Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/660
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AUGMENTIN XR (Tablet, Extended Release)
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dailymed-instance:dosage |
AUGMENTIN XR should be taken at the start of
a meal to enhance the absorption of amoxicillin and to minimize the
potential for gastrointestinal intolerance. Absorption of the amoxicillin
component is decreased when AUGMENTIN XR is taken on an empty stomach
(see CLINICAL PHARMACOLOGY). The recommended
dose of AUGMENTIN XR is 4,000 mg/250 mg daily according
to the following table: Tablets of AUGMENTIN(250 mg or 500 mg) CANNOT be
used to provide the same dosages as AUGMENTIN XR Extended Release
Tablets. This is because AUGMENTIN XR contains 62.5 mg of clavulanic acid, while the
AUGMENTIN 250-mg and 500-mg tablets
each contain 125 mg of clavulanic
acid. In addition, the Extended Release Tablet provides an extended
time course of plasma amoxicillin concentrations compared to immediate-release
Tablets. Thus, two AUGMENTIN 500-mg tablets are not equivalent to one AUGMENTIN XR tablet. Scored AUGMENTIN XR Extended Release Tablets
are available for greater convenience for adult patients who have
difficulty swallowing. The scored tablet is not intended to reduce
the dosage of medication taken; as stated in the table above, the
recommended dose of AUGMENTIN XR is two tablets twice a day (q12h).<br/>Renally Impaired Patients: The pharmacokinetics of AUGMENTIN XR have not been
studied in patients with renal impairment. AUGMENTIN XR is contraindicated
in patients with a creatinine clearance of<30 mL/min. and
in hemodialysis patients (see CONTRAINDICATIONS).<br/>Hepatically Impaired Patients: Hepatically impaired patients should be dosed with
caution and hepatic function monitored at regular intervals (see WARNINGS).<br/>Pediatric Use: Safety and effectiveness
in pediatric patients younger than 16 years have not been established.<br/>Geriatric Use: No dosage adjustment
is required for the elderly (see PRECAUTIONS, Geriatric Use).
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dailymed-instance:descripti... |
AUGMENTIN XR is an oral antibacterial combination
consisting of the semisynthetic antibiotic amoxicillin (present as
amoxicillin trihydrate and amoxicillin sodium) 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 trihydrate
molecular formula is CHNOS���3HO, and the molecular weight is 419.45.
Chemically, amoxicillin trihydrate 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: The amoxicillin sodium
molecular formula is CHNNaOS, and the molecular weight is 387.39. Chemically, amoxicillin
sodium is [2S-[2��,5��,6��(S *)]]-6-[[Amino(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic
acid monosodium salt 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: Citric acid, colloidal silicon dioxide, hypromellose,
magnesium stearate, microcrystalline cellulose, polyethylene glycol,
sodium starch glycolate, titanium dioxide, and xanthan gum. Each tablet of AUGMENTIN XR contains 12.6 mg
(0.32 mEq) of potassium and 29.3 mg (1.27 mEq) of sodium.
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dailymed-instance:clinicalP... |
Amoxicillin and clavulanate potassium are well
absorbed from the gastrointestinal tract after oral administration
of AUGMENTIN XR. AUGMENTIN XR is an extended-release
formulation which provides sustained plasma concentrations of amoxicillin.
Amoxicillin systemic exposure achieved with AUGMENTIN XR is similar
to that produced by the oral administration of equivalent doses of
amoxicillin alone. In a study of healthy adult volunteers, the pharmacokinetics
of AUGMENTIN XR were compared when administered in a fasted state,
at the start of a standardized meal (612 kcal, 89.3 g carb,
24.9 g fat, and 14.0 g protein), or 30 minutes after
a high-fat meal. When the systemic exposure to both amoxicillin and
clavulanate is taken into consideration, AUGMENTIN XR is optimally
administered at the start of a standardized meal. Absorption of amoxicillin
is decreased in the fasted state. AUGMENTIN XR is not recommended
to be taken with a high-fat meal, because clavulanate absorption is
decreased. Thepharmacokinetics of the components of AUGMENTIN XR
following administration of two AUGMENTIN XR tablets at the start
of a standardized meal are presented below. Median (range). The half-life of amoxicillin after the oral administration
of AUGMENTIN XR is approximately 1.3 hours, and that of clavulanate
is approximately 1.0 hour. Clearance
of amoxicillin is predominantly renal, with approximately 60% to 80%
of the dose being excreted unchanged in urine, whereas clearance of
clavulanate has both a renal (30% to 50%) and a non-renal component. Concurrent administration of probenecid delays amoxicillin
excretion but does not delay renal excretion of clavulanate. In a study of adults, the pharmacokinetics of amoxicillin
and clavulanate were not affected by administration of an antacid
(MAALOX), either simultaneously with or 2 hours after
AUGMENTIN XR. Neither component in AUGMENTIN
XR is highly protein-bound; clavulanate 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, its spectrum of activity does not include organisms which
produce these enzymes. Clavulanic acid is a��-lactam, structurally
related to penicillin, 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 found responsible for transferred drug resistance. The clavulanic acid component of AUGMENTIN XR 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. Amoxicillin/clavulanic acid has been shown to be active
against most isolates of the following microorganisms, both in vitro
and in clinical infections as described in the INDICATIONS AND USAGE section.<br/>Aerobic Gram-Positive Microorganisms: Streptococcus pneumoniae (including isolates with penicillin
MICs���2 mcg/mL) Staphylococcus aureus (including��-lactamase���producing
isolates) NOTE: Staphylococci which are resistant to methicillin/oxacillin must
be considered resistant to amoxicillin/clavulanic acid.<br/>Aerobic Gram-Negative Microorganisms: Haemophilus influenzae (including��-lactamase���producing
isolates) Moraxella
catarrhalis (including��-lactamase���producing
isolates) Haemophilus
parainfluenzae (including��-lactamase���producing
isolates) Klebsiella pneumoniae (all
known isolates are��-lactamase���producing) The following in vitro data are available, but their clinical significance is unknown. At least 90% of the following microorganisms
exhibit in vitro minimum inhibitory concentrations (MICs) less than
or equal to the susceptible breakpoint for amoxicillin/clavulanic
acid.However, the safety and efficacy of amoxicillin/clavulanic
acid in treating infections due to these microorganisms have not been
established in adequate and well-controlled trials.<br/>Aerobic Gram-Positive Microorganisms: Streptococcus pyogenes<br/>Anaerobic Microorganisms: Bacteroides fragilis (including��-lactamase���producing
isolates) Fusobacterium
nucleatum (including��-lactamase���producing
isolates) Peptostreptococcus
magnus Peptostreptococcus micros NOTE:S. pyogenes, P. magnus, and P. micros do not produce��-lactamase, and therefore, are susceptible to amoxicillin alone.
Adequate and well-controlled clinical trials have established the
effectiveness of amoxicillin alone in treating certain clinical infections
due to S. pyogenes.<br/>Susceptibility Test Methods: When available, the clinical microbiology laboratory
should provide cumulative results of in vitro susceptibility test
results for antimicrobial drugs used in local hospitals and practice
areas to the physician as periodic reports that describe the susceptibility
profile of nosocomial and community-acquired pathogens. These reports
should aid the physician in selecting the most effective antimicrobial.<br/>Dilution Technique: Quantitative methods are used to determine antimicrobial
minimum inhibitory concentrations (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 dilution methods (broth or
agar; broth for S. pneumoniae and H.influenzae) or equivalent with standardized
inoculum concentration 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
criteria provided in Table 2.<br/>Diffusion Technique: Quantitative methods that require measurement of
zone diameters also provide reproducible estimates of the susceptibility
of bacteria to antimicrobials. One such standardized technique requires
the use of a standardized inoculum concentration.This
procedure uses paper disks impregnated with 30 mcg amoxicillin/clavulanate
potassium (20 mcg amoxicillin plus 10 mcg clavulanate potassium)
to test susceptibility of microorganisms to amoxicillin/clavulanate
potassium. Disk diffusion zone sizes should be interpreted according
to criteria provided in Table 2. NOTE: 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/clavulanate
acid. An amoxicillin/clavulanate acid MIC should be determined on
isolates of S. pneumoniae with
oxacillin zone sizes of���19 mm. NOTE:��-lactamase���negative,
ampicillin-resistant H. influenzae isolates must be considered resistant to amoxicillin/clavulanic acid. A report of S (���Susceptible���) indicates
that the antimicrobial is likely to inhibit growth of the pathogen
if the antimicrobial compound in the blood reaches the concentration
usually achievable. A report of I (���Intermediate���) indicates
that the result should be considered equivocal, and, if the microorganism
is not fully susceptible to alternative, clinically feasible antimicrobials,
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 doses of antimicrobial 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 R (���Resistant���) indicates that the antimicrobial
is not likely to inhibit growth of the pathogen if the antimicrobial
compound in the blood reaches the concentration usually achievable;
other therapy should be selected. Standardized
susceptibility test procedures require the use of quality control
microorganisms to determine the performance of the test procedures.Standard amoxicillin/clavulanate potassium powder should
provide the MIC ranges for the quality control organisms in Table
3. For the disk diffusion technique, the 30 mcg amoxicillin/clavulanate
potassium disk should provide the zone diameter ranges for the quality
control organisms in Table 3.
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dailymed-instance:activeIng... | |
dailymed-instance:contraind... |
AUGMENTIN XR 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 treatment with amoxicillin/clavulanate
potassium. AUGMENTIN XR is contraindicated
in patients with severe renal impairment (creatinine clearance<30 mL/min.)
and in hemodialysis patients.
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dailymed-instance:supply |
AUGMENTIN XR Extended Release Tablets: Each white, oval
film-coated bilayer scored tablet, debossed with AUGMENTIN XR, contains
amoxicillin trihydrate and amoxicillin sodium equivalent to a total
of 1,000 mg of amoxicillin and clavulanate potassium equivalent
to 62.5 mg of clavulanic acid.
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dailymed-instance:activeMoi... | |
dailymed-instance:inactiveI... |
dailymed-ingredient:citric_acid,
dailymed-ingredient:colloidal_silicon_dioxide,
dailymed-ingredient:hypromellose,
dailymed-ingredient:magnesium_stearate,
dailymed-ingredient:microcrystalline_cellulose,
dailymed-ingredient:polyethylene_glycol,
dailymed-ingredient:potassium,
dailymed-ingredient:sodium,
dailymed-ingredient:sodium_starch_glycolate,
dailymed-ingredient:titanium_dioxide,
dailymed-ingredient:xanthan_gum
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dailymed-instance:precautio... |
General: While amoxicillin/clavulanate
potassium 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
if therapy is for longer than the drug is approved for administration. 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 spp. or Candida spp.), the drug should be discontinued and/or appropriate therapy
instituted. Prescribing AUGMENTIN XR
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 Patients: AUGMENTIN XR
should be taken every 12 hours with a meal or snack to reduce
the possibility of gastrointestinal upset. If diarrhea develops and
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. Patients should be counseled that
antibacterial drugs, including AUGMENTIN XR, should only be used
to treat bacterial infections. They do not treat viral infections
(e.g., the common cold). When AUGMENTIN XR 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 XR
or other antibacterial drugs in the future. Discard any unused medicine.<br/>Drug Interactions: Probenecid decreases
the renal tubular secretion of amoxicillin. Concurrent use with AUGMENTIN
XR 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. In
controlled clinical trials of AUGMENTIN XR, 25 patients received concomitant
allopurinol and AUGMENTIN XR. No rashes were reported in these patients.
However, this sample size is too small to allow for any conclusions
to be drawn regarding the risk of rashes with concomitant AUGMENTIN
XR and allopurinol use. In common with other
broad-spectrum antibiotics, AUGMENTIN XR may reduce the efficacy of
oral contraceptives.<br/>Drug/Laboratory Test Interactions: Oral administration
of AUGMENTIN XR 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 XR, 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 XR.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies
in animals have not been performed to evaluate carcinogenic potential.
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 mouselymphoma assay, where weak activity was found
at very high, cytotoxic concentrations. AUGMENTIN at oral doses of
up to 1,200 mg/kg/day (1.9 times the maximum human dose of amoxicillin
and 15 times the maximum human dose of clavulanate 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/>Pregnancy:<br/>Teratogenic Effects: Pregnancy Category B. Reproduction studies performed
in pregnant rats and mice given AUGMENTIN at oral doses up to 1,200 mg/kg/day
revealed no evidence of harm to the fetus due to AUGMENTIN. In terms
of body surface area, the doses in rats were 1.6 times the maximum
human oral dose of amoxicillin and 13 times the maximum human dose
for clavulanate. For mice, these doses were 0.9 and 7.4 times the
maximum human oral dose of amoxicillin and clavulanate, respectively.
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 XR 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 inneonates.<br/>Nursing Mothers: Ampicillin-class
antibiotics are excreted in the milk; therefore, caution should be
exercised when AUGMENTIN XR is administered to a nursing woman.<br/>Pediatric Use: Safety and effectiveness
in pediatric patients younger than 16 years have not been established.<br/>Geriatric Use: Of the total
number of subjects in clinical studies of AUGMENTIN XR, 18.4% were
65 years or older and 7.2% were 75 years or older. No overall differences
in safety and effectiveness were observed between these subjects and
younger subjects, and other clinical experience has not reported 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 dose-dependent 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,
it may be useful to monitor renal function. Each tablet of AUGMENTIN XR contains 29.3 mg (1.27 mEq)
of sodium.
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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 XR, 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 control center
suggested that overdosages of less than 250 mg/kg of amoxicillin
are not associated with significantclinical 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).
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dailymed-instance:genericMe... |
amoxicillin sodium, amoxicillin and clavulanate potassium
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dailymed-instance:fullName |
AUGMENTIN XR (Tablet, Extended Release)
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dailymed-instance:adverseRe... |
In clinical trials, 5,643 patients have been
treated with AUGMENTIN XR. The majority of side effects observed in
clinical trials were of a mild and transient nature; 2% of patients
discontinued therapy because of drug-related side effects. The most
frequently reported adverse effects which were suspected or probably
drug-related were diarrhea (14.5%), vaginal mycosis (3.3%) nausea
(2.1%), and loose stools (1.6%). AUGMENTIN XR had a higher rate of
diarrhea which required corrective therapy (3.8% versus 2.6% for AUGMENTIN
XR and all comparators, respectively). 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. 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 or AUGMENTIN XR. It has
been reportedmore 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 millionprescriptions 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.<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. 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, headache, 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 XR, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS
HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER
ALLERGENS. IF AN ALLERGIC REACTION OCCURS, AUGMENTIN XR 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 XR, 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 diarrhea following antibiotic use.
Careful medical history is necessary since CDAD has been reported
to occur over two months after the administration ofantibacterial
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 XR should be used
with caution in patients with evidence of hepatic dysfunction. Hepatic
toxicity associated with the use of amoxicillin/clavulanate potassium
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 XR Extended Release Tablets are indicated
for the treatment of patients with community-acquired pneumonia or
acute bacterial sinusitis due to confirmed, or suspected��-lactamase���producing
pathogens (i.e., H. influenzae, M. catarrhalis, H. parainfluenzae, K. pneumoniae , or methicillin-susceptible S. aureus ) and S. pneumoniae with reduced susceptibility
to penicillin (i.e., penicillin MICs = 2 mcg/mL). AUGMENTIN
XR is not indicated for the treatment of infections due to S. pneumoniae with penicillin MICs���4 mcg/mL.
Data are limited with regard to infections due to S. pneumoniae with penicillin
MICs���4 mcg/mL (see CLINICAL STUDIES). Of the common epidemiological risk factors for patients with
resistant pneumococcal infections, only age>65 years was studied.
Patients with other common risk factors for resistant pneumococcal
infections (e.g., alcoholism, immune-suppressive illness, and presence
of multiple co-morbid conditions) were not studied. In patients with community-acquired pneumonia in whom penicillin-resistant S. pneumoniae is suspected, bacteriological
studies should be performed to determine the causative organisms and
their susceptibility when AUGMENTIN XR is prescribed. Acute bacterial sinusitis or community-acquired pneumonia due
to a penicillin-susceptible strain of S. pneumoniae plus a��-lactamase���producing
pathogen can be treated with another AUGMENTIN (amoxicillin/clavulanate
potassium) product containing lower daily doses of amoxicillin (i.e.,
500 mg q8h or 875 mg q12h). Acute bacterial sinusitis or
community-acquired pneumonia due to S.
pneumoniae alone can be treated with amoxicillin. To reduce the development of drug-resistant bacteria
and maintain the effectiveness of AUGMENTIN XR and other antibacterial
drugs, AUGMENTIN XR 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 beconsidered 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.
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AUGMENTIN XR
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