Gentamicin Sulfate

Gentamicin Sulfate Manufacturers

• Bayer Healthcare Llc
  

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  Gentamicin Sulfate | Golden State Medical Supply, Inc.

  

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  Patients should use fluticasone propionate nasal spray at regular intervals for optimal effect.

  Adults

  The recommended starting dosage in adults is 2 sprays (50 mcg of fluticasone propionate each) in each nostril once daily (total daily dose, 200 mcg). The same dosage divided into 100 mcg given twice daily (e.g., 8 a.m. and 8 p.m.) is also effective. After the first few days, patients may be able to reduce their dosage to 100 mcg (1 spray in each nostril) once daily for maintenance therapy. Some patients (12 years of age and older) with seasonal allergic rhinitis may find as-needed use of 200 mcg once daily effective for symptom control (see Clinical Trials). Greater symptom control may be achieved with scheduled regular use.

  Adolescents and Children (4 Years of Age and Older)

  Patients should be started with 100 mcg (1 spray in each nostril once daily). Patients not adequately responding to 100 mcg may use 200 mcg (2 sprays in each nostril). Once adequate control is achieved, the dosage should be decreased to 100 mcg (1 spray in each nostril) daily.

  The maximum total daily dosage should not exceed 2 sprays in each nostril (200 mcg/day). (See Individualization of Dosageand Clinical Trials sections.)

  Fluticasone propionate nasal spray is not recommended for children under 4 years of age.

  Directions for Use

  An illustrated patient leaflet for proper use accompanies each package of fluticasone propionate nasal spray.

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• General Injectables & Vaccines, Inc
  

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  Gentamicin Sulfate | General Injectables & Vaccines, Inc

  

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  Gentamicin Sulfate Injection, USP may be given intramuscularly or by intravenous infusion. 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 after intramuscular injection) is expected to be in the range of 4 to 6 mcg/mL. When monitoring peak concentrations after intramuscular or intravenous administration, 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) 40 mg/mL Patient's
  Weight*
  
  Usual Dose
  for Serious
  Infections
  1 mg/kg q8h
  
  
  
  
  Dose for Life-
  Threatenting
  Infections
  (Reduce as Soons
  as Clinically
  Indicated)
  kg
  (lb)
  
  (3 mg/kg/day)
  
  
  1.7 mg/kg q8h**
  (5 mg/kg/day)
  
  
  mg/
  dose
  
  mL/
  dose
  mg/dose
  
  mL/dose
  
  
  
  q8h
  
  q8h
  
  40
  (88)
  40
  
  1
  66
  
  
  1.6
  45
  (99)
  45
  
  1.1
  75
  
  1.9
  50
  (110)
  50
  
  1.25
  83
  
  2.1
  55
  (121)
  55
  
  1.4
  91
  
  2.25
  60
  (132)
  60
  
  1.5
  100
  
  2.5
  65
  (143)
  65
  
  1.6
  108
  
  2.7
  70
  (154)
  70
  
  1.75
  116
  
  2.9
  75
  (165)
  75
  
  1.9
  125
  
  3.1
  80
  (176)
  80
  
  2
  133
  
  3.3
  85
  (187)
  85
  
  2.1
  141
  
  3.5
  90
  (198)
  90
  
  2.25
  150
  
  3.75
  95
  (209)
  95
  
  2.4
  158
  
  4
  100
  (220)
  100
  
  2.5
  166
  
  4.2
  * 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.
  Children: 6 to 7.5 mg/kg/day (2 to 2.5 mg/kg administered every 8 hours).
  Infants and Neonates: 7.5 mg/kg/day (2.5 mg/kg administered every 8 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 may be diluted in 50 to 200 mL of sterile isotonic saline solution or in a sterile solution of 5% dextrose in water, in infants and children, the volume of diluent should be less. The solution may be infused over a period of one-half to two hours. The recommended dosage for intravenous and intramuscular administration is identical. 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 2.0 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 2.0 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 Impariment (Dosage at Eight-Hour Intervals After the Usual Initial Dose) Serum
  Creatinine
  (mg %) Approximate
  Creatinine
  Clearance Rate
  (mL/min/1.73M2) Percent of
  Usual Doses
  Shown in
  Table 1 less than or equal to 1.0
  greater than 100
  100
  1.1-1.3
  70-100
  80
  1.4-1.6
  55-70
  80
  1.7-1.9
  45-55
  55
  2.0-22
  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
  less than 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. 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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  

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• Physicians Total Care, Inc.
  

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  Gentamicin Sulfate | Physicians Total Care, Inc.

  

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  A small amount of GENTAMICIN OINTMENT or CREAM should be applied gently to lesions three to four times a day. The area treated may be covered with a gauze dressing if desired. In impetigo contagiosa, the crusts should be removed before application of GENTAMICIN OINTMENT or CREAM to permit maximum contact between the antibiotic and the infection. Care should be exercised to avoid further contamination of the infected skin. Infected stasis ulcers have responded well to GENTAMICIN under gelatin packing.

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• Stat Rx Usa Llc
  

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  Gentamicin Sulfate | Stat Rx Usa Llc

  

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  A small amount of gentamicin sulfate cream should be applied gently to the lesions three or four times daily. The area treated may be covered with a gauze dressing if desired. In impetigo contagiosa, the crusts should be removed before application of gentamicin sulfate to permit maximum contact between the antibiotic and the infection. Care should be exercised to avoid further contamination of the infected skin. Infected stasis ulcers have responded well to treatment with gentamicin sulfate under gelatin packing.

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• Hospira, Inc.
  

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  Gentamicin Sulfate | Hospira, Inc.

  

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  Gentamicin Sulfate Injection, USP is administered by intravenous infusion only after dilution in a 50 or 100 mL ADD-Vantage Flexible Diluent Container of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (See INSTRUCTIONS FOR USE).

  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. When monitoring peak concentrations after intravenous administration, 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*

  
  Usual Dose
  for Serious Infections

  1 mg/kg q8h

  Dose for Life-Threatening
  Infections (Reduce as
  Soon as Clinically Indicated)

  1.7 mg/kg q8h**

  kg

  (lb)

  (3 mg/kg/day)

  (5 mg/kg/day)

  *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.

  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

  166

  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 may be diluted in 50 or 100 mL of sterile 0.9% Sodium Chloride Injection, USP or in a sterile solution of 5% Dextrose Injection,USP. 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 2.0 mg/100 mL could be given 60 mg (1 mg/kg) every 16 hours (2x8).

  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 2.0 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 Rate

  (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.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  INSTRUCTIONS FOR USE

  To Open Diluent Container:

  Peel overwrap from the corner and remove 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.

  To Assemble Vial and Flexible Diluent Container:

  (Use Aseptic Technique)

  Remove the protective covers from the top of the vial and the vial port on the diluent container as follows:

  a. To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (SEE FIGURE 1.), then pull straight up to remove the cap. (SEE FIGURE 2.) NOTE: Once the breakaway cap has been removed, do not access vial with syringe.

  Fig. 1

  Fig. 2

  b. To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover. (SEE FIGURE 3.)

  Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately 1/2 turn (180°) after the first audible click. (SEE FIGURE 4.) The clicking sound does not assure a seal; the vial must be turned as far as it will go. NOTE: Once vial is seated, do not attempt to remove. (SEE FIGURE 4.)

  Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly.

  Label appropriately.

  Fig. 3

  Fig. 4

  To Prepare Admixture:

  Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial.

  With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container. (SEE FIGURE 5.)

  Pull the inner cap from the drug vial. (SEE FIGURE 6.) Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix.

  Mix container contents thoroughly and use within 24 hours of admixing.

  Fig. 5

  Fig. 6

  Preparation for Administration

  (Use Aseptic Technique)

  Confirm the activation and admixture of vial contents.

  Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired.

  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 pin is firmly seated. NOTE: See full directions on administration set carton.

  Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then 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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• E. Fougera & Co., A Division Of Fougera Pharmaceuticals Inc.
  

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  Gentamicin Sulfate | E. Fougera & Co., A Division Of Fougera Pharmaceuticals Inc.

  

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  A small amount of gentamicin sulfate cream should be applied gently to the lesions three or four times daily. The area treated may be covered with a gauze dressing if desired. In impetigo contagiosa, the crusts should be removed before application of gentamicin sulfate to permit maximum contact between the antibiotic and the infection. Care should be exercised to avoid further contamination of the infected skin. Infected stasis ulcers have responded well to treatment with gentamicin sulfate under gelatin packing.

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• Dispensing Solutions, Inc.
  

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  Gentamicin Sulfate | Dispensing Solutions, Inc.

  

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  A small amount of gentamicin sulfate cream should be applied gently to the lesions three or four times daily. The area treated may be covered with a gauze dressing if desired. In impetigo contagiosa, the crusts should be removed before application of gentamicin sulfate to permit maximum contact between the antibiotic and the infection. Care should be exercised to avoid further contamination of the infected skin. Infected stasis ulcers have responded well to treatment with gentamicin sulfate under gelatin packing.

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• Mwi/vetone
  

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  Gentamicin Sulfate | Mwi/vetone

  

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  The recommended dose is 20 to 25 mL (2.0 - 2.5 grams) gentamicin sulfate solution per day for 3 to 5 days during estrus. Each dose should be diluted with 200-500 mL of sterile physiological saline before aseptic uterine infusion.
  

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• Vettek
  

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  Gentamicin Sulfate | Vettek

  

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  The recommended dose is 20 to 25 mL (2.0 - 2.5 grams) gentamicin sulfate solution per day for 3 to 5 days during estrus. Each dose should be diluted with 200-500 mL of sterile physiological saline before aseptic uterine infusion.
  

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• Cardinal Health
  

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  Gentamicin Sulfate | Cardinal Health

  

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  Gentamicin Sulfate Injection, USP may be given intramuscularly or by intravenous infusion. 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 after intramuscular injection) is expected to be in the range of 4 to 6 mcg/mL. When monitoring peak concentrations after intramuscular or intravenous administration, 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)

  40 mg/mL

  Patient’s

  Weight*

  Usual Dose

  for Serious

  Infections

  1 mg/kg q8h

  Dose for Life-

  Threatening

  Infections

  (Reduce as Soon

  as Clinically

  Indicated)

  1.7 mg/kg q8h**

  kg

  (lb)

  (3 mg/kg/day)

  (5 mg/kg/day)

  mg/

  mL/

  mg/

  mL/

  dose

  dose

  dose

  dose

  q8h

  q8h

  40

  (88)

  40

  1

  66

  1.6

  45

  (99)

  45

  1.1

  75

  1.9

  50

  (110)

  50

  1.25

  83

  2.1

  55

  (121)

  55

  1.4

  91

  2.25

  60

  (132)

  60

  1.5

  100

  2.5

  65

  (143)

  65

  1.6

  108

  2.7

  70

  (154)

  70

  1.75

  116

  2.9

  75

  (165)

  75

  1.9

  125

  3.1

  80

  (176)

  80

  2

  133

  3.3

  85

  (187)

  85

  2.1

  141

  3.5

  90

  (198)

  90

  2.25

  150

  3.75

  95

  (209)

  95

  2.4

  158

  4

  100

  (220)

  100

  2.5

  166

  4.2

  * 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.

  Children: 6 to 7.5 mg/kg/day (2 to 2.5 mg/kg administered every 8 hours).

  Infants and Neonates: 7.5 mg/kg/day (2.5 mg/kg administered every 8 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 may be diluted in 50 to 200 mL of sterile isotonic saline solution or in a sterile solution of 5% dextrose in water, in infants and children, the volume of diluent should be less. The solution may be infused over a period of one-half to two hours.

  The recommended dosage for intravenous and intramuscular administration is identical.

  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 2.0 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 2.0 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 Rate

  (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. 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.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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• Perrigo New York Inc
  

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  Gentamicin Sulfate | Perrigo New York Inc

  

  ---

  A small amount of Gentamicin Sulfate Cream USP, 0.1% should be applied gently to lesions three or four times a day. The area treated may be covered with a gauze dressing if desired. In impetigo contagiosa, the crusts should be removed before application of Gentamicin Sulfate Cream USP, 0.1% to permit maximum contact between the antibiotic and the infection. Care should be exercised to avoid further contamination of the infected skin. Infected stasis ulcers have responded well to Gentamicin Sulfate under gelatin packing.

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• Bayer Healthcare Llc
  

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  Gentamicin Sulfate | Bayer Healthcare Llc

  

  ---

  Chickens:

  Each day-old chicken should be aseptically injected subcutaneously in the neck with GentaPoult® (Gentamicin Sulfate Injection) diluted with sterile, physiologic saline solution to provide 0.2 mg gentamicin in a 0.2 mL dose. This concentration can be provided by diluting GentaPoult® (Gentamicin Sulfate Injection) as follows:

   

  GentaPoult®

  (Gentamicin Sulfate Injection)

   

  Sterile Saline

   

   

  No. of

   

  Dose/

  Chicken mL mL Doses mL 1 99 500 0.2 2 198 1000 0.2 4 396 2000 0.2 10 990 5000 0.2 100 (1 vial) 9900 50000 0.2

   Turkeys:

  Each 1 to 3 day-old turkey should be aseptically injected subcutaneously in the neck with GentaPoult® (Gentamicin Sulfate Injection) diluted with sterile, physiologic saline solution to provide 1.0 mg gentamicin in a 0.2 mL dose. The dose should be injected under the loose skin on the top of the neck, halfway between the head and base of the neck. This concentration can be provided by diluting GentaPoult® (Gentamicin Sulfate Injection) as follows:

  GentaPoult®

  (Gentamicin Sulfate Injection)

   

  Sterile Saline

   

   

  No. of

   

  Dose/

  Turkey mL mL Doses mL 1 19 100 0.2 2 38 200 0.2 4 76 400 0.2 10 190 1000 0.2 100 (1 vial) 1900 10000 0.2

  Clean and sterilize needles and syringes by boiling in water for 15 minutes prior to use. Disinfect the injection site and top of the bottle with a suitable disinfectant, such as 70% isopropyl alcohol. Use all precautions to prevent contamination of vial contents.

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• Hospira, Inc.
  

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  Gentamicin Sulfate | Hospira, Inc.

  

  ---

  Gentamicin Sulfate Injection, USP may be given intramuscularly or by intravenous infusion. 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 after intramuscular injection) is expected to be in the range of 4 to 6 mcg/mL. When monitoring peak concentrations after intramuscular or intravenous administration, 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)

  40 mg/mL

  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/

  mL/

  mg/

  mL/

  dose

  dose

  dose

  dose

  q8h

  q8h

  40

  (88)

  40

  1

  66

  1.6

  45

  (99)

  45

  1.1

  75

  1.9

  50

  (110)

  50

  1.25

  83

  2.1

  55

  (121)

  55

  1.4

  91

  2.25

  60

  (132)

  60

  1.5

  100

  2.5

  65

  (143)

  65

  1.6

  108

  2.7

  70

  (154)

  70

  1.75

  116

  2.9

  75

  (165)

  75

  1.9

  125

  3.1

  80

  (176)

  80

  2

  133

  3.3

  85

  (187)

  85

  2.1

  141

  3.5

  90

  (198)

  90

  2.25

  150

  3.75

  95

  (209)

  95

  2.4

  158

  4

  100

  (220)

  100

  2.5

  166

  4.2

  * 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.

  Children: 6 to 7.5 mg/kg/day (2 to 2.5 mg/kg administered every 8 hours).

  Infants and Neonates: 7.5 mg/kg/day (2.5 mg/kg administered every 8 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 may be diluted in 50 to 200 mL of sterile isotonic saline solution or in a sterile solution of 5% dextrose in water, in infants and children, the volume of diluent should be less. The solution may be infused over a period of one-half to two hours.

  The recommended dosage for intravenous and intramuscular administration is identical.

  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 2.0 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 2.0 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 Rate

  (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. 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.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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• Hospira, Inc.
  

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  Gentamicin Sulfate | Hospira, Inc.

  

  ---

  Gentamicin Sulfate Injection, USP may be given intramuscularly or by intravenous infusion.

  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 after intramuscular injection) is expected to be in the range of 4 to 6 mcg/mL. When monitoring peak concentrations after intramuscular or intravenous administration, 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) 40 mg/mL

  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 mL/dose mg/dose mL/dose q8h q8h 40

  (88)

  40 1 66 1.6 45

  (99)

  45 1.1 75 1.9

  50

  (110)

  50

  1.25

  83

  2.1

  55

  (121)

  55

  1.4

  91

  2.25

  60

  (132)

  60

  1.5

  100

  2.5

  65

  (143)

  65

  1.6

  108

  2.7

  70

  (154)

  70

  1.75

  116

  2.9

  75

  (165)

  75

  1.9

  125

  3.1

  80

  (176)

  80

  2

  133

  3.3

  85

  (187)

  85

  2.1

  141

  3.5

  90

  (198)

  90

  2.25

  150

  3.75

  95

  (209)

  95

  2.4

  158

  4

  100

  (220)

  100

  2.5

  166

  4.2

  * 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.

  Children: 6 to 7.5 mg/kg/day (2 to 2.5 mg/kg administered every 8 hours).
  Infants and Neonates: 7.5 mg/kg/day (2.5 mg/kg administered every 8 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 may be diluted in 50 to 200 mL of sterile isotonic saline solution or in a sterile solution of 5% dextrose in water, in infants and children, the volume of diluent should be less. The solution may be infused over a period of one-half to two hours.

  The recommended dosage for intravenous and intramuscular administration is identical.

  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 2.0 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 2.0 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 Rate
  (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. 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.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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