Canada - English - Health Canada

bimeda-mtc animal health inc - amoxicillin (amoxicillin trihydrate) - tablet - 400mg - amoxicillin (amoxicillin trihydrate) 400mg - cats; dogs

Ireland - English - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - amoxicillin; clavulanic acid - powder for oral suspension - 400 mg/57 mg/5ml - combinations of penicillins, incl. beta-lactamase inhibitors; amoxicillin and enzyme inhibitor

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

medreich australia pty ltd - amoxicillin trihydrate, quantity: 1006.25 mg; potassium clavulanate, quantity: 148.875 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; isopropyl alcohol; propylene glycol; dichloromethane; purified talc; ethylcellulose; hypromellose; magnesium stearate; titanium dioxide; hyprolose; industrial methylated spirit - apo-amoxy/clav 500/125 and apo-amoxy/clav 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 (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 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 should not require the addition of another antibiotic due to the amoxicillin content of these products.

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

medreich australia pty ltd - amoxicillin trihydrate, quantity: 575 mg; potassium clavulanate, quantity: 148.875 mg - tablet, film coated - excipient ingredients: propylene glycol; magnesium stearate; croscarmellose sodium; dichloromethane; purified talc; microcrystalline cellulose; ethylcellulose; hypromellose; isopropyl alcohol; titanium dioxide; hyprolose; industrial methylated spirit - amoxyclav generichealth 500/125 and amoxyclav generichealth 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 (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 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 should not require the addition of another antibiotic due to the amoxicillin content of these products.

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

medreich australia pty ltd - amoxicillin trihydrate, quantity: 1006.25 mg; potassium clavulanate, quantity: 148.875 mg - tablet, film coated - excipient ingredients: purified talc; propylene glycol; isopropyl alcohol; hypromellose; ethylcellulose; croscarmellose sodium; dichloromethane; microcrystalline cellulose; magnesium stearate; titanium dioxide; hyprolose; industrial methylated spirit - amoxyclav generichealth 500/125 and amoxyclav generichealth 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 (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 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 should not require the addition of another antibiotic due to the amoxicillin content of these products.

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

medreich australia pty ltd - amoxicillin trihydrate, quantity: 575 mg; potassium clavulanate, quantity: 148.875 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; isopropyl alcohol; microcrystalline cellulose; propylene glycol; purified talc; dichloromethane; hypromellose; ethylcellulose; magnesium stearate; titanium dioxide; hyprolose; industrial methylated spirit - apo-amoxy/clav 500/125 and apo-amoxy/clav 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 (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 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 should not require the addition of another antibiotic due to the amoxicillin content of these products.

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

preferred pharmaceuticals, inc. - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9) - amoxicillin anhydrous 125 mg in 5 ml - amoxicillin for oral suspension is indicated in the treatment of infections due to susceptible (only β-lactamase–negative) isolates of streptococcus species (α- and β-hemolytic isolates only), streptococcus pneumoniae , staphylococcus spp., or haemophilus influenzae . amoxicillin for oral suspension is indicated in the treatment of infections due to susceptible (only β-lactamase–negative) isolates of escherichia coli , proteus mirabilis , or enterococcus faecalis . amoxicillin for oral suspension is indicated in the treatment of infections due to susceptible (only β-lactamase-negative) isolates of streptococcus spp. (α- and β-hemolytic isolates only), staphylococcus spp., or e. coli . amoxicillin for oral suspension is indicated in the treatment of infections due to susceptible (only β-lactamase-negative) isolates of streptococcus spp. (α- and β-hemolytic isolates only), s. pneumoniae , staphylococcus spp., or h. influenzae . triple therapy for helicobacter pylori with clarithromycin and lansoprazole: amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or 1 year history of a duodenal ulcer) to eradicate h. pylori . eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence. dual therapy for h. pylori with lansoprazole: amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or 1 year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (see the clarithromycin package insert, microbiology.) eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence. to reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by 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 is contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or stevens-johnson syndrome) to amoxicillin or to other β-lactam antibiotics (e.g., penicillins and cephalosporins). teratogenic effects: reproduction studies have been performed in mice and rats at doses up to 2000 mg/kg (3 and 6 times the 3 g human dose, based on body surface area). there was no evidence of harm to the fetus due to amoxicillin. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, amoxicillin should be used during pregnancy only if clearly needed. oral ampicillin is poorly absorbed during labor. it is not known whether use of amoxicillin 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. penicillins have been shown to be excreted in human milk. amoxicillin use by nursing mothers may lead to sensitization of infants. caution should be exercised when amoxicillin is administered to a nursing woman. because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed. dosing of amoxicillin should be modified in pediatric patients 12 weeks or younger (≤ 3 months). [see dosage and administration (2.2).] an analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. these analyses have not identified differences in responses between the elderly and younger patients, but a 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 toxic 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 <30 ml/min). see dosing in renal impairment (2.4) for specific recommendations in patients with renal impairment.

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

teva pharmaceuticals usa, inc. - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin anhydrous 500 mg - amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are 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 te

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

putney, inc. - amoxicillin anhydrous (unii: 9em05410q9) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin anhydrous 50 mg - indications: amoxicillin trihydrate and clavulanate potassium tablets are indicated in the treatment of: dogs: skin and soft tissue infections such as wounds, abscesses, cellulitis, superficial/juvenile and deep pyoderma due to susceptible strains of the following organisms: β-lactamase-producing staphylococcus aureus , non-β-lactamase-producing staphylococcus aureus , staphylococcus spp., streptococcus spp., and e. coli . periodontal infections due to susceptible strains of both aerobic and anaerobic bacteria. amoxicillin trihydrate and clavulanate potassium tablets have been shown to be clinically effective for treating cases of canine periodontal disease. cats: skin and soft tissue infections such as wounds, abscesses, and cellulitis/dermatitis due to susceptible strains of the following organisms: β-lactamase-producing staphylococcus aureus , non-β-lactamase-producing staphylococcus aureus , staphylococcus spp., streptococcus spp., e. coli , and pasteurella spp. urinary tract infections (cystitis)

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

micro labs pty ltd - amoxicillin trihydrate, quantity: 57.4 mg/ml (equivalent: amoxicillin, qty 50 mg/ml) - suspension, powder for - excipient ingredients: sorbitol; sodium benzoate; saccharin sodium; disodium edetate; xanthan gum; silicon dioxide; flavour - it is indicated for the treatment of the following infections due to susceptible strains of sensitive organisms:,note: therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. however, in emergency cases where the causative organism has not been identified, therapy with amoxicillin may be useful. clinical judgement will decide whether combination with another antibiotic would provide a sufficiently broad spectrum of activity pending sensitivity test results.,skin and skin structure: staphylococcus, non-penicillinase producing; streptococcus; e.coli,respiratory (acute and chronic): h.influenzae, streptococcus; s.pneumoniae; staphylococcus, non-penicillinase-producing; e.coli,genitourinary tract (complicated and uncomplicated, acute and chronic): e.coli, p.mirabilis and s.faecalis.,gonorrhoea: n.gonorrhoeae (non-penicillinase producing).,prophylaxis of endocarditis: [trade name] may be used for the prophylaxis of bacterial endocarditis in individuals at particular risk, such as those with a prosthetic heart valve or those who have previously had endocarditis.