Ireland - English - HPRA (Health Products Regulatory Authority)

imed healthcare ltd. - amoxicillin trihydrate clavulanate potassium - tablets - 250/125 milligram

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - amoxicillin trihydrate 28.698 mg/ml equivalent to amoxycillin 25mg/ml; potassium clavulanate 7.446 mg/ml equivalent to clavulanic acid 6.25mg/ml - powder for oral suspension - 125 mg/5ml - active: amoxicillin trihydrate 28.698 mg/ml equivalent to amoxycillin 25mg/ml potassium clavulanate 7.446 mg/ml equivalent to clavulanic acid 6.25mg/ml excipient: aspartame colloidal silicon dioxide golden syrup flavour 52927 ap0551 hydrated silica hypromellose orange flavour phs-134215 orange flavour sd653970 raspberry flavour nn07943 succinic acid xanthan gum - augmentin should be used in accordance with local official antibiotic prescribing guidelines and local susceptibility data. augmentin is indicated for the short term treatment of common bacterial infections in adults and children such as: upper respiratory tract infections (including ent): e.g. tonsillitis, sinusitis, otitis media lower respiratory tract infections: e.g. acute exacerbations of chronic bronchitis, lobar and broncho pneumonia genito-urinary tract infections: e.g. cystitis, urethritis, pyelonephritis, female genital infections skin and soft tissue infections bone and joint infections: e.g. osteomyelitis other infections: e.g. septic abortion, puerperal sepsis, intra-abdominal sepsis, septicaemia, peritonitis, post-surgical infections susceptibility to augmentin will vary with geography and time. local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary. infections caused by amoxicillin susceptible organisms are amenable to augmentin treatment due to its amoxicillin content. mixed infections caused by amoxicillin susceptible organism in conjunction with augmentin susceptible beta-lactamase-producing organisms may therefore be treated by augmentin.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - amoxicillin trihydrate 57.394 mg/ml equivalent to amoxycillin 50mg/ml; potassium clavulanate 14.89 mg/ml equivalent to clavulanic acid 12.5mg/ml - powder for oral suspension - 250 mg/5ml - active: amoxicillin trihydrate 57.394 mg/ml equivalent to amoxycillin 50mg/ml potassium clavulanate 14.89 mg/ml equivalent to clavulanic acid 12.5mg/ml excipient: aspartame colloidal silicon dioxide golden syrup flavour 52927 ap0551 hydrated silica hypromellose orange flavour phs-134215 orange flavour sd653970 raspberry flavour nn07943 succinic acid xanthan gum - augmentin should be used in accordance with local official antibiotic prescribing guidelines and local susceptibility data. augmentin is indicated for the short term treatment of common bacterial infections in adults and children such as: upper respiratory tract infections (including ent): e.g. tonsillitis, sinusitis, otitis media lower respiratory tract infections: e.g. acute exacerbations of chronic bronchitis, lobar and broncho pneumonia genito-urinary tract infections: e.g. cystitis, urethritis, pyelonephritis, female genital infections skin and soft tissue infections bone and joint infections: e.g. osteomyelitis other infections: e.g. septic abortion, puerperal sepsis, intra-abdominal sepsis, septicaemia, peritonitis, post-surgical infections susceptibility to augmentin will vary with geography and time. local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary. infections caused by amoxicillin susceptible organisms are amenable to augmentin treatment due to its amoxicillin content. mixed infections caused by amoxicillin susceptible organism in conjunction with augmentin susceptible beta-lactamase-producing organisms may therefore be treated by augmentin.

Ireland - English - HPRA (Health Products Regulatory Authority)

b & s healthcare - amoxicillin trihydrate clavulanate potassium - tablets - 250/125 milligram

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

glaxosmithkline pharmaceutical kenya limited, kenya - amoxicillin , clavulanic acid - tablets - 250 mg + 125 mg

United States - English - NLM (National Library of Medicine)

allegis holdings, llc - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - augmentin is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: - lower respiratory tract infections - caused by beta‑lactamase–producing isolates of haemophilus influenzae and moraxella catarrhalis . - acute bacterial otitis media - caused by beta‑lactamase–producing isolates of h. influenzae and m. catarrhalis . - sinusitis - caused by beta‑lactamase–producing isolates of h. influenzae and m. catarrhalis . - skin and skin structure infections - caused by beta‑lactamase–producing isolates of staphylococcus aureus , escherichia coli , and klebsiella species. - urinary tract infections - caused by beta‑lactamase–producing isolates of e. coli , klebsiella species, and enterobacter species. limitations of use when susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, augmentin should not be used. usage to reduce the development of drug‑resistant bacteria and maintain the effectiveness of augmentin and other antibacterial drugs, augmentin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. augmentin is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or stevens-johnson syndrome) to amoxicillin, clavulanate or to other beta‑lactam antibacterial drugs (e.g., penicillins and cephalosporins). augmentin is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with augmentin. teratogenic effects : pregnancy category b. reproduction studies performed in pregnant rats and mice given augmentin (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to augmentin. the amoxicillin doses in rats and mice (based on body surface area) were approximately 4 and 2 times the maximum recommended adult human oral dose (875 mg every 12 hours). for clavulanate, these dose multiples were approximately 9 and 4 times the maximum recommended adult human oral dose (125 mg every 8 hours). there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. oral ampicillin‑class antibacterials are poorly absorbed during labor. it is not known whether 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 of the necessity for an obstetrical intervention. amoxicillin has been shown to be excreted in human milk. amoxicillin and clavulanate potassium use by nursing mothers may lead to sensitization of infants. caution should be exercised when amoxicillin and clavulanate potassium is administered to a nursing woman. the safety and effectiveness of augmentin for oral suspension and chewable tablets have been established in pediatric patients. use of augmentin in pediatric patients is supported by evidence from studies of augmentin tablets in adults with additional data from a study of augmentin for oral suspension in pediatric patients aged 2 months to 12 years with acute otitis media [see clinical studies ( 14.2)] . because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed; clavulanate elimination is unaltered in this age group. dosing of amoxicillin and clavulanate potassium should be modified in pediatric patients aged less than 12 weeks (less than 3 months) [see dosage and administration ( 2.3)]. of the 3,119 patients in an analysis of clinical studies of augmentin, 32% were greater than or equal to 65 years old, and 14% were greater than or equal to 75 years old. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but 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 adverse reactions to this drug may be greater in patients with impaired renal function. 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. amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (gfr less than 30 ml/min). see patients with renal impairment [see dosage and administration ( 2.4)] for specific recommendations in patients with renal impairment.

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

smith_kb -

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - amoxicillin as trihydrate; clavulanic acid as potassium salt - powder for suspension - amoxicillin as trihydrate 50 mg/ml; clavulanic acid as potassium salt 12.5 mg/ml - ampicillin and enzyme inhibitor - ampicillin and enzyme inhibitor - augmentin is indicated for the treatment of the following infections in adults and children: • acute bacterial sinusitis (adequately diagnosed)• acute otitis media• acute exacerbations of chronic bronchitis (adequately diagnosed)• community acquired pneumonia• cystitis• pyelonephritis• skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis.• bone and joint infections, in particular osteomyelitis.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - amoxicillin as trihydrate; clavulanic acid as potassium salt - powder for suspension - clavulanic acid as potassium salt 57 mg / 5 ml; amoxicillin as trihydrate 400 mg / 5 ml - amoxicillin and enzyme inhibitor - amoxicillin and enzyme inhibitor - augmentin is indicated for the treatment of the following infections in adults and children: • acute bacterial sinusitis (adequately diagnosed)• acute otitis media• acute exacerbations of chronic bronchitis (adequately diagnosed)• community acquired pneumonia• cystitis• pyelonephritis• skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis.• bone and joint infections, in particular osteomyelitis.• recurrent tonsillitis

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

glaxosmithkline pharmaceutical sdn. bhd. - amoxycillin trihydrate; potassium clavulanate -