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 particu

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

alphapharm 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 infecti

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

alphapharm 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 infecti

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.

New Zealand - English - Medsafe (Medicines Safety Authority)

actavis new zealand limited - amoxicillin trihydrate 30.3 mg/ml equivalent to 25 mg/ml amoxicillin, on reconstitution;   - powder for oral suspension - 125 mg/5ml - active: amoxicillin trihydrate 30.3 mg/ml equivalent to 25 mg/ml amoxicillin, on reconstitution   excipient: carmellose sodium citric acid colloidal silicon dioxide erythrosine essence btm dm 7020a purified talc sodium benzoate sucrose - amoxicillin is indicated for the treatment of infections due to susceptible organisms. amoxicillin may be useful in instituting therapy prior to bacteriology; however bacteriological studies to determine the causative organisms and their sensitivity to amoxicillin should be determined. amoxicillin may be used for the prevention of bacteraemia, associated with procedures such as dental extraction, in patients at risk of developing bacterial endocarditis.

New Zealand - English - Medsafe (Medicines Safety Authority)

actavis new zealand limited - amoxicillin trihydrate 60.26 mg/ml equivalent to 50 mg/ml amoxicillin, on reconstitution;   - powder for oral suspension - 250 mg/5ml - active: amoxicillin trihydrate 60.26 mg/ml equivalent to 50 mg/ml amoxicillin, on reconstitution   excipient: carmellose sodium citric acid colloidal silicon dioxide erythrosine essence btm dm 7020a purified talc sodium benzoate sucrose - amoxicillin is indicated for the treatment of infections due to susceptible organisms. amoxicillin may be useful in instituting therapy prior to bacteriology; however bacteriological studies to determine the causative organisms and their sensitivity to amoxicillin should be determined. amoxicillin may be used for the prevention of bacteraemia, associated with procedures such as dental extraction, in patients at risk of developing bacterial endocarditis.

Malta - English - Medicines Authority

sun pharmaceutical industries europe b.v. polarisavenue 87, 2132, jh hoofdorp, netherlands - amoxicillin trihydrate - dispersible tablet - amoxicillin trihydrate 750 mg - antibacterials for systemic use

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

unichem laboratories limited, india - amoxicillin trihydrate , potassium clavulanate - powder for oral suspension - amoxicillin trihydrate equivalent to amoxicillin 125 mg + potassium clavulanate, diluted equivalent to clavulanic acid 31.25

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

teva pharmaceuticals usa, inc. - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9) - amoxicillin anhydrous 250 mg - adults and pediatric patients - upper respiratory tract infections of the ear, nose, and throat: amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are 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 . - infections of the genitourinary tract: amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (only β-lactamase-negative) isolates of escherichia coli , proteus mirabilis , or enterococcus faecalis . - infections of the skin and skin structure: amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are 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 . - infections of the lower respiratory tract: amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are 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 . adult patients only - helicobacter pylori infection and duodenal ulcer disease: triple therapy for helicobacter pylori (h. 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. usage 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 antibacterial drugs (e.g., penicillins and cephalosporins). 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. the safety and effectiveness of amoxicillin for the treatment of upper respiratory tract infections, and infections of the genitourinary tract, skin and skin structure and lower respiratory tract have been established in pediatric patients. the safety and effectiveness of amoxicillin for the treatment of h. pylori infection have not been established in pediatric patients. 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 or younger) [see dosage and administration (2.3)] . 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 less than 30 ml/min). see dosing in renal impairment (2.5) for specific recommendations in patients with renal impairment.