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

micro labs limited - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin anhydrous 250 mg - amoxicillin and clavulanate potassium tablets 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 test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets should not be used. usage to reduce the development of drug‑resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets 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 tablets are 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 tablets are 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 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.

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

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

stat rx usa llc - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin anhydrous 500 mg - amoxicillin and clavulanate potassium tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: caused by β-lactamase-producing strains of h. influenzae and m. catarrhalis . caused by β-lactamase-producing strains of h. influenzae and m. catarrhalis . caused by β-lactamase-producing strains of h. influenzae and m. catarrhalis . caused by β-lactamase-producing strains of s. aureus , e. coli , and klebsiella spp. caused by β-lactamase-producing strains of e. coli , klebsiella spp., and enterobacter spp. while amoxicillin and clavulanate potassium tablets are indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with amoxicillin and clavulanate potassium tablets due to their amoxicillin content; therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase-producing organisms susceptible to amoxicillin and clavulanate po

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

northstar rx llc - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin anhydrous 250 mg - amoxicillin and clavulanate potassium tablets 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 test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets should not be used. usage to reduce the development of drug‑resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets 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 tablets are 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 tablets are contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium tablets. 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 tablets 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.

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

nucare pharmaceuticals, inc. - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9) - amoxicillin anhydrous 250 mg - 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 . 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 . 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 . 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. pneum

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

nucare pharmaceuticals,inc. - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9) - amoxicillin anhydrous 250 mg - 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 . 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 . 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 . 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. pneum

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

nucare pharmaceuticals, inc. - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9) - amoxicillin anhydrous 875 mg - amoxicillin tablets 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 . amoxicillin tablets are indicated in the treatment of infections due to susceptible (only β-lactamase–negative) isolates of escherichia coli, proteus mirabilis , or enterococcus faecalis. amoxicillin tablets 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. amoxicillin tablets 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, s

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

stat rx usa llc - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9) - amoxicillin 875 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/lans

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

central texas community health centers - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9) - amoxicillin anhydrous 500 mg - 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 . 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 . 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 . 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 . triple therapy for helicobacter pylori with clarithromycin and lansoprazole: amoxicillin capsules in combinati

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.