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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.

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sandoz inc - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9) - amoxicillin anhydrous 250 mg - amoxicillin is indicated in the treatment of infections due to susceptible (only beta-lactamase–negative) isolates of streptococcus species. (α- and β-hemolytic isolates only), streptococcus pneumoniae , staphylococcus spp., or haemophilus influenzae . amoxicillin is indicated in the treatment of infections due to susceptible (only beta-lactamase–negative) isolates of escherichia coli, proteus mirabilis , or enterococcus faecalis . amoxicillin is indicated in the treatment of infections due to susceptible (only beta-lactamase–negative) isolates of streptococcus spp. (α- and β-hemolytic isolates only), staphylococcus spp., or e. coli . amoxicillin is indicated in the treatment of infections due to susceptible (only beta-lactamase–negative) isolates of streptococcus spp. (α- and β-hemolytic isolates only), s. pneumoniae, staphylococcus spp., or h. influenzae . amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with h. pylori inf

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

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ranbaxy pharmaceutical inc. - amoxicillin (unii: 804826j2hu) (amoxicillin - unii:804826j2hu) - capsule - 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 plu

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lake erie medical dba quality care products llc - 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 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: - due to streptococcus species. (α- and β-hemolytic isolates only), streptococcus pneumoniae , staphylococcus spp., or haemophilus influenzae . - due to escherichia coli, proteus mirabilis , or enterococcus faecalis . - due to streptococcus spp. (α- and β-hemolytic isolates only), staphy

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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)

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.

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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)

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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.