FDA
Augmentin '400'
The FDA lists this product in 2 strengths and forms.
Indications
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)
1.1Lower Respiratory Tract
Infections caused by beta‑lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis .
1.2Acute 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 .
1.4Skin and Skin Structure
Infections caused by beta‑lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.
1.5Urinary Tract
Infections caused by beta‑lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species .
1.6Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, Amoxicillin and Clavulanate Potassium should not be used.
At a glance
- Brand name
- Augmentin '400'
- Active substance
- amoxicillin
- Route
- Oral
- Dosage form
- For suspension
- Applicant
- US Antibiotics
- Status
- Discontinued
- FDA approval
- 31 May 1996
- Application
- NDA050725-002



