Is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid.Amoxicillin molecular formula is C16H19N3O5S3H2O and the molecular weight is 419.Amoxicillin is (2S, 5R, 6R)-6-heptane-2-carboxylic acid trihydrate and may be represented structurally as: Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus.Is a ОІ-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of ОІ-lactamases by blocking the active sites of these enzymes.Is particularly active against the clinically important plasmid mediated ОІ-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins.Clavulanate potassium molecular formula is C8H8KNO5 and the molecular weight is 237.Chemically, clavulanate potassium is potassium (Z)-(2R,5R )-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo-heptane-2-carboxylate, and may be represented structurally as: Each film coated tablet contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt or 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt.Addition, each 500 mg/125 mg and 875 mg/125 mg amoxicillin and clavulanate potassium tablet contains 0.Potassium.Inactive Ingredients: Colloidal silicon dioxide, croscarmellose sodium dried, crospovidone dried, ethylcellulose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose dried, polysorbate 80, talc, titanium dioxide, triethyl citrat.CLINICAL PHARMACOLOGY Amoxicillin and clavulanate potassium are well absorbed from the gastrointestinal tract after oral administration of amoxicillin/clavulanate potassium.In the fasted or fed state has minimal effect on the pharmacokinetics of amoxicillin.Amoxicillin/clavulanate potassium can be given without regard to meals, absorption of clavulanate potassium when taken with food is greater relative to the fasted state.1 study, the relative bioavailability of clavulanate was reduced when amoxicillin/clavulanate potassium was dosed at 30 and 150 minutes after the start of a high-fat breakfast.Safety and efficacy of amoxicillin/clavulanate potassium have been established in clinical trials where amoxicillin/clavulanate potassium was taken without regard to meals.Mean amoxicillin and clavulanate potassium pharmacokinetic parameters are shown in the table below: Dose and regimen AUC0-24 (mcghr/mL) Cmax (mcg/mL) amoxicillin/clavulanate potassium amoxicillin ( S.Clavulanate potassium( S.Amoxicillin ( S.Clavulanate potassium ( S.250/125 mg q8h 26.6 3.1.0.Mg q12h 33.6 1.1.0.500/125 mg q8h 53.7 3.2.0.Mg q12h 53.2 3.2.0.Of 14 normal volunteers (n=15 for clavulanate potassium in the low-dose regimens).Occurred approximately 1.After the dose.At the start of a light meal.Amoxicillin serum concentrations achieved with amoxicillin/clavulanate potassium are similar to those produced by the oral administration of equivalent doses of amoxicillin alone.Half-life of amoxicillin after the oral administration of amoxicillin/clavulanate potassium is 1.And that of clavulanic acid is 1. Approximately 50% to 70% of the amoxicillin and approximately 25% to 40% of the clavulanic acid are excreted unchanged in urine during the first 6 hours after administration of a single 250-mg or 500-mg tablet of amoxicillin/clavulanate potassium.Concurrent administration of probenecid delays amoxicillin excretion but does not delay renal excretion of clavulanic acid.Neitherponent in amoxicillin/clavulanate potassium is highly protein-bound; clavulanic acid has been found to be approximately 25% bound to human serum and amoxicillin approximately 18% bound.Amoxicillin diffuses readily into most body tissues and fluids with the exception of the brain and spinal fluid.Results of experiments involving the administration of clavulanic acid to animals suggest that thispound, like amoxicillin, is well distributed in body tissues.MICROBIOLOGY Amoxicillin is a semisynthetic antibiotic with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms.Is, however, susceptible to degradation by ОІ-lactamases and, therefore, the spectrum of activity does not include organisms which produce these enzymes.Acid is a ОІ-lactam, structurally related to the penicillins, which possesses the ability to inactivate a wide range of ОІ-lactamase enzymesmonly found in microorganisms resistant to penicillins and cephalosporins.It has good activity against the clinically important plasmid-mediated ОІ-lactamases frequently responsible for transferred drug resistance.The formulation of amoxicillin and clavulanic acid in amoxicillin/clavulanate potassium protects amoxicillin from degradation by ОІ-lactamase enzymes and effectively extends the antibiotic spectrum of amoxicillin to include many bacteria normally resistant to amoxicillin and other ОІ-lactam antibiotics.Amoxicillin/clavulanate potassium possesses the properties of a broad-spectrum antibiotic and a ОІ-lactamase inhibitor.Amoxicillin/clavulanic acid has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.GRAM-POSITIVE AEROBES: Staphylococcus aureus (ОІ-lactamase and non-ОІ-lactamase producing).Staphylococci which are resistant to methicillin/oxacillin must be considered resistant to amoxicillin/clavulanic acid.GRAM-NEGATIVE AEROBES: Enterobacter species (Although most strains of Enterobacter species are resistant in vitro, clinical efficacy has been demonstrated with amoxicillin/clavulanate potassium in urinary tract infections caused by these organisms.Escherichia coli (ОІ-lactamase and non-ОІ-lactamase producing) Haemophilus influenzae (ОІ-lactamase and non-ОІ-lactamase producing) Klebsiella species (All known strains are ОІ-lactamase producing.Moraxella catarrhalis (ОІ-lactamase and non-ОІ-lactamase producing) The following in vitro data are available, but their clinical significance is unknown.Amoxicillin/clavulanic acid exhibits in vitro minimal inhibitory concentrations (MICs) of 2 mcg/mL or less against most (90%) strains of Streptococcus pneumoniae; MICs of 0.Or less against most (90%) strains of Neisseria gonorrhoeae; MICs of 4 mcg/mL or less against most (90%) strains of staphylococci and anaerobic bacteria; and MICs of 8 mcg/mL or less against most (90%) strains of other listed organisms.With the exception of organisms shown to respond to amoxicillin alone, the safety and effectiveness of amoxicillin/clavulanic acid in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.Because amoxicillin has greater in vitro activity against S.Does ampicillin or penicillin, the majority of S.With intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin.GRAM-POSITIVE AEROBES: Enterococcus faecalisII Staphylococcus epidermidis (ОІ-lactamase and non-ОІ-lactamase producing) Staphylococcus saprophyticus (ОІ-lactamase and non-ОІ-lactamase producing) Streptococcus pneumoniae II , Streptococcus pyogenes II viridans group Streptococcus II GRAM-NEGATIVE AEROBES: Eikenella corrodens (ОІ-lactamase and non-ОІ-lactamase producing) Neisseria gonorrhoeae II (ОІ-lactamase and non-ОІ-lactamase producing) Proteus mirabilis II (ОІ-lactamase and non-ОІ-lactamase producing) ANAEROBIC BACTERIA: Bacteroides species, including Bacteroides fragilis (ОІ-lactamase and non-ОІ-lactamase producing) Fusobacterium species (ОІ-lactamase and non-ОІ-lactamase producing) Peptostreptococcus species II Adequate and well-controlled clinical trials have established the effectiveness of amoxicillin alone in treating certain clinical infections due to these organisms.Are non-ОІ-lactamase-producing organisms and, therefore, are susceptible to amoxicillin alone.SUSCEPTIBILITY TESTING: Dilution Techniques: Quantitative methods are used to determine antimicrobial minimal inhibitory concentrations (MICs).MICs provide estimates of the susceptibility of bacteria to antimicrobialpounds.MICs should be determined using a standardized procedure.Are based on a dilution method1 (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of amoxicillin/clavulanate potassium powder.The rmended dilution pattern utilizes a constant amoxicillin/clavulanate potassium ratio of 2 to 1 in all tubes with varying amounts of amoxicillin.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.MIC values should be interpreted according to the following criteria: RMENDED RANGES FOR AMOXICILLIN/CLAVULANIC ACID SUSCEPTIBILITY TESTING For Gram-Negative Enteric Aerobes: MIC (mcg/mL) Interpretation 8/4 Susceptible (S) 16/8 Intermediate (I) 32/16 Resistant (R) For Staphylococcus and Haemophilus species: MIC (mcg/mL) Interpretation 4/2 Susceptible (S) 8/4 Resistant (R) Staphylococci which are susceptible to amoxicillin/clavulanic acid but resistant to methicillin/oxacillin must be considered as resistant.FOR STREPTOCOCCUS PNEUMONIAE FROM NON-MENINGITIS SOURCES: Isolates should be tested using amoxicillin/clavulanic acid and the following criteria should be used: MIC (mcg/mL) Interpretation 2/1 Susceptible (S) 4/2 Intermediate (I) 8/4 Resistant (R) Note: These interpretive criteria are based on the rmended doses for respiratory tract infections.A report of "Susceptible" indicates that the pathogen is likely to be inhibited if the antimicrobialpound in the blood reaches the concentration usually achievable.Report of "Intermediate" indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated.Category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used.Category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation.Report of "Resistant" indicates that the pathogen is not likely to be inhibited if the antimicrobialpound in the blood reaches the concentrations usually achievable; other therapy should be selected.Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures.Amoxicillin/clavulanate potassium powder should provide the following MIC values: MicroorganismMIC Range (mcg/mL) Escherichia coli ATCC 25922 2 to 8 Escherichia coli ATCC 35218 4 to 16 Enterococcus faecalis ATCC 29212 0.1.Haemophilus influenzae ATCC 49247 2 to 16 Staphylococcus aureus ATCC 29213 0.0.Streptococcus pneumoniae ATCC 49619 0.0.As concentration of amoxicillin in the presence of clavulanic acid at a constant 2 parts amoxicillin to 1 part clavulanic acid.DIFFUSION TECHNIQUES: Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobialpounds.Standardized procedure2 requires the use of standardized inoculum concentrations.Procedure uses paper disks impregnated with 30 mcg of amoxicillin/clavulanate potassium (20 mcg amoxicillin plus 10 mcg clavulanate potassium) to test the susceptibility of microorganisms to amoxicillin/clavulanic acid.Reports from the laboratory providing results of the standard single-disk susceptibility test with a 30 mcg amoxicillin/clavulanate potassium (20 mcg amoxicillin plus 10 mcg clavulanate potassium) disk should be interpreted according to the following criteria: RMENDED RANGES FOR AMOXICILLIN/CLAVULANIC ACID SUSCEPTIBILITY TESTING For Staphylococcus species and H.Zone Diameter (mm) Interpretation 20 Susceptible (S) 19 Resistant (R) For Other Organisms Except S.And N.Zone Diameter (mm) Interpretation 18 Susceptible (S) 14 to 17 Intermediate (I) 13 Resistant (R) Staphylococci which are resistant to methicillin/oxacillin must be considered as resistant to amoxicillin/clavulanic acid.A A broth microdilution method should be used for testing H.Beta-lactamase negative, ampicillin-resistant strains must be considered resistant to amoxicillin/clavulanic acid.B Susceptibility of S.Should be determined using a 1-mcg oxacillin disk.With oxacillin zone sizes of 20 mm are susceptible to amoxicillin/clavulanic acid.Amoxicillin/clavulanic acid MIC should be determined on isolates of S.Oxacillin zone sizes of 19 mm.C A broth microdilution method should be used for testing N.Interpreted according to penicillin breakpoints.Should be as stated above for results using dilution techniques.Involves correlation of the diameter obtained in the disk test with the MIC for amoxicillin/clavulanic acid.As with standardized dilution techniques, diffusion methods require the use of laboratory control microorganisms that are used to control the technical aspects of the laboratory procedures.The diffusion technique, the 30-mcg amoxicillin/clavulanate potassium (20 mcg amoxicillin plus 10-mcg clavulanate potassium) disk should provide the following zone diameters in these laboratory quality control strains.Microorganism Zone Diameter (mm) Escherichia coli ATCC 25922 19 to 25 Escherichia coli ATCC 35218 18 to 22 Staphylococcus aureus ATCC 25923 28 to 36 INDICATIONS AND USAGE Amoxicillin/clavulanate potassium is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: Lower Respiratory Tract Infections - caused by ОІ-lactamase-producing strains of H.And M. Otitis Media - caused by ОІ-lactamase-producing strains of H.Catarrhalis.Sinusitis - caused by ОІ-lactamase-producing strains of H.M. Skin and Skin Structure Infections - caused by ОІ-lactamase-producing strains of S.E.And Klebsiella spp.Tract Infections - caused by ОІ-lactamase-producing strains of E.Klebsiella spp.Enterobacter spp.While amoxicillin/clavulanate potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to amoxicillin/clavulanate potassium treatment due to its amoxicillin content, therefore, mixed infections caused by ampicillin-susceptible organisms and ОІ-lactamase-producing organisms susceptible to amoxicillin/clavulanate potassium should not require the addition of another antibiotic.Amoxicillin has greater in vitro activity against S.Than does ampicillin or penicillin, the majority of S.Strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and amoxicillin/clavulanate potassium..To reduce the development of drug-resistant bacteria and maintain the effectivness of amoxicillin/clavulanate potassium and other antibacterial drugs, amoxicillin/clavulanate potassium should be used only to treat or prevent infections, that are proven or strongly suspected to be caused by susceptible bacteria.And susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.The absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.Bacteriological studies, to determine the causative organisms and their susceptibility to amoxicillin/clavulanate potassium, should be performed together with any indicated surgical procedures.Amoxicillin/clavulanate potassium is contraindicated in patients with a history of allergic reactions to any penicillin.Also contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin/clavulanate potassium.WARNINGS SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY.REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY AND/OR A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS.HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS.INITIATING THERAPY WITH AMOXICILLIN/CLAVULANATE POTASSIUM, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS OR OTHER ALLERGENS.AN ALLERGIC REACTION OCCURS, AMOXICILLIN/CLAVULANATE POTASSIUM SHOULD BE DISCONTINUED AND THE APPROPRIATE THERAPY INSTITUTED.ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE.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.With antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia.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.Of pseudomembranous colitis usually respond to drug discontinuation alone.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.Colitis.Potassium should be used with caution in patients with evidence of hepatic dysfunction.Toxicity associated with the use of amoxicillin/clavulanate potassium is usually reversible.Rare occasions, deaths have been reported (less than 1 death reported per estimated 4 million prescriptions worldwide).Have generally been cases associated with serious underlying diseases or coitant medications.And -.PRECAUTIONS 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 during prolonged therapy.A high percentage of patients with mononucleosis who receive ampicillin develop an erythematous skin rash.Ampicillin-class antibiotics should not be administered to patients with mononucleosis.Of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy.Superinfections occur (usually involving Pseudomonas or Candida), the drug should be discontinued and/or appropriate therapy instituted.Prescribing amoxicillin/clavulanate potassium 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 resistance bacteria.DRUG INTERACTIONS Probenecid decreases the renal tubular secretion of amoxicillin.Amoxicillin/clavulanate potassium may result in increased and prolonged blood levels of amoxicillin.Of probenecid cannot be rmended.The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs aspared to patients receiving ampicillin alone.Not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients.Are no data with amoxicillin/clavulanate potassium and allopurinol administered concurrently.Inmon with other broad-spectrum antibiotics, amoxicillin/clavulanate potassium may reduce the efficacy of oral contraceptives.DRUG/LABORATORY TEST INTERACTIONS Oral administration of amoxicillin/clavulanate potassium will result in high urine concentrations of amoxicillin.Urine concentrations of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using Clinitest (R), Benedict's Solution or Fehling's Solution.This effect may also occur with amoxicillin and therefore amoxicillin/clavulanate potassium, it is rmended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix (R)) 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.May also occur with amoxicillin and therefore amoxicillin/clavulanate potassium.For Patients: Patients should be counseled that antibacterial drugs including amoxicillin/clavulanate potassium, should only be used to treat bacterial infections.Do not treat viral infections (e.Themon cold).Amoxicillin/clavulanate potassium is prescribed to treat a bacterial infection, patients should be told that although it ismon to feel better early in the course of therapy, the medication should be taken exactly as directed.Doses or notpleting the full course of therapy may: (1) decrease the effectivness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by amoxicillin/clavulanate potassium or other antibacterial drugs in the future.CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY Long-term studies in animals have not been performed to evaluate carcinogenic potential.Mutagenesis: The mutagenic potential of amoxicillin/clavulanate potassium 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.Were negative apart from the in vitro mouse lymphoma assay where weak activity was found at very high, cytotoxic concentrations.Of Fertility: Amoxicillin/clavulanate potassium at oral doses of up to 1200 mg/kg/day (5.The maximum human dose, 1480 mg/m2/day, based on body surface area) was found to have no effect on fertility and reproductive performance in rats, dosed with a 2:1 ratio formulation of amoxicillin:clavulanate.Teratogenic effects.B): Reproduction studies performed in pregnant rats and mice given amoxicillin/clavulanate potassium at oral dosages up to 1200 mg/kg/day, equivalent to 7200 and 4080 mg/m2/day, respectively (4.Times the maximum human oral dose based on body surface area), revealed no evidence of harm to the fetus due to amoxicillin/clavulanate potassium.Are, however, no adequate and well-controlled studies in pregnant women.Animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.Labor and Delivery: Oral ampicillin-class antibiotics are generally poorly absorbed during labor.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 amoxicillin/clavulanate potassium 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.A single study in women with premature rupture of fetal membranes, it was reported that prophylactic treatment with amoxicillin/clavulanate potassium may be associated with an increased risk of necrotizing enterocolitis in neonates.Nursing Mothers: Ampicillin-class antibiotics are excreted in the milk; therefore, caution should be exercised when amoxicillin/clavulanate potassium is administered to a nursing woman.Pediatric Use: Pediatric patients weighing 40 Kg or more should be dosed according to the adult rmendations (see : ).And effectiveness of Amoxicillin and Clavulanate Potassium Tablets in pediatric patients weighing less than 40 kg have not been established.Prescribing information for Amoxicillin and Clavulanate Powder for Oral Suspension and Chewable Tablets).Use: An analysis of clinical studies of Amoxicillin and Clavulanate Potassium Tablets was conducted to determine whether subjects aged 65 and over respond differently from younger subjects.3,119 patients in this analysis, 68% were < 65 years old, 32% were 65 years old and 14% were 75 years old.Analysis and other reported clinical experience have not identified differences in responses between the elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out.This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.Elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.ADVERSE REACTIONS Amoxicillin/clavulanate potassium is generally well tolerated.Of side effects observed in clinical trials were of a mild and transient nature and less than 3% of patients discontinued therapy because of drug-related side effects.Most frequently reported adverse effects were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%).Incidence of side effects, and in particular diarrhea, increased with the higher rmended dose.Less frequently reported reactions include: abdominal difort, flatulence and headache.The following adverse reactions have been reported for ampicillin-class antibiotics: GASTROINTESTINAL Diarrhea, nausea, vomiting, indigestion, gastritis, stomatitis, glossitis, black "hairy" tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudomembranous colitis.Of pseudomembranous colitis symptoms may occur during or after antibiotic treatment..HYPERSENSITIVITY REACTIONS Skin rashes, pruritus, urticaria, angioedema, serum sickness-like reactions (urticaria or skin rash apanied 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.Reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids.Reactions occur, the drug should be discontinued, unless the opinion of the physician dictates otherwise.Occasional fatal hypersensitivity (anaphylactic) reactions can occur with oral penicillin..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.Including increases in serum transaminases (AST and/or ALT), serum bilirubin and/or alkaline phosphatase, has been infrequently reported with amoxicillin/clavulanate potassium.Has been reported moremonly in elderly, in males, or in patients on prolonged treatment.Histologic findings on liver biopsy have consisted of predominantly cholestatic, hepatocellular, or mixed cholestatic-hepatocellular changes.Onset of signs/symptoms of hepatic dysfunction may occur during or several weeks after therapy has been discontinued.Hepatic dysfunction, which may be severe, is usually reversible.Rare occasions, deaths have been reported (less than 1 death reported per estimated 4 million prescriptions worldwide).Have generally been cases associated with serious underlying diseases or coitant medications.RENAL Interstitial nephritis and hematuria have been reported rarely.Also been reported (see ).HEMIC AND LYMPHATIC SYSTEMS Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia and agranulocytosis have been reported during therapy with penicillins.Reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.Slight thrombocytosis was noted in less than 1% of the patients treated with amoxicillin/clavulanate potassium.Have been rare reports of increased prothrombin time in patients receiving amoxicillin/clavulanate potassium and anticoagulant therapy coitantly.NERVOUS SYSTEM Agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, insomnia, and reversible hyperactivity have been reported rarely.MISCELLANEOUS Tooth discoloration (brown, yellow, or gray staining) has been rarely reported.Reports occured in pediatric patients.Reduced or eliminated with brushing or dental cleaning in most cases.OVERDOSAGE Following overdosage, patients have experienced primarily gastrointestinal symptoms including stomach and abdominal pain, vomiting, and diarrhea.Hyperactivity, or drowsiness have also been observed in a small number of patients.In the case of overdosage, discontinue amoxicillin/clavulanate potassium, treat symptomatically, and institute supportive measures as required.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.Prospective study of 51 pediatric patients at a poison center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms and do not require gastric emptying.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.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.Blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of both amoxicillin and clavulanate.Amoxicillin and clavulanate are removed from the circulation by hemodialysis.Rmended dosing for patients with impaired renal function.DOSAGE AND ADMINISTRATION Since both the Amoxicillin and Clavulanate Potassium Tablets, 250 mg/125 mg and 500 mg/125 mg contain the same amount of clavulanic acid (125 mg, as the potassium salt), two Amoxicillin and Clavulanate Potassium Tablets 250 mg/125 mg are not equivalent to one Amoxicillin and Clavulanate Potassium Tablet, USP (amoxicillin, 500 mg, as the trihydrate and clavulanic acid, 125 mg, as clavulanate potassium); therefore, two Amoxicillin and Clavulanate Potassium Tablets 250 mg/125 mg should not be substituted for one Amoxicillin and Clavulanate Potassium Tablet, USP (amoxicillin, 500 mg, as thetrihydrate and clavulanic acid, 125 mg, as clavulanate potassium) .DOSAGE ADULTS The usual adult dose is one Amoxicillin and Clavulanate Potassium Tablet, USP (amoxicillin, 500 mg, as the trihydrate and clavulanic acid, 125 mg, as clavulanate potassium) every 12 hours or one Amoxicillin and Clavulanate Potassium Tablet 250 mg/125 mg every 8 hours.Read more New azetidinone cholesterol absorption inhibitors
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