Amoxicillin and Clavulanate
Generic Name: Amoxicillin and Clavulanate potassium
Dosage Form: Tablets
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate potassium chewable tablets and other antibacterial drugs, Amoxicillin and Clavulanate potassium chewable tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Amoxicillin and Clavulanate Description
Amoxicillin and Clavulanate potassium tablets USP (chewable) are an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the b-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. Chemically, amoxicillin is (2S,5R,6R) - 6 - [(R) - ( - ) - 2 - amino - 2 - (p - hydroxyphenyl)acetamido] - 3,3 - dimethyl - 7 - oxo - 4 - thia - 1 - azabicyclo[3.2.0]heptane - 2 - carboxylic acid trihydrate and may be represented structurally as:
C16H19N3O5S·3H2O M.W. 419.46
Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a ß-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of ???-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated ß-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. Chemically, clavulanate potassium is potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:
C8H8KNO5 M.W. 237.25
Each chewable tablet contains 200 mg amoxicillin as the trihydrate and 28.5 mg clavulanic acid as the potassium salt or contains 400 mg amoxicillin as the trihydrate and 57 mg clavulanic acid as the potassium salt. Each Amoxicillin and Clavulanate potassium tablet USP, (chewable) 200 mg/28.5 mg contains 0.14 mEq potassium. Each Amoxicillin and Clavulanate potassium tablet USP, (chewable) 400 mg/57 mg contains 0.29 mEq potassium.
Inactive Ingredients: aspartame*1,colloidal silicon dioxide, FD&C Red #40 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, SA84 artificial ripe banana flavor, and S.D. artificial cherry flavor.
Amoxicillin and Clavulanate - Clinical Pharmacology
Amoxicillin and Clavulanate potassium are well absorbed from the gastrointestinal tract after oral administration of Amoxicillin and Clavulanate potassium. Dosing in the fasted or fed state has minimal effect on the pharmacokinetics of amoxicillin. While Amoxicillin and Clavulanate potassium can be given without regard to meals, absorption of clavulanate potassium when taken with food is greater relative to the fasted state. In 1 study, the relative bioavailability of clavulanate was reduced when Amoxicillin and Clavulanate potassium was dosed at 30 and 150 minutes after the start of a high fat breakfast. The safety and efficacy of Amoxicillin and Clavulanate potassium have been established in clinical trials where Amoxicillin and Clavulanate potassium was taken without regard to meals.
Oral administration of single doses of Amoxicillin and Clavulanate potassiumchewable tablets, 400 mg/57 mg and 400 mg/57 mg per 5 mL suspension to 28 adult volunteers yielded comparable pharmacokinetic data:
|
* Administered at the start of a light meal.
† Mean values of 28 normal volunteers. Peak concentrations occurred approximately 1 hour after
the dose.
|
|
Dose*
|
AUC0-¥(mcg.hr/mL)
|
Cmax (mcg/mL)†
|
|
(amoxicillin/clavulanate potassium)
|
amoxicillin (± S.D.)
|
clavulanate potassium (± S.D.) |
amoxicillin (± S.D.) |
clavulanatepotassium(± S.D.) |
| 400 mg/57 mg (5 mL of suspension) |
17.29 ± 2.28 |
2.34 ± 0.94 |
6.94 ± 1.24 |
1.10 ± 0.42 |
| 400 mg/57 mg (1 chewable tablet) |
17.24 ± 2.64 |
2.17 ± 0.73 |
6.67 ± 1.37 |
1.03 ± 0.33 |
Oral administration of 5 mL of Amoxicillin and Clavulanate potassiumoral suspension, 250 mg/62.5 mg per 5 mL or the equivalent dose of 10 mL Amoxicillin and Clavulanate potassiumoral suspension, 125 mg/31.25 mg per 5 mL provides average peak serum concentrations approximately 1 hour after dosing of 6.9 mcg/mL for amoxicillin and 1.6 mcg/mL for clavulanic acid. The areas under the serum concentration curves obtained during the first 4 hours after dosing were 12.6 mcg.hr/mL for amoxicillin and 2.9 mcg.hr/mL for clavulanic acid when 5 mL of Amoxicillin and Clavulanate potassiumoral suspension, 250 mg/62.5 mg per 5 mL or equivalent dose of 10 mL of Amoxicillin and Clavulanate potassium oral suspension, 125 mg/31.25 mg per 5 mL was administered to adult volunteers. One Amoxicillin and Clavulanate potassiumchewable tablet, 250 mg/62.5 mg or 2 Amoxicillin and Clavulanate potassiumchewable tablets, 125 mg/31.25 mg are equivalent to 5 mL of Amoxicillin and Clavulanate potassiumoral suspension, 250 mg/62.5 mg per 5 mL and provide similar serum levels of amoxicillin and clavulanic acid.
Amoxicillin serum concentrations achieved with Amoxicillin and Clavulanate potassiumare similar to those produced by the oral administration of equivalent doses of amoxicillin alone. The half-life of amoxicillin after the oral administration of Amoxicillin and Clavulanate potassiumis 1.3 hours and that of clavulanic acid is 1.0 hour. Time above the minimum inhibitory concentration of 1.0 mcg/mL for amoxicillin has been shown to be similar after corresponding q12h and q8h dosing regimens of Amoxicillin and Clavulanate potassiumin adults and children.
Approximately 50% to 70% of the amoxicillin and approximately 25% to 40% of the clavulanic acid are excreted unchanged in urine during the first 6 hours after administration of 10 mL of Amoxicillin and Clavulanate potassiumoral suspension, 250 mg/62.5 mg per 5 mL.
Concurrent administration of probenecid delays amoxicillin excretion but does not delay renal excretion of clavulanic acid.
Neither component in Amoxicillin and Clavulanate potassiumis 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. The results of experiments involving the administration of clavulanic acid to animals suggest that this compound, 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 oralsuspension to fasting children, average concentrations of 3.0 mcg/mL of amoxicillin and 0.5 mcg/mL of clavulanic acid were detected in middle ear effusions.
Microbiology
Amoxicillin is a semisynthetic antibiotic with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Amoxicillin is, however, susceptible to degradation by ß-lactamases, and therefore, the spectrum of activity does not include organisms which produce these enzymes. Clavulanic acid is a ß-lactam, structurally related to the penicillins, which possesses the ability to inactivate a wide range of ß-lactamase enzymes commonly found in microorganisms resistant to penicillins and cephalosporins. In particular, it has good activity against the clinically important plasmid mediated ß-lactamases frequently responsible for transferred drug resistance.
The formulation of amoxicillin and clavulanic acid in Amoxicillin and Clavulanate potassiumprotects amoxicillin from degradation by ß-lactamase enzymes and effectively extends the antibiotic spectrum of amoxicillin to include many bacteria normally resistant to amoxicillin and other ß-lactam antibiotics. Thus, Amoxicillin and Clavulanate potassiumpossesses the distinctive properties of a broad-spectrum antibiotic and a ß-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 (ß-lactamase and non-ß-lactamase-producing)§2
Gram-Negative Aerobes
Enterobacter species (Although most strains of Enterobacter species are resistant in vitro, clinical efficacy has been demonstrated with Amoxicillin and Clavulanate potassiumin urinary tract infections caused by these organisms.)
Escherichia coli (ß-lactamase and non-ß-lactamase-producing)
Haemophilus influenzae (ß-lactamase and non-ß-lactamase-producing)
Klebsiella species (All known strains are ß-lactamase-producing.)
Moraxella catarrhalis (ß-lactamase and non-ß-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
Where can I get more information about Amoxicillin and Clavulanate Tablets ? We recommend to use www.Drugs.com
Typical mistypes for Amoxicillin and Clavulanate Tablets
zmoxicillin and clavulanate tablets, smoxicillin and clavulanate tablets, wmoxicillin and clavulanate tablets, qmoxicillin and clavulanate tablets, anoxicillin and clavulanate tablets, akoxicillin and clavulanate tablets, ajoxicillin and clavulanate tablets, amixicillin and clavulanate tablets, amkxicillin and clavulanate tablets, amlxicillin and clavulanate tablets, ampxicillin and clavulanate tablets, am0xicillin and clavulanate tablets, am9xicillin and clavulanate tablets, amozicillin and clavulanate tablets, amocicillin and clavulanate tablets, amodicillin and clavulanate tablets, amosicillin and clavulanate tablets, amoxucillin and clavulanate tablets, amoxjcillin and clavulanate tablets, amoxkcillin and clavulanate tablets, amoxocillin and clavulanate tablets, amox9cillin and clavulanate tablets, amox8cillin and clavulanate tablets, amoxixillin and clavulanate tablets, amoxivillin and clavulanate tablets, amoxifillin and clavulanate tablets, amoxidillin and clavulanate tablets, amoxicullin and clavulanate tablets, amoxicjllin and clavulanate tablets, amoxickllin and clavulanate tablets, amoxicollin and clavulanate tablets, amoxic9llin and clavulanate tablets, amoxic8llin and clavulanate tablets, amoxiciklin and clavulanate tablets, amoxiciplin and clavulanate tablets, amoxiciolin and clavulanate tablets, amoxicilkin and clavulanate tablets, amoxicilpin and clavulanate tablets, amoxiciloin and clavulanate tablets, amoxicillun and clavulanate tablets, amoxicilljn and clavulanate tablets, amoxicillkn and clavulanate tablets, amoxicillon and clavulanate tablets, amoxicill9n and clavulanate tablets, amoxicill8n and clavulanate tablets, amoxicillib and clavulanate tablets, amoxicillim and clavulanate tablets, amoxicillij and clavulanate tablets, amoxicillih and clavulanate tablets, amoxicillin znd clavulanate tablets, amoxicillin snd clavulanate tablets, amoxicillin wnd clavulanate tablets, amoxicillin qnd clavulanate tablets, amoxicillin abd clavulanate tablets, amoxicillin amd clavulanate tablets, amoxicillin ajd clavulanate tablets, amoxicillin ahd clavulanate tablets, amoxicillin ans clavulanate tablets, amoxicillin anx clavulanate tablets, amoxicillin anc clavulanate tablets, amoxicillin anf clavulanate tablets, amoxicillin anr clavulanate tablets, amoxicillin ane clavulanate tablets, amoxicillin and xlavulanate tablets, amoxicillin and vlavulanate tablets, amoxicillin and flavulanate tablets, amoxicillin and dlavulanate tablets, amoxicillin and ckavulanate tablets, amoxicillin and cpavulanate tablets, amoxicillin and coavulanate tablets, amoxicillin and clzvulanate tablets, amoxicillin and clsvulanate tablets, amoxicillin and clwvulanate tablets, amoxicillin and clqvulanate tablets, amoxicillin and claculanate tablets, amoxicillin and clabulanate tablets, amoxicillin and clagulanate tablets, amoxicillin and clafulanate tablets, amoxicillin and clavylanate tablets, amoxicillin and clavhlanate tablets, amoxicillin and clavjlanate tablets, amoxicillin and clavilanate tablets, amoxicillin and clav8lanate tablets, amoxicillin and clav7lanate tablets, amoxicillin and clavukanate tablets, amoxicillin and clavupanate tablets, amoxicillin and clavuoanate tablets, amoxicillin and clavulznate tablets, amoxicillin and clavulsnate tablets, amoxicillin and clavulwnate tablets, amoxicillin and clavulqnate tablets, amoxicillin and clavulabate tablets, amoxicillin and clavulamate tablets, amoxicillin and clavulajate tablets, amoxicillin and clavulahate tablets, amoxicillin and clavulanzte tablets, amoxicillin and clavulanste tablets, amoxicillin and clavulanwte tablets, amoxicillin and clavulanqte tablets, amoxicillin and clavulanare tablets, amoxicillin and clavulanafe tablets, amoxicillin and clavulanage tablets, amoxicillin and clavulanaye tablets, amoxicillin and clavulana6e tablets, amoxicillin and clavulana5e tablets, amoxicillin and clavulanatw tablets, amoxicillin and clavulanats tablets, amoxicillin and clavulanatd tablets, amoxicillin and clavulanatr tablets, amoxicillin and clavulanat4 tablets, amoxicillin and clavulanat3 tablets, amoxicillin and clavulanate rablets, amoxicillin and clavulanate fablets, amoxicillin and clavulanate gablets, amoxicillin and clavulanate yablets, amoxicillin and clavulanate 6ablets, amoxicillin and clavulanate 5ablets, amoxicillin and clavulanate tzblets, amoxicillin and clavulanate tsblets, amoxicillin and clavulanate twblets, amoxicillin and clavulanate tqblets, amoxicillin and clavulanate tavlets, amoxicillin and clavulanate tanlets, amoxicillin and clavulanate tahlets, amoxicillin and clavulanate taglets, amoxicillin and clavulanate tabkets, amoxicillin and clavulanate tabpets, amoxicillin and clavulanate taboets, amoxicillin and clavulanate tablwts, amoxicillin and clavulanate tablsts, amoxicillin and clavulanate tabldts, amoxicillin and clavulanate tablrts, amoxicillin and clavulanate tabl4ts, amoxicillin and clavulanate tabl3ts, amoxicillin and clavulanate tablers, amoxicillin and clavulanate tablefs, amoxicillin and clavulanate tablegs, amoxicillin and clavulanate tableys, amoxicillin and clavulanate table6s, amoxicillin and clavulanate table5s, amoxicillin and clavulanate tableta, amoxicillin and clavulanate tabletz, amoxicillin and clavulanate tabletx, amoxicillin and clavulanate tabletd, amoxicillin and clavulanate tablete, amoxicillin and clavulanate tabletw, moxicillin and clavulanate tablets, aoxicillin and clavulanate tablets, amxicillin and clavulanate tablets, amoicillin and clavulanate tablets, amoxcillin and clavulanate tablets, amoxiillin and clavulanate tablets, amoxicllin and clavulanate tablets, amoxicilin and clavulanate tablets, amoxicilin and clavulanate tablets, amoxicilln and clavulanate tablets, amoxicilli and clavulanate tablets, amoxicillinand clavulanate tablets, amoxicillin nd clavulanate tablets, amoxicillin ad clavulanate tablets, amoxicillin an clavulanate tablets, amoxicillin andclavulanate tablets, amoxicillin and lavulanate tablets, amoxicillin and cavulanate tablets, amoxicillin and clvulanate tablets, amoxicillin and claulanate tablets, amoxicillin and clavlanate tablets, amoxicillin and clavuanate tablets, amoxicillin and clavulnate tablets, amoxicillin and clavulaate tablets, amoxicillin and clavulante tablets, amoxicillin and clavulanae tablets, amoxicillin and clavulanat tablets, amoxicillin and clavulanatetablets, amoxicillin and clavulanate ablets, amoxicillin and clavulanate tblets, amoxicillin and clavulanate talets, amoxicillin and clavulanate tabets, amoxicillin and clavulanate tablts, amoxicillin and clavulanate tables, amoxicillin and clavulanate tablet, maoxicillin and clavulanate tablets, aomxicillin and clavulanate tablets, amxoicillin and clavulanate tablets, amoixcillin and clavulanate tablets, amoxciillin and clavulanate tablets, amoxiicllin and clavulanate tablets, amoxiclilin and clavulanate tablets, amoxicililn and clavulanate tablets, amoxicillni and clavulanate tablets, amoxicilli nand clavulanate tablets, amoxicillina nd clavulanate tablets, amoxicillin nad clavulanate tablets, amoxicillin adn clavulanate tablets, amoxicillin an dclavulanate tablets, amoxicillin andc lavulanate tablets, amoxicillin and lcavulanate tablets, amoxicillin and calvulanate tablets, amoxicillin and clvaulanate tablets, amoxicillin and clauvlanate tablets, amoxicillin and clavluanate tablets, amoxicillin and clavualnate tablets, amoxicillin and clavulnaate tablets, amoxicillin and clavulaante tablets, amoxicillin and clavulantae tablets, amoxicillin and clavulanaet tablets, amoxicillin and clavulanat etablets, amoxicillin and clavulanatet ablets, amoxicillin and clavulanate atblets, amoxicillin and clavulanate tbalets, amoxicillin and clavulanate talbets, amoxicillin and clavulanate tabelts, amoxicillin and clavulanate tabltes, amoxicillin and clavulanate tablest, aamoxicillin and clavulanate tablets, ammoxicillin and clavulanate tablets, amooxicillin and clavulanate tablets, amoxxicillin and clavulanate tablets, amoxiicillin and clavulanate tablets, amoxiccillin and clavulanate tablets, amoxiciillin and clavulanate tablets, amoxicilllin and clavulanate tablets, amoxicilllin and clavulanate tablets, amoxicilliin and clavulanate tablets, amoxicillinn and clavulanate tablets, amoxicillin and clavulanate tablets, amoxicillin aand clavulanate tablets, amoxicillin annd clavulanate tablets, amoxicillin andd clavulanate tablets, amoxicillin and clavulanate tablets, amoxicillin and cclavulanate tablets, amoxicillin and cllavulanate tablets, amoxicillin and claavulanate tablets, amoxicillin and clavvulanate tablets, amoxicillin and clavuulanate tablets, amoxicillin and clavullanate tablets, amoxicillin and clavulaanate tablets, amoxicillin and clavulannate tablets, amoxicillin and clavulanaate tablets, amoxicillin and clavulanatte tablets, amoxicillin and clavulanatee tablets, amoxicillin and clavulanate tablets, amoxicillin and clavulanate ttablets, amoxicillin and clavulanate taablets, amoxicillin and clavulanate tabblets, amoxicillin and clavulanate tabllets, amoxicillin and clavulanate tableets, amoxicillin and clavulanate tabletts, amoxicillin and clavulanate tabletss, etc.
|
|
| © Copyright by drug-information.ru 2001-2019. All rights reserved |
