INDICATIONS
Amoxicillin; clavulanate potassium is indicated
in the treatment of infections caused by susceptible strains
of the designated organisms in the conditions listed below.
Lower Respiratory Tract Infections: Caused by b-lactamase-producing
strains of Haemophilus influenzae and Moraxella (Branhamella)
catarrhalis.
Otitis Media: Caused by b-lactamase-producing
strains of Haemophilus influenzae and Moraxella (Branhamella)
catarrhalis.
Sinusitis: Caused by b-lactamase-producing
strains of Haemophilus influenzae and Moraxella (Branhamella)
catarrhalis.
Skin and Skin Structure Infections: Caused
by b-lactamase-producing strains of Staphylococcus aureus,
Escherichia coli and Klebsiella spp.
Urinary Tract Infections: Caused by b-lactamase-producing
strains of Escherichia coli, Klebsiella spp. and Enterobacter
spp.
While amoxicillin; clavulanate potassium is indicated only
for the conditions listed above, infections caused by ampicillin-susceptible
organisms are also amenable to amoxicillin; clavulanate
potassium treatment due to its amoxicillin content. Therefore,
mixed infections caused by ampicillin-susceptible organisms
and b-lactamase-producing organisms susceptible to amoxicillin;
clavulanate potassium should not require the addition of
another antibiotic. Because amoxicillin has greater in vitro
activity against Streptococcus pneumoniae than does ampicillin
or penicillin, the majority of S. pneumoniae strains with
intermediate susceptibility to ampicillin or penicillin
are fully susceptible to amoxicillin and amoxicillin; clavulanate
potassium. (See CLINICAL PHARMACOLOGY, Microbiology.)
Bacteriological studies, to determine the causative organisms
and their susceptibility to amoxicillin; clavulanate potassium,
should be performed together with any indicated surgical
procedures.
Therapy may be instituted prior to obtaining the results
from bacteriological and susceptibility studies to determine
the causative organisms and their susceptibility to amoxicillin;
clavulanate potassium when there is reason to believe the
infection may involve any of the b-lactamase-producing organisms
listed above. Once the results are known, therapy should
be adjusted, if appropriate.
DOSAGE AND ADMINISTRATION
Oral Solution and Chewable Tablets
Pediatric Patients
Based on the amoxicillin component, amoxicillin;
clavulanate potassium should be dosed as follows.
Neonates and Infants Aged <12 weeks (3 months):
Due to incompletely developed renal function affecting elimination
of amoxicillin in this age group, the recommended dose of
amoxicillin; clavulanate potassium is 30 mg/kg/day divided
q12h, based on the amoxicillin component. Clavulanate elimination
is unaltered in this age group. Experience with the 200
mg/5 ml formulation in this age group is limited and, thus,
use of the 125 mg/5 ml oral suspension is recommended.
| TABLE 10
Patients Aged 12 Weeks (3 Months) and Older |
| Infections |
Dosing Regimen |
| |
q12h* |
q8h |
| |
200
mg/5 ml or 400 mg/5 ml oral suspension† |
125
mg/5 ml or 250 mg/5 ml oral suspension† |
| Otitis
media,‡ sinusitis, lower respiratory tract infections,
and more severe infections | 45 mg/kg/day q12h |
40 mg/kg/day q8h |
| Less severe infections |
25 mg/kg/day q12h |
20 mg/kg/day q8h |
| * The
q12h regimen is recommended as it is associated
with significantly less diarrhea. (See CLINICAL
STUDIES.) However, the q12h formulations (200
mg and 400 mg) contain aspartame and should not
be used by phenylketonurics. |
| † Each
strength of amoxicillin; clavulanate potassium
suspension is available as a chewable tablet for
use by older children. |
| ‡ Duration
of therapy studied and recommended for acute otitis
media is 10 days. |
Pediatric Patients Weighing 40 kg and More should be dosed
according to the following adult recommendations: The usual
adult dose is 1 amoxicillin; clavulanate potassium 500 mg
tablet every 12 hours or 1 amoxicillin; clavulanate potassium
250 mg tablet every 8 hours. For more severe infections
and infections of the respiratory tract, the dose should
be 1 amoxicillin; clavulanate potassium 875 mg tablet every
12 hours or 1 amoxicillin; clavulanate potassium 500 mg
tablet every 8 hours. Among adults treated with 875 mg every
12 hours, significantly fewer experienced severe diarrhea
or withdrawals with diarrhea vs. adults treated with 500
mg every 8 hours. For detailed adult dosage recommendations,
please see complete prescribing information for amoxicillin;
clavulanate potassium Tablets.
Hepatically impaired patients should be dosed with caution
and hepatic function monitored at regular intervals. (See
WARNINGS.)
Adults
Adults who have difficulty swallowing may be given
the 125 mg/5 ml or 250 mg/5 ml suspension in place of the
500 mg tablet. The 200 mg/5 ml suspension or the 400 mg/5
ml suspension may be used in place of the 875 mg tablet.
See dosage recommendations above for children weighing 40
kg or more.
The amoxicillin; clavulanate potassium 250 mg tablet and
the 250 mg chewable tablet do not contain the same amount
of clavulanic acid (as the potassium salt). The amoxicillin;
clavulanate potassium 250 mg tablet contains 125 mg of clavulanic
acid, whereas the 250 mg chewable tablet contains 62.5 mg
of clavulanic acid. Therefore, the amoxicillin; clavulanate
potassium 250 mg tablet and the 250 mg chewable tablet should
not be substituted for each other, as they are not interchangeable.
Due to the different amoxicillin to clavulanic acid ratios
in the amoxicillin; clavulanate potassium 250 mg tablet
(250/125) versus the amoxicillin; clavulanate potassium
250 mg chewable tablet (250/62.5), the amoxicillin; clavulanate
potassium 250 mg tablet should not be used until the child
weighs at least 40 kg and more.
Directions For Mixing Oral Suspension
Prepare a Suspension at Time of Dispensing as Follows:
Tap bottle until all the powder flows freely. Add approximately
2/3 of the total amount of water for reconstitution (see
TABLE 11) and shake vigorously to suspend powder. Add remainder
of the water and again shake vigorously.
|
TABLE 11
|
| Bottle Size |
Amount of Water Required
for Reconstitution |
| Amoxicillin;
Clavulanate Potassium 125 mg/5 ml Suspension* |
| 75 ml |
67 ml |
| 100 ml |
90 ml |
| 150 ml |
134 ml |
| Amoxicillin;
Clavulanate Potassium 200 mg/5 ml Suspension† |
| 50 ml |
47 ml |
| 75 ml |
69 ml |
| 100 ml |
91 ml |
| Amoxicillin;
Clavulanate Potassium 250 mg/5 ml Suspension‡ |
| 75 ml |
65 ml |
| 100 ml |
87 ml |
| 150 ml |
130 ml |
| Amoxicillin;
Clavulanate Potassium 400 mg/5 ml Suspension§ |
| 50 ml |
44 ml |
| 75 ml |
66 ml |
| 100 ml |
87 ml |
|
* Each teaspoonful (5
ml) will contain 125 mg amoxicillin and 31.25
mg of clavulanic acid as the potassium salt.
† Each teaspoonful (5 ml) will contain
200 mg amoxicillin and 28.5 mg of clavulanic acid
as the potassium salt.
‡ Each teaspoonful (5 ml) will contain
250 mg amoxicillin and 62.5 mg of clavulanic acid
as the potassium salt.
§ Each teaspoonful (5 ml) will contain
400 mg amoxicillin and 57.0 mg of clavulanic acid
as the potassium salt.
|
Note: SHAKE ORAL SUSPENSION WELL BEFORE
USING.
Reconstituted suspension must be stored under refrigeration
and discarded after 10 days.
Administration
Amoxicillin; clavulanate potassium may be taken
without regard to meals; however, absorption of clavulanate
potassium is enhanced when amoxicillin; clavulanate potassium
is administered at the start of a meal. To minimize the
potential for gastrointestinal intolerance, amoxicillin;
clavulanate potassium should be taken at the start of a
meal.
Tablets
Since both the amoxicillin; clavulanate potassium
250 mg and 500 mg tablets contain the same amount of clavulanic
acid (125 mg, as the potassium salt), 2 amoxicillin; clavulanate
potassium 250 mg tablets are not equivalent to 1 amoxicillin;
clavulanate potassium 500 mg tablet. Therefore, 2 amoxicillin;
clavulanate potassium 250 mg tablets should not be susbstituted
for 1 amoxicillin; clavulanate potassium 500 mg tablet.
Adults: The usual adult dose is 1 amoxicillin;
clavulanate potassium 500 mg tablet every 12 hours or 1
amoxicillin; clavulanate potassium 250 mg tablet every 8
hours. For more severe infections and infections of the
respiratory tract, the dose should be 1 amoxicillin; clavulanate
potassium 875 mg tablet every 12 hours or 1 amoxicillin;
clavulanate potassium 500 mg tablet every 8 hours.
Patients with impaired renal function do not generally require
a reduction in dose unless the impairment is severe. Severely
impaired patients with a glomerular filtration rate of <30
ml/minute should not receive the 875 mg tablet. Patients
with a glomerular filtration rate of 10 to 30 ml/minute
should receive 500 mg or 250 mg every 12 hours, depending
on the severity of the infection. Patients with a less than
10 ml/minute glomerular filtration rate should receive 500
mg or 250 mg every 24 hours, depending on severity of the
infection.
Hemodialysis patients should receive 500 mg or 250 mg every
24 hours, depending on severity of the infection. They should
receive an additional dose both during and at the end of
dialysis.
Hepatically impaired patients should be dosed with caution
and hepatic function monitored at regular intervals. (See
WARNINGS.)
Pediatric Patients: Pediatric patients
weighing 40 kg or more should be dosed according to the
adult recommendations.
Due to the different amoxicillin to clavulanic acid ratios
in the amoxicillin; clavulanate potassium 250 mg tablet
(250/125) versus the amoxicillin; clavulanate potassium
250 mg chewable tablet (250/62.5), the amoxicillin; clavulanate
potassium 250 mg tablet should not be used until the pediatric
patient weighs at least 40 kg or more.
Administration
Amoxicillin; clavulanate potassium may be taken
without regard to meals; however, absorption of clavulanate
potassium is enhanced when amoxicillin; clavulanate potassium
is administered at the start of a meal. To minimize the
potential for gastrointestinal intolerance, amoxicillin;
clavulanate potassium should be taken at the start of a
meal.
HOW SUPPLIED
Augmentin Oral Suspension and Chewable Tablets
Augmentin 125 mg/5 ml for Oral Suspension: Each
5 ml of reconstituted banana-flavored suspension contains
125 mg amoxicillin and 31.25 mg clavulanic acid as the potassium
salt.
Augmentin 200 mg/5 ml for Oral Suspension:
Each 5 ml of reconstituted orange-raspberry-flavored suspension
contains 200 mg amoxicillin and 28.5 mg clavulanic acid
as the potassium salt.
Augmentin 250 mg/5 ml for Oral Suspension:
Each 5 ml of reconstituted orange-flavored suspension contains
250 mg amoxicillin and 62.5 mg clavulanic acid as the potassium
salt.
Augmentin 400 mg/5 ml for Oral Suspension:
Each 5 ml of reconstituted orange-raspberry-flavored suspension
contains 400 mg amoxicillin and 57 mg clavulanic acid as
the potassium salt.
Augmentin 125 mg Chewable Tablets: Each mottled yellow,
round, lemon-lime-flavored tablet, debossed with BMP 189,
contains 125 mg amoxicillin as the trihydrate and 31.25
mg clavulanic acid as the potassium salt.
Augmentin 200 mg Chewable Tablets: Each
mottled pink, round, biconvex, cherry-banana-flavored tablet
contains 200 mg amoxicillin as the trihydrate and 28.5 mg
clavulanic acid as the potassium salt.
Augmentin 250 mg Chewable Tablets: Each
mottled yellow, round, lemon-lime-flavored tablet, debossed
with BMP 190, contains 250 mg amoxicillin as the trihydrate
and 62.5 mg clavulanic acid as the potassium salt.
Augmentin 400 mg Chewable Tablets: Each
mottled pink, round, biconvex, cherry-banana-flavored tablet
contains 400 mg amoxicillin as the trihydrate and 57.0 mg
clavulanic acid as the potassium salt.
Augmentin Tablets
Augmentin 250 mg Tablets: Each white oval filmcoated
tablet, debossed wtih AUGMENTIN on 1 side and 250/150 on
the other side, contains 250 mg amoxicillin as the trihydrate
and 125 mg clavulanic acid as the potassium salt.
Augmentin 500 mg Tablets: Each white oval
filmcoated tablet, debossed with AUGMENTIN on 1 side and
500/125 on the other side, contains 500 mg amoxicillin as
the trihydrate and 125 mg clavulanic acid as the potassium
salt.
Augmentin 875 mg Tablets: Each scored
white capsule-shaped tablet, debossed with AUGMENTIN 875
on 1 side and SB on the other side, contains 875 mg amoxicillin
as the trihydrate and 125 mg clavulanic acid as the potassium
salt.
Storage
Store tablets and dry powder at or below 25°C
(77°F). Dispense in tightly closed, moisture-proof containers.
REFERENCES
1. National Committee for Clinical Laboratory
Standards. Methods for Dilution Antimicrobial Susceptibility
Tests for Bacteria That Grow Aerobically¾Third Edition.
Approved Standard NCCLS Document M7-A3, Vol. 13, No. 25.
NCCLS, Villanova, PA, Dec. 1993.
2. National Committee for Clinical Laboratory
Standards. Performance Standard for Antimicrobial Disk Susceptibility
Tests¾Fifth Edition. Approved Standard NCCLS Document
M2-A5, Vol. 13, No. 24. NCCLS, Villanova, PA, Dec. 1993.
3. Swanson-Biearman B, Dean BS, Lopez
G, Krenzelok EP. The effects of penicillin and cephalosporin
ingestions in children less than six years of age. Vet Hum
Toxicol 1988;30:66-67.
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