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

neopharma inc - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin and clavulanate potassium 600mg/42.9mg per 5 ml powder for oral suspension is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to s. pneumoniae (penicillin mics ≤ 2 mcg/ml), h. influenzae (including β‑lactamase – producing strains), or m. catarrhalis (including β‑lactamase-producing strains) characterized by the following risk factors: - antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following: -       age ≤ 2 years -       daycare attendance [see clinical pharmacology, microbiology ( 12.4)]             note: acute otitis media due to s. pneumoniae alone can be treated with amoxicillin. amoxicillin and clavulanate potassium 600mg/42.9mg per 5 ml powder for oral suspension is not indicated for the treatment of acute otitis media due to s. pneumoniae with penicillin mic ≥ 4 mcg/ml. therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to bel

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

asclemed usa, inc. - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9) - 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

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sandoz inc - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin and clavulanate potassium 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: limitations of use when susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium should not be used. usage to reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium 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 is con

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

aurobindo pharma limited - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9) - adults and pediatric patients - upper respiratory tract infections of the ear, nose, and throat:   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 . - infections of the genitourinary tract:   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 . - infections of the skin and skin structure: 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 . - infections of the lower respiratory tract: 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 . adult patients only - helicobacter pylori infection and duodenal ulcer disease: triple therapy for helicobacter pylori ( h. pylori)   with clarithromycin and   lansoprazole :   amoxicillin for oral suspension, 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 for oral suspension, 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 for oral suspension and other antibacterial drugs, amoxicillin for oral suspension 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 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 antibacterial drugs (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. 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.

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

proficient rx lp - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9) - 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: 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), staphylococcus spp., or e. coli . due to streptococcus spp. (α- and β-hemolytic isolates only), s. pneumoniae, staphylococcus spp., or h. influenzae . 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. 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. 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). 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. 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 dosage and administration (2.4) for specific recommendations in patients with renal impairment.

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

pd-rx pharmaceuticals, inc. - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9) - 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.

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

pd-rx pharmaceuticals, inc. - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9) - adults and pediatric patients - upper respiratory tract infections of the ear, nose, and throat:   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 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 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

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

pd-rx pharmaceuticals, inc. - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9) - 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 capsules are 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

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

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

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

asclemed usa, inc. - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9) - adults and pediatric patients - upper respiratory tract infections of the ear, nose, and throat: 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 capsules 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 capsules 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