminoglycosides to short term.
Patients with Normal Renal FunctionAdults: The recommended dosage of Gentamicin Sulfate in 0.9% Sodium Chloride Injection for patients with serious infections and normal renal function is 3 mg/kg/day administered in three equal doses every eight hours (Table 1).
For patients with life-threatening infections, dosages up to 5 mg/kg/day may be administered in three or four equal doses. The dosage should be reduced to 3 mg/kg/day as soon as clinically indicated (Table 1).
It is desirable to measure both peak and trough serum concentrations of gentamicin to determine the adequacy and safety of the dosage. When such measurements are feasible, they should be carried out periodically during therapy to assure adequate but not excessive drug levels. For example, the peak concentration (at 30 to 60 minutes following cessation of infusion) is expected to be in the range of 4 to 6 mcg/mL. When monitoring peak concentrations, dosage should be adjusted so that prolonged levels above 12 mcg/mL are avoided. When monitoring trough concentrations (just prior to the next dose), dosage should be adjusted so that levels above 2 mcg/mL are avoided. Determination of the adequacy of a serum level for a particular patient must take into consideration the susceptibility of the causative organism, the severity of the infection, and the status of the patient’s host-defense mechanisms.
In patients with extensive burns, altered pharmacokinetics may result in reduced serum concentrations of aminoglycosides. In such patients treated with gentamicin, measurement of serum concentrations is recommended as a basis for dosage adjustment.
Table 1. * The dosage of aminoglycosides in obese patients should be based on an estimate of the lean body mass. † For q6h schedules, dosage should be recalculated. Dosage Schedule Guide for Adults With Normal Renal Function
(Dosage at Eight-Hour Intervals) Patient’s
Weight* Usual Dose
for Serious
Infections
1 mg/kg q8h
(3 mg/kg/day)
Dose for Life-Threatening
Infections (Reduce as Soon
as Clinically Indicated)
1.7 mg/kg q8h†
(5 mg/kg/day) kg (lb) mg/dose
q8h mg/dose
q8h 40 ( 88) 40 66 45 ( 99) 45 75 50 (110) 50 83 55 (121) 55 91 60 (132) 60 100 65 (143) 65 108 70 (154) 70 116 75 (165) 75 125 80 (176) 80 133 85 (187) 85 141 90 (198) 90 150 95 (209) 95 158 100 (220) 100 166Children: 6 to 7.5 mg/kg/day (2 to 2.5 mg/kg administered every eight hours).
Infants and Neonates: 7.5 mg/kg/day (2.5 mg/kg administered every eight hours).
Premature or Full-Term Neonates One Week of Age or Less: 5 mg/kg/day (2.5 mg/kg administered every 12 hours).
NOTE: For further information concerning the use of gentamicin in infants and children, see Pediatric Gentamicin Sulfate Injection product information.
The usual duration of treatment for all patients is seven to ten days. In difficult and complicated infections, a longer course of therapy may be necessary. In such cases monitoring of renal, auditory, and vestibular functions is recommended, since toxicity is more apt to occur with treatment extended for more than ten days. Dosage should be reduced if clinically indicated.
For Intravenous Administration
The intravenous administration of gentamicin may be particularly useful for treating patients with bacterial septicemia or those in shock. It may also be the preferred route of administration for some patients with congestive heart failure, hematologic disorders, severe burns, or those with reduced muscle mass. For intermittent intravenous administration in adults, a single dose of Gentamicin Sulfate in 0.9% Sodium Chloride Injection may be administered according to individual patient requirements from the appropriate premixed container. The solution may be infused over a period of one-half to two hours.
Gentamicin Sulfate Injection should not be physically premixed with other drugs, but should be administered separately in accordance with the recommended route of administration and dosage schedule.
Patients with Impaired Renal FunctionDosage must be adjusted in patients with impaired renal function to assure therapeutically adequate, but not excessive blood levels. Whenever possible, serum concentrations of gentamicin should be monitored. One method of dosage adjustment is to increase the interval between administration of the usual doses. Since the serum creatinine concentration has a high correlation with the serum half-life of gentamicin, this laboratory test may provide guidance for adjustment of the interval between doses. The interval between doses (in hours) may be approximated by multiplying the serum creatinine level (mg/100 mL) by 8. For example, a patient weighing 60 kg with a serum creatinine level of 2 mg/100 mL could be given 60 mg (1 mg/kg) every 16 hours (2 x 8).
In patients with serious systemic infections and renal impairment, it may be desirable to administer the antibiotic more frequently but in reduced dosage. In such patients, serum concentrations of gentamicin should be measured so that adequate, but not excessive levels result. A peak and trough concentration measured intermittently during therapy will provide optimal guidance for adjusting dosage. After the usual initial dose, a rough guide for determining reduced dosage at eight-hour intervals is to divide the normally recommended dose by the serum creatinine level (Table 2). For example, after an initial dose of 60 mg (1 mg/kg), a patient weighing 60 kg with a serum creatinine level of 2 mg/100 mL could be given 30 mg every eight hours (60 ÷ 2). It should be noted that the status of renal function may be changing over the course of the infectious process.
It is important to recognize that deteriorating renal function may require a greater reduction of dosage than that specified in the above guidelines for patients with stable renal impairment.
This container system may be inappropriate for the dosage requirements of children, infants, and neonates. Other dosage forms may be more appropriate.
Table 2 Dosage Adjustment Guide For Patients
With Renal Impairment
(Dosage at Eight-Hour Intervals After the Usual Initial Dose) Serum
Creatinine
(mg %) Approximate Creatinine
Clearance
(mL/min/1.73m²) Percent of Usual Doses
Shown in Table 1 ≤1 >100 100 1.1 - 1.3 70 - 100 80 1.4 - 1.6 55 - 70 65 1.7 - 1.9 45 - 55 55 2 - 2.2 40 - 45 50 2.3 - 2.5 35 - 40 40 2.6 - 3 30 - 35 35 3.1 - 3.5 25 - 30 30 3.6 - 4 20 - 25 25 4.1 - 5.1 15 - 20 20 5.2 - 6.6 10 - 15 15 6.7 - 8 <10 10In adults with renal failure undergoing hemodialysis, the amount of gentamicin removed from the blood may vary depending upon several factors including the dialysis method used. An eight hour hemodialysis may reduce serum concentrations of gentamicin by approximately 50%. The recommended dosage at the end of each dialysis period is 1 to 1.7 mg/kg depending upon the severity of infection.
In children, a dose of 2 mg/kg may be administered.
The above dosage schedules are not intended as rigid recommendations but are provided as guides to dosage when the measurement of gentamicin serum levels is not feasible.
A variety of methods are available to measure gentamicin concentrations in body fluids; these include microbiologic, enzymatic and radioimmunoassay techniques.
Gentamicin Sulfate 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, 80, or 100 mg use the appropriate container. If the prescribed dose is higher or lower than that of the supplied container adjustments can be made. If the dose is higher than the contents of a 100 mg container the additional amount should be removed from a container of gentamicin sulfate (60 mg/mL) and added to the 100 mg container. If the prescribed dose is less than that contained in a supplied container, use the container with the dose closest to (but above) the prescribed dose, removing and discarding an appropriate amount from it.
Do not use plastic containers in series connection.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Use only if solution is clear and container and seals are intact.
If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.
These solutions are intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.
Instructions for the Administration of Gentamicin Sulfate in 0.9% Sodium Chloride Injection.
This product is intended for use only as an IV secondary medication unit.
Use aseptic technique when removing contents from these units.
Do not add other drugs to Gentamicin Sulfate in 0.9% Sodium Chloride Injection.
All injections in VIAFLEX Plus plastic containers are intended for intravenous administration using sterile equipment.
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