AUGMENTIN 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 AUGMENTIN is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with AUGMENTIN due to its amoxicillin content; therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase–producing organisms susceptible to AUGMENTIN should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and AUGMENTIN. (See Microbiology.)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN and other antibacterial drugs, AUGMENTIN 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.

Bacteriological studies, to determine the causative organisms and their susceptibility to AUGMENTIN, should be performed together with any indicated surgical procedures.

Since both the 250-mg and 500-mg tablets of AUGMENTIN contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250-mg tablets of AUGMENTIN are not equivalent to one 500-mg tablet of AUGMENTIN; therefore, two 250-mg tablets of AUGMENTIN should not be substituted for one 500-mg tablet of AUGMENTIN.

Dosage

Adults: The usual adult dose is one 500-mg tablet of AUGMENTIN every 12hours or one 250-mg tablet of AUGMENTIN every 8hours. For more severe infections and infections of the respiratory tract, the dose should be one 875-mg tablet of AUGMENTIN every 12hours or one 500-mg tablet of AUGMENTIN every 8hours.

Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive the 875-mg tablet. Patients with a glomerular filtration rate of 10 to 30mL/min. should receive 500mg or 250mg every 12hours, depending on the severity of the infection. Patients with a less than 10mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

Hemodialysis patients should receive 500mg or 250mg every 24hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals. (See WARNINGS.)

Pediatric Patients: Pediatric patients weighing 40kg or more should be dosed according to the adult recommendations.

Due to the different amoxicillin to clavulanic acid ratios in the 250-mg tablet of AUGMENTIN (250/125) versus the 250-mg chewable tablet of AUGMENTIN (250/62.5), the 250-mg tablet of AUGMENTIN should not be used until the pediatric patient weighs at least 40 kg or more.

Administration: AUGMENTIN may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when AUGMENTIN is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, AUGMENTIN should be taken at the start of a meal.

AUGMENTIN 250-mg Tablets: Each white oval filmcoated tablet, debossed with AUGMENTIN on 1 side and 250/125 on the other side, contains 250mg amoxicillin as the trihydrate and 125mg clavulanic acid as the potassium salt.

NDC 0029-6075-27..................................bottles of 30
NDC 0029-6075-31..................................Unit Dose (10x10) 100 tablets

AUGMENTIN 500-mg Tablets: Each white oval filmcoated tablet, debossed with AUGMENTIN on 1 side and 500/125 on the other side, contains 500mg amoxicillin as the trihydrate and 125mg clavulanic acid as the potassium salt.

NDC 0029-6080-12..................................bottles of 20
NDC 0029-6080-31..................................Unit Dose (10x10) 100 tablets

AUGMENTIN 875-mg Tablets: Each scored white capsule-shaped tablet, debossed with AUGMENTIN 875 on 1 side and scored on the other side, contains 875mg amoxicillin as the trihydrate and 125mg clavulanic acid as the potassium salt.

NDC 0029-6086-12..................................bottles of 20
NDC 0029-6086-21..................................Unit Dose (10x10) 100 tablets

AUGMENTIN is Also Supplied as:

AUGMENTIN 125 mg/5 mL (125 mg amoxicillin/31.25 mg clavulanic acid) For Oral Suspension:

NDC 0029-6085-39..................................75 mL bottle
NDC 0029-6085-23..................................100 mL bottle
NDC 0029-6085-22..................................150 mL bottle

AUGMENTIN 200 mg/5 mL (200 mg amoxicillin/28.5 mg clavulanic acid) For Oral Suspension:

NDC 0029-6087-29..................................50 mL bottle
NDC 0029-6087-39..................................75 mL bottle
NDC 0029-6087-51..................................100 mL bottle

AUGMENTIN 250 mg/5 mL (250 mg amoxicillin/62.5 mg clavulanic acid) For Oral Suspension:

NDC 0029-6090-39..................................75 mL bottle
NDC 0029-6090-23..................................100 mL bottle
NDC 0029-6090-22..................................150 mL bottle

AUGMENTIN 400 mg/5 mL (400 mg amoxicillin/57 mg clavulanic acid) For Oral Suspension:

NDC 0029-6092-29..................................50 mL bottle
NDC 0029-6092-39..................................75 mL bottle
NDC 0029-6092-51..................................100 mL bottle

AUGMENTIN 125 mg (125 mg amoxicillin/31.25 mg clavulanic acid) Chewable Tablets:

NDC 0029-6073-47 carton of 30 (5x6) tablets

AUGMENTIN 200 mg (200 mg amoxicillin/28.5 mg clavulanic acid) Chewable Tablets:

NDC 0029-6071-12 carton of 20 tablets

AUGMENTIN 250 mg (250 mg amoxicillin/62.5 mg clavulanic acid) Chewable Tablets:

NDC 0029-6074-47 carton of 30 (5x6) tablets

AUGMENTIN 400 mg (400 mg amoxicillin/57.0 mg clavulanic acid) Chewable Tablets:

NDC 0029-6072-12 carton of 20 tablets

Store tablets and dry powder at or below 25°C (77°F). Dispense in original container.

GlaxoSmithKline, Research Triangle Park, NC 27709. December 2006. FDA revision date: 3/26/2008

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