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AugmentinXR
Overview
What is AugmentinXR?
AUGMENTIN XR is an oral antibacterial combination consisting of
the semisynthetic antibiotic amoxicillin (present as amoxicillin trihydrate and
amoxicillin sodium) and the β-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 (2,5,6)-6-[()-(-)-2-Amino-2-(-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 [2-[2α,5α,6β(*)]]-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 . It is a β-lactam structurally
related to the penicillins and possesses the ability to inactivate a wide
variety of β-lactamases by blocking the active sites of these enzymes.
Clavulanic acid is particularly active against the clinically important
plasmid-mediated β-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 ()-(2,5)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate,
and may be represented structurally as:
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.
What does AugmentinXR look like?
What are the available doses of AugmentinXR?
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What should I talk to my health care provider before I take AugmentinXR?
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How should I use AugmentinXR?
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 β-lactamase−producing pathogens (i.e.,
, , , , or
methicillin-susceptible ) and with reduced susceptibility to penicillin
(i.e., penicillin MICs = 2 mcg/mL). AUGMENTIN XR is not indicated for the
treatment of infections due to with
penicillin MICs ≥ 4 mcg/mL. Data are limited with regard to infections due to
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 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 plus a
β-lactamase−producing pathogen can be treated with another AUGMENTIN (amoxicillin/clavulanate potassium) product containing lower
daily doses of amoxicillin (i.e., 500 mg every 8 hours or 875 mg every 12
hours). Acute bacterial sinusitis or community-acquired pneumonia due to 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 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.
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 (every 12
hours).
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).
Hepatically impaired patients should be dosed with caution and
hepatic function monitored at regular intervals (see WARNINGS).
Pediatric patients who weigh 40 kg or more and can swallow
tablets should receive the adult dose.
No dosage adjustment is required for the elderly (see
PRECAUTIONS, Geriatric Use).
What interacts with AugmentinXR?
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.
What are the warnings of AugmentinXR?
The risk of myopathy during treatment with another HMG-CoA reductase inhibitor is increased with concurrent therapy with either erythromycin, cyclosporine, niacin, or fibrates. However, neither myopathy nor significant increases in CPK levels have been observed in three reports involving a total of 100 post-transplant patients (24 renal and 76 cardiac) treated for up to two years concurrently with pravastatin 10-40 mg and cyclosporine. Some of these patients also received other concomitant immunosuppressive therapies. Further, in clinical trials involving small numbers of patients who were treated concurrently with pravastatin and niacin, there were no reports of myopathy. Also, myopathy was not reported in a trial of combination pravastatin (40 mg/day) and gemfibrozil (1200 mg/day), although 4 of 75 patients on the combination showed marked CPK elevations versus one of 73 patients receiving placebo. There was a trend toward more frequent CPK elevations and patient withdrawals due to musculoskeletal symptoms in the group receiving combined treatment as compared with the groups receiving placebo, gemfibrozil, or pravastatin monotherapy (see ).
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.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed
against may need to be discontinued.
Appropriate fluid and electrolyte management, protein supplementation,
antibiotic treatment of 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).
What are the precautions of AugmentinXR?
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
spp. or 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.
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.
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.
Abnormal prolongation of prothrombin time (increased international normalized
ratio [INR]) has been reported rarely in patients receiving amoxicillin and oral
anticoagulants. Appropriate monitoring should be undertaken when anticoagulants
are prescribed concurrently. Adjustments in the dose of oral anticoagulants may
be necessary to maintain the desired level of anticoagulation.
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.
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.
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 (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.
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.
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 in neonates.
Ampicillin-class antibiotics are excreted in the milk; therefore,
caution should be exercised when AUGMENTIN XR is administered to a nursing
woman.
The safety and effectiveness of AUGMENTIN XR have been
established for pediatric patients weighing ≥ 40 kg who are able to swallow
tablets. Use of AUGMENTIN XR in these pediatric patients is supported by
evidence from adequate and well-controlled trials of adults with acute bacterial
sinusitis and community-acquired pneumonia with additional data from a pediatric
pharmacokinetic study.
A pharmacokinetic study in pediatric patients (7 to 15 years of age and
weighing ≥ 40 kg) was conducted (see CLINICAL PHARMACOLOGY).
The adverse event profile in 44 pediatric patients who received at least one
dose of AUGMENTIN XR was consistent with the established adverse event profile
for the product in adults.
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.
What are the side effects of AugmentinXR?
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:
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).
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).
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 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.
Interstitial nephritis and hematuria have been reported rarely.
Crystalluria has also been reported (see OVERDOSAGE).
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.
Agitation, anxiety, behavioral changes, confusion, convulsions,
dizziness, headache, insomnia, and reversible hyperactivity have been reported
rarely.
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.
What should I look out for while using AugmentinXR?
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.
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.
Clostridium difficile
C. difficile.
C. difficile
C. difficile
If CDAD is suspected or confirmed, ongoing antibiotic use not directed
against may need to be discontinued.
Appropriate fluid and electrolyte management, protein supplementation,
antibiotic treatment of 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).
What might happen if I take too much AugmentinXR?
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 significant clinical symptoms
and do not require gastric emptying.
Interstitial nephritis resulting in oliguric renal failure has been reported
in a small number of patients after overdosage with amoxicillin.
Crystalluria, in some cases leading to renal failure, has also been reported
after amoxicillin overdosage in adult and pediatric patients. In case of
overdosage, adequate fluid intake and diuresis should be maintained to reduce
the risk of amoxicillin crystalluria.
Renal impairment appears to be reversible with cessation of drug
administration. High blood levels may occur more readily in patients with
impaired renal function because of decreased renal clearance of both amoxicillin
and clavulanate. Both amoxicillin and clavulanate are removed from the
circulation by hemodialysis (see DOSAGE AND ADMINISTRATION).
How should I store and handle AugmentinXR?
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Preserve in tight, light-resistant containers.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Preserve in tight, light-resistant containers.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.NDC 54868-4735-0 Bottles of 20NDC 54868-4735-2 Bottles of 28 (7 day XR pack)NDC 54868-4735-1 Bottles of 40 (10 day XR pack) 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.NDC 54868-4735-0 Bottles of 20NDC 54868-4735-2 Bottles of 28 (7 day XR pack)NDC 54868-4735-1 Bottles of 40 (10 day XR pack) 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.NDC 54868-4735-0 Bottles of 20NDC 54868-4735-2 Bottles of 28 (7 day XR pack)NDC 54868-4735-1 Bottles of 40 (10 day XR pack) 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.NDC 54868-4735-0 Bottles of 20NDC 54868-4735-2 Bottles of 28 (7 day XR pack)NDC 54868-4735-1 Bottles of 40 (10 day XR pack)
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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. The pharmacokinetics of the components of AUGMENTIN XR following
administration of two AUGMENTIN XR tablets at the start of a standardized meal
are presented in Table 1.
a
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.
In a study of pediatric patients with acute bacterial sinusitis, 7 to 15
years of age, and weighing at least 40 kg, the pharmacokinetics of amoxicillin
and clavulanate were assessed following administration of AUGMENTIN XR
2000 mg/125 mg (as two 1000 mg/62.5 mg tablets) every 12 hours with food
(Table 2).
a
b
c
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
β-lactamases, and therefore, its spectrum of activity does not include organisms
which produce these enzymes. Clavulanic acid is a β-lactam, structurally related
to penicillin, which possesses the ability to inactivate a wide range of
β-lactamase enzymes commonly found in microorganisms resistant to penicillins
and cephalosporins. In particular, it has good activity against the clinically
important plasmid-mediated β-lactamases frequently found responsible for
transferred drug resistance.
The clavulanic acid component of AUGMENTIN XR protects amoxicillin from
degradation by β-lactamase enzymes and effectively extends the antibiotic
spectrum of amoxicillin to include many bacteria normally resistant to
amoxicillin and other β-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.
Streptococcus pneumoniae
Staphylococcus aureus
NOTE
Haemophilus influenzae
Moraxella catarrhalis
Haemophilus parainfluenzae
Klebsiella pneumoniae
The following in vitro data are available, .
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.
Streptococcus pyogenes
Bacteroides fragilis
Fusobacterium nucleatum
Peptostreptococcus magnus
Peptostreptococcus micros
NOTE:
S. pyogenes
P. magnus
P. micros
S. pyogenes.
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.
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
and ) 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.
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 3.
NOTE:
S.
pneumoniae
S. pneumoniae
NOTE:
H. influenzae
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.
a
Haemophilus
Non-Clinical Toxicology
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.
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.
Clostridium difficile
C. difficile.
C. difficile
C. difficile
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of 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).
Immunosuppressive Drugs, Gemfibrozil, Niacin (Nicotinic Acid), Erythromycin:See .
Cytochrome P450 3A4 Inhibitors and data indicate that pravastatin is not metabolized by cytochrome P450 3A4 to a clinically significant extent. This has been shown in studies with known cytochrome P450 3A4 inhibitors (see and below). Other examples of cytochrome P450 3A4 inhibitors include ketoconazole, mibefradil, and erythromycin.
Diltiazem: Steady-state levels of diltiazem (a known, weak inhibitor of P450 3A4) had no effect on the pharmacokinetics of pravastatin. In this study, the AUC and C of another HMG-CoA reductase inhibitor which is known to be metabolized by cytochrome P450 3A4 increased by factors of 3.6 and 4.3, respectively.
Itraconazole: The mean AUC and C for pravastatin were increased by factors of 1.7 and 2.5, respectively, when given with itraconazole (a potent P450 3A4 inhibitor which also inhibits p-glycoprotein transport) as compared to placebo. The mean t½ was not affected by itraconazole, suggesting that the relatively small increases in C and AUC were due solely to increased bioavailability rather than a decrease in clearance, consistent with inhibition of p-glycoprotein transport by itraconazole. This drug transport system is thought to affect bioavailability and excretion of HMG-CoA reductase inhibitors, including pravastatin. The AUC and C of another HMG-CoA reductase inhibitor which is known to be metabolized by cytochrome P450 3A4 increased by factors of 19 and 17, respectively, when given with itraconazole.
Antipyrine:Since concomitant administration of pravastatin had no effect on the clearance of antipyrine, interactions with other drugs metabolized via the same hepatic cytochrome isozymes are not expected.
Cholestyramine/Colestipol:Concomitant administration resulted in an approximately 40 to 50% decrease in the mean AUC of pravastatin. However, when pravastatin was administered 1 hour before or 4 hours after cholestyramine or 1 hour before colestipol and a standard meal, there was no clinically significant decrease in bioavailability or therapeutic effect. (See .)
Warfarin:Concomitant administration of 40 mg pravastatin had no clinically significant effect on prothrombin time when administered in a study to normal elderly subjects who were stabilized on warfarin.
Cimetidine:The AUC for pravastatin when given with cimetidine was not significantly different from the AUC for pravastatin when given alone. A significant difference was observed between the AUC’s for pravastatin when given with cimetidine compared to when administered with antacid.
Digoxin:In a crossover trial involving 18 healthy male subjects given 20 mg pravastatin and 0.2 mg digoxin concurrently for 9 days, the bioavailability parameters of digoxin were not affected. The AUC of pravastatin tended to increase, but the overall bioavailability of pravastatin plus its metabolites SQ 31,906 and SQ 31,945 was not altered.
Cyclosporine:Some investigators have measured cyclosporine levels in patients on pravastatin (up to 20 mg), and to date, these results indicate no clinically meaningful elevations in cyclosporine levels. In one single-dose study, pravastatin levels were found to be increased in cardiac transplant patients receiving cyclosporine.
Gemfibrozil:In a crossover study in 20 healthy male volunteers given concomitant single doses of pravastatin and gemfibrozil, there was a significant decrease in urinary excretion and protein binding of pravastatin. In addition, there was a significant increase in AUC, C, and T for the pravastatin metabolite SQ 31,906. Combination therapy with pravastatin and gemfibrozil is generally not recommended. (See .)
In interaction studies with (1 hour prior to Pravastatin), or , no statistically significant differences in bioavailability were seen when pravastatin sodium was administered.
Endocrine Function
HMG-CoA reductase inhibitors interfere with cholesterol synthesis and lower circulating cholesterol levels and, as such, might theoretically blunt adrenal or gonadal steroid hormone production. Results of clinical trials with pravastatin in males and postmenopausal females were inconsistent with regard to possible effects of the drug on basal steroid hormone levels. In a study of 21 males, the mean testosterone response to human chorionic gonadotropin was significantly reduced (p<0.004) after 16 weeks of treatment with 40 mg of pravastatin. However, the percentage of patients showing a ³50% rise in plasma testosterone after human chorionic gonadotropin stimulation did not change significantly after therapy in these patients. The effects of HMG-CoA reductase inhibitors on spermatogenesis and fertility have not been studied in adequate numbers of patients. The effects, if any, of pravastatin on the pituitary-gonadal axis in pre-menopausal females are unknown. Patients treated with pravastatin who display clinical evidence of endocrine dysfunction should be evaluated appropriately. Caution should also be exercised if an HMG-CoA reductase inhibitor or other agent used to lower cholesterol levels is administered to patients also receiving other drugs (e.g., ketoconazole, spironolactone, cimetidine) that may diminish the levels or activity of steroid hormones.
In a placebo-controlled study of 214 pediatric patients with HeFH, of which 106 were treated with pravastatin (20 mg in the children aged 8-13 years and 40 mg in the adolescents aged 14-18 years) for two years, there were no detectable differences seen in any of the endocrine parameters [ACTH, cortisol, DHEAS, FSH, LH, TSH, estradiol (girls) or testosterone (boys)] relative to placebo. There were no detectable differences seen in height and weight changes, testicular volume changes, or Tanner score relative to placebo.
CNS Toxicity
CNS vascular lesions, characterized by perivascular hemorrhage and edema and mononuclear cell infiltration of perivascular spaces, were seen in dogs treated with pravastatin at a dose of 25 mg/kg/day. These effects in dogs were observed at approximately 59 times the human dose of 80 mg/day, based on AUC. Similar CNS vascular lesions have been observed with several other drugs in this class.
A chemically similar drug in this class produced optic nerve degeneration (Wallerian degeneration of retinogeniculate fibers) in clinically normal dogs in a dose-dependent fashion starting at 60 mg/kg/day, a dose that produced mean plasma drug levels about 30 times higher than the mean drug level in humans taking the highest recommended dose (as measured by total enzyme inhibitory activity). This same drug also produced vestibulocochlear Wallerian-like degeneration and retinal ganglion cell chromatolysis in dogs treated for 14 weeks at 180 mg/kg/day, a dose which resulted in a mean plasma drug level similar to that seen with the 60 mg/kg/day dose.
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 spp. or 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.
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.
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.
Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported rarely in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
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.
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.
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 (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.
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.
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 in neonates.
Ampicillin-class antibiotics are excreted in the milk; therefore, caution should be exercised when AUGMENTIN XR is administered to a nursing woman.
The safety and effectiveness of AUGMENTIN XR have been established for pediatric patients weighing ≥ 40 kg who are able to swallow tablets. Use of AUGMENTIN XR in these pediatric patients is supported by evidence from adequate and well-controlled trials of adults with acute bacterial sinusitis and community-acquired pneumonia with additional data from a pediatric pharmacokinetic study.
A pharmacokinetic study in pediatric patients (7 to 15 years of age and weighing ≥ 40 kg) was conducted (see CLINICAL PHARMACOLOGY).
The adverse event profile in 44 pediatric patients who received at least one dose of AUGMENTIN XR was consistent with the established adverse event profile for the product in adults.
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.
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:
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).
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).
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 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.
Interstitial nephritis and hematuria have been reported rarely. Crystalluria has also been reported (see OVERDOSAGE).
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.
Agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, headache, insomnia, and reversible hyperactivity have been reported rarely.
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
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