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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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nucare pharmaceuticals, inc. - penicillin v potassium (unii: 146t0tu1jb) (penicillin v - unii:z61i075u2w) - penicillin v 500 mg - penicillin v potassium tablets, usp and penicillin v potassium for oral solution, usp, are indicated in the treatment of mild to moderately severe infections due to penicillin g- sensitive microorganisms. therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. note: severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin v during the acute stage. indicated surgical procedures should be performed. the following infections will usually respond to adequate dosage of penicillin v: streptococcal infections (without bacteremia): mild-to-moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. note: streptococci in groups a, c, g, h, l, and m are very sensitive to penicillin. other groups, including group d (enterococcus) are resistant. pneumococcal infections : mild to moderately severe infections of the respiratory tract. staphylococcal infect

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hikma pharmaceuticals usa inc. - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin anhydrous 875 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: reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate potassium tablets (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 tablets. 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 powder 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 powder 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 tablets 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 tablets, 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.

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preferred pharmaceuticals inc. - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin anhydrous 200 mg in 5 ml - 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 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 a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*: caused by beta‑lactamase–producing isolates of haemophilus influenzae and moraxella catarrhalis . caused by beta‑lactamase–producing isolates of h. influenzae and m. catarrhalis . caused by beta‑lactamase–pro

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pd-rx pharmaceuticals, inc. - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin anhydrous 500 mg - amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) 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 en

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roerig - penicillin g potassium (unii: vl775zth4c) (penicillin g - unii:q42t66vg0c) - penicillin g 5000000 [iu] - penicillin g potassium for injection, usp is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below. appropriate culture and susceptibility tests should be done before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to penicillin g. therapy with penicillin g potassium for injection, usp may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the organisms listed below; however, once these results become available, appropriate therapy should be continued. septicemia, empyema, pneumonia, pericarditis, endocarditis, meningitis streptococcus pyogenes (group a β-hemolytic streptococcus), other β-hemolytic streptococci including groups c, h, g, l and m, streptococcus pneumoniae and staphylococcus species (non-penicillinase producing strains) anthrax bacillus anthracis actinomycosis (cervico-facial disease and thoracic and abdominal disease) actinomyces israelii botulism (adjunctive therapy to antitoxin), gas gangrene, and tetanus (adjunctive therapy to human tetanus immune globulin) clostridium species diphtheria (adjunctive therapy to antitoxin and prevention of the carrier state) corynebacterium diphtheriae erysipelothrix endocarditis erysipelothrix rhusiopathiae fusospirochetosis (severe infections of the oropharynx [vincent's], lower respiratory tract and genital area) fusobacterium species and spirochetes listeria infections including meningitis and endocarditis listeria monocytogenes pasteurella infections including bacteremia and meningitis pasteurella multocida haverhill fever streptobacillus moniliformis rat bite fever spirillum minus or streptobacillus moniliformis disseminated gonococcal infections neisseria gonorrhoeae (penicillin-susceptible) syphilis (congenital and neurosyphilis) treponema pallidum meningococcal meningitis and/or septicemia neisseria meningitidis gram-negative bacillary infections (bacteremias) penicillin g is not the drug of choice in the treatment of gram-negative bacillary infections. gram-negative bacillary organisms (i.e . enterobacteriaceae) to reduce the development of drug-resistant bacteria and maintain effectiveness of penicillin g potassium and other antibacterial drugs, penicillin g 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. a history of a hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication.

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lake erie medical dba quality care products llc - penicillin v potassium (unii: 146t0tu1jb) (penicillin v - unii:z61i075u2w) - penicillin v 500 mg - penicillin v potassium tablets, usp and penicillin v potassium for oral solution, usp, are indicated in the treatment of mild to moderately severe infections due to penicillin g- sensitive microorganisms. therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. note: severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin v during the acute stage. indicated surgical procedures should be performed. the following infections will usually respond to adequate dosage of penicillin v: streptococcal infections (without bacteremia): mild-to-moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. note: streptococci in groups a, c, g, h, l, and m are very sensitive to penicillin. other groups, including group d (enterococcus) are resistant. pneumococcal infections : mild to moderately severe infections of the respiratory tract. staphylococcal infections - penicillin g sensi

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par pharmaceutical - penicillin v potassium (unii: 146t0tu1jb) (penicillin v - unii:z61i075u2w) - penicillin v 250 mg - penicillin v potassium tablets, usp and penicillin v potassium for oral solution, usp, are indicated in the treatment of mild to moderately severe infections due to penicillin g- sensitive microorganisms. therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. note: severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin v during the acute stage. indicated surgical procedures should be performed. the following infections will usually respond to adequate dosage of penicillin v: streptococcal infections (without bacteremia): mild-to-moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. note: streptococci in groups a, c, g, h, l, and m are very sensitive to penicillin. other groups, including group d (enterococcus) are resistant. pneumococcal infections : mild to moderately severe infections of the respiratory tract. staphylococcal infections - penicillin g sensi

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golden state medical supply, inc. - penicillin v potassium (unii: 146t0tu1jb) (penicillin v - unii:z61i075u2w) - penicillin v 250 mg - penicillin v potassium tablets, usp and penicillin v potassium for oral solution, usp, are indicated in the treatment of mild to moderately severe infections due to penicillin g- sensitive microorganisms. therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. note: severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin v during the acute stage. indicated surgical procedures should be performed. the following infections will usually respond to adequate dosage of penicillin v: streptococcal infections (without bacteremia): mild-to-moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. note: streptococci in groups a, c, g, h, l, and m are very sensitive to penicillin. other groups, including group d (enterococcus) are resistant. pneumococcal infections : mild to moderately severe infections of the respiratory tract. staphylococcal infect

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blenheim pharmacal, inc. - penicillin v potassium (unii: 146t0tu1jb) (penicillin v - unii:z61i075u2w) - penicillin v 250 mg - penicillin v potassium tablets, usp and penicillin v potassium for oral solution, usp, are indicated in the treatment of mild to moderately severe infections due to penicillin g- sensitive microorganisms. therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. note: severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin v during the acute stage. indicated surgical procedures should be performed. the following infections will usually respond to adequate dosage of penicillin v: streptococcal infections (without bacteremia): mild-to-moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. note: streptococci in groups a, c, g, h, l, and m are very sensitive to penicillin. other groups, including group d (enterococcus) are resistant. pneumococcal infections : mild to moderately severe infections of the respiratory tract. staphylococcal infect