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

ranbaxy pharmaceuticals inc. - amoxicillin (unii: 804826j2hu) (amoxicillin - unii:804826j2hu), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - powder, for suspension - 200 mg in 5 ml - amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: lower respiratory tract infections - caused by β-lactamase-producing strains of h. influenzae and m. catarrhalis . otitis media - caused by β-lactamase-producing strains of h. influenzae and m. catarrhalis . sinusitis - caused by β-lactamase-producing strains of h. influenzae and m. catarrhalis . skin and skin structure infections - caused by β-lactamase-producing strains of s. aureus , e. coli , and klebsiella spp. urinary tract infections - caused by β-lactamase-producing strains of e. coli , klebsiella spp. and enterobacter spp. while amoxicillin and clavulanate potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with amoxicillin and clavulanate potassium due

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

sandoz inc - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin anhydrous 600 mg in 5 ml - amoxicillin and clavulanate potassium for oral suspension is indicated for the treatment of pediatric patients with limitations of use acute otitis media due to s. pneumoniae alone can be treated with amoxicillin. amoxicillin and clavulanate potassium for oral suspension is not indicated for the treatment of acute otitis media due to s. pneumoniae with penicillin mic greater than or equal to 4 mcg /ml. therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both s. pneumoniae (penicillin mic less than or equal to 2 mcg/ml) and the ß-lactamase-producing organisms listed above. 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 treatment with amoxicillin and clavulanate potassium. there are 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. reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate potassium (2:1 ratio formulation of amoxicillin:clavulanate) at oral dosages up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to amoxicillin and clavulanate potassium. the amoxicillin doses in rodents (based on body surface area and assuming a 20 kg child) were approximately 2 times (rats) or equal to (mice) the recommended clinical amoxicillin and clavulanate potassium for oral suspension dose of 90/6.4 mg/kg/day. for clavulanate, these dose multiples were approximately 15 times and 7.5 times the recommended daily dose of amoxicillin and clavulanate potassium for oral suspension. oral ampicillin-class antibacterial drugs are generally poorly absorbed during labor. studies in guinea pigs have shown that intravenous administration of ampicillin decreased the uterine tone, frequency of contractions, height of contractions, and duration of contractions. however, it is not known whether the 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 that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary. in a single study in women with premature rupture of fetal membranes, it was reported that prophylactic treatment with amoxicillin and clavulanate potassium may be associated with an increased risk of necrotizing enterocolitis in neonates. ampicillin-class antibacterial drugs are excreted in human milk; therefore, caution should be exercised when amoxicillin and clavulanate potassium is administered to a nursing woman. safety and efficacy of amoxicillin and clavulanate potassium for oral suspension in infants younger than 3 months have not been established. safety and efficacy of amoxicillin and clavulanate potassium for oral suspension have been demonstrated for treatment of acute otitis media in infants and children 3 months to 12 years [see clinical studies (14)]. the safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension have been established for the treatment of pediatric patients (3 months to 12 years) with acute bacterial sinusitis. this use is supported by evidence from adequate and well-controlled studies of amoxicillin and clavulanate potassium extended-release tablets in adults with acute bacterial sinusitis, studies of amoxicillin and clavulanate potassium for oral suspension in pediatric patients with acute otitis media, and by similar pharmacokinetics of amoxicillin and clavulanate in pediatric patients taking amoxicillin and clavulanate potassium for oral suspension [see clinical pharmacology (12)] and adults taking amoxicillin and clavulanate potassium extended-release tablets.

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 600 mg in 5 ml - amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 ml is indicated for the treatment of pediatric patients with - recurrent or persistent acute otitis media due to s. pneumoniae (penicillin mics less than or equal to 2 mcg/ml), h. influenzae (including β-lactamase–producing strains), or m. catarrhalis (including β-lactamase–producing strains) characterized by the following risk factors: - antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) day care attendance [see microbiology (12.4)] . limitations of use acute otitis media due to s. pneumoniae alone can be treated with amoxicillin. amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 ml is not indicated for the treatment of acute otitis media due to s. pneumoniae with penicillin mic greater than or equal to 4 mcg/ml. therapy may be instituted prior to obtaining the results from bacteriological studies when t

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

direct rx - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin anhydrous 875 mg - to reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets, usp and other antibacterial drugs, amoxicillin and clavulanate potassium tablets, usp 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 tablets, usp are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*: 1.1 lower respiratory tract infections caused by beta-lactamase–producing isolates of haemophilus influenzae and moraxella catarrhalis. 1.2 acute bacterial otitis media

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

direct rx - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9) - amoxicillin anhydrous 500 mg - 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 a penicillin-class antibacterial indicated for treatment of infections due tosusceptible (only β-lactamase–negative) isolates of the designated bacteria in the conditions listed below: infections of the ear, nose, and throat – due to streptococcus species. (α- and β-hemolytic isolates only), streptococcus pneumoniae, staphylococcus spp., or haemophilus influenzae. infections of the genitourinary tract – due to escherichia coli, proteus mirabilis, or enterococcus faecalis. infections of the skin a

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

liberty pharmaceuticals, 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. triple therapy: amoxicillin/clarithromycin/lansoprazole amoxicillin, in combination with clarithromycin plus

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

hikma pharmaceuticals usa inc. - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin 600 mg in 5 ml - amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 ml is indicated for the treatment of pediatric patients with - recurrent or persistent acute otitis media due to s. pneumoniae (penicillin mics less than or equal to 2 mcg/ml), h. influenzae (including β-lactamase-producing strains), or m. catarrhalis (including β-lactamase-producing strains) characterized by the following risk factors: -antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) day care attendance [see microbiology (12.4)] . limitations of use acute otitis media due to s. pneumoniae alone can be treated with amoxicillin. amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 ml is not indicated for the treatment of acute otitis media due to s. pneumoniae with penicillin mic greater than or equal to 4 mcg/ml. therapy may be instituted prior to obtaining the results from bacteriological studies when t

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; cetyl alcohol; sodium lauryl sulfate - short-term treatment of bacterial infection at the following sites when caused by amoxycillin/clavulanic acid sensitive, beta-lactamase producing organisms. skin and skin structure infections. urinary tract infections (uncomplicated and complicated). 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 curam tablets. 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 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 curam tablets should not require the addition of another antibiotic due to the amoxycillin content of curam tablets.

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; cetyl alcohol; sodium lauryl sulfate - short-term treatment of bacterial infection at the following sites when caused by amoxycillin/clavulanic acid sensitive, beta-lactamase producing organisms. skin and skin structure infections. urinary tract infections (uncomplicated and complicated). 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 curam tablets. 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 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 curam tablets should not require the addition of another antibiotic due to the amoxycillin content of curam tablets.

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

nucare pharamaceuticals,inc. - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin anhydrous 600 mg in 5 ml - to reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension, usp and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, usp 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 for oral suspension, usp is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to s. pneumoniae (penicillin mics ≤ 2 mcg/ml), h. influenzae (including beta-lactamase – producing strains), or m. catarrhalis (including beta-lactamase-­producing strains) characterized by the following risk factors: - antiba