augmentin xr amoxicillin and clavulanate potassium tablet film coated extended release
1 INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN XR and other antibacterial drugs, AUGMENTIN XR 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. AUGMENTIN XR Extended Release Tablets are indicated for the treatment of patients with community-acquired pneumonia or acute bacterial sinusitis due to confirmed, or suspected β-lactamase–producing pathogens (i.e., H. influenzae, M. catarrhalis, H. parainfluenzae, K. pneumoniae, or methicillin-susceptible S. aureus ) and S. pneumoniae with reduced susceptibility to penicillin (i.e., penicillin MICs = 2 mcg/mL). AUGMENTIN XR is not indicated for the treatment of infections due to S. pneumoniae with penicillin MICs ≥ 4 mcg/mL. Data are limited with regard to infections due to S. pneumoniae with penicillin MICs ≥ 4 mcg/ml [see Clinical Studies (14) ]. In patients with community-acquired pneumonia in whom penicillin-resistant S. pneumoniae is suspected, bacteriological studies should be performed to determine the causative organisms and their susceptibility when AUGMENTIN XR is prescribed. Acute bacterial sinusitis or community-acquired pneumonia due to a penicillin-susceptible strain of S. pneumoniae plus a β-lactamase–producing pathogen can be treated with another AUGMENTIN ® (amoxicillin/clavulanate potassium) product containing lower daily doses of amoxicillin (i.e., 500 mg every 8 hours or 875 mg every 12 hours). Acute bacterial sinusitis or community-acquired pneumonia due to S. pneumoniae alone can be treated with amoxicillin. AUGMENTIN XR Extended Release Tablets are a combination of a penicillin-class antibacterial drug and a beta-lactamase inhibitor indicated for treatment of community-acquired pneumonia and acute bacterial sinusitis.
dr reddys laboratories inc
OVAL WHITE Augmentin XR
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16 HOW SUPPLIED/STORAGE AND HANDLING AUGMENTIN XR Extended Release Tablets : Each white, oval film‑coated bilayer scored tablet, debossed with AUGMENTIN XR, contains amoxicillin trihydrate and amoxicillin sodium equivalent to a total of 1,000 mg of amoxicillin and clavulanate potassium equivalent to 62.5 mg of clavulanic acid. NDC 43598‑020‑28 Bottles of 28 (7 day XR pack) NDC 43598‑020‑40 Bottles of 40 (10 day XR pack) Storage Dispense in original container. Store tablets at or below 25°C (77°F). Keep out of reach of children.
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