AUGMENTIN amoxicillin and clavulanate potassium

Get an overview of AUGMENTIN (amoxicillin and clavulanate potassium powder, for suspension), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in AUGMENTIN can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as AUGMENTIN.

Drug Basics

Brand Name: AUGMENTIN

Generic Name: AMOXICILLIN AND CLAVULANATE POTASSIUM

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: POWDER, FOR SUSPENSION

Data Current As Of: 2018-10-05

indications & usage

To reduce the development of drug‑resistant bacteria and maintain the effectiveness of AUGMENTIN (amoxicillin/clavulanate potassium) and other antibacterial drugs, AUGMENTIN 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® 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*:

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 & 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, AUGMENTIN should not be used.

patient counseling information

information for patients

Patients should be informed that AUGMENTIN may be taken every 8 hours or every 12 hours, depending on the dose prescribed.  Each dose should be taken with a meal or snack to reduce the possibility of gastrointestinal upset.

Patients should be counseled that antibacterial drugs, including AUGMENTIN, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When AUGMENTIN is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by AUGMENTIN or other antibacterial drugs in the future.

Counsel patients that diarrhea is a common problem caused by antibacterials, and it usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken their last dose of the antibacterial. If diarrhea is severe or lasts more than 2 or 3 days, patients should contact their physician.

Patients should be advised to keep suspension refrigerated.  Shake well before using.  When dosing a child with the suspension (liquid) of AUGMENTIN, use a dosing spoon or medicine dropper.  Be sure to rinse the spoon or dropper after each use.  Bottles of suspension of AUGMENTIN may contain more liquid than required.  Follow your doctor’s instructions about the amount to use and the days of treatment your child requires.  Discard any unused medicine.

Patients should be aware that AUGMENTIN contains a penicillin class drug product that can cause allergic reactions in some individuals.

AUGMENTIN is a registered trademark of GlaxoSmithKline and is licensed to Dr. Reddy’s Laboratories Inc.

CLINITEST is a registered trademark of Miles, Inc.

Manufactured. By:
Dr. Reddy’s Laboratories Tennessee LLC,
Bristol, TN 37620

Issued: 02/2014

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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