New Zealand - English - Medsafe (Medicines Safety Authority)

miro healthcare limited - amoxicillin trihydrate 287.5mg equivalent to amoxicillin 250 mg;  ;   - capsule - 250 mg - active: amoxicillin trihydrate 287.5mg equivalent to amoxicillin 250 mg     excipient: brilliant blue fcf carmoisine croscarmellose sodium gelatin ink magnesium stearate methyl hydroxybenzoate propyl hydroxybenzoate purified water quinoline yellow sodium laurilsulfate sunset yellow fcf   titanium dioxide   - amoxicillin is indicated for the treatment of the following infections due to susceptible strains of sensitive organisms: upper respiratory infections: otitis media, pharyngitis, sinusitis and tonsillitis. lower respiratory infections: bronchitis, bronchopneumonia and lobar pneumonia. urinary tract infections: cystitis, cysto-pyelitis, urethritis, and gonococcal urethritis. prophylaxis: against ?-haemolytic (viridans group) and ?-haemolytic streptococci before dental, oral or upper respiratory tract surgery or instrumentation. prophylaxis: of bacterial endocarditis in patients with any of the following conditions: congenital cardiac malformations, rheumatic and other acquired valvular lesions, prosthetic heart valves, previous history of bacterial endocarditis, hypertrophic cardiomyopathy, surgically constructed systemic-pulmonary shunts, mitral valve prolapse with valvular regurgitation or mitral valve prolapse without valvular regurgitation but associated with thickening and/or redundancy of the valve leaflets. amoxicillin is further indicated for the treatment of cutaneous infections. in emergency cases where the causative organism is not yet identified, therapy may be initiated with amoxicillin on the basis of clinical judgement, while awaiting the results of bacteriologic studies to determine its antimicrobial sensitivity.

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: 1060.2 mg (equivalent: amoxicillin, qty 1000 mg); potassium clavulanate, quantity: 238.25 mg (equivalent: clavulanic acid, qty 200 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.

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

dr. reddy's laboratories inc - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), amoxicillin sodium (unii: 544y3d6myh) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin anhydrous 562.5 mg - to reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium extended release tablets and other antibacterial drugs, amoxicillin and clavulanate potassium extended release tablets should be used only to treat 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 extended release tablets is indicated for the treatment of patients with community-acquired pneumonia or acute bacterial sinusitis due to confirmed, or suspected β-lactamase–producing pathogens (i.e., h. influenzae , m. catarrhalis , h. parainfluenzae , k. pneumoniae , or methicillin-susceptible s. aureus ) and s. pneumoniae with reduced susceptibility to penic

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

sandoz pty ltd - amoxicillin trihydrate, quantity: 1005 mg (equivalent: amoxicillin, qty 875 mg); potassium clavulanate, quantity: 149 mg (equivalent: clavulanic acid, qty 125 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; magnesium stearate; purified talc; povidone; silicon dioxide; triethyl citrate; hypromellose; titanium dioxide; ethylcellulose; sodium lauryl sulfate; cetyl alcohol - short-term treatment of bacterial infections at the following sites when caused by amoxycillin/clavulanic acid sensitive, beta-lactamase producing organisms: skin and skin structure infections. urinary tract infections (complicated and uncomplicated). upper respiratory tract infections, such as sinusitis, otitis media and recurrent tonsillitis. lower respiratory tract infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis. appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to amoxycillin/clavulanic acid tablet preparations. however, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed in the microbiological section, therapy may be instituted prior to obtaining the results from bacteriological and susceptible studies. once these results are known, therapy should be adjusted if appropriate. the treatment of mixed infections cause by amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to amoxycillin/clavulanic acid tablet preparations should not require the addition of another antibiotic due to the amoxycillin content of these products.

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

sandoz pty ltd - amoxicillin trihydrate, quantity: 574 mg (equivalent: amoxicillin, qty 500 mg); potassium clavulanate, quantity: 149 mg (equivalent: clavulanic acid, qty 125 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; magnesium stearate; purified talc; povidone; triethyl citrate; hypromellose; titanium dioxide; ethylcellulose; sodium lauryl sulfate; cetyl alcohol - short-term treatment of bacterial infections at the following sites when caused by amoxycillin/clavulanic acid sensitive, beta-lactamase producing organisms: skin and skin structure infections. urinary tract infections (complicated and uncomplicated). upper respiratory tract infections, such as sinusitis, otitis media and recurrent tonsillitis. lower respiratory tract infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis. appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to amoxycillin/clavulanic acid tablet preparations. however, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed in the microbiological section, therapy may be instituted prior to obtaining the results from bacteriological and susceptible studies. once these results are known, therapy should be adjusted if appropriate. the treatment of mixed infections cause by amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to amoxycillin/clavulanic acid tablet preparations should not require the addition of another antibiotic due to the amoxycillin content of these products.

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

physicians total care, inc. - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9) - amoxicillin anhydrous 250 mg - amoxicillin is indicated in the treatment of infections due to susceptible (only β-lactamase-negative) strains of the designated microorganisms in the conditions listed below: infections of the ear, nose, and throat - due to streptococcus spp. (α- and β-hemolytic strains only), s. pneumoniae, staphylococcus spp., or h. influenzae. infections of the genitourinary tract - due to e. coli, p. mirabilis, or e. faecalis. infections of the skin and skin structure - due to streptococcus spp. (α- and β-hemolytic strains only), staphylococcus spp., or e. coli infections of the lower respiratory tract - due to streptococcus spp. (α- and β-hemolytic strains only), s. pneumoniae, staphylococcus spp., or h. influenzae. gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to n. gonorrhoeae (males and females). h. pylori eradication to reduce the risk of duodenal ulcer recurrence amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treat

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

direct rx - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9) - amoxicillin anhydrous 400 mg in 5 ml - to reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin for oral suspension, usp and other antibacterial drugs, amoxicillin for oral suspension, usp 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 for oral suspension, usp is indicated in the treatment of infections due to susceptible (only β-lactamase–negative) isolates of the designated bacteria in the conditions listed below: 1.1 infections of the ear, nose, and throatdue to streptococcus species (α- and   β-hemolytic isolates only), streptococcus pneumoniae, staphylococcus spp., or haemophilus influenzae.1.2 infections of the genitourinary tract due to escherichia coli, proteus mirabilis, or enterococcus faecalis.1.3 infections of the skin and skin structuredue to streptococcus spp. (α- and β-hemolytic isolates only), staphylococcus spp., or e. coli.1.4 infections of the lower respiratory tractdue to streptococcus spp. (α- and β-hemolytic isolates only), s. pneumoniae, staphylococcus spp., or h. influenzae.1.5 gonorrhea, acute uncomplicated (ano-genital and urethral infections) due to neisseria gonorrhoeae. because of high rates of amoxicillin resistance, amoxicillin for oral suspension, usp is not recommended for empiric treatment of gonorrhea. amoxicillin for oral suspension, usp use should be limited to situations where n. gonorrhoeae isolates are known to be susceptible to amoxicillin.1.6 triple therapy for helicobacter pylori with clarithromycin and lansoprazole amoxicillin for oral suspension, usp, 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.1.7 dual therapy for h. pylori with lansoprazole amoxicillin for oral suspension, usp, 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. amoxicillinfor oral suspension is contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or stevens-johnson syndrome) to amoxicillin for oral suspension or to other β-lactam antibiotics (e.g., penicillins and cephalosporins). 8.1 pregnancy teratogenic effects: pregnancy category b. 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.8.2 labor and delivery 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. 8.3 nursing mothers 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.8.4 pediatric use 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).]8.5 geriatric use 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.8.6 dosing in renal impairment amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (gfr <30 ml/min). see dosage and administration (2.4) for specific recommendations in patients with renal impairment.

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

sandoz inc - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), amoxicillin sodium (unii: 544y3d6myh) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin anhydrous 562.5 mg - amoxicillin and clavulanate potassium extended-release tablets is indicated for the treatment of infections in adults and pediatric patients with due to confirmed, or suspected β-lactamase-producing pathogens (i.e., h. influenzae, m. catarrhalis, h. parainfluenzae, k. pneumoniae , or methicillin-susceptible s. aureus ) and s. pneumoniae with reduced susceptibility to penicillin (i.e., penicillin mics equal to 2 mcg/ml). limitations of use amoxicillin and clavulanate potassium extended-release tablets is not indicated for the treatment of infections due to s. pneumoniae with penicillin mics greater than or equal to 4 mcg/ml. data are limited with regard to infections due to s. pneumoniae with penicillin mics greater than or equal to 4 mcg/ml [see clinical studies (14)] . usage to reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium extended-release tablets and other antibacterial drugs, amoxicillin and clavulanate potassium extended-releas