WARNINGS AND PRECAUTIONS

• Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. Careful inquiry should be made concerning previous hypersensitivity to penicillins, cephalosporins, or other drugs before initiating therapy with Co-amoxiclav. Serious anaphylactoid reactions require immediate emergency treatment with epinephrine. Oxygen, IV steroids, and airway management, including intubation, should also be instituted.

• CDAD and colitis have been reported with nearly all antibacterial agents, and may range in severity from mild to life threatening. It is important to consider this diagnosis in patients who present with diarrhea following administration of antibacterial agents.

• Since hepatic toxicity has been associated with Co-amoxiclav therapy, the drug should be used with caution in patients with evidence of hepatic dysfunction.

• In patients with renal impairment, the dose of Co-amoxiclav should be adjusted based on the degree of impairment [see Dosage and Administration].

• During administration of high doses of amoxicillin, it is recommended to maintain adequate fluid intake and urinary output in order to reduce the possibility of crystalluria associated with amoxicillin therapy.

• Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly with Co-amoxiclav since prolongation of prothrombin time has been reported rarely in patients receiving Co-amoxiclav.

• Although Co-amoxiclav has a low toxicity profile, the renal, hepatic, and hematopoietic status of patients undergoing prolonged treatment with the drug should be evaluated periodically.

• As with other antibacterial drugs, long term or repeated use may result in overgrowth of non-susceptible organisms, including fungi.