Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - amoxicillin sodium, quantity: 530.1 mg (equivalent: amoxicillin, qty 500 mg); potassium clavulanate, quantity: 119.2 mg (equivalent: clavulanic acid, qty 100 mg) - injection, powder for - excipient ingredients: - curam is an antibiotic alternative to narrow spectrum and broad-spectrum antibiotics for the treatment of polymicrobial infections; especially in mixed gram negative and gram positive infections, and situations where microbial confirmation has not yet been obtained.,infections caused by amoxicillin susceptible organisms are amenable to curam treatment due to its amoxicillin content.,infections caused by beta-lactamase producing amoxicillin resistant organisms are also amenable to curam due to its clavulanic acid content.,susceptibility to curam will vary with geography and time. local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary. amoxicillin/clavulanic acid should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data.,curam is indicated for the short term treatment of serious bacterial infections such as:,? upper respiratory tract infections (including ent): e.g. mastoiditis, tonsillitis, otitis media, epiglotitis and sinusitis when accompanied by severe signs and symptoms,? lower respiratory tract infections: e.g. acute exacerbations of chronic bronchitis, lobar, broncho-pneumonia and community acquired pneumonia,? genito-urinary tract infections: e.g. cystitis, urethritis, pyelonephritis, female genital infections,? gastrointestinal infections e.g. intra-abdominal sepsis, peritonitis.,? skin and skin structure infections, in particular cellulitis, animal bites, diabetic foot infections, vascular surgery infection/ischaemic soft tissue infection, severe dental abscess,? other infections e.g. septic abortion, puerperal sepsis, post-surgical infections.,? curam is indicated for prophylaxis against infection in major surgical procedures that may be associated with higher risk of infectious complications eg. gastrointestinal surgery.

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - amoxicillin sodium, quantity: 1.06 g (equivalent: amoxicillin, qty 1 g); potassium clavulanate, quantity: 238.3 mg (equivalent: clavulanic acid, qty 200 mg) - injection, powder for - excipient ingredients: - curam is an antibiotic alternative to narrow spectrum and broad-spectrum antibiotics for the treatment of polymicrobial infections; especially in mixed gram negative and gram positive infections, and situations where microbial confirmation has not yet been obtained.,infections caused by amoxicillin susceptible organisms are amenable to curam treatment due to its amoxicillin content.,infections caused by beta-lactamase producing amoxicillin resistant organisms are also amenable to curam due to its clavulanic acid content.,susceptibility to curam will vary with geography and time. local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary. amoxicillin/clavulanic acid should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data.,curam is indicated for the short term treatment of serious bacterial infections such as:,? upper respiratory tract infections (including ent): e.g. mastoiditis, tonsillitis, otitis media, epiglotitis and sinusitis when accompanied by severe signs and symptoms,? lower respiratory tract infections: e.g. acute exacerbations of chronic bronchitis, lobar, broncho-pneumonia and community acquired pneumonia,? genito-urinary tract infections: e.g. cystitis, urethritis, pyelonephritis, , female genital infections,? gastrointestinal infections: e.g. intra-abdominal sepsis, peritonitis.,? skin and skin structure infections, in particular cellulitis, animal bites, diabetic foot infections, vascular surgery infection/ischaemic soft tissue infection, severe dental abscess,? other infections e.g. septic abortion, puerperal sepsis, post-surgical infections.,? curam is indicated for prophylaxis against infection in major surgical procedures that may be associated with higher risk of infectious complications eg. gastrointestinal surgery.

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - amoxicillin sodium, quantity: 2.12 g (equivalent: amoxicillin, qty 2 g); potassium clavulanate, quantity: 238.3 mg (equivalent: clavulanic acid, qty 200 mg) - injection, powder for - excipient ingredients: - curam is an antibiotic alternative to narrow spectrum and broad-spectrum antibiotics for the treatment of polymicrobial infections; especially in mixed gram negative and gram positive infections, and situations where microbial confirmation has not yet been obtained.,infections caused by amoxicillin susceptible organisms are amenable to curam treatment due to its amoxicillin content.,infections caused by beta-lactamase producing amoxicillin resistant organisms are also amenable to curam due to its clavulanic acid content.,susceptibility to curam will vary with geography and time. local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary. amoxicillin/clavulanic acid should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data.,curam is indicated for the short term treatment of serious bacterial infections such as:,? upper respiratory tract infections (including ent): e.g. mastoiditis, tonsillitis, otitis media, epiglotitis and sinusitis when accompanied by severe signs and symptoms,? lower respiratory tract infections: e.g. acute exacerbations of chronic bronchitis, lobar, broncho-pneumonia and community acquired pneumonia,? genito-urinary tract infections: e.g. cystitis, urethritis, pyelonephritis, female genital infections,? gastrointestinal infections e.g. intra-abdominal sepsis, peritonitis.,? skin and skin structure infections, in particular cellulitis, animal bites, diabetic foot infections, vascular surgery infection/ischaemic soft tissue infection, severe dental abscess,? other infections e.g. septic abortion, puerperal sepsis, post-surgical infections.,? curam is indicated for prophylaxis against infection in major surgical procedures that may be associated with higher risk of infectious complications eg. gastrointestinal surgery.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

aurobindo sa-nv - amoxicillin trihydrate 573,4 mg - eq. amoxicillin 500 mg; clavulanic acid 125 mg - film-coated tablet - 500 mg - 125 mg - amoxicillin trihydrate 573.4 mg; clavulanic acid 125 mg - amoxicillin and enzyme inhibitor

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

aurobindo sa-nv - amoxicillin trihydrate 1003,44 mg - eq. amoxicillin 875 mg; clavulanic acid 125 mg - film-coated tablet - 875 mg - 125 mg - clavulanic acid 125 mg; amoxicillin trihydrate 1003.44 mg - amoxicillin and enzyme inhibitor

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

hikma pharmaceuticals usa inc. - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanic acid (unii: 23521w1s24) (clavulanic acid - unii:23521w1s24) - amoxicillin anhydrous 200 mg in 5 ml - amoxicillin and clavulanate potassium for oral suspension 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, amoxicillin and clavulanate potassium for oral suspension should not be used. usage to reduce the development of drug‑resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension 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. amoxicillin and clavulanate potassium suspension 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).  amoxicillin and clavulanate potassium suspension is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium suspension.  teratogenic effects : pregnancy category b. reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate potassium (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 amoxicillin and clavulanate potassium. 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/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/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 amoxicillin and clavulanate potassium for oral suspension has been established in pediatric patients. use of amoxicillin and clavulanate potassium in pediatric patients is supported by evidence from studies of amoxicillin and clavulanate potassium tablets in adults with additional data from a study of amoxicillin and clavulanate potassium 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 amoxicillin and clavulanate potassium, 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 30ml/min). see patients with renal impairment [see dosage and administration (2.4)] for specific recommendations in patients with renal impairment.

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

preferred pharmaceuticals, inc. - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanic acid (unii: 23521w1s24) (clavulanic acid - unii:23521w1s24) - amoxicillin anhydrous 200 mg in 5 ml - amoxicillin and clavulanate potassium for oral suspension 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: limitations of use when susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium for oral suspension should not be used. usage to reduce the development of drug‑resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension 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 contri

Australia - English - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - amoxicillin sodium, quantity: 530.1 mg; potassium clavulanate, quantity: 119.13 mg - injection, powder for - excipient ingredients: - amoxiclav juno is an antibiotic alternative to narrow spectrum and broad-spectrum antibiotics for the treatment of polymicrobial infections; especially in mixed gram negative and gram positive infections, and situations where microbial confirmation has not yet been obtained. infections caused by amoxicillin susceptible organisms are amenable to amoxiclav juno treatment due to its amoxicillin content. infections caused by ?-lactamase producing amoxicillin resistant organisms are also amenable to amoxiclav juno due to its clavulanic acid content. susceptibility to amoxiclav juno will vary with geography and time. local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary. amoxicillin/clavulanic acid should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data. amoxiclav juno is indicated for the short term treatment of serious bacterial infections such as: ? ? upper respiratory tract infections (including ent): e.g. mastoiditis, tonsillitis, otitis media, epiglotitis and sinusitis when accompanied by severe signs and symptoms ? lower respiratory tract infections: e.g. acute exacerbations of chronic bronchitis, lobar, broncho-pneumonia and community acquired pneumonia ? genito-urinary tract infections: e.g. cystitis, urethritis, pyelonephritis, , female genital infections ? gastrointestinal infections ? e.g. intra-abdominal sepsis, peritonitis. ? skin and skin structure infections, in particular cellulitis, animal bites, diabetic foot infections, vascular surgery infection/ischaemic soft tissue infection, severe dental abscess ? other infections e.g. septic abortion, puerperal sepsis, post-surgical infections. ? ? amoxiclav juno is indicated for prophylaxis against infection in major surgical procedures that may be associated with higher risk of infectious complications eg. gastronitestinal surgery.

Australia - English - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - amoxicillin sodium, quantity: 2120.4 mg; potassium clavulanate, quantity: 238.25 mg - injection, powder for - excipient ingredients: - amoxiclav juno is an antibiotic alternative to narrow spectrum and broad-spectrum antibiotics for the treatment of polymicrobial infections; especially in mixed gram negative and gram positive infections, and situations where microbial confirmation has not yet been obtained. infections caused by amoxicillin susceptible organisms are amenable to amoxiclav juno treatment due to its amoxicillin content. infections caused by ?-lactamase producing amoxicillin resistant organisms are also amenable to amoxiclav juno due to its clavulanic acid content. susceptibility to amoxiclav juno will vary with geography and time. local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary. amoxicillin/clavulanic acid should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data. amoxiclav juno is indicated for the short term treatment of serious bacterial infections such as: ? upper respiratory tract infections (including ent): e.g. mastoiditis, tonsillitis, otitis media, epiglotitis and sinusitis when accompanied by severe signs and symptoms ? lower respiratory tract infections: e.g. acute exacerbations of chronic bronchitis, lobar, broncho-pneumonia and community acquired pneumonia ? genito-urinary tract infections: e.g. cystitis, urethritis, pyelonephritis, , female genital infections ? gastrointestinal infections ? e.g. intra-abdominal sepsis, peritonitis. ? skin and skin structure infections, in particular cellulitis, animal bites, diabetic foot infections, vascular surgery infection/ischaemic soft tissue infection, severe dental abscess ? other infections e.g. septic abortion, puerperal sepsis, post-surgical infections. ? amoxiclav juno is indicated for prophylaxis against infection in major surgical procedures that may be associated with higher risk of infectious complications eg. gastronitestinal surgery.

Australia - English - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - amoxicillin trihydrate, quantity: 1004.5 mg (equivalent: amoxicillin, qty 875 mg); potassium clavulanate, quantity: 148.87 mg (equivalent: clavulanic acid, qty 125 mg) - tablet, film coated - excipient ingredients: ethylcellulose; purified talc; triethyl citrate; polysorbate 80; crospovidone; croscarmellose sodium; magnesium stearate; hyprolose; microcrystalline cellulose; colloidal anhydrous silica; titanium dioxide - amoxycillin and clavulanic acid tablets are indicated for short term treatment of bacterial infections at the following sites when caused by sensitive organisms (refer to microbiology): urinary tract infections (uncomplicated and complicated); lower respiratory tract infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis; upper respiratory tract infections, such as sinusitis, otitis media and recurrent tonsillitis; skin and skin structure infections. appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to amoxycillin and clavulanic acid tablets. however, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed above, therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies. once these results are known, therapy should be adjusted if appropriate. the treatment of mixed infection