Indicated in the treatment of infections caused by susceptible strains of the designated organisms 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 and 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.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including AUGMENTIN, and has ranged in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

AUGMENTIN is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with AUGMENTIN.

The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy.

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials, including AUGMENTIN. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens.

Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of AUGMENTIN. Hepatic toxicity is usually reversible; however, deaths have been reported. Hepatic function should be monitored at regular intervals in patients with hepatic impairment.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including AUGMENTIN, and may range in severity from mild diarrhea to fatal colitis.

A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash. Thus, AUGMENTIN should not be administered to patients with mononucleosis.

AUGMENTIN may affect intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives

Co-administration of probenecid is not recommended.

Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently with AUGMENTIN.

The concurrent administration of allopurinol and amoxicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients.

High urine concentrations of amoxicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST, Benedict’s Solution, or Fehling’s Solution. Since this effect may also occur with AUGMENTIN, it is recommended that glucose tests based on enzymatic glucose oxidase reactions be used.

Following administration of amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted.

There are no adequate and well-controlled studies in pregnant women.

Amoxicillin has been shown to be excreted in human milk. Amoxicillin/clavulanate potassium use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin/clavulanate potassium is administered to a nursing woman.

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• Chronic obstructive pulmonary disease. GoToSource

• Helicobacter pylori infection. GoToSource

• Prophylaxis use for dental surgery. GoToSource

• For preterm rupture of membranes. GoToSource

• Septic arthritis. GoToSource

Diarrhea and pseudomembranous colitis. GoToSource

Drug-induced liver injury. GoToSource

Stevens-johnson syndrome (life-threatening skin condition). GoToSource

Generalized exanthematous pustulosis (skin eruption). GoToSource

Kounis syndrome (acute coronary syndrome or myocardial infarction resulting from allergic reaction). GoToSource

Pemphigus (blistering disorder of the skin). GoToSource

Systemic drug-related intertriginous and flexural exanthema (skin rash). GoToSource

Aseptic meningitis. GoToSource

Cholestatic hepatitis. GoToSource

Linear immunoglobulin A bullous dermatosis (autoimmune blistering skin disorder). GoToSource

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