Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2115
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AUGMENTIN ES (Suspension)
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AUGMENTIN ES-600, 600 mg/5 mL,
does not contain the same amount ofclavulanic acid (as the potassium salt)
as any of the other suspensions of AUGMENTIN. AUGMENTIN ES-600 contains
42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/5 mL
suspension of AUGMENTIN contains 28.5 mg of clavulanic acid per 5 mL
and the 400 mg/5 mL suspension contains 57 mg of clavulanic
acid per 5 mL. Therefore, the 200 mg/5 mL and 400 mg/5 mL
suspensionsof AUGMENTIN should notbe substituted for AUGMENTIN ES-600, as
they are not interchangeable.<br/>Dosage:<br/>Pediatric patients 3 months and older: Based on the amoxicillin component (600mg/5mL), the recommended dose
of AUGMENTIN ES-600 is 90mg/kg/day
divided every 12hours, administered for
10 days (see chart below).<br/>Pediatric patients weighing 40 kg and more: Experience with AUGMENTIN ES-600 (600 mg/5 mL
formulation) in this group is not available.<br/>Adults: Experience with AUGMENTIN ES-600 (600 mg/5 mL
formulation) in adults is not available and adults who have difficulty swallowing
should not be given AUGMENTIN ES-600 (600 mg/5 mL) in place
of the 500-mg or 875-mg tablet of AUGMENTIN. Hepatically
impaired patients should be dosed with caution and hepatic function monitored
at regular intervals. (See WARNINGS.)<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. NOTE: SHAKE ORAL SUSPENSION
WELL BEFORE USING.<br/>Information for the Pharmacist: For patients who wish to alter the taste of AUGMENTIN ES-600,
immediately after reconstitution 1 drop of FLAVORx(apple,
banana cream, bubble gum, cherry, or watermelon flavor) may be added for every
5 mL of AUGMENTIN ES-600. The resulting suspension is stable for
10 days under refrigeration. Other than the 5 flavors listed above, GlaxoSmithKline
has not evaluated the stability of AUGMENTIN ES-600 when mixed with other
flavors distributed by FLAVORx.<br/>Administration: To minimize the potential for gastrointestinal intolerance,
AUGMENTIN ES-600should be taken
at the start of a meal. Absorption of clavulanate potassium may be enhanced
when AUGMENTIN ES-600is administered
at the start of a meal.
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| dailymed-instance:descripti... |
AUGMENTIN ES-600 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: Powder for Oral Suspension���Colloidal silicon dioxide,
strawberry cream flavor, xanthan gum, aspartame���, sodium carboxymethylcellulose,
and silicon dioxide. ���See PRECAUTIONS���Information
for the Patient/Phenylketonurics. Each 5 mL of
reconstituted 600 mg/5 mL oral suspension of AUGMENTIN ES-600
contains 0.23 mEq potassium.
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The pharmacokinetics of amoxicillin and clavulanate were
determined in a study of 19 pediatric patients, 8 months to 11 years, given
AUGMENTIN ES-600 at an amoxicillin dose of 45 mg/kg q12h with
a snack or meal. The mean plasma amoxicillin and clavulanate pharmacokinetic
parameter values are listed in the following table. Arithmetic mean��standard deviation, except Tvalues which are medians (ranges). The
effect of food on the oral absorption of AUGMENTIN ES-600 has not been
studied. 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 ES-600
is highly protein-bound; clavulanic acid has been found to be approximately
25% bound to human serum and amoxicillin approximately 18% bound. Oral
administration of a single dose of AUGMENTIN ES-600 at 45 mg/kg
(based on the amoxicillin component) to pediatric patients, 9 months
to 8 years, yielded the following pharmacokinetic data for amoxicillin
in plasma and middle ear fluid (MEF): Dose administered immediately prior
to eating. 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 ES-600 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 ES-600 possesses
the distinctive properties of a broad-spectrum antibiotic and a��-lactamase
inhibitor. 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���2mcg/mL)<br/>Aerobic Gram-Negative Microorganisms: Haemophilus
influenzae (including��-lactamase���producing isolates) Moraxella
catarrhalis (including��-lactamase���producing isolates) 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 efficacyof 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: Staphylococcus
aureus (including��-lactamase���producing isolates) NOTE: Staphylococci which are resistant to methicillin/oxacillin
must be considered resistant to amoxicillin/clavulanic acid. Streptococcus pyogenes NOTE:S. pyogenes 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 dilutionmethods (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 3.<br/>Diffusion Technique: Quantitative methods that require measurement of zone diameters
also provides 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 3. 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/clavulanic acid. An amoxicillin/clavulanic
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 4. 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 4. ATCC is a trademark of
the American Type Culture Collection. When
using Haemophilus Test Medium (HTM).
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AUGMENTIN ES-600is
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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AUGMENTIN ES-600, 600 mg/5 mL, for Oral Suspension: Each 5 mL of reconstituted strawberry cream-flavored
suspension contains 600 mg amoxicillin and 42.9 mg clavulanic acid
as the potassium salt.
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General: Whileamoxicillin/clavulanate
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 or Candida), the drug should
be discontinued and/or appropriate therapy instituted. Prescribing
AUGMENTIN ES-600 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 ES-600should
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. Keep suspension
refrigerated. Shake well before using. When dosing a child with the suspension
(liquid) of AUGMENTIN ES-600, use a dosing spoon or medicine dropper.
Be sure to rinse the spoon or dropper after each use. Bottles ofsuspension of AUGMENTIN ES-600 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 ES-600,
should only be used to treat bacterial infections. They do not treat viral
infections (e.g., the common cold). When AUGMENTIN ES-600 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 ES-600 or other antibacterial drugs
in the future.<br/>Phenylketonurics: Each 5 mL of the 600 mg/5 mL suspension of
AUGMENTIN ES-600 contains 7 mg phenylalanine.<br/>Drug Interactions: Probenecid decreases the renal tubular secretion of amoxicillin.
Concurrent use with AUGMENTIN ES-600 may result in increased and prolonged
blood levels of amoxicillin. Co-administration 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 ES-600and allopurinol administered concurrently. In
common with other broad-spectrum antibiotics, amoxicillin/clavulanate 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 ES-600, 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 ES-600.<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 mouse lymphoma assay where weak activity was found at very
high, cytotoxic concentrations. AUGMENTIN at oral doses of up to 1,200 mg/kg/day
(5.7 times the maximum adult human dose 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
(4.9 and 2.8 times the maximum adult human oral dose based on body surface
area, respectively), 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 human milk;
therefore, caution should be exercised when AUGMENTIN is administered to a
nursing woman.<br/>Pediatric Use: Safety and efficacy of AUGMENTIN ES-600in infants younger than 3 months have not been established.
Safety and efficacy of AUGMENTIN ES-600have been demonstrated for treatment of acute otitis media in infants
and children 3 months to 12 years (see Description of Clinical Studies). The
safety and effectiveness of AUGMENTIN ES���600 have been established
for the treatment of pediatric patients (3 months to 12 years) with
acute bacterial sinusitis. This use is supported by evidence from adequate
and well-controlled studies of AUGMENTIN XR���Extended Release
Tablets in adults with acute bacterial sinusitis, studies of AUGMENTIN ES-600
in pediatric patients with acute otitis media, and by similar pharmacokinetics
of amoxicillin and clavulanate in pediatric patients taking AUGMENTIN ES-600
(see CLINICAL PHARMACOLOGY) and adults taking AUGMENTIN XR.
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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 ES-600, 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 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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amoxicillin and clavulanate potassium
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AUGMENTIN ES (Suspension)
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AUGMENTIN ES-600is generally well tolerated. The majority of
side effects observed in pediatric clinical trials of acute otitis media were
either mild or moderate, and transient in nature; 4.4% of patients discontinued
therapy because of drug-related side effects. The most commonly reported side
effects with probable or suspected relationship to AUGMENTIN ES-600were contact dermatitis, i.e., diaper rash (3.5%),
diarrhea (2.9%), vomiting (2.2%), moniliasis (1.4%), and rash (1.1%). The
most common adverse experiences leading to withdrawal that wereof probable
or suspected relationship to AUGMENTIN ES-600were diarrhea (2.5%) and vomiting (1.4%). 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 shouldbe 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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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 ES-600, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS
HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS.
IF AN ALLERGIC REACTION OCCURS, AUGMENTIN ES-600 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 amoxicillin/clavulanate potassium, 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 ES-600should be used with caution in patients with evidence of hepatic
dysfunction. Hepatic toxicity associated with the use of amoxicillin/clavulanate
potassiumis 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 ES-600
is indicated for the treatment of pediatric patients with recurrent or persistent
acute otitis media due to S. pneumoniae (penicillin MICs���2 mcg/mL), H. influenzae (including��-lactamase���producing strains), or M. catarrhalis (including��-lactamase���producing
strains) characterized by the following risk factors: ���age���2 years ���daycare attendance [See CLINICAL PHARMACOLOGY, Microbiology.] NOTE: Acute otitis media due to S. pneumoniaealone can be treated with amoxicillin. AUGMENTIN ES-600 is
not indicated for the treatment of acute otitis media due to S. pneumoniaewith penicillin MIC���4 mcg/mL. Therapy
may be instituted prior to obtaining the results from bacteriological studies
when there is reason to believe the infection may involve both S.
pneumoniae (penicillin MIC���2 mcg/mL) and the��-lactamase���producing
organisms listed above. To reduce the development of
drug-resistant bacteria and maintain the effectiveness of AUGMENTIN ES-600
and other antibacterial drugs, AUGMENTIN ES-600 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.
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AUGMENTIN ES
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