amoxicillin as amoxicillin trihydrate 875 MG clavulanic acid as clavulanate potassium 125 MG Oral Tablet
1 INDICATIONS AND 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 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*: Amoxicillin and Clavulanate Potassium is a combination penicillin-class antibacterial and beta‑lactamase inhibitor indicated for treatment of the following: Lower respiratory tract infections (1.1) Acute bacterial otitis media (1.2) Sinusitis (1.3) Skin and skin structure infections (1.4) Urinary tract infections (1.5) 1.1 Lower Respiratory Tract Infections caused by beta‑lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis . 1.2 Acute Bacterial Otitis Media caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis . 1.3 Sinusitis caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis . 1.4 Skin and Skin Structure Infections caused by beta‑lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species. 1.5 Urinary Tract Infections caused by beta‑lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species . 1.6 Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, Amoxicillin and Clavulanate Potassium should not be used.
Dr. Reddy's Laboratories Inc
OVAL WHITE AUGMENTIN 875
AUGMENTIN 875 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING Tablets: 250‑mg/125-mg Tablets: Each white oval film-coated tablet, debossed with AUGMENTIN on one side and 250/125 on the other side, contains 250mg amoxicillin as the trihydrate and 125mg clavulanic acid as the potassium salt. NDC 43598-218-30 bottles of 30 NDC 43598-218-78 Unit Dose (10x10) 100 tablets 500‑mg/125-mg Tablets: Each white oval film-coated tablet, debossed with AUGMENTIN on one side and 500/125 on the other side, contains 500mg amoxicillin as the trihydrate and 125mg clavulanic acid as the potassium salt. NDC 43598-206-14 bottles of 20 NDC 43598-206-78 Unit Dose (10x10) 100 tablets 875‑mg/125-mg Tablets: Each scored white capsule‑shaped tablet, debossed with AUGMENTIN 875 on one side and scored on the other side, contains 875mg amoxicillin as the trihydrate and 125mg clavulanic acid as the potassium salt. NDC 43598-221-14 bottles of 20 NDC 43598-221-78 Unit Dose (10x10) 100 tablets Powder for Oral Suspension: 125 mg/31.25 mg per 5 mL: Banana-flavored powder for oral suspension (each 5 mL of reconstituted suspension contains 125 mg amoxicillin and 31.25 mg of clavulanic acid as the potassium salt). NDC 43598-212-51 75 mL bottle NDC 43598-212-52 100 mL bottle NDC 43598-212-53 150 mL bottle 200 mg/28.5 mg per 5 mL: orange-favored powder for oral suspension (each 5 mL of reconstituted suspension contains 200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt). NDC 43598-213-50 50 mL bottle NDC 43598-213-51 75 mL bottle NDC 43598-213-52 100 mL bottle 250 mg/62.5 mg per 5 mL: orange-flavored powder for oral suspension (each 5 mL of reconstituted suspension contains 250 mg amoxicillin and 62.5 mg of clavulanic acid as the potassium salt). NDC 43598-204-51 75 mL bottle NDC 43598-204-52 100 mL bottle NDC 43598-204-53 150 mL bottle 400 mg/57 mg per 5 mL: orange-flavored powder for oral suspension (each 5 mL of reconstituted suspension contains 400 mg amoxicillin and 57.0 mg of clavulanic acid as the potassium salt). NDC 43598-208-50 50 mL bottle NDC 43598-208-51 75 mL bottle NDC 43598-208-52 100 mL bottle Chewable Tablets: 125-mg/31.25-mg Chewable Tablets: Each mottled yellow, round, lemon-lime-flavored tablet, debossed with BMP 189, contains 125 mg amoxicillin and 31.25 mg clavulanic acid as the potassium salt. NDC 43598-214-31 carton of 30 tablets 200-mg/28.5 mg Chewable Tablets: Each mottled pink, round, biconvex, cherry-banana-flavored tablet, debossed with PL over C20, contains 200 mg amoxicillin and 28.5 mg clavulanic acid as the potassium salt. NDC 43598-215-14 carton of 20 tablets 250-mg/62.5-mg Chewable Tablets: Each mottled yellow, round, lemon-lime-flavored tablet, debossed with BMP 190, contains 250 mg amoxicillin and 62.5 mg clavulanic acid as the potassium salt. NDC 43598-216-31 carton of 30 tablets 400-mg/57-mg Chewable Tablets: Each mottled pink, round, biconvex, cherry-banana-flavored tablet, debossed with PL over C40, contains 400 mg amoxicillin and 57.0 mg clavulanic acid as the potassium salt. NDC 43598-217-14 carton of 20 tablets Dispense in original container. Store tablets and dry powder at or below 25°C (77°F). Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Keep out of the reach of children.
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