Marekani - Kiingereza - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9) - amoxicillin anhydrous 200 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: am

Marekani - Kiingereza - 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.

Marekani - Kiingereza - 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.

Marekani - Kiingereza - 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 200 mg in 5 ml - amoxicillin and clavulanate potassium for oral suspension is 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 for oral suspension should not be used. 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 amoxicillin and clavulanate potassium for oral suspension.   teratogenic effects : pregnancy category b. reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate potassium for oral suspension (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 for oral suspension. 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 for oral suspension 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 for oral suspension 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 for oral suspension, 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.

Marekani - Kiingereza - NLM (National Library of Medicine)

aurobindo pharma limited - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin anhydrous 200 mg in 5 ml - amoxicillin and clavulanate potassium for oral suspension is 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 for oral suspension should not be used. 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 amoxicillin and clavulanate potassium for oral suspension.   teratogenic effects : pregnancy category b. reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate potassium for oral suspension (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 for oral suspension. 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 for oral suspension 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 for oral suspension 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 for oral suspension, 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.

Marekani - Kiingereza - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanic acid (unii: 23521w1s24) (clavulanic acid - unii:23521w1s24) - amoxicillin anhydrous 200 mg in 5 ml - amoxicillin and clavulanate potassium for oral suspension is 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 for oral suspension should not be used. 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 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 suspension is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium suspension.  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/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/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 has 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 30ml/min). see patients with renal impairment [see dosage and administration (2.4)] for specific recommendations in patients with renal impairment.

Marekani - Kiingereza - NLM (National Library of Medicine)

wg critical care, llc - ampicillin sodium (unii: jfn36l5s8k) (ampicillin - unii:7c782967rd), sulbactam sodium (unii: dkq4t82ye6) (sulbactam - unii:s4tf6i2330) - ampicillin 10 g in 100 ml - ampicillin and sulbactam for injection, usp is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. skin and skin structure infections caused by beta-lactamase producing strains of staphylococcus aureus, escherichia coli,* klebsiella spp.* (including k. pneumoniae* ),proteus mirabilis,* bacteroides fragilis,* enterobacter spp.,* and acinetobacter calcoaceticus.* note: for information on use in pediatric patients see precautions , pediatric use and clinical studies sections. intra-abdominal infections caused by beta-lactamase producing strains of escherichia coli, klebsiella spp. (including k. pneumoniae* ), bacteroides spp. (including b. fragilis ), and enterobacter spp.* gynecological infections caused by beta-lactamase producing strains of escherichia coli,* and bacteroides spp.* (including b. fragilis* ). * efficacy for this organism in this organ system was studied in fewer than 10 infections. while ampicillin and sulbactam for injection, usp is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with ampicillin and sulbactam for injection, usp due to its ampicillin content. therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to ampicillin and sulbactam for injection, usp should not require the addition of another antibacterial. appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to ampicillin and sulbactam for injection, usp. therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies, when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. once the results are known, therapy should be adjusted if appropriate. to reduce the development of drug-resistant bacteria and maintain the effectiveness of ampicillin and sulbactam for injection, usp and other antibacterial drugs, ampicillin and sulbactam for injection, 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. the use of ampicillin and sulbactam for injection is contraindicated in individuals with a history of serious hypersensitivity reactions (e.g., anaphylaxis or stevens-johnson syndrome) to ampicillin, sulbactam or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins). ampicillin and sulbactam for injection is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with ampicillin and sulbactam for injection.

Marekani - Kiingereza - NLM (National Library of Medicine)

sandoz gmbh - ampicillin sodium (unii: jfn36l5s8k) (ampicillin - unii:7c782967rd) - ampicillin 125 mg - ampicillin for injection, usp is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions: respiratory tract infections caused by streptococcus pneumoniae . staphylococcus aureus (penicillinase and nonpenicillinase-producing), h. influenzae, and group a beta-hemolytic streptococci. bacterial meningitis caused by e. coli, group b streptococci, and other gram-negative bacteria (listeria monocytogenes, n. meningitidis ). the addition of an aminoglycoside with ampicillin may increase its effectiveness against gram-negative bacteria. septicemia and endocarditis caused by susceptible gram-positive organisms including streptococcus spp., penicillin g-susceptible staphylococci, and enterococci. gram-negative sepsis caused by e. coli, proteus mirabilis and salmonella spp. responds to ampicillin. endocarditis due to enterococcal strains usually respond to intravenous therapy. the addition of an aminoglycoside may enhance the effectiveness of

Marekani - Kiingereza - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - ampicillin sodium (unii: jfn36l5s8k) (ampicillin - unii:7c782967rd), sulbactam sodium (unii: dkq4t82ye6) (sulbactam - unii:s4tf6i2330) - ampicillin 1 g in 1.5 g - ampicillin and sulbactam for injection, usp is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. skin and skin structure infections caused by beta-lactamase producing strains of staphylococcus aureus, escherichia coli* , klebsiella spp.* (including k. pneumoniae *), proteus mirabilis *, bacteroides fragilis *, enterobacter spp.*, and acinetobacter calcoaceticus *. note: for information on use in pediatric patients see precautions-pediatric use and clinical studies sections. intra-abdominal infections caused by beta-lactamase producing strains of escherichia coli, klebsiella spp. (including k. pneumoniae *), bacteroides spp. (including b. fragilis ), and enterobacter spp.* gynecological infections caused by beta-lactamase producing strains of escherichia coli *,  and bacteroides spp.* (including b. fragilis *). *efficacy for this organism in this organ system was studied in fewer than 10 infections. while ampicillin and sulbactam for injection, usp is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with ampicillin and sulbactam for injection, usp due to its ampicillin content. therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to ampicillin and sulbactam for injection, usp should not require the addition of another antibacterial. appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to ampicillin and sulbactam for injection, usp. therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. once the results are known, therapy should be adjusted if appropriate. to reduce the development of drug-resistant bacteria and maintain effectiveness of ampicillin and sulbactam for injection, usp and other antibacterial drugs, ampicillin and sulbactam for injection, 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. the use of ampicillin and sulbactam for injection is contraindicated in individuals with a history of serious hypersensitivity reactions (e.g., anaphylaxis or stevens-johnson syndrome) to ampicillin, sulbactam or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins). ampicillin and sulbactam for injection is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with ampicillin and sulbactam for injection.

Marekani - Kiingereza - NLM (National Library of Medicine)

eugia us llc - piperacillin sodium (unii: m98t69q7hp) (piperacillin anhydrous - unii:9i628532gx), tazobactam sodium (unii: uxa545abtt) (tazobactam - unii:se10g96m8w) - piperacillin anhydrous 2 g - piperacillin and tazobactam for injection is indicated in adults and pediatric patients (2 months of age and older) for the treatment of appendicitis (complicated by rupture or abscess) and peritonitis caused by beta-lactamase producing isolates of escherichia coli or the following members of the bacteroides fragilis group: b. fragilis , b. ovatus , b. thetaiotaomicron , or b. vulgatus . piperacillin and tazobactam for injection is indicated in adults and pediatric patients (2 months of age and older) for the treatment of nosocomial pneumonia (moderate to severe) caused by beta-lactamase producing isolates of staphylococcus aureus and by piperacillin and tazobactam-susceptible acinetobacter baumannii , haemophilus influenzae , klebsiella pneumoniae , and pseudomonas aeruginosa (nosocomial pneumonia caused by p. aeruginosa should be treated in combination with an aminoglycoside) [see dosage and administration (2)] . piperacillin and tazobactam for injection is indicated in adults for the treatment of uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses and ischemic/diabetic foot infections caused by beta-lactamase producing isolates of staphylococcus aureus . piperacillin and tazobactam for injection is indicated in adults for the treatment of postpartum endometritis or pelvic inflammatory disease caused by beta-lactamase producing isolates of escherichia coli . piperacillin and tazobactam for injection is indicated in adults for the treatment of community-acquired pneumonia (moderate severity only) caused by beta-lactamase producing isolates of haemophilus influenzae . to reduce the development of drug-resistant bacteria and maintain the effectiveness of piperacillin and tazobactam for injection and other antibacterial drugs, piperacillin and tazobactam for injection should be used only to treat or prevent 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. piperacillin and tazobactam for injection is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or beta-lactamase inhibitors. risk summary piperacillin and tazobactam cross the placenta in humans. however, there are insufficient data with piperacillin and/or tazobactam in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. no fetal structural abnormalities were observed in rats or mice when piperacillin and tazobactam was administered intravenously during organogenesis at doses 1 to 2 times and 2 to 3 times the human dose of piperacillin and tazobactam, respectively, based on body-surface area (mg/m2 ). however, fetotoxicity in the presence of maternal toxicity was observed in developmental toxicity and peri/postnatal studies conducted in rats (intraperitoneal administration prior to mating and throughout gestation or from gestation day 17 through lactation day 21) at doses less than the maximum recommended human daily dose based on body-surface area (mg/m2 ) (see data) . the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data in embryo-fetal development studies in mice and rats, pregnant animals received intravenous doses of piperacillin and tazobactam up to 3,000/750 mg/kg/day during the period of organogenesis. there was no evidence of teratogenicity up to the highest dose evaluated, which is 1 to 2 times and 2 to 3 times the human dose of piperacillin and tazobactam, in mice and rats respectively, based on body-surface area (mg/m2 ). fetal body weights were reduced in rats at maternally toxic doses at or above 500/62.5 mg/kg/day, minimally representing 0.4 times the human dose of both piperacillin and tazobactam based on body-surface area (mg/m2 ). a fertility and general reproduction study in rats using intraperitoneal administration of tazobactam or the combination piperacillin and tazobactam prior to mating and through the end of gestation, reported a decrease in litter size in the presence of maternal toxicity at 640 mg/kg/day tazobactam (4 times the human dose of tazobactam based on body-surface area), and decreased litter size and an increase in fetuses with ossification delays and variations of ribs, concurrent with maternal toxicity at ≥640/160 mg/kg/day piperacillin and tazobactam (0.5 times and 1 times the human dose of piperacillin and tazobactam, respectively, based on body-surface area). peri/postnatal development in rats was impaired with reduced pup weights, increased stillbirths, and increased pup mortality concurrent with maternal toxicity after intraperitoneal administration of tazobactam alone at doses ≥320 mg/kg/day (2 times the human dose based on body surface area) or of the combination piperacillin and tazobactam at doses ≥640/160 mg/kg/day (0.5 times and 1 times the human dose of piperacillin and tazobactam, respectively, based on body-surface area) from gestation day 17 through lactation day 21. risk summary piperacillin is excreted in human milk; tazobactam concentrations in human milk have not been studied. no information is available on the effects of piperacillin and tazobactam on the breastfed child or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for piperacillin and tazobactam and any potential adverse effects on the breastfed child from piperacillin and tazobactam or from the underlying maternal condition. the safety and effectiveness of piperacillin and tazobactam for intra-abdominal infections, and nosocomial pneumonia have been established in pediatric patients 2 months of age and older. use of piperacillin and tazobactam in pediatric patients 2 months of age and older with intra-abdominal infections including appendicitis and/or peritonitis is supported by evidence from well-controlled studies and pharmacokinetic studies in adults and in pediatric patients. this includes a prospective, randomized, comparative, open-label clinical trial with 542 pediatric patients 2 to 12 years of age with intra-abdominal infections (including appendicitis and/or peritonitis), in which 273 pediatric patients received piperacillin and tazobactam [see  adverse reactions (6.1) and clinical pharmacology (12.3) ] . use of piperacillin and tazobactam in pediatric patients 2 months of age and older with nosocomial pneumonia is supported by evidence from well-controlled studies in adults with nosocomial pneumonia, a simulation study performed with a population pharmacokinetic model, and a retrospective, cohort study of pediatric patients with nosocomial pneumonia in which 140 pediatric patients were treated with piperacillin and tazobactam and 267 patients treated with comparators (which included ticarcillin-clavulanate, carbapenems, ceftazidime, cefepime, or ciprofloxacin) [see adverse reactions (6.1) and clinical pharmacology (12.3)]. the safety and effectiveness of piperacillin and tazobactam have not been established in pediatric patients less than 2 months of age [see clinical pharmacology (12) and dosage and administration (2)] . dosage of piperacillin and tazobactam in pediatric patients with renal impairment has not been determined. patients over 65 years are not at an increased risk of developing adverse effects solely because of age. however, dosage should be adjusted in the presence of renal impairment [see dosage and administration (2) ] . in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. piperacillin and tazobactam for injection contains 54 mg (2.35 meq) of sodium per gram of piperacillin in the combination product. at the usual recommended doses, patients would receive between 648 and 864 mg/day (28.2 and 37.6 meq) of sodium. the geriatric population may respond with a blunted natriuresis to salt loading. this may be clinically important with regard to such diseases as congestive heart failure. 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. in patients with creatinine clearance ≤ 40 ml/min and dialysis patients (hemodialysis and capd), the intravenous dose of piperacillin and tazobactam for injection should be reduced to the degree of renal function impairment [see dosage and administration (2) ] . dosage adjustment of piperacillin and tazobactam for injection is not warranted in patients with hepatic cirrhosis [see clinical pharmacology (12.3) ] .  as with other semisynthetic penicillins, piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients.