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