Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2601
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AUGMENTIN (Powder, For Suspension)
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dailymed-instance:dosage |
Dosage:<br/>Pediatric Patients: Based on the amoxicillin component, AUGMENTIN should be
dosed as follows:<br/>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 AUGMENTIN 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.<br/>Patients aged 12 weeks (3 months) and older: 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 suspension of AUGMENTIN
is available as a chewable tablet for use by older children. Duration of therapy studied and recommended
for acute otitis media is 10 days.<br/>Pediatric Patients Weighing 40 kg and More: Should be dosed according
to the following adult recommendations: The usual adult dose is one 500-mg
tablet of AUGMENTIN every 12 hours or one 250-mg tablet of AUGMENTIN
every 8 hours. For more severe infections and infections of the respiratory
tract, the dose should be one 875-mg tablet of AUGMENTIN every 12 hours
or one 500-mg tablet of AUGMENTIN every 8 hours. Among adults treated
with 875 mg every 12 hours, significantly fewer experienced severe
diarrhea or withdrawals with diarrhea versus adults treated with 500 mg
every 8 hours. For detailed adult dosage recommendations, please see
complete prescribing information for tablets of AUGMENTIN. Hepatically
impaired patients should be dosed with caution and hepatic function monitored
at regular intervals. (See WARNINGS.)<br/>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 250-mg
tablet of AUGMENTIN and the 250-mg chewable tablet do not contain the same
amount of clavulanic acid (as the potassium salt). The 250-mg tablet of AUGMENTIN
contains 125 mg of clavulanic acid, whereas the 250-mg chewable tablet
contains 62.5 mg of clavulanic acid. Therefore, the 250-mg tablet of
AUGMENTIN 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 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 child weighs at
least 40 kg and more.<br/>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 below) and shake vigorously
to suspend powder. Add remainder of the water and again shake vigorously. AUGMENTIN 125 mg/5 mL Suspension Each teaspoonful (5 mL) will contain 125 mg
amoxicillin and 31.25 mg of clavulanic acid as the potassium salt. AUGMENTIN 200 mg/5 mL Suspension Each teaspoonful (5 mL) will contain 200 mg
amoxicillin and 28.5 mg of clavulanic acid as the potassium salt. AUGMENTIN 250 mg/5 mL Suspension Each teaspoonful (5 mL) will contain 250 mg
amoxicillin and 62.5 mg of clavulanic acid as the potassium salt. AUGMENTIN 400 mg/5 mL Suspension 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: 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 CHKNO,
and 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: Powder for Oral Suspension���Colloidal silicon dioxide,
flavorings (see HOW SUPPLIED), xanthan gum, and 1 or more of the following:
Aspartame���, hypromellose, mannitol, silica gel, silicon dioxide, and
sodium saccharin. Chewable Tablets���Colloidal silicon dioxide, flavorings
(see HOW SUPPLIED), magnesium stearate, mannitol, and 1 or more of the following:
Aspartame���, D&C Yellow No. 10, FD&C Red No. 40, glycine, sodium
saccharin and succinic acid. ���See PRECAUTIONS���Information
for the Patient. Each 125-mg chewable tablet and each
5 mL of reconstituted 125 mg/5 mL oral suspension of AUGMENTIN
contains 0.16 mEq potassium. Each 250-mg chewable tablet and each 5 mL
of reconstituted 250 mg/5 mL oral suspension of AUGMENTIN contains
0.32 mEq potassium. Each 200-mg chewable tablet and each 5 mL of
reconstituted 200 mg/5 mL oral suspension of AUGMENTIN contains
0.14 mEq potassium. Each 400-mg chewable tablet and each 5 mL of
reconstituted 400 mg/5 mL oral suspension of AUGMENTIN contains
0.29 mEq of 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. Oral
administration of single doses of 400-mg chewable tablets of AUGMENTIN and
400 mg/5 mL suspension to 28 adult volunteers yielded comparable
pharmacokinetic data: Administered at
the start of a light meal. Mean
values of 28 normal volunteers. Peak concentrations occurred approximately
1 hour after the dose. Oral administration of
5 mL of 250 mg/5 mL suspension of AUGMENTIN or the equivalent
dose of 10 mL of 125 mg/5 mL suspension of AUGMENTIN provides
average peak serum concentrations approximately 1 hour after dosing of
6.9 mcg/mL for amoxicillin and 1.6 mcg/mL for clavulanic acid. The
areas under the serum concentration curves obtained during the first 4 hours
after dosing were 12.6 mcg.hr/mL for amoxicillin and 2.9 mcg.hr/mL
forclavulanic acid when 5 mL of 250 mg/5 mL suspension of
AUGMENTIN or equivalent dose of 10 mL of 125 mg/5 mL suspension
of AUGMENTIN was administered to adult volunteers. One 250-mg chewable tablet
of AUGMENTIN or two 125-mg chewable tablets of AUGMENTIN are equivalent to
5 mL of 250 mg/5 mL suspension of AUGMENTIN and provide similar
serum levels of amoxicillin and clavulanic acid. 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. Time above the minimum inhibitory
concentration of 1.0 mcg/mL for amoxicillin has been shown to be similar
after corresponding q12h and q8h dosing regimens of AUGMENTIN in adults and
children. 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 10 mL
of 250 mg/5 mL suspension 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. Two hours after
oral administration of a single 35 mg/kg dose of suspension of AUGMENTIN
to fasting children, average concentrations of 3.0 mcg/mL of amoxicillin
and 0.5 mcg/mL of clavulanic acid were detected in middle ear effusions.<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 distinctive 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 Enterobacter species 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; 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-Pos:<br/>itive 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 For Gram-Negative Enteric Aerobes: For Staphylococcusand Haemophilus species: Staphylococci
which are susceptible to amoxicillin/clavulanic acid but resistant to methicillin/oxacillin
must be considered as resistant. ForS. 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 that 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: 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 potassium (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 ForStaphylococcusspecies
and H. influenzae: For Other Organisms Except S.pneumoniaeand N.gonorrhoeae: 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 (20mcg amoxicillin plus 10mcg clavulanate potassium) disk should provide
the following zone diameters in these laboratory quality control strains:
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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
125 mg/5 mL for Oral Suspension: Each 5mL of reconstituted banana-flavored suspension contains 125mg amoxicillin and 31.25mg clavulanic acid as the potassium salt. NDC
0029-6085-3975 mL bottle NDC 0029-6085-22150 mL bottle NDC
0029-6085-23 100 mL bottle AUGMENTIN 200 mg/5 mL for Oral
Suspension: Each 5 mL of reconstituted orange-flavored suspension
contains 200 mg amoxicillin and 28.5 mg clavulanic acid as the potassium
salt. NDC 0029-6087-29 50 mL bottle NDC 0029-6087-51
100 mL bottle NDC 0029-6087-39 75 mL bottle AUGMENTIN 250 mg/5 mL for Oral Suspension: Each
5mL of reconstituted orange-flavored suspension
contains 250mg amoxicillin and 62.5mg clavulanic acid as the potassium salt. NDC
0029-6090-39 75 mL bottle NDC 0029-6090-22 150 mL bottle NDC
0029-6090-23 100 mL bottle AUGMENTIN 400 mg/5 mL for Oral
Suspension: Each 5mL of reconstituted
orange-flavored suspension contains 400mg
amoxicillin and 57mg clavulanic acid as
the potassium salt. NDC 0029-6092-29 50 mL bottle
NDC 0029-6092-51 100 mL bottle NDC 0029-6092-39
75 mL bottle AUGMENTIN
125-mg Chewable Tablets: Each mottled yellow, round, lemon-lime-flavored
tablet, debossed with BMP 189, contains 125mg
amoxicillin as the trihydrate and 31.25mg
clavulanic acid as the potassium salt. NDC 0029-6073-47
carton of 30 tablets 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. NDC 0029-6071-12
carton of 20 tablets 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. NDC
0029-6074-47 carton of 30 tablets 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. NDC 0029-6072-12
carton of 20 tablets AUGMENTIN
is Also Supplied as: AUGMENTIN
250-mg Tablets (250 mg
amoxicillin/125 mg clavulanic acid): NDC 0029-6075-27
bottles of 30 NDC 0029-6075-31 100 Unit Dose tablets AUGMENTIN 500-mg Tablets (500 mg amoxicillin/125 mg
clavulanic acid): NDC 0029-6080-12 bottles of 20 NDC
0029-6080-31 100 Unit Dose tablets AUGMENTIN
875-mg Tablets (875mg amoxicillin/125mg clavulanic acid): NDC
0029-6086-12 bottles of 20 NDC 0029-6086-21 100 Unit Dose tablets Store
tablets and dry powder at or below 25��C (77��F). Dispense in original
containers. Store reconstituted suspension under refrigeration. Discard unused
suspension after 10 days.
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dailymed-ingredient:aspartame,
dailymed-ingredient:colloidal_silicon_dioxide,
dailymed-ingredient:flavorings,
dailymed-ingredient:hypromellose,
dailymed-ingredient:mannitol,
dailymed-ingredient:silica_gel,
dailymed-ingredient:silicon_dioxide,
dailymed-ingredient:sodium_saccharin,
dailymed-ingredient:xanthan_gum
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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/>Information for the Patient: AUGMENTIN may be taken
every 8 hours or every 12 hours, depending on the strength of the
product prescribed. Each dose should be taken with a meal or snack to reduce
the possibility of gastrointestinal upset. Many antibiotics can cause diarrhea.
If diarrhea is severe or lasts more than 2 or 3 days, call your doctor. Diarrhea is a common problem caused by antibiotics which usually ends when
the antibiotic is discontinued. Sometimes after starting treatment with antibiotics,
patients can develop watery and bloody stools (with or without stomach cramps
and fever) even as late as 2 or more months after having taken the last dose
of the antibiotic. If this occurs, patients should contact their physician
as soon as possible. Keep suspension refrigerated.
Shake well before using. When dosing a child with the suspension (liquid)
of AUGMENTIN, use a dosing spoon or medicine dropper. Be sure to rinse the
spoon or dropper after each use. Bottles of suspension of AUGMENTIN may contain
more liquid than required. Follow your doctor's instructions about
the amount to use and the days of treatment your child requires. Discard any
unused medicine. 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 asdirected. 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/>Phenylketonurics: Each 200-mg chewable tablet of AUGMENTIN contains 2.1 mg
phenylalanine; each 400-mg chewable tablet contains 4.2 mg phenylalanine;
each 5 mL of either the 200 mg/5 mL or 400 mg/5 mL
oral suspension contains 7 mg phenylalanine. The other products of AUGMENTIN
do not contain phenylalanine and can be used by phenylketonurics. Contact
your physician or pharmacist.<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 and allopurinol 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/>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 will be 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: Because of incompletely developed renal function in neonates
and young infants, the elimination of amoxicillin may be delayed. Dosing of
AUGMENTIN should be modified in pediatric patients younger than 12 weeks
(3 months). (See DOSAGE AND ADMINISTRATION���Pediatric.)
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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.
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dailymed-instance:genericMe... |
amoxicillin and clavulanate potassium
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dailymed-instance:fullName |
AUGMENTIN (Powder, For Suspension)
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dailymed-instance:adverseRe... |
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. From the original premarketing studies,
where both pediatric and adult patients were enrolled, 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. In pediatric patients (aged
2 months to 12 years), 1 US/Canadian clinical trial was conducted
which compared 45/6.4 mg/kg/day (divided q12h) of AUGMENTIN for 10 days
versus 40/10 mg/kg/day (divided q8h) of AUGMENTIN for 10 days in
the treatment of acute otitis media. A total of 575 patients were enrolled,
and only the suspension formulations were used in this trial. Overall, the
adverse event profile seen was comparable to that noted above; however, there
were differences in the rates of diarrhea, skin rashes/urticaria, and diaper
area rashes. (See CLINICAL STUDIES.) 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, hypersensitivity vasculitis, 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 hepatitis and
cholestatic jaundice, (See CONTRAINDICATIONS.) 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. Clostridium difficile associated
diarrhea (CDAD) has been reported with use of nearly all antibacterial agents,
including AUGMENTIN, and may range in severity from mild diarrhea to fatal
colitis. Treatment with antibacterial agents alters the normal flora of the
colon leading to overgrowth of C. difficile. C. difficile
produces toxins A and B which contribute to the development of CDAD. Hypertoxin
producing strains of C. difficile cause increased morbidity and mortality,
as these infections can be refractory to antimicrobial therapy and may require
colectomy. CDAD must be considered in all patients who present with diarrheafollowing antibiotic use. Careful medical history is necessary since CDAD
has been reported to occur over two months after the administration of antibacterial
agents. If CDAD is suspected or confirmed, ongoing
antibiotic use not directed against C. difficile may need to be discontinued.
Appropriate fluid and electrolyte management, protein supplementation, antibiotic
treatment of C. difficile, and surgical evaluation should be instituted as
clinically indicated. 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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dailymed-instance:indicatio... |
AUGMENTIN 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��-lactamase���producing
strains of H. influenzae and M. catarrhalis. Otitis Media���caused by��-lactamase���producing
strains of H. influenzae and M. catarrhalis. Sinusitis���caused by��-lactamase���producing
strains of H. influenzae and M. catarrhalis. Skin and Skin Structure Infections���caused
by��-lactamase���producing strains of S.
aureus, E. coli, and Klebsiella spp. 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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dailymed-instance:name |
AUGMENTIN
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