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

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.

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

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

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

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

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

rebel distributors corp - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin anhydrous 400 mg in 5 ml - amoxicillin and clavulanate potassium is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: lower respiratory tract infections − caused by β-lactamase−producing strains of h. influenzae and m. catarrhalis . otitis media − caused by β-lactamase−producing strains of h. influenzae and m. catarrhalis . sinusitis − caused by β-lactamase−producing strains of h. influenzae and m. catarrhalis . skin and skin structure infections − caused by β-lactamase−producing strains of s. aureus , e. coli , and klebsiella spp. urinary tract infections − caused by β-lactamase−producing strains of e. coli , klebsiella spp. and enterobacter spp. while amoxicillin and clavulanate potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with amoxicillin and clavulanate potassium due to its amoxicillin content. therefore, mixed infections caused by ampicilli

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

physicians total care, inc. - amoxicillin (unii: 804826j2hu) (amoxicillin - unii:804826j2hu), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin 400 mg - amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: lower respiratory tract infections - caused by β-lactamase-producing strains of h. influenzae and m. catarrhalis . otitis media - caused by β-lactamase-producing strains of h. influenzae and m. catarrhalis . sinusitis - caused by β-lactamase-producing strains of h. influenzae and m. catarrhalis . skin and skin structure infections - caused by β-lactamase-producing strains of s. aureus , e. coli , and klebsiella spp. urinary tract infections - caused by β-lactamase-producing strains of e. coli , klebsiella spp. and enterobacter spp. while amoxicillin and clavulanate potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with amoxicillin and clavulanate

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

nucare 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‑lacta

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

pd-rx pharmaceuticals, 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, 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

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - amoxicillin trihydrate, quantity: 1005 mg (equivalent: amoxicillin, qty 875 mg); potassium clavulanate, quantity: 149 mg (equivalent: clavulanic acid, qty 125 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; magnesium stearate; purified talc; povidone; silicon dioxide; triethyl citrate; hypromellose; titanium dioxide; ethylcellulose; cetyl alcohol; sodium lauryl sulfate - short-term treatment of bacterial infection at the following sites when caused by amoxycillin/clavulanic acid sensitive, beta-lactamase producing organisms. skin and skin structure infections. urinary tract infections (uncomplicated and complicated). upper respiratory tract infections, such as sinusitis, otitis media and recurrent tonsillitis. lower respiratory tract infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis. appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to curam tablets. however, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed in the microbiological section, therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies. once these results are known, therapy should be adjusted if appropriate. the treatment of mixed infections caused by amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to curam tablets should not require the addition of another antibiotic due to the amoxycillin content of curam tablets.

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - clavulanic acid, amoxicillin - powder for solution for infusion or injection - clavulanic acid 200 mg amoxicillin 1000 mg - antibacterials for systemic use

Kenya - English - Pharmacy and Poisons Board

medicef pharma c/o medox pharmaceuticals ltd p.o. box 52771-00200, nairobi - amoxicillin and clavulanic acid - dispersible tablet - amoxicillin 200 mg clavulanic acid 28.5 mg - amoxicillin and enzyme inhibitor