Gentamicin Sulfate Dosage

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Dosage of Gentamicin Sulfate in details

The dose of a drug and dosage of the drug are two different terminologies. Dose is defined as the quantity or amount of medicine given by the doctor or taken by the patient at a given period. Dosage is the regimen prescribed by the doctor about how many days and how many times per day the drug is to be taken in specified dose by the patient. The dose is expressed in mg for tablets or gm, micro gm sometimes, ml for syrups or drops for kids syrups. The dose is not fixed for a drug for all conditions, and it changes according to the condition or a disease. It also changes on the age of the patient.
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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.

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 3).

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 3).

It is desirable to measure both peak and trough serum concentrations of Gentamicin Sulfate 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 Sulfate, measurement of serum concentrations is recommended as a basis for dosage adjustment.

Table 3 Dosage Schedule Guide For Adults With Normal Renal Function
* The dosage of aminoglycosides in obese patients should be based on an estimate of the lean body mass.

** For q6h schedules, dosage should be recalculated.

(Dosage at Eight-Hour Intervals)

Patient’s

Weight*

Usual Dose

for Serious Infections

Dose for Life-Threatening

Infections (Reduce as Soon as Clinically Indicated)

kg

(lb)

1 mg/kg q8h

(3 mg/kg/day)

1.7 mg/kg q8h**

(5 mg/kg/day)

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 Sulfate 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 Sulfate 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 Sulfate 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 Sulfate, 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 Sulfate 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 2.0 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 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 in Table 3

≤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 Sulfate 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 Sulfate 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 Sulfate serum levels is not feasible.

A variety of methods are available to measure Gentamicin Sulfate 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.

What other drugs will affect Gentamicin Sulfate?

Other drugs, especially those that affect the kidneys, can interact with Gentamicin Sulfate resulting in dangerous side effects and/or decreased effectiveness. Do not take any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products, without first talking to your doctor during treatment with Gentamicin Sulfate.

Gentamicin Sulfate interactions

Interactions are the effects that happen when the drug is taken along with the food or when taken with other medications. Suppose if you are taking a drug Gentamicin Sulfate, it may have interactions with specific foods and specific medications. It will not interact with all foods and medications. The interactions vary from drug to drug. You need to be aware of interactions of the medicine you take. Most medications may interact with alcohol, tobacco, so be cautious.
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The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: aminoglycoside antibiotics given by injection (such as amikacin, Gentamicin Sulfate, tobramycin).

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.


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References

  1. DailyMed. "GENTAMICIN SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
  3. European Chemicals Agency - ECHA. "Gentamicin: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

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