Australien - engelska - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - potassium clavulanate, quantity: 151.917 mg; amoxicillin trihydrate, quantity: 573.892 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; dichloromethane; isopropyl alcohol; sodium starch glycollate; titanium dioxide; hypromellose; propylene glycol; purified talc; ethylcellulose - amclavox duo 500/125 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 (complicated and uncomplicated),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 infection.,appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to amoxicillin 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 infections caused by amoxicillin susceptible organisms and beta-lactamase producing organisms susceptible to amoxicillin and clavulanic acid tablets preparations should not require the addition of another antibiotic due to the amoxicillin content of these products.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

micro labs pty ltd - potassium clavulanate, quantity: 151.917 mg; amoxicillin trihydrate, quantity: 1004.31 mg - tablet, film coated - excipient ingredients: isopropyl alcohol; sodium starch glycollate; dichloromethane; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; titanium dioxide; hypromellose; macrogol 400 - amoxyclav b&b 875/125 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 (complicated and uncomplicated),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 amoxicillin 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 infections caused by amoxicillin susceptible organisms and beta-lactamase producing organisms susceptible to amoxicillin and clavulanic acid tablets preparations should not require the addition of another antibiotic due to the amoxicillin content of these products.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

micro labs pty ltd - potassium clavulanate, quantity: 151.917 mg; amoxicillin trihydrate, quantity: 1004.31 mg - tablet, film coated - excipient ingredients: dichloromethane; isopropyl alcohol; microcrystalline cellulose; sodium starch glycollate; magnesium stearate; colloidal anhydrous silica; titanium dioxide; hypromellose; macrogol 400 - amoxyclav mlabs 875/125 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 (complicated and uncomplicated),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 infection.,appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to amoxicillin 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 infections caused by amoxicillin susceptible organisms and beta-lactamase producing organisms susceptible to amoxicillin and clavulanic acid tablets preparations should not require the addition of another antibiotic due to the amoxicillin content of these products.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

micro labs pty ltd - potassium clavulanate, quantity: 151.917 mg; amoxicillin trihydrate, quantity: 573.892 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; dichloromethane; isopropyl alcohol; sodium starch glycollate; titanium dioxide; hypromellose; macrogol 400 - comox 500/125 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 (complicated and uncomplicated),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 infection.,appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to amoxicillin 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 infections caused by amoxicillin susceptible organisms and beta-lactamase producing organisms susceptible to amoxicillin and clavulanic acid tablets preparations should not require the addition of another antibiotic due to the amoxicillin content of these products.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

micro labs pty ltd - potassium clavulanate, quantity: 151.917 mg; amoxicillin trihydrate, quantity: 573.892 mg - tablet, film coated - excipient ingredients: isopropyl alcohol; colloidal anhydrous silica; magnesium stearate; sodium starch glycollate; dichloromethane; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 400 - amoxyclav mlabs 500/125 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 (complicated and uncomplicated),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 infection.,appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to amoxicillin 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 infections caused by amoxicillin susceptible organisms and beta-lactamase producing organisms susceptible to amoxicillin and clavulanic acid tablets preparations should not require the addition of another antibiotic due to the amoxicillin content of these products.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - potassium clavulanate, quantity: 149.774 mg (equivalent: clavulanic acid, qty 125 mg); amoxicillin trihydrate, quantity: 1012.617 mg (equivalent: amoxicillin, qty 875 mg) - tablet, film coated - excipient ingredients: magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; sodium starch glycollate type a; dichloromethane; isopropyl alcohol; titanium dioxide; hypromellose; purified talc; diethyl phthalate; ethylcellulose - clavam 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 infection.,appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to clavam 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 infections caused by amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to clavam tablets should not require the addition of another antibiotic due to the amoxycillin content of these products.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - amoxicillin trihydrate,potassium clavulanate -

USA - engelska - NLM (National Library of Medicine)

micro labs limited - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - 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 for oral 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 for oral suspension is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium. teratogenic effects: 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 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 amoxicillin and clavulanate potassium for oral suspension have 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 30 ml/min). see patients with renal impairment [see dosage and administration ( 2.4)] for specific recommendations in patients with renal impairment.

USA - engelska - NLM (National Library of Medicine)

usantibiotics, llc - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin and clavulanate potassium 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 should not be used. usage to reduce the development of drug‑resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium 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 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 is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium. 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 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 amoxicillin and clavulanate potassium for oral suspension and chewable tablets have 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 30 ml/min). see patients with renal impairment [see dosage and administration (2.4)] for specific recommendations in patients with renal impairment.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

micro labs pty ltd - amoxicillin trihydrate, quantity: 573.892 mg; potassium clavulanate, quantity: 151.917 mg - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; dichloromethane; sodium starch glycollate; colloidal anhydrous silica; isopropyl alcohol; titanium dioxide; hypromellose; propylene glycol; purified talc; ethylcellulose - amoxyclav b&b 500/125 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 (complicated and uncomplicated),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 amoxicillin 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 infections caused by amoxicillin susceptible organisms and beta-lactamase producing organisms susceptible to amoxicillin and clavulanic acid tablets preparations should not require the addition of another antibiotic due to the amoxicillin content of these products.