Gentamicin

Gentamicin Manufacturers

• App Pharmaceuticals, Llc
  

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  Gentamicin | Preferred Pharmaceuticals, Inc.

  

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  Dosage should be adjusted according to severity of pain and response of the patient. The usual adult dosage is:

   

   Single Doses (range)

   Maximum 24 Hour Dose

   Codeine Phosphate

   15 mg to 60 mg

  360 mg

   Acetaminophen

   300 mg to 1000 mg

    4000 mg

  The usual dose of codeine phosphate in children is 0.5 mg/kg.

  Doses may be repeated up to every 4 hours.

  The prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours based upon the above dosage guidance. This information should be conveyed in the prescription.

  It should be kept in mind, however, that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.

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• General Injectables & Vaccines, Inc
  

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  Gentamicin | 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.

  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.

  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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• Cardinal Health
  

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  Gentamicin | Cardinal Health

  

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  Gentamicin Injection may be given intramuscularly or intravenously.  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.

  DOSAGE FOR PATIENTS

  WITH NORMAL RENAL FUNCTION

  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.)

  It is desirable to measure periodically both peak and trough serum concentrations of gentamicin when feasible 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 3 to 5 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.

  The usual duration of treatment is 7 to 10 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 10 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, a single dose of Gentamicin Injection may be diluted in 0.9% Sodium Chloride Injection or in 5% Dextrose Injection.  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 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.

  DOSAGE FOR 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.  In adults, 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).  These guidelines may be considered when treating infants and children with serious renal impairment.

  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 1).  For example, after an initial dose of 20 mg (2 mg/kg), a child weighing 10 kg with a serum creatinine level of 2 mg/100 mL could be given 10 mg every eight hours (20 ÷ 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 1

  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 Above

    ≤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

  10

  In patients 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%.  In children, the recommended dose at the end of each dialysis period is 2 to 2.5 mg/kg depending upon the severity of the 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.

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• App Pharmaceuticals, Llc
  

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  Gentamicin | Hospira, Inc.

  

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  Labetalol hydrochloride injection is intended for intravenous use in hospitalized patients. DOSAGE MUST BE INDIVIDUALIZED depending upon the severity of hypertension and the response of the patient during dosing.

  Patients should always be kept in a supine position during the period of intravenous drug administration. A substantial fall in blood pressure on standing should be expected in these patients. The patient’s ability to tolerate an upright position should be established before permitting any ambulation, such as using toilet facilities.

  Either of two methods of administration of labetalol hydrochloride injection may be used: a) repeated intravenous injections, b) slow continuous infusion.

  Repeated Intravenous Injection

  Initially, labetalol hydrochloride injection should be given in a dose of 20 mg labetalol HCl (which corresponds to 0.25 mg/kg for an 80 kg patient) by slow intravenous injection over a 2-minute period.

  Immediately before the injection and at 5 and 10 minutes after injection, supine blood pressure should be measured to evaluate response. Additional injections of 40 mg or 80 mg can be given at 10 minute intervals until a desired supine blood pressure is achieved or a total of 300 mg labetalol HCl has been injected. The maximum effect usually occurs within 5 minutes of each injection.

  Slow Continuous Infusion

  Labetalol hydrochloride injection is prepared for continuous intravenous infusion by diluting the contents with commonly used intravenous fluids (see below). Examples of methods of preparing the infusion solution are:

  The contents of either two 20 mL vials (40 mL), or one 40 mL vial, are added to 160 mL of a commonly used intravenous fluid such that the resultant 200 mL of solution contains 200 mg of labetalol hydrochloride, 1 mg/mL. The diluted solution should be administered at a rate of 2 mL/min to deliver 2 mg/min.

  Alternatively, the contents of either two 20 mL vials (40 mL), or one 40 mL vial, of labetalol hydrochloride injection are added to 250 mL of a commonly used intravenous fluid. The resultant solution will contain 200 mg of labetalol hydrochloride, approximately 2 mg/3 mL. The diluted solution should be administered at a rate of 3 mL/min to deliver approximately 2 mg/min.

  The rate of infusion of the diluted solution may be adjusted according to the blood pressure response, at the discretion of the physician. To facilitate a desired rate of infusion, the diluted solution can be infused using a controlled administration mechanism, e.g., graduated burette or mechanically driven infusion pump.

  Since the half-life of labetalol is 5 to 8 hours, steady-state blood levels (in the face of a constant rate of infusion) would not be reached during the usual infusion time period. The infusion should be continued until a satisfactory response is obtained and should then be stopped and oral labetalol hydrochloride started. The effective intravenous dose is usually in the range of 50 to 200 mg. A total dose of up to 300 mg may be required in some patients.

  Blood Pressure Monitoring

  The blood pressure should be monitored during and after completion of the infusion or intravenous injections. Rapid or excessive falls in either systolic or diastolic blood pressure during intravenous treatment should be avoided. In patients with excessive systolic hypertension, the decrease in systolic pressure should be used as indicator of effectiveness in addition to the response of the diastolic pressure.

  Initiation of Dosing with Labetalol Hydrochloride Tablets

  Subsequent oral dosing with labetalol hydrochloride tablets should begin when it has been established that the supine diastolic blood pressure has begun to rise. The recommended initial dose is 200 mg, followed in 6 to 12 hours by an additional dose of 200 or 400 mg, depending on the blood pressure response. Thereafter, inpatient titration with labetalol hydrochloride tablets may proceed as follows:

  Inpatient Titration Instructions * If needed, the total daily dose may be given in three divided doses.

  Regimen

  Daily Dose*

  200 mg b.i.d.

  400 mg

  400 mg b.i.d.

  800 mg

  800 mg b.i.d.

  1600 mg

  1200 mg b.i.d.

  2400 mg

  While in the hospital, the dosage of labetalol hydrochloride tablets may be increased at 1 day intervals to achieve the desired blood pressure reduction.

  For subsequent outpatient titration or maintenance dosing see Labetalol Hydrochloride Tablets Product Information DOSAGE AND ADMINISTRATION for additional recommendations.

  Compatibility with commonly used intravenous fluids

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

  Labetalol hydrochloride injection was tested for compatibility with commonly used intravenous fluids at final concentrations of 1.25 mg to 3.75 mg labetalol hydrochloride per mL of the mixture. Labetalol hydrochloride injection was found to be compatible with and stable (for 24 hours refrigerated or at room temperature) in mixtures with the following solutions:

  Ringers Injection, USP

  Lactated Ringers Injection, USP

  5% Dextrose and Ringers Injection

  5% Lactated Ringers and 5% Dextrose Injection

  5% Dextrose Injection, USP

  0.9% Sodium Chloride Injection, USP

  5% Dextrose and 0.2% Sodium Chloride Injection, USP

  2.5% Dextrose and 0.45% Sodium Chloride Injection, USP

  5% Dextrose and 0.9% Sodium Chloride Injection, USP

  5% Dextrose and 0.33% Sodium Chloride Injection, USP

  Labetalol hydrochloride injection was NOT compatible with 5% Sodium Bicarbonate Injection, USP. Care should be taken when administering alkaline drugs, including furosemide, in combination with labetalol. Compatibility should be assured prior to administering these drugs together.

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• Cardinal Health
  

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  Gentamicin | Cardinal Health

  

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  Gentamicin Injection may be given intramuscularly or intravenously.  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.

  DOSAGE FOR PATIENTS WITH NORMAL RENAL FUNCTION

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

  It is desirable to measure periodically both peak and trough serum concentrations of gentamicin when feasible 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 3 to 5 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.

  The usual duration of treatment is 7 to 10 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 10 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, a single dose of Gentamicin Injection may be diluted in 0.9% Sodium Chloride Injection or in 5% Dextrose Injection.  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 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.

  DOSAGE FOR 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. In adults, 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).  These guidelines may be considered when treating children with serious renal impairment.

  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 I).  For example, after an initial dose of 20 mg (2 mg/kg), a child weighing 10 kg with a serum creatinine level of 2 mg/100 mL could be given 10 mg every eight hours (20 ÷ 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 I

  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/1.73 m2)

  Percent of

  Usual Doses

  Shown Above

  ≤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

  10

  In patients 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%.  In children, the recommended dose at the end of each dialysis period is 2 to 2.5 mg/kg depending upon the severity of the 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.

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• Cardinal Health
  

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  Gentamicin | Ani Pharmaceuticals, Inc.

  

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  Carefully consider the potential benefits and risks of etodolac capsules and other treatment options before deciding to use etodolac capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

  After observing the response to initial therapy with etodolac capsules, the dose and frequency should be adjusted to suit an individual patient's needs.

  Dosage adjustment of etodolac capsules is generally not required in patients with mild to moderate renal impairment. Etodolac should be used with caution in such patients, because, as with other NSAIDs, it may further decrease renal function in some patients with impaired renal function (see WARNINGS, Renal Effects).

  Analgesia

  The recommended total daily dose of etodolac capsules for acute pain is up to 1000 mg, given as 200 to 400 mg every 6 to 8 hours. Doses of etodolac greater than 1000 mg/day have not been adequately evaluated in well-controlled trials.

  Osteoarthritis and Rheumatoid Arthritis

  The recommended starting dose of etodolac capsules for the management of the signs and symptoms of osteoarthritis or rheumatoid arthritis is: 300 mg b.i.d., t.i.d., or 400 mg b.i.d., or 500 mg b.i.d. A lower dose of 600 mg/day may suffice for long-term administration. Physicians should be aware that doses above 1000 mg/day have not been adequately evaluated in well-controlled clinical trials.

  In chronic conditions, a therapeutic response to therapy with etodolac capsules is sometimes seen within one week of therapy, but most often is observed by two weeks. After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required.

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• Fresenius Kabi Usa, Llc
  

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  Gentamicin | Fresenius Kabi Usa, Llc

  

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  Gentamicin Injection may be given intramuscularly or intravenously.  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.

  DOSAGE FOR PATIENTS

  WITH NORMAL RENAL FUNCTION

  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.)

  It is desirable to measure periodically both peak and trough serum concentrations of gentamicin when feasible 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 3 to 5 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.

  The usual duration of treatment is 7 to 10 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 10 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, a single dose of Gentamicin Injection may be diluted in 0.9% Sodium Chloride Injection or in 5% Dextrose Injection.  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 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.

  DOSAGE FOR 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.  In adults, 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).  These guidelines may be considered when treating infants and children with serious renal impairment.

  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 1).  For example, after an initial dose of 20 mg (2 mg/kg), a child weighing 10 kg with a serum creatinine level of 2 mg/100 mL could be given 10 mg every eight hours (20 ÷ 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 1

  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 Above

    ≤1

            >100

  100

  1.1 to 1.3

  70 to 100

  80

  1.4 to 1.6

  55 to 70

  65

  1.7 to 1.9

  45 to 55

  55

  2 to 2.2

  40 to 45

  50

  2.3 to 2.5

  35 to 40

  40

      2.6 to 3

  30 to 35

  35

  3.1 to 3.5

  25 to 30

  30

      3.6 to 4

  20 to 25

  25

  4.1 to 5.1

  15 to 20

  20

  5.2 to 6.6

  10 to 15

  15

      6.7 to 8

           <10

  10

  In patients 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%.  In children, the recommended dose at the end of each dialysis period is 2 to 2.5 mg/kg depending upon the severity of the 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.

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• Fresenius Kabi Usa, Llc
  

  ×

  Gentamicin | Fresenius Kabi Usa, Llc

  

  ---

  Gentamicin injection may be given IM or IV.  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 injection for patients with serious infections and normal renal function is 3 mg/kg/day, administered in three equal doses every eight hours (Table I).

  For patients with life-threatening infections, dosages up to 5 mg/kg/day may be administered in three or four equal doses.  This dosage should be reduced to 3 mg/kg/day as soon as clinically indicated (Table I).

  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 IM injection) is expected to be in the range of 4 to 6 mcg/mL.  When monitoring peak concentrations after IM or IV 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 I

  DOSAGE SCHEDULE GUIDE

  FOR ADULTS WITH NORMAL

  RENAL FUNCTION

  (Dosage at Eight-Hour Intervals)

  40 mg per 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 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).

  For further information concerning the use of gentamicin in infants and children, see gentamicin injection (pediatric) product information.

  The usual duration of treatment for all patients is 7 to 10 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 10 days.  Dosage should be reduced if clinically indicated.

  
  

  FOR INTRAVENOUS ADMINISTRATION

  The IV 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 IV administration in adults, a single dose of gentamicin injection may be diluted in 50 to 200 mL of sterile isotonic saline solution or in a sterile solution of dextrose 5% 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 IM and IV administration is identical.

  Gentamicin 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 FUNCTION

  Dosage must be adjusted in patients with impaired renal function to assure therapeutically adequate, but not excessive blood levels.  Whenever possible serum concentration 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 II).  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 II
  

  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

  > 100

  100

  1.1 to 1.3

  70 to 100

  80

  1.4 to 1.6

  55 to 70

  65

  1.7 to 1.9

  45 to 55

  55

  2 to 2.2

  40 to 45

  50

  2.3 to 2.5

  35 to 40

  40

  2.6 to 3

  30 to 35

  35

  3.1 to 3.5

  25 to 30

  30

  3.6 to 4

  20 to 25

  25

  4.1 to 5.1

  15 to 20

  20

  5.2 to 6.6

  10 to 15

  15

  6.7 to 8

  < 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 dosage at the end of each dialysis period is 1 to 1.7 mg/kg depending upon the severity of the 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 measurement of gentamicin serum level 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.

  Close
  No Recall

  More Info
• Fresenius Kabi Usa, Llc
  

  ×

  Gentamicin | Fresenius Kabi Usa, Llc

  

  ---

  Gentamicin injection may be given IM or IV.  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 injection for patients with serious infections and normal renal function is 3 mg/kg/day, administered in three equal doses every eight hours (Table I).

  For patients with life-threatening infections, dosages up to 5 mg/kg/day may be administered in three or four equal doses.  This dosage should be reduced to 3 mg/kg/day as soon as clinically indicated (Table I).

  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 IM injection) is expected to be in the range of 4 to 6 mcg/mL.  When monitoring peak concentrations after IM or IV 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 I

  DOSAGE SCHEDULE GUIDE

  FOR ADULTS WITH NORMAL

  RENAL FUNCTION

  (Dosage at Eight-Hour Intervals)

  40 mg per 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 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).

  For further information concerning the use of gentamicin in infants and children, see gentamicin injection (pediatric) product information.

  The usual duration of treatment for all patients is 7 to 10 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 10 days.  Dosage should be reduced if clinically indicated.

  
  

  FOR INTRAVENOUS ADMINISTRATION

  The IV 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 IV administration in adults, a single dose of gentamicin injection may be diluted in 50 to 200 mL of sterile isotonic saline solution or in a sterile solution of dextrose 5% 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 IM and IV administration is identical.

  Gentamicin 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 FUNCTION

  Dosage must be adjusted in patients with impaired renal function to assure therapeutically adequate, but not excessive blood levels.  Whenever possible serum concentration 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 II).  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 II
  

  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 I)

  ≤ 1

  > 100

  100

  1.1 to 1.3

  70 to 100

  80

  1.4 to 1.6

  55 to 70

  65

  1.7 to 1.9

  45 to 55

  55

  2 to 2.2

  40 to 45

  50

  2.3 to 2.5

  35 to 40

  40

  2.6 to 3

  30 to 35

  35

  3.1 to 3.5

  25 to 30

  30

  3.6 to 4

  20 to 25

  25

  4.1 to 5.1

  15 to 20

  20

  5.2 to 6.6

  10 to 15

  15

  6.7 to 8

  < 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 dosage at the end of each dialysis period is 1 to 1.7 mg/kg depending upon the severity of the 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 measurement of gentamicin serum level 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.

  Close
  No Recall

  More Info
• Fresenius Kabi Usa, Llc
  

  ×

  Gentamicin | Fresenius Kabi Usa, Llc

  

  ---

  Gentamicin Injection may be given intramuscularly or intravenously.  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.

  DOSAGE FOR PATIENTS

  WITH NORMAL RENAL FUNCTION

  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).

  It is desirable to measure periodically both peak and trough serum concentrations of gentamicin when feasible 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 3 to 5 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.

  The usual duration of treatment is 7 to 10 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 10 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, a single dose of Gentamicin Injection may be diluted in 0.9% Sodium Chloride Injection or in 5% Dextrose Injection.  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 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.

  DOSAGE FOR 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.  In adults, 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).  These guidelines may be considered when treating infants and children with serious renal impairment.

  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 1).  For example, after an initial dose of 20 mg (2 mg/kg), a child weighing 10 kg with a serum creatinine level of 2 mg/100 mL could be given 10 mg every eight hours (20 ÷ 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 1

  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 Above

    ≤ 1

            > 100

  100

  1.1 to 1.3

  70 to 100

  80

  1.4 to 1.6

  55 to 70

  65

  1.7 to 1.9

  45 to 55

  55

     2 to 2.2

  40 to 45

  50

  2.3 to 2.5

  35 to 40

  40

    2.6 to 3

  30 to 35

  35
  

  3.1 to 3.5

  25 to 30

  30

    3.6 to 4

  20 to 25

  25

  4.1 to 5.1

  15 to 20

  20

  5.2 to 6.6

  10 to 15

  15

     6.7 to 8

           < 10

  10

  In patients 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%.  In children, the recommended dose at the end of each dialysis period is 2 to 2.5 mg/kg depending upon the severity of the 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.

  Close
  No Recall

  More Info
• Fresenius Kabi Usa, Llc
  

  ×

  Gentamicin | Fresenius Kabi Usa, Llc

  

  ---

  Gentamicin injection may be given IM or IV.  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 injection for patients with serious infections and normal renal function is 3 mg/kg/day, administered in three equal doses every eight hours (Table 3).

  For patients with life-threatening infections, dosages up to 5 mg/kg/day may be administered in three or four equal doses.  This dosage should be reduced to 3 mg/kg/day as soon as clinically indicated (Table 3).

  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 IM injection) is expected to be in the range of 4 to 6 mcg/mL.  When monitoring peak concentrations after IM or IV 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 3 DOSAGE SCHEDULE GUIDE FOR ADULTS WITH NORMAL RENAL FUNCTION

                                (Dosage at Eight-Hour Intervals)

                                             40 mg per 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 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).

  For further information concerning the use of gentamicin in infants and children, see gentamicin injection (pediatric) product information.

  The usual duration of treatment for all patients is 7 to 10 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 10 days.  Dosage should be reduced if clinically indicated.

  
  

                                                                FOR INTRAVENOUS ADMINISTRATION

  The IV 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 IV administration in adults, a single dose of gentamicin injection may be diluted in 50 to 200 mL of sterile isotonic saline solution or in a sterile solution of dextrose 5% 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 IM and IV administration is identical.

  Gentamicin 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 FUNCTION

  Dosage must be adjusted in patients with impaired renal function to assure therapeutically adequate, but not excessive blood levels.  Whenever possible serum concentration 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 4).  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 4 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 Above

  ≤1

      > 100

  100

    1.1 to 1.3

   70 to 100

  80

    1.4 to 1.6

  55 to 70

  65

    1.7 to 1.9

  45 to 55

  55

       2 to 2.2

  40 to 45

  50

    2.3 to 2.5

  35 to 40

  40

    2.6 to 3

  30 to 35

  35

    3.1 to 3.5

  25 to 30

  30

    3.6 to 4

  20 to 25

  25

    4.1 to 5.1

  15 to 20

  20

    5.2 to 6.6

  10 to 15

  15

    6.7 to 8

       < 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 dosage at the end of each dialysis period is 1 to 1.7 mg/kg depending upon the severity of the 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 measurement of gentamicin serum level 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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