A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Pediatric Gentamicin Indications, Dosage, Storage, Stability - Pediatric Gentamicin
Pediatric Gentamicin Indications, Dosage, Storage, Stability - Pediatric Gentamicin
INDICATIONS
Pediatric Gentamicin Sulfate Injection is indicated in the treatment
of serious infections caused by susceptible
strains of the following microorganisms: Pseudomonas aeruginosa,
Proteus species
(indole-positive and indole-negative), Escherichia coli Klebsiella-Enterobactor-Serratia
species, Citrobacter
species and Staphylococcus species (coagulase-positive and
coagulase-negative).
Clinical studies have shown Pediatric Gentamicin Sulfate Injection
to be effective in bacterial neonatal
sepsis; bacterial septicemia; and serious bacterial infections of
the central nervous
system (meningitis),
urinary tract, respiratory
tract, gastrointestinal
tract (including peritonitis),
skin, bone and soft
tissue (including burns).
Aminoglycosides, including gentamicin, are not indicated in uncomplicated
initial episodes of urinary
tract infections unless
the causative organisms are susceptible
to these antibiotics and are not susceptible
to antibiotics having low potential
for toxicity.
Specimens for bacterial culture
should be obtained to isolate
and identify causative organisms and to determine their susceptibility
to gentamicin.
Gentamicin may be considered as initial
therapy in suspected
or confirmed gram-negative infections, and therapy
may be instituted before obtaining results of susceptibility
testing. The decision to continue therapy
with this drug should be
based on the results of susceptibility
tests, the severity of the infection
and the important additional concepts contained in the DESCRIPTION
:
WARNINGS Box. If the causative organisms are resistant to gentamicin,
other appropriate
therapy should be instituted.
In serious infections when the causative organisms are unknown,
gentamicin may be administered as initial
therapy in conjunction
with a penicillin-type or cephalosporin-type drug
before obtaining results of susceptibility
testing. If anaerobic
organisms are suspected as etiologic agents, consideration should
be given to using other antimicrobial
therapy in conjunction
with gentamicin. Following identification
of the organism and
its susceptibility, appropriate antibiotic
therapy should then
be continued.
Gentamicin has been used effectively in combination with carbenicillin
for the treatment
of life-threatening infections caused by Pseudomonas aeruginosa.
It has also been found effective when used in conjunction with a
penicillin-type drug for
the treatment of endocarditis
caused by group D streptococci
. Pediatric Gentamicin Sulfate Injection has also been shown to
be effective in the treatment
of serious staphylococcal
infections. While not the antibiotic
of first choice.
Pediatric Gentamicin Sulfate Injection may be considered when penicillins
or other less potentially toxic
drugs are contraindicated and bacterial susceptibility tests and
clinical judgment
indicate its use. It may also be considered in mixed
infections caused by susceptible
strains of staphylococci and gram-negative
organisms. In the neonate
with suspected bacterial sepsis or staphylococcal
pneumonia, a penicillin-type
drug is also usually indicated
as concomitant therapy
with gentamicin.
DOSAGE AND ADMINISTRATION
Pediatric Gentamicin Sulfate 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.
PATIENTS WITH NORMAL RENAL FUNCTION
Children: 6 to 7.5 mg/kg/day. (2.0 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 Weak of Age or Less:
5 mg/kg/day. (2.5 mg/kg administered every 12 hours.)
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 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 does), 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 aminogl ycosides. In
such patients treated with
gentamicin, measurement of serum
concentrations is recommended as a basis
for dosage adjustment.
The usual duration
of treatment is seven
to ten days. In difficult
and complicated infections, a longer course of therapy
may be necessary. In such cases moni toring 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 bacteri al 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 Pediatric
Gentamicin Sulfate Injection may be diluted in sterile
isotonic saline solution
or in a sterile solution
of dextrose 5% in water.
The solution may be infused over a period
of one-half to two hours.
The recommended dosage
for intravenous
and intramuscular
administration is identical. Pediatric Gentamicin Sulfate Injection
should not be physically mixed 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. 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
creati nine level of 2.0 mg/100 mL could be given 60 mg (1 mg/kg)
every 16 hours (2 x 8).
These guides 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
does, 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 (2.0 mg/kg), a child
weighing 10 kg with a serum
creatinine level
of 2.0 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 Does)
|
Serum Creatinine
(mg%)
|
Approximate Creatinine
Clearance Rate
(mL/min/1.73M²)
|
Percent of Usual Doses
Shown Above
|
|
£ 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 patients with renal
failure undergoing hemodialysis,
the amount of gentamicin removed from the blood
may vary depending upon several factors incl uding 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 2.0 to 2.5
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.
HOW SUPPLIED
Pediatric Gentamicin Sulfate Injection:
10 mg/mL (pediatric)
Also available Gentamicin Sulfate Injection:
40 mg/mL
- 2 mL(80 mg) DOSETTE vials packaged in 25s (NDC 0641-0395-25)
- 20 mL Multiple Dose vials packaged in 10s (NDC 0641-2331-43)
- 1.5 mL (60 mg) DOSETTE Cartridge-Needle Units (22 gauge, 1 1/4
inch) packaged in 10s (NDC 0641-3251-03)
- 2 mL (80 mg) DOSETTE Cartridge-Needle Units (22 gauge, 1 1/4
inch) packaged in 10s (NDC 0641-3252-03)
STORAGE
Store at controlled room
temperature 15°-30°C
(59°-86°F). Avoid freezing.
Additional package Inserts may be obtained by contacting the professional
Services Department.
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