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Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Pulmonary/Respiratory Diseases | Family Medicine | Infections and Infectious Diseases | Vaccines

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Augmentin (amoxicillin/clavulanate)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: SmithKline Beecham
Approval Status: Approved February 1996
Treatment Area: sinusitis, bronchitis, pneumonia

General Information

A new adult dosing regimen of Augmentin has been approved. Augmentin is an antibiotic used to treat various respiratory-tract infections, including sinusitis, bronchitis, and pneumonia.

In the new regimen, Augmentin is administered twice a day (BID), every 12 hours, in contrast to three-times-a-day regimen used since Augmentin was introduced in the United States.

The BID regimen for more severe infections and infections of the respiratory tract consists of a new tablet containing 875 mg of amoxicillin and 125 mg of clavulanate potassium. In addition, the currently marketed tablet containing 500 mg of amoxicillin and 125 mg of clavulanate potassium can now be prescribed on a twice-a-day regimen for less severe infections that may be treated with a lower dose.

Augmentin should not be used in subjects with a history of allergic reactions to any penicillin or with a previous history of Augmentin-associated cholestatic jaundice/hepatic dysfunction.

Side Effects

The side effects of Augmentin, which are primarily mild and self-limiting, include diarrhea and nausea. In adult subjects treated for more severe infections during clinical trials, there was a 60% reduction in the number of subjects experiencing severe diarrhea or withdrawing from trials because of diarrhea.