Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3840
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AUGMENTIN (Tablet, Film Coated)
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Since both the 250-mg and 500-mg
tablets of AUGMENTIN contain the same amount of clavulanic acid (125 mg,
as the potassium salt), two 250-mg tablets of AUGMENTIN are not equivalent
to one 500-mg tablet of AUGMENTIN; therefore, two 250-mg tablets of AUGMENTIN
should not be substituted for one 500-mg tablet of AUGMENTIN. Dosage<br/>Adults: The usual adult dose
is one 500-mg tablet of AUGMENTIN every 12hours
or one 250-mg tablet of AUGMENTIN every 8hours.
For more severe infections and infections of the respiratory tract, the dose
should be one 875-mg tablet of AUGMENTIN every 12hours or one 500-mg tablet of AUGMENTIN every 8hours. 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/min.
should not receive the 875-mg tablet.
Patients with a glomerular filtration rate of 10 to 30mL/min. should receive 500mg
or 250mg every 12hours, depending on the severity of the infection. Patients with
a less than 10mL/min. glomerular filtration
rate should receive 500 mg or 250 mg every 24 hours, depending on severity
of the infection. Hemodialysis patients should receive
500mg or 250mg every 24hours, 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.)<br/>Pediatric Patients: Pediatric patients weighing 40kg or more should be dosed according to the adult recommendations. Due to the different amoxicillin to clavulanic acid ratios
in the 250-mg tablet of AUGMENTIN (250/125) versus the 250-mg chewable tablet
of AUGMENTIN (250/62.5), the 250-mg tablet of AUGMENTIN should not be used
until the pediatric patient weighs at least 40 kg or more.<br/>Administration: AUGMENTIN may be taken without regard to meals; however,
absorption of clavulanate potassium is enhanced when AUGMENTIN is administered
at the start of a meal. To minimize the potential for gastrointestinal intolerance,
AUGMENTIN should be taken at the start of a meal.
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dailymed-instance:descripti... |
AUGMENTIN is an oral
antibacterial combination consisting of the semisynthetic antibiotic amoxicillin
and the��-lactamase inhibitor, clavulanate potassium (the potassium
salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived
from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin
molecular formula is CHNOS���3HO,
and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic
acid trihydrate and may be represented structurally as: Clavulanic
acid is produced by the fermentation of Streptomyces
clavuligerus . It is a��-lactam structurally related to the
penicillins and possesses the ability to inactivate a wide variety of��-lactamases
by blocking the active sites of these enzymes. Clavulanic acid is particularly
active against the clinically important plasmid-mediated��-lactamases
frequently responsible for transferred drug resistance to penicillins and
cephalosporins. The clavulanate potassium molecular formula is CHKNOand
the molecular weight is 237.25. Chemically, clavulanate potassium is potassium
(Z)-(2R, 5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate,
and may be represented structurally as:<br/>Inactive Ingredients: Colloidal silicon dioxide, hypromellose, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, sodium starch glycolate,
and titanium dioxide. Each tablet of AUGMENTIN contains
0.63 mEq potassium.
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Amoxicillin and clavulanate potassium are well absorbed
from the gastrointestinal tract after oral administration of AUGMENTIN. Dosing
in the fasted or fed state has minimal effect on the pharmacokinetics of amoxicillin.
While AUGMENTIN can be given without regard to meals, absorption of clavulanate
potassium when taken with food is greater relative to the fasted state. In
1 study, the relative bioavailability of clavulanate was reduced when AUGMENTIN
was dosed at 30 and 150 minutes after the start of a high-fat breakfast.
The safety and efficacy of AUGMENTIN have been established in clinical trials
where AUGMENTIN was taken without regard to meals. Meanamoxicillin
and clavulanate potassium pharmacokinetic parameters are shown in the table
below: Mean values of 14 normal volunteers (n = 15
for clavulanate potassium in the low-dose regimens). Peak concentrations occurred
approximately 1.5 hours after the dose. Administered
at the start of a light meal. Amoxicillin serum concentrations
achieved with AUGMENTIN are similar to those produced by the oral administration
of equivalent doses of amoxicillin alone. The half-life of amoxicillin after
the oral administration of AUGMENTIN is 1.3 hours and that of clavulanic acid
is 1.0 hour. Approximately 50% to 70% of the
amoxicillin and approximately 25% to 40% of the clavulanic acid are excreted
unchanged in urine during the first 6 hours after administration of a
single 250-mg or 500-mg tablet of AUGMENTIN. Concurrent
administration of probenecid delays amoxicillin excretion but does not delay
renal excretion of clavulanic acid. Neither component
in AUGMENTIN is highly protein-bound; clavulanic acid has been found to be
approximately 25% bound to human serum and amoxicillin approximately 18% bound. Amoxicillin
diffuses readily into most body tissues and fluids with the exception of the
brain and spinal fluid. The results of experiments involving the administration
of clavulanic acid to animals suggest that this compound, like amoxicillin,
is well distributed in body tissues.<br/>Microbiology: Amoxicillin is a semisynthetic antibiotic with a broad spectrum
of bactericidal activity against many gram-positive and gram-negative microorganisms.
Amoxicillin is, however, susceptible to degradation by��-lactamases,
and therefore, the spectrum of activity does not include organisms which produce
these enzymes. Clavulanic acid is a��-lactam, structurally related to
the penicillins, which possesses the ability to inactivate a wide range of��-lactamase enzymes commonly found in microorganisms resistant to penicillins
and cephalosporins. In particular, it has good activity against the clinically
important plasmid-mediated��-lactamases frequently responsible for transferred
drug resistance. The formulation of amoxicillin and
clavulanic acid in AUGMENTIN protects amoxicillin from degradation by��-lactamase
enzymes and effectively extends the antibiotic spectrum of amoxicillin to
include many bacteria normally resistant to amoxicillin and other��-lactam
antibiotics. Thus, AUGMENTIN possesses the properties of a broad-spectrum
antibiotic and a��-lactamase inhibitor. Amoxicillin/clavulanic
acid has been shown to be active against most strains of the following microorganisms,
both in vitro and in clinical infections as described in INDICATIONS AND USAGE.<br/>Gram-Positive Aerobes: Staphylococcus
aureus (��-lactamase and non�����-lactamase���producing) Staphylococci which are resistant to methicillin/oxacillin must be considered
resistant to amoxicillin/clavulanic acid.<br/>Gram-Negative Aerobes: Enterobacter species (Although most strains of Enterobacterspecies are resistant in vitro, clinical efficacy has been demonstrated
with AUGMENTIN in urinary tract infections caused by these organisms.) Escherichia coli (��-lactamase and non�����-lactamase���producing) Haemophilus influenzae (��-lactamase and
non�����-lactamase���producing) Klebsiella species (All known strains are��-lactamase���producing.) Moraxella catarrhalis (��-lactamase and
non�����-lactamase���producing) The
following in vitro data are available, but
their clinical significance is unknown. Amoxicillin/clavulanic acid exhibits in
vitro minimal inhibitory concentrations (MICs) of 2 mcg/mL or less against
most (���90%) strains of Streptococcus pneumoniae; MICs of 0.06 mcg/mL or less against most
(���90%) strains of Neisseria gonorrhoeae ; MICs of 4 mcg/mL or less against most (���90%) strains
of staphylococci and anaerobic bacteria; and MICs of 8 mcg/mL or less
against most (���90%) strains of other listed organisms. However, with
the exception of organisms shown to respond to amoxicillin alone, the safety
and effectiveness of amoxicillin/clavulanic acid in treating clinical infections
due to these microorganisms have not been established in adequate and well-controlled
clinical trials. Because amoxicillin
has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S.
pneumoniae strains with intermediate susceptibility to ampicillin
or penicillin are fully susceptible to amoxicillin.<br/>Gram-Positive Aerobes: Enterococcus
faecalis Staphylococcus
epidermidis (��-lactamase and non�����-lactamase���producing) Staphylococcus saprophyticus (��-lactamase
and non�����-lactamase���producing) Streptococcus pneumoniae Streptococcus pyogenes viridans
group Streptococcus<br/>Gram-Negative Aerobes: Eikenella
corrodens (��-lactamase and non�����-lactamase���producing) Neisseria gonorrhoeae(��-lactamase
and non�����-lactamase���producing) Proteus mirabilis(��-lactamase and non�����-lactamase���producing)<br/>Anaerobic Bacteria: Bacteroides species, including Bacteroides fragilis (��-lactamase and non�����-lactamase���producing) Fusobacterium species (��-lactamase and
non�����-lactamase���producing) Peptostreptococcus species Adequate
and well-controlled clinical trials have established the effectiveness of
amoxicillin alone in treating certain clinical infections due to these organisms. These
are non�����-lactamase���producing organisms, and therefore,
are susceptible to amoxicillin alone.<br/>Susceptibility Testing:<br/>Dilution Techniques: Quantitative methods are used to determine antimicrobial
MICs. These MICs provide estimates of the susceptibility of bacteria to antimicrobial
compounds. The MICs should be determined using a standardized procedure. Standardized
procedures are based on a dilution method(broth or agar) or equivalent
with standardized inoculum concentrations and standardized concentrations
of amoxicillin/clavulanate potassium powder. The recommended
dilution pattern utilizes a constant amoxicillin/clavulanate potassium ratio
of 2 to 1 in all tubes with varying amounts of amoxicillin. MICs are expressed
in terms of the amoxicillin concentration in the presence of clavulanic acid
at a constant 2 parts amoxicillin to 1 part clavulanic acid. The MIC values
should be interpreted according to the following criteria: RECOMMENDED
RANGES FOR AMOXICILLIN/CLAVULANIC ACID SUSCEPTIBILITY TESTING<br/>For Gram-Negative Enteric Aerobes:<br/>For Staphylococcus** and Haemophilus species: Staphylococci which are susceptible to amoxicillin/clavulanic
acid but resistant to methicillin/oxacillin must be considered as resistant.<br/>For S. pneumoniae from non-meningitis sources: Isolates should be tested using amoxicillin/clavulanic acid
and the following criteria should be used: NOTE: These interpretive
criteria are based on the recommended doses for respiratory tract infections. A
report of���Susceptible���indicates that the pathogen is likely
to be inhibited if the antimicrobial compound in the blood reaches the concentration
usually achievable. A report of���Intermediate���indicates that
the result should be considered equivocal, and, if the microorganism is not
fully susceptible to alternative, clinically feasible drugs, the test should
be repeated. This category implies possible clinical applicability in body
sites where the drug is physiologically concentrated or in situations where
high dosage of drug can be used. This category also provides a buffer zone,
which prevents small uncontrolled technical factors from causing major discrepancies
in interpretation. A report of���Resistant���indicates that the
pathogen is not likely to be inhibited if the antimicrobial compound in the
blood reaches the concentrations usually achievable; other therapy should
be selected. Standardized susceptibility test procedures
require the use of laboratory control microorganisms to control the technical
aspects of the laboratory procedures. Standard amoxicillin/clavulanate potassium
powder should provide the following MIC values: MicroorganismMIC
Range (mcg/mL) Escherichia
coli ATCC 25922 2 to 8 Escherichia
coli ATCC 35218 4 to 16 Enterococcus
faecalis ATCC 29212 0.25 to 1.0 Haemophilus
influenzae ATCC 49247 2 to 16 Staphylococcus
aureus ATCC 29213 0.12 to 0.5 Streptococcus
pneumoniae ATCC 49619 0.03 to 0.12 Expressed
as concentration of amoxicillin in the presence of clavulanic acid at a constant
2 parts amoxicillin to 1 part clavulanic acid.<br/>Diffusion Techniques: Quantitative methods that require measurement of zone diameters
also provide reproducible estimates of the susceptibility of bacteria to antimicrobial
compounds. One such standardized procedurerequires the use of
standardized inoculum concentrations. This procedure uses paper disks impregnated
with 30 mcg of amoxicillin/clavulanate potassium (20 mcg amoxicillin
plus 10 mcg clavulanate potassium) to test the susceptibility of microorganisms
to amoxicillin/clavulanic acid. Reports from the laboratory
providing results of the standard single-disk susceptibility test with a 30-mcg
amoxicillin/clavulanate acid (20 mcg amoxicillin plus 10 mcg clavulanate
potassium) disk should be interpreted according to the following criteria: RECOMMENDED
RANGES FOR AMOXICILLIN/CLAVULANIC ACID SUSCEPTIBILITY TESTING<br/>For Staphylococcus������species and H. influenzaea:<br/>For Other Organisms Except S. pneumoniae and N. gonorrhoea: Staphylococci which are resistant
to methicillin/oxacillin must be considered as resistant to amoxicillin/clavulanic
acid. A broth microdilution method should
be used for testing H. influenzae.
Beta-lactamase���negative, ampicillin-resistant strains must be considered
resistant to amoxicillin/clavulanic acid. Susceptibility
of S. pneumoniae should be determined
using a 1-mcg oxacillin disk. Isolates with oxacillin zone sizes of���20 mm
are susceptible to amoxicillin/clavulanic acid. An amoxicillin/clavulanic
acid MIC should be determined on isolates of S.
pneumoniae with oxacillin zone sizes of���19 mm. A
broth microdilution method should be used for testing N.
gonorrhoeae and interpreted according to penicillin breakpoints. Interpretation
should be as stated above for results using dilution techniques. Interpretation
involves correlation of the diameter obtained in the disk test with the MIC
for amoxicillin/clavulanic acid. As with standardized
dilution techniques, diffusion methods require the use of laboratory control
microorganisms that are used to control the technical aspects of the laboratory
procedures. For the diffusion technique, the 30-mcg amoxicillin/clavulanate
potassium (20-mcg amoxicillin plus 10-mcg clavulanate potassium) disk should
provide the following zone diameters in these laboratory quality control strains: MicroorganismZone
Diameter (mm) Escherichia
coli ATCC 25922 19 to 25 Escherichia
coli ATCC 35218 18 to 22 Staphylococcus
aureus ATCC 25923 28 to 36
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AUGMENTIN is contraindicated
in patients with a history of allergic reactions to any penicillin. It is
also contraindicated in patients with a previous history of cholestatic jaundice/hepatic
dysfunction associated with AUGMENTIN.
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dailymed-instance:supply |
AUGMENTIN 250-mg Tablets: Each white oval filmcoated tablet, debossed with AUGMENTIN
on 1 side and 250/125 on the other side, contains 250mg amoxicillin as the trihydrate and 125mg clavulanic acid as the potassium salt. NDC
0029-6075-27 bottles of 30 NDC 0029-6075-31 Unit Dose
(10x10) 100 tablets<br/>AUGMENTIN 500-mg Tablets: Each white oval filmcoated tablet, debossed with AUGMENTIN
on 1 side and 500/125 on the other side, contains 500mg amoxicillin as the trihydrate and 125mg clavulanic acid as the potassium salt. NDC
0029-6080-12 bottles of 20 NDC 0029-6080-31 Unit Dose
(10x10) 100 tablets<br/>AUGMENTIN 875-mg Tablets: Each scored white capsule-shaped tablet, debossed with AUGMENTIN
875 on 1 side and scored on the other side, contains 875mg amoxicillin as the trihydrate and 125mg clavulanic acid as the potassium salt. NDC
0029-6086-12 bottles of 20 NDC 0029-6086-21 Unit Dose
(10x10) 100 tablets<br/>AUGMENTIN is Also Supplied as: AUGMENTIN 125 mg/5 mL (125 mg
amoxicillin/31.25 mg clavulanic acid) For Oral Suspension: NDC
0029-6085-39 75 mL bottle NDC 0029-6085-23 100 mL bottle NDC
0029-6085-22 150 mL bottle AUGMENTIN 200 mg/5 mL
(200 mg amoxicillin/28.5 mg clavulanic acid) For Oral Suspension: NDC
0029-6087-29 50 mL bottle NDC 0029-6087-39 75 mL bottle NDC
0029-6087-51 100 mL bottle AUGMENTIN 250 mg/5 mL
(250 mg amoxicillin/62.5 mg clavulanic acid) For Oral Suspension: NDC
0029-6090-39 75 mL bottle NDC 0029-6090-23 100 mL
bottle NDC 0029-6090-22 150 mL bottle AUGMENTIN
400 mg/5 mL (400 mg amoxicillin/57 mg clavulanic acid)
For Oral Suspension: NDC 0029-6092-29 50 mL bottle NDC
0029-6092-39 75 mL bottle NDC 0029-6092-51 100 mL
bottle AUGMENTIN 125 mg (125 mg amoxicillin/31.25 mg
clavulanic acid) Chewable Tablets: NDC 0029-6073-47
carton of 30 (5x6) tablets AUGMENTIN 200 mg (200 mg
amoxicillin/28.5 mg clavulanic acid) Chewable Tablets: NDC
0029-6071-12 carton of 20 tablets AUGMENTIN 250 mg
(250 mg amoxicillin/62.5 mg clavulanic acid) Chewable Tablets: NDC
0029-6074-47 carton of 30 (5x6) tablets AUGMENTIN 400
mg (400 mg amoxicillin/57.0 mg clavulanic acid) Chewable Tablets: NDC
0029-6072-12 carton of 20 tablets Store tablets and
dry powder at or below 25��C (77��F). Dispense in original container.
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dailymed-instance:precautio... |
General: While AUGMENTIN possesses the characteristic low toxicity
of the penicillin group of antibiotics, periodic assessment of organ system
functions, including renal, hepatic, and hematopoietic function, is advisable
during prolonged therapy. A high percentage of patients
with mononucleosis who receive ampicillin develop an erythematous skin rash.
Thus, ampicillin-class antibiotics should not be administered to patients
with mononucleosis. The possibility of superinfections
with mycotic or bacterial pathogens should be kept in mind during therapy.
If superinfections occur (usually involving Pseudomonas or Candida), the drug should
be discontinued and/or appropriate therapy instituted. Prescribing
AUGMENTIN in the absence of a proven or strongly suspected bacterial infection
or a prophylactic indication is unlikely to provide benefit to the patient
and increases the risk of the development of drug-resistant bacteria.<br/>Drug Interactions: Probenecid decreases the renal tubular secretion of amoxicillin.
Concurrent use with AUGMENTIN may result in increased and prolonged blood
levels of amoxicillin. Coadministration of probenecid cannot be recommended. The
concurrent administration of allopurinol and ampicillin increases substantially
the incidence of rashes in patients receiving both drugs as compared to patients
receiving ampicillin alone. It is not known whether this potentiation of ampicillin
rashes is due to allopurinol or the hyperuricemia present in these patients.
There are no data with AUGMENTIN andallopurinol administered concurrently. In
common with other broad-spectrum antibiotics, AUGMENTIN may reduce the efficacy
of oral contraceptives.<br/>Drug/Laboratory Test Interactions: Oral administration of AUGMENTIN will result in high urine
concentrations of amoxicillin. High urine concentrations of ampicillin may
result in false-positive reactions when testing for the presence of glucose
in urine using CLINITEST, Benedict's Solution, or
Fehling's Solution. Since this effect may also occur with amoxicillin
and therefore AUGMENTIN, it is recommended that glucose tests based on enzymatic
glucose oxidase reactions (such as CLINISTIX) be used. Following
administration of ampicillin to pregnant women, a transient decrease in plasma
concentration of total conjugated estriol, estriol-glucuronide, conjugated
estrone and estradiol has been noted. This effect may also occur with amoxicillin
and therefore AUGMENTIN.<br/>Information for Patients: Patients should be counseled
that antibacterial drugs including AUGMENTIN, should only be used to treat
bacterial infections. They do not treat viral infections (e.g., the common
cold). When AUGMENTIN is prescribed to treat a bacterial infection, patients
should be told that although it is common to feel better early in the course
of therapy, the medication should be taken exactly as directed. Skipping doses
or not completing the full course of therapy may: (1) decrease the effectiveness
of the immediate treatment, and (2) increase the likelihood that bacteria
will develop resistance and will not be treatable by AUGMENTIN or other antibacterial
drugs in the future.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies
in animals have not been performed to evaluate carcinogenic potential.<br/>Mutagenesis: The mutagenic potential of AUGMENTIN was investigated in
vitro with an Ames test, a human lymphocyte cytogenetic assay, a yeast test
and a mouse lymphoma forward mutation assay, and in vivo with mouse micronucleus
tests and a dominant lethal test. All were negative apart from the in vitro
mouse lymphoma assay where weak activity was found at very high, cytotoxic
concentrations.<br/>Impairment of Fertility: AUGMENTIN at
oral doses of up to 1,200 mg/kg/day (5.7 times the maximum human
dose, 1,480 mg/m/day, based on body surface area) was found
to have no effect on fertility and reproductive performance in rats, dosed
with a 2:1 ratio formulation of amoxicillin:clavulanate.<br/>Teratogenic effects: Pregnancy (Category
B). Reproduction studies performed in pregnant rats and mice given AUGMENTIN
at oral dosages up to 1,200 mg/kg/day, equivalent to 7,200 and 4,080 mg/m/day,
respectively (4.9 and 2.8 times the maximum human oral dose based on
body surface area), revealed no evidence of harm to the fetus due to AUGMENTIN.
There are, however, no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of human response,
this drug should be used during pregnancy only if clearly needed.<br/>Labor and Delivery: Oral ampicillin-class
antibiotics are generally poorly absorbed during labor. Studies in guinea
pigs have shown that intravenous administration of ampicillin decreased the
uterine tone, frequency of contractions, height of contractions, and duration
of contractions; however, it is not known whether the use of AUGMENTIN in
humans during labor or delivery has immediate or delayed adverse effects on
the fetus, prolongs the duration of labor, or increases the likelihood that
forceps delivery or other obstetrical intervention or resuscitation of the
newborn willbe necessary. In a single study in women with premature rupture
of fetal membranes, it was reported that prophylactic treatment with AUGMENTIN
may be associated with an increased risk of necrotizing enterocolitis in neonates.<br/>Nursing Mothers: Ampicillin-class antibiotics are excreted in the milk; therefore,
caution should be exercised when AUGMENTIN is administered to a nursing woman.<br/>Pediatric Use: Pediatric patients weighing
40kg or more should be dosed according
to the adult recommendations (see DOSAGE AND ADMINISTRATION: Pediatric Patients).
Safety and effectiveness of AUGMENTIN Tablets in pediatric patients weighing
less than 40 kg have not been established. (See prescribing information for
AUGMENTIN Powder for Oral Suspension and Chewable Tablets.)<br/>Geriatric Use: An analysis of clinical
studies of AUGMENTIN was conducted to determine whether subjects aged 65 and
over respond differently from younger subjects. Of the 3,119 patients in this
analysis, 68% were<65 years old, 32% were���65 years old and 14%
were���75 years old.This analysis
and other reported clinical experience have not identified differences in
responses between the elderly and younger patients, but a greater sensitivity
of some older individuals cannot be ruled out. This
drug is known to be substantially excreted by the kidney, and the risk of
toxic reactions to this drug may be greater in patients with impaired renal
function. Because elderly patients are more likely to have decreased renal
function, care should be taken in dose selection, and it may be useful to
monitor renal function.
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dailymed-instance:overdosag... |
Following overdosage, patients have experienced primarily
gastrointestinal symptoms including stomach and abdominal pain, vomiting,
and diarrhea. Rash, hyperactivity, or drowsiness have also been observed in
a small number of patients. In the case of overdosage,
discontinue AUGMENTIN, treat symptomatically, and institute supportive measures
as required. If the overdosage is very recent and there is no contraindication,
an attempt at emesis or other means of removal of drug from the stomach may
be performed. A prospective study of 51 pediatric patients at a poison center
suggested that overdosages of less than 250 mg/kg of amoxicillin are
not associated with significant clinical symptoms and do not require gastric
emptying. Interstitial nephritis resulting
in oliguric renal failure has been reported in a small number of patients
after overdosage with amoxicillin. Crystalluria, in
some cases leading to renal failure, has also been reported after amoxicillin
overdosage in adult and pediatric patients. In case of overdosage, adequate
fluid intake and diuresis should be maintained to reduce the risk of amoxicillin
crystalluria. Renal impairment appears to be reversible
with cessation of drug administration. High blood levels may occur more readily
in patients with impaired renal function because of decreased renal clearance
of both amoxicillin and clavulanate. Both amoxicillin and clavulanate are
removed from the circulation by hemodialysis. (See DOSAGE AND ADMINISTRATION
for recommended dosing for patients with impaired renal function.)
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amoxicillin and clavulanate potassium
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AUGMENTIN (Tablet, Film Coated)
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AUGMENTIN is generally
well tolerated. The majority of side effects observed in clinical trials were
of a mild and transient nature and less than 3% of patients discontinued therapy
because of drug-related side effects. The most frequently reported adverse
effects were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria
(3%), vomiting (1%) and vaginitis (1%). The overall incidence of side effects,
and in particular diarrhea, increased with the higher recommended dose. Other
less frequently reported reactions include:Abdominal discomfort, flatulence,
and headache. The following adverse reactions have
been reported for ampicillin-class antibiotics:<br/>Gastrointestinal: Diarrhea, nausea, vomiting, indigestion, gastritis, stomatitis,
glossitis, black���hairy���tongue, mucocutaneous candidiasis,
enterocolitis, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous
colitis symptoms may occur during or after antibiotic treatment. (See WARNINGS.)<br/>Hypersensitivity Reactions: Skin rashes, pruritus, urticaria, angioedema, serum sickness���like
reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia,
and frequently fever), erythema multiforme (rarely Stevens-Johnson syndrome),
acute generalized exanthematous pustulosis, and an occasional case of exfoliative
dermatitis (including toxic epidermal necrolysis) have been reported. These
reactions may be controlled with antihistamines and, if necessary, systemic
corticosteroids. Whenever such reactions occur, the drug should be discontinued,
unless the opinion of the physician dictates otherwise. Serious and occasional
fatal hypersensitivity (anaphylactic) reactions can occur with oral penicillin.
(See WARNINGS.)<br/>Liver: A moderate rise in AST (SGOT) and/or ALT (SGPT) has been
noted in patients treated with ampicillin-class antibiotics but the significance
of these findings is unknown. Hepatic dysfunction, including increases in
serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase,
has been infrequently reported with AUGMENTIN. It has been reported more commonly
in the elderly, in males, or in patients on prolonged treatment. The histologic
findings on liver biopsy have consisted of predominantly cholestatic, hepatocellular,
or mixed cholestatic-hepatocellular changes. The onset of signs/symptoms of
hepatic dysfunction may occur during or several weeks after therapy has been
discontinued. The hepatic dysfunction, which may be severe, is usually reversible.
On rare occasions, deaths have been reported (less than 1 death reported per
estimated 4 million prescriptions worldwide). These have generally been cases
associated with serious underlying diseases or concomitant medications.<br/>Renal: Interstitial nephritis
and hematuria have been reported rarely. Crystalluria has also been reported (see OVERDOSAGE).<br/>Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic
purpura, eosinophilia, leukopenia, and agranulocytosis have been reported
during therapy with penicillins. These reactions are usually reversible on
discontinuation of therapy and are believed to be hypersensitivity phenomena.
A slight thrombocytosis was noted in less than 1% of the patients treated
with AUGMENTIN. There have been reports of increased prothrombin time in patients
receiving AUGMENTIN and anticoagulant therapy concomitantly.<br/>Central Nervous System: Agitation, anxiety, behavioral changes, confusion, convulsions,
dizziness, insomnia, and reversible hyperactivity have been reported rarely.<br/>Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) has
been rarely reported. Most reports occurred in pediatric patients. Discoloration
was reduced or eliminated with brushing or dental cleaning in most cases.
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dailymed-instance:warning |
SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC)
REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. THESE REACTIONS
ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY
AND/OR A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS. THERE HAVE BEEN REPORTS
OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED
SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS. BEFORE INITIATING THERAPY
WITH AUGMENTIN, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY
REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC
REACTION OCCURS, AUGMENTIN SHOULD BE DISCONTINUED AND THE APPROPRIATE THERAPY
INSTITUTED. SERIOUS ANAPHYLACTIC REACTIONS REQUIRE
IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS,
AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS
INDICATED. Pseudomembranous
colitis has been reported with nearly all antibacterial agents, including
AUGMENTIN, and has ranged in severity from mild to life-threatening; therefore,
it is important to consider this diagnosis in patients who present with diarrhea
subsequent to the administration of antibacterial agents. Treatment
with antibacterial agents alters the normal flora of the colon and may permit
overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of���antibiotic-associated colitis.��� After
the diagnosis of pseudomembranous colitis has been established, appropriate
therapeutic measures should be initiated. Mild cases of pseudomembranous colitis
usually respond to drug discontinuation alone. In moderate to severe cases,
consideration should be given to management with fluids and electrolytes,
protein supplementation, and treatment with an antibacterial drug clinically
effective against C. difficile colitis. AUGMENTIN should be used with caution in patients
with evidence of hepatic dysfunction. Hepatic toxicity associated with the
use of AUGMENTIN is usually reversible. On rare occasions, deaths have been
reported (less than 1 death reported per estimated 4 million prescriptions
worldwide). These have generally been cases associated with serious underlying
diseases or concomitant medications. (See CONTRAINDICATIONS and ADVERSE REACTIONS:
Liver.)
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AUGMENTIN is indicated
in the treatment of infections caused by susceptible strains of the designated
organisms in the conditions listed below:<br/>Lower Respiratory Tract Infections: ���caused by��-lactamase���producing strains
of H. influenzae and M. catarrhalis.<br/>Otitis Media: ���caused by��-lactamase���producing strains
of H. influenzae and M.
catarrhalis.<br/>Sinusitis: ���caused by��-lactamase���producing strains
of H. influenzae and M.
catarrhalis.<br/>Skin and Skin Structure Infections: ���caused by��-lactamase���producing strains
of S. aureus, E.
coli, and Klebsiella spp.<br/>Urinary Tract Infections: ���caused by��-lactamase���producing strains
of E. coli, Klebsiella spp., and Enterobacter spp. While
AUGMENTIN is indicated only for the conditions listed above, infections caused
by ampicillin-susceptible organisms are also amenable to treatment with AUGMENTIN
due to its amoxicillin content; therefore, mixed infections caused by ampicillin-susceptible
organisms and��-lactamase���producing organisms susceptible to
AUGMENTIN should not require the addition of another antibiotic. Because amoxicillin
has greater in vitro activity against S. 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 AUGMENTIN. (See Microbiology.) To
reduce the development of drug-resistant bacteria and maintain the effectiveness
of AUGMENTIN and other antibacterial drugs, AUGMENTIN should be used only
to treat or prevent infections that are proven or strongly suspected to be
caused by susceptible bacteria. When culture and susceptibility information
are available, they should be considered in selecting or modifying antibacterial
therapy. In the absence of such data, local epidemiology and susceptibility
patterns may contribute to the empiric selection of therapy. Bacteriological
studies, to determine the causative organisms and their susceptibility to
AUGMENTIN, should be performed together with any indicated surgical procedures.
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AUGMENTIN
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