Mox 500

750 mg to 1 g twice daily in combination with a proton pump inhibitor (e.g. omeprazole, lansoprazole) and another antibiotic (e.g. Lyme disease (see section 4.4) Early stage: 500 mg to 1 g every 8 hours up to a maximum of 4 g/day in divided doses for 14 days (10 to 21 days) Late stage (systemic involvement): 500 mg to 2 g every 8 hours up to a maximum of 6 g/day in divided doses for 10 to 30 days.

*Consideration should be given to the official treatment guidelines for each indication.

Children MIC) is considered to be the major determinant of efficacy for amoxicillin. The main amoxicillin 500 uses mechanisms of resistance to amoxicillin are: • Inactivation by bacterial beta-lactamases.

• Alteration of PBPs, which reduce the affinity of the antibacterial agent for the target.

Impermeability of bacteria or efflux pump mechanisms may cause or contribute to bacterial resistance, particularly in Gram-negative bacteria. MIC breakpoints for amoxicillin are those of the European Committee on Antimicrobial Susceptibility Testing (EUCAST) version 5.0. MIC breakpoint (mg/L) Susceptible ? Staphylococcus spp. 1 Wild type Enterobacteriaceae are categorised as susceptible to aminopenicillins.

Some countries prefer to categorise wild type moxilin capsules isolates of E.

When this is the case, use the MIC breakpoint S ? 0.5 mg/L. 2 Most staphylococci are penicillinase producers, which are resistant to amoxicillin.

Methicillin resistant isolates are, with few exceptions, resistant to all beta-lactam agents.

3 Susceptibility to amoxicillin can be inferred from ampicillin.

4 The susceptibility of streptococcus groups A, B, C and G to penicillins is inferred from the benzylpenicillin susceptibility. 5 Breakpoints relate only to non-meningitis isolates.

For isolates categorised as intermediate to ampicillin avoid oral treatment with amoxicillin. Susceptibility inferred from the MIC of ampicillin. 6 Breakpoints are based on intravenous administration.

Beta-lactamase positive isolates should be reported resistant. 7 Beta lactamase producers should be reported resistant. 8 Susceptibility to amoxicillin can be inferred from benzylpenicillin. 9 The breakpoints are based on epidemiological cut-off values (ECOFFs), which distinguish wild-type isolates from those with reduced susceptibility. 10 The non-species related breakpoints are based on doses of at least 0.5 g x 3or 4 doses daily (1.5 to 2 g/day). The prevalence of resistance may vary geographically and with time for selected species, and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable. In vitro susceptibility of micro-organisms to Amoxicillin. Beta-hemolytic streptococci (Groups A, B, C and G) Listeria monocytogenes. Species for which acquired resistance may be a problem.

Inherently resistant organisms † Enterococcus faecium † Acinetobacter spp.

(many strains of Bacteroides fragilis are resistant). † Natural intermediate susceptibility in the absence of acquired mechanism of resistance.

? Almost all S.aureus are resistant to amoxilcillin due to production of penicillinase. In addition, all methicillin-resistant strains are resistant to amoxicillin. Amoxicillin fully dissociates in aqueous solution at physiological pH. It is rapidly and well absorbed by the oral

route

Haemodialysis can be used for elimination of amoxicillin.

About 18% of total plasma amoxicillin is bound to protein and the apparent volume of distribution is around 0.3 to 0.4 l/kg.

Following intravenous administration, amoxicillin has been found in gall bladder, abdominal tissue, skin, fat, muscle tissues, synovial and peritoneal fluids, bile and pus. Amoxicillin does not adequately distribute into the cerebrospinal fluid. From animal studies there is no evidence for significant tissue retention of drug-derived material.

Amoxicillin, like most penicillins, can be detected in breast milk (see section 4.6).

Amoxicillin has been shown to cross the placental barrier (see section 4.6). Amoxicillin is partly excreted in the urine as the inactive penicilloic acid in quantities equivalent to up to 10 to 25% of the initial dose.

The major route of elimination for amoxicillin is via the kidney.

Amoxicillin has a mean elimination half-life of approximately one hour and a mean total clearance of approximately 25 l/hour in healthy subjects. Approximately 60 to 70% of the amoxicillin is excreted unchanged in urine during the first 6 hours after administration of a single 250 mg or 500 mg dose of amoxicillin. Various studies have found the urinary excretion to be 50-85% for amoxicillin over a 24 hour period. Concomitant use of probenecid delays amoxicillin excretion (see section 4.5). The elimination half-life of amoxicillin is similar for children aged around 3 months to 2 years and older children and adults.

For very young children (including preterm newborns) in the first week of life the interval of administration should not exceed twice daily administration due to immaturity of the renal pathway of elimination. Because 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.

Following oral administration of amoxicillin/ to healthy males and female subjects, gender has no significant impact on the pharmacokinetics of amoxicillin.

The total serum clearance of amoxicillin decreases proportionately with decreasing renal function (see sections 4.2 and 4.4). Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals.

Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development.

Carcinogenicity studies have not been conducted with amoxicillin. This leaflet is for parents and carers about how to use this medicine in children. Our information sometimes differs from that provided by the manufacturers, because their information is usually aimed at adults. Keep it somewhere safe so that you can read it again.

If your child has ever had a reaction to any medicine, tell your doctor before giving amoxicillin. Amoxicillin (sometimes spelt amoxycillin) Common brands: Amoxil®, Amix®, Amoram®, Amoxident®, Galenamox®, Rimoxallin® Why is it important for my child to take this medicine?

It is important that your child takes this medicine in the way that your doctor has told you to so that it kills the harmful bacteria and gets rid of their infection.

Capsules: 250 mg and 500 mg Liquid medicine (suspension): 125 mg or 250 mg in 5 mL and 125mg in 1.25ml: these may contain a small amount of sugar. This should be first thing in the morning, early afternoon and at bedtime. Ideally, these times should be at least 4 hours apart.