Is an analog of ampicillin, derived from the basic penicillin nucleus, 6- aminopenicillanic acid.Amoxicillin molecular formula is C 16H19N3O5S3H2O, and the molecular weight is 419.Chemically, 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: Powder for Oral Suspension:Each 5 mL of reconstituted amoxicillin and clavulanate potassium for oral suspension 200 mg/5 mL contains 0.Potassium.5 mL of reconstituted amoxicillin and clavulanate potassium for oral suspension 400 mg/5 mL contains 0.Inactive Ingredients: Aspartame, colloidal silicon dioxide, flavor strawberry, flavor strawberry guarana, monosodium citrate, silicon dioxide, sodium citrate (as dihydrate), xanthan gum.Chewable Tablets:Each 200 mg/28.Chewable tablet contains 0.Each 400 mg chewable tablet contains 0.Of potassium.Aspartame, FD 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.Two hours after oral administration of a single 35 mg/kg dose of amoxicillin and clavulanate potassium suspension to fasting children, average concentrations of 3 mcg/mL of amoxicillin and 0.Of clavulanic acid were detected in middle ear effusions.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 and 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 and clavulanate potassium possess the distinctive 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.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: Enterobacterspecies (Although most strains of Enterobacter species are resistant in vitro, clinical efficacy has been demonstrated with amoxicillin and 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) Klebsiellaspecies (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 0.Or less against most ( 90%) strains of Streptococcus pneumoniaeв•'; 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.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.Amoxicillin has greater in vitro activity against S.Ampicillin or penicillin, the majority of S.With intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin.Gram-Positive Aerobes: Enterococcus faecalis Staphylococcus epidermidis (ОІ-lactamase and non-ОІ-lactamase-producing) Staphylococcus saprophyticus (ОІ-lactamase and non-ОІ-lactamase-producing) Streptococcus pneumoniae Streptococcus pyogenes viridans group Streptococcus Gram-Negative Aerobes: Eikenella corrodens(ОІ-lactamase and non-ОІ-lactamase-producing) Neisseria gonorrhoeae(ОІ-lactamase and non-ОІ-lactamase-producing) Proteus mirabilis(ОІ-lactamase and non-ОІ-lactamase-producing) Anaerobic Bacteria: Bacteroidesspecies, including Bacteroides fragilis (ОІ-lactamase and non-ОІ-lactamase-producing) Fusobacteriumspecies (ОІ-lactamase and non-ОІ-lactamase-producing) Peptostreptococcusspecies Adequate and well-controlled clinical trials have established the effectiveness of amoxicillin alone in treating certain clinical infections due to these organisms.These are non-ОІ-producing organisms, and therefore, are susceptible to amoxicillin alone.Susceptibility Testing:Dilution Techniques: Quantitative methods are used to determine antimicrobial MICs.Provide estimates of the susceptibility of bacteria to antimicrobialpounds.MICs should be determined using a standardized procedure.Procedures are based on a dilution method 1 (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 to1 part clavulanic acid.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 S.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 that 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: Microorganism MIC Range (mcg/mL) E.ATCC 25922 2 to 8 E.ATCC 35218 4 to 16 E.ATCC 29212 0.1 H.ATCC 49247 2 to 16 S.ATCC 29213 0. S.ATCC 49619 0.0.Expressed 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.Such standardized procedure 2 requires the use of standardized inoculum concentrations.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.AA broth microdilution method should be used for testing H.Beta-lactamase-negative, ampicillin-resistant strains must be considered resistant to amoxicillin/clavulanic acid.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.With oxacillin zone sizes of 19 mm.CA broth microdilution method should be used for testing N.Interpreted according to penicillin breakpoints.Interpretation 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) E.ATCC 25922 19 to 25 mm E.ATCC 35218 18 to 22 mm S.ATCC 25923 28 to 36 mm INDICATIONS AND USAGE Amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) 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.M. 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.Urinary Tract Infections- caused by ОІ-lactamase-producing strains of E.Spp.Enterobacter spp.While amoxicillin and clavulanate potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with amoxicillin and clavulanate potassium due to its amoxicillin content.Infections caused by ampicillin-susceptible organisms and ОІ-lactamase-producing organisms susceptible to amoxicillin and 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.With intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and amoxicillin and clavulanate potassium.Microbiology.To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) 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 and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) should be performed together with any indicated surgical procedures.Amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are contraindicated in patients with a history of allergic reactions to any penicillin.Is also contraindicated in patients with a previous history of amoxicillin and clavulanate potassium associated cholestatic jaundice/hepatic dysfunction.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 AND CLAVULANATE POTASSIUM, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS.AN ALLERGIC REACTION OCCURS AMOXICILLIN AND 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.Clostridium difficileassociated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including amoxicillin and clavulanate potassium, and may range in severity from mild diarrhea to fatal colitis.With antibacterial agents alters the normal flora of the colon leading to overgrowth of C. C.Toxins A and B which contribute to the development of CDAD.Producing strains of C.Increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.Be considered in all patients who present with diarrhea following antibiotic use.Medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C.May need to be discontinued.Fluid and electrolyte management, protein supplementation, antibiotic treatment of C.And surgical evaluation should be instituted as clinically indicated.Amoxicillin and clavulanate potassium should be used with caution in patients with evidence of hepatic dysfunction.Toxicity associated with the use of amoxicillin and clavulanate potassium is usually reversible.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.CONTRAINDICATIONS and ADVERSE REACTIONS ― Liver.General:While amoxicillin and 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.Antibiotics should not be administered to patients with mononucleosis.Of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy.Occur (usually involving Pseudomonas or Candida), the drug should be discontinued and/or appropriate therapy instituted.Amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) 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.FOR THE PATIENT Amoxicillin and clavulanate potassium may be taken every 8 hours or every 12 hours, depending on the strength of the product prescribed.Should be taken with a meal or snack to reduce the possibility of gastrointestinal upset.Antibiotics can cause diarrhea.Diarrhea is severe or lasts more than 2 or 3 days, call your doctor.Diarrhea is amon problem caused by antibiotics which usually ends when the antibiotic is discontinued.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.This occurs, patients should contact their physician as soon as possible.Keep suspension refrigerated.Well before using.Dosing a child with amoxicillin and clavulanate potassium for oral suspension (liquid), use a dosing spoon or medicine dropper.Sure to rinse the spoon or dropper after each use.Amoxicillin and clavulanate potassium for oral suspension may contain more liquid than required.Your doctor's instructions about the amount to use and the days of treatment your child requires.Any unused medicine.Patients should be counseled that antibacterial drugs including amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) should only be used to treat bacterial infections.Do not treat viral infections (e.Themon cold).And clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) 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 effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) or other antibacterial drugs in the future.Phenylketonurics Each 200 mg amoxicillin and clavulanate potassium chewable tablet contains 3.Phenylalanine; each 400 mg chewable tablet contains 7 mg phenylalanine; each 5 mL of either the 200 mg/5 mL or 400 mg/5 mL oral suspension contains 7 mg phenylalanine.Other products of amoxicillin and clavulanate potassium do not contain phenylalanine and can be used by phenylketonurics.Your physician or pharmacist.DRUG INTERACTIONS Probenecid decreases the renal tubular secretion of amoxicillin.With amoxicillin and clavulanate potassium may result in increased and prolonged blood levels of amoxicillin.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 and clavulanate potassium and allopurinol administered concurrently.Inmon with other broad-spectrum antibiotics, amoxicillin and clavulanate potassium may reduce the efficacy of oral contraceptives.DRUG/LABORATORY TEST INTERACTIONS Oral administration of amoxicillin and 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 and 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.Effect may also occur with amoxicillin and therefore amoxicillin and clavulanate potassium.CARCINOGENESIS AND MUTAGENESIS AND IMPAIRMENT OF FERTILITY Long-term studies in animals have not been performed to evaluate carcinogenic potential.Mutagenesis:The mutagenic potential of amoxicillin and 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 and clavulanate potassium at oral doses of up to 1,200 mg/kg/day (5.The maximum human dose, 1,480 mg/m 2/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:Pregnancy (Category B).Studies performed in pregnant rats and mice given amoxicillin and clavulanate potassium at oral dosages up to 1,200 mg/kg/day, equivalent to 7,200 and 4,080 mg/m 2/day, respectively (4.2.The maximum human oral dose based on body surface area), revealed no evidence of harm to the fetus due to amoxicillin and 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.Is not known whether the use of amoxicillin and 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 and 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 and clavulanate potassium is administered to a nursing woman.PEDIATRIC USE Because of ipletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed.Of amoxicillin and clavulanate potassium should be modified in pediatric patients younger than 12 weeks (3 months).DOSAGE AND ADMINISTRATION―Pediatric.ADVERSE REACTIONS Amoxicillin and 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.The original premarketing studies, where both pediatric and adult patients were enrolled, the most frequently reported adverse effects were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%).Overall incidence of side effects, and in particular diarrhea, increased with the higher rmended dose.Less frequently reported reactions include: Abdominal difort, flatulence, and headache.In pediatric patients (aged 2 months to 12 years), 1 US/Canadian clinical trial was conducted whichpared amoxicillin and clavulanate potassium 45/6.(divided q12h) for 10 days versus amoxicillin and clavulanate potassium 40/10 mg/kg/day (divided q8h) for 10 days in the treatment of acute otitis media.Total of 575 patients were enrolled, and only the suspension formulations were used in this trial.The adverse event profile seen wasparable to that noted above; however, there were differences in the rates of diarrhea, skin rashes/urticaria, and diaper area rashes.CLINICAL STUDIES.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.Pseudomembranous colitis symptoms may occur during or after antibiotic treatment.WARNINGS.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, hypersensitivity vasculitis, 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.Such 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.WARNINGS.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.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 amoxicillin and clavulanate potassium.Has been reported moremonly in the elderly, in males, or in patients on prolonged treatment.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.Dysfunction, which may be severe, is usually reversible.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.Has also been reported (see OVERDOSAGE).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 and clavulanate potassium.Have been reports of increased prothrombin time in patients receiving amoxicillin and clavulanate potassium and anticoagulant therapy coitantly.Central 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 occurred 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.Or drowsiness have also been observed in a small number of patients.In the case of overdosage, discontinue amoxicillin and 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.Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin.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.DOSAGE AND ADMINISTRATION Dosage: Pediatric Patients:Based on the amoxicillinponent, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) should be dosed as follows: Neonates and infants aged < 12 weeks (3 months):Due to ipletely developed renal function affecting elimination of amoxicillin in this age group, the rmended dose of amoxicillin and clavulanate potassium is 30 mg/kg/day divided q12h, based on the amoxicillinponent.Is unaltered in this age group.With the 200 mg/5 mL formulation in this age group is limited and, thus, use of the 125 mg/5 mL oral suspension is rmended.Aged 12 weeks (3 months) and older INFECTIONS DOSING REGIMEN q12h q8h 200 mg/5 mL or 400 mg/5 mL oral suspension 125 mg/5 mL or 250 mg/5 mL oral suspension Otitis media, sinusitis, lower respiratory tract infections, and more severe infections 45 mg/kg/day q12h 40 mg/kg/day q8h Less severe infections 25 mg/kg/day q12h 20 mg/kg/day q8h The q12h regimen is rmended as it is associated with significantly less diarrhea.CLINICAL STUDIES.The q12h formulations (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics.Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children.Of therapy studied and rmended for acute otitis media is 10 days.Pediatric Patients Weighing 40 kg and More:Should be dosed according to the following adult rmendations: The usual adult dose is one amoxicillin 500 mg and clavulanate potassium tablet every 12 hours or one amoxicillin 250 mg and clavulanate potassium tablet every 8 hours.More severe infections and infections of the respiratory tract, the dose should be one amoxicillin 875 mg and clavulanate potassium tablet every 12 hours or one amoxicillin 500 mg and clavulanate potassium tablet every 8 hours.Adults treated with 875 mg every 12 hours, significantly fewer experienced severe diarrhea or withdrawals with diarrhea versus adults treated with 500 mg every 8 hours.Detailed adult dosage rmendations, please seeplete prescribing information for amoxicillin and clavulanate potassium tablets.Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals.WARNINGS.Adults:Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500 mg tablet.200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875 mg tablet.Dosage rmendations above for children weighing 40 kg or more.The amoxicillin/clavulanate potassium 250 mg tablet and the 250 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt).Potassium 250 mg tablet contains 125 mg of clavulanic acid, whereas the 250 mg chewable tablet contains 62.Clavulanic acid.Amoxicillin/clavulanate potassium 250 mg tablet and the 250 mg chewable tablet should not be substituted for each other, as they are not interchangeable.Due to the different amoxicillin to clavulanic acid ratios in amoxicillin/clavulanate potassium 250 mg tablet (250/125) versus amoxicillin/clavulanate potassium 250 mg chewable tablet (250/62.250 mg tablet should not be used until the child weighs at least 40 kg and more.For Mixing Oral Suspension: Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely.Approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder.Remainder of the water and again shake vigorously.Potassium for Oral Suspension, 200 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 50 mL 47 mL 75 mL 70 mL 100 mL 94 mL Each teaspoonful (5 mL) will contain 200 mg amoxicillin and 28.Clavulanic acid as the potassium salt.Potassium for Oral Suspension, 400 mg/5 mL Bottle Size Amount of Water Required for Reconstitution 50 mL 46 mL 75 mL 68 mL 100 mL 90 mL Each teaspoonful (5 mL) will contain 400 mg amoxicillin and 57 mg clavulanic acid as the potassium salt.ORAL SUSPENSION WELL BEFORE USING.Reconstituted suspension must be stored under refrigeration and discarded after 10 days.And clavulanate potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium is administered at the start of a meal.Minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium should be taken at the start of a meal.HOW SUPPLIED Amoxicillin and Clavulanate Potassium For Oral Suspension, USP 200 mg/5 mL Each 5 mL of reconstituted white to pale yellow colored, strawberry flavored suspension contains 200 mg of amoxicillin and 28.Of clavulanic acid as the potassium salt and is available as follows: NDC 63304-977-03 50 mL bottles NDC 63304-977-01 75 mL bottles NDC 63304-977-04 100 mL bottles 400 mg/5 mL Each 5 mL of reconstituted white to pale yellow colored, strawberry flavored suspension contains 400 mg of amoxicillin and 57 mg of clavulanic acid as the potassium salt and is available as follows: NDC 63304-979-03 50 mL bottles NDC 63304-979-01 75 mL bottles NDC 63304-979-04 100 mL bottles Amoxicillin and Clavulanate Potassium Tablets, USP (Chewable): 200 mg/ 28.Amoxicillin and clavulanate potassium tablets (chewable) 200 mg/28.200 mg of amoxicillin as the trihydrate and 28.Of clavulanic acid as clavulanate potassium.Tablet is a pink colored, circular, biconvex, mottled tablet, debossed with 'RX753' on one side and plain on the other side.63304-753-03 Bottles of 10 NDC 63304-753-20 Bottles of 20 NDC 63304-753-01 Bottles of 100 NDC 63304-753-21 Unit-Dose Blister Packs of 20 400 mg/57 mg Amoxicillin and clavulanate potassium tablets (chewable) 400 mg/57 mg contain 400 mg of amoxicillin as the trihydrate and 57 mg of clavulanic acid as clavulanate potassium.Is a pink colored, circular, biconvex, mottled tablet, debossed with 'RX754' on one side and plain on the other side.NDC 63304-754-03 Bottles of 10 NDC 63304-754-20 Bottles of 20 NDC 63304-754-01 Bottles of 100 NDC 63304-754-21 Unit-Dose Blister Packs of 20 Store dry powder and tablets at 20 - 25 C (68 - 77 F).USP Controlled Room Temperature).In tightly closed, moisture-proof containers.Reconstituted suspension under refrigeration.Suspension after 10 days.CLINICAL STUDIES In pediatric patients (aged 2 months to 12 years), 1 US/Canadian clinical trial was conducted whichpared amoxicillin/ clavulanate potassium 45/6.Q12h) for 10 days versus amoxicillin/clavulanate potassium 40/10 mg/kg/day (divided q8h) for 10 days in the treatment of acute otitis media.The suspension formulations were used in this trial.Total of 575 patients were enrolled, with an even distribution among the 2 treatment groups and aparable number of patients were evaluable (i.84%) per treatment group.Otitis media-specific criteria were required for eligibility and a strong correlation was found at the end of therapy and follow-up between these criteria and physician assessment of clinical response.Clinical efficacy rates at the end of therapy visit (defined as 2 to 4 days after thepletion of therapy) and at the follow-up visit (defined as 22to 28 days postpletion of therapy) wereparable for the 2 treatment groups, with the following cure rates obtained for the evaluable patients: At end of therapy, 87.= 265) and 82.= 260) for 45 mg/kg/day q12h and 40 mg/kg/day q8h, respectively.Follow-up, 67.= 249) and 68.= 243) for 45 mg/kg/day q12h and 40 mg/kg/day q8h, respectively.The incidence of diarrhea was significantly lower in patients in the q12h treatment grouppared to patients who received the q8h regimen (14.Respectively).Addition, the number of patients with either severe diarrhea or who were withdrawn with diarrhea was significantly lower in the q12h treatment group (3.7.The q12h/10 day and q8h/10 day, respectively).The q12h treatment group, 3 patients (1%) were withdrawn with an allergic reaction, while 1 patient (0.The q8h group was withdrawn for this reason.Number of patients with a candidal infection of the diaper area was 3.6.The q12h and q8h groups, respectively.It is not known if the finding of a statistically significant reduction in diarrhea with the oral suspensions dosed q12h, versus suspensions dosed q8h, can be extrapolated to the chewable tablets.Of mannitol in the chewable tablets may contribute to a different diarrhea profile.Oral suspensions are sweetened with aspartame only.Diarrhea was defined as either: (a) 3 or more watery or 4 or more loose/watery stools in 1 day; OR (b) 2 watery stools per day or 3 loose/watery stools per day for 2 consecutive days.REFERENCES 1.For Clinical Laboratory Standards.For Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically-Third Edition.Standard NCCLS Document M7-A3, Vol.No.NCCLS, Villanova, PA, Dec. 2.For Clinical Laboratory Standards.Standard for Antimicrobial Disk Susceptibility Tests-Fifth Edition.NCCLS Document M2-A5, Vol.24.Villanova, PA, Dec. 3.B, Dean BS, Lopez G, Krenzelok EP.Effects of penicillin and cephalosporin ingestions in children less than six years of age.Hum Toxicol 1988;30:66-67.CLINITEST is a registered trademark of Miles, Inc.Is a registered trademark of Bayer Corporation.Manufactured for: Ranbaxy Pharmaceuticals Inc.Jacksonville, FL 32257 USA by: Ranbaxy Laboratories Limited New Delhi - 110 019, India April 2008 Amoxicillin and clavulanate potassium (Amoxicillin and clavulanate potassium) PRODUCT INFO Product Code 63304-977 Dosage Form POWDER, FOR SUSPENSION Route Of Administration ORAL DEA Schedule INGREDIENTS Name (Active Moiety) Type Strength AMOXICILLIN (Amoxicillin) Active 200 MILLIGRAM In 5 MILLILITER CLAVULANATE POTASSIUM (Clavulanic acid) Active 28.In 5 MILLILITER ASPARTAME Inactive COLLOIDAL SILICON DIOXIDE Inactive FLAVOR STRAWBERRY Inactive FLAVOR STRAWBERRY GUARANA Inactive MONOSODIUM CITRATE Inactive SILICON DIOXIDE Inactive SODIUM CITRATE( AS DIHYDRATE) Inactive XANTHAN GUM Inactive IMPRINT INFORMATION Characteristic Appearance Characteristic Appearance Color Score Shape Symbol Imprint Code Coating Size PACKAGING # NDC Package Description Multilevel Packaging 1 63304-977-03 50 MILLILITER In 1 BOTTLE None 2 63304-977-01 75 MILLILITER In 1 BOTTLE None 3 63304-977-04 100 MILLILITER In 1 BOTTLE None Amoxicillin and clavulanate potassium (Amoxicillin and clavulanate potassium) PRODUCT INFO Product Code 63304-979 Dosage Form POWDER, FOR SUSPENSION Route Of Administration ORAL DEA Schedule INGREDIENTS Name (Active Moiety) Type Strength AMOXICILLIN (Amoxicillin) Active 400 MILLIGRAM In 5 MILLILITER CLAVULANATE POTASSIUM (Clavulanic acid) Active 57 MILLIGRAM In 5 MILLILITER ASPARTAME Inactive COLLOIDAL SILICON DIOXIDE Inactive FLAVOR STRAWBERRY Inactive FLAVOR STRAWBERRY GUARANA Inactive MONOSODIUM CITRATE Inactive SILICON DIOXIDE Inactive SODIUM CITRATE( AS DIHYDRATE) Inactive XANTHAN GUM Inactive IMPRINT INFORMATION Characteristic Appearance Characteristic Appearance Color Score Shape Symbol Imprint Code Coating Size PACKAGING # NDC Package Description Multilevel Packaging 1 63304-979-03 50 MILLILITER In 1 BOTTLE None 2 63304-979-01 75 MILLILITER In 1 BOTTLE None 3 63304-979-04 100 MILLILITER In 1 BOTTLE None Amoxicillin and clavulanate potassium (Amoxicillin and clavulanate potassium) PRODUCT INFO Product Code 63304-753 Dosage Form TABLET, CHEWABLE Route Of Administration ORAL DEA Schedule INGREDIENTS Name (Active Moiety) Type Strength AMOXICILLIN (Amoxicillin) Active 200 MILLIGRAM In 1 TABLET CLAVULANATE POTASSIUM (Clavulanic acid) Active 28.In 1 TABLET ASPARTAME Inactive FD&C RED NO.Read more New azetidinone cholesterol absorption inhibitors
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