Augmentin ES Side Effects, and Drug Interactions - Amoxicillin and Clavulanate

Augmentin ES Side Effects, and Drug Interactions - Amoxicillin and Clavulanate

SIDE EFFECTS

Augmentin ES-600 is generally well tolerated. The majority of side effects observed in pediatric clinical trials of acute otitis media were either mild or moderate, and transient in nature; 4.4% of patients discontinued therapy because of drug-related side effects. The most commonly reported side effects with probable or suspected relationship to Augmentin ES-600 were contact dermatitis, i.e., diaper rash (3.5%), diarrhea (2.9%), vomiting (2.2%), moniliasis (1.4%), and rash (1.1%). The most common adverse experiences leading to withdrawal that were of probable or suspected relationship to Augmentin ES-600 were diarrhea (2.5%) and vomiting (1.4%).

The following adverse reactions have been reported for ampicillin class antibiotics:

Gastrointestinal:   Diarrhea, nausea, vomiting, indigestion, gastritis, stomatitis, glossitis, black "hairy" tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. (See WARNINGS .)

Hypersensitivity Reactions:    Skin rashes, pruritus, urticaria, angioedema, serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia and frequently fever), erythema multiforme (rarely Stevens-Johnson Syndrome), acute generalized exanthematous pustulosis and an occasional case of exfoliative dermatitis (including toxic epidermal necrolysis) have been reported. These reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, the drug should be discontinued, unless the opinion of the physician dictates otherwise. Serious and occasional fatal hypersensitivity (anaphylactic) reactions can occur with oral penicillin. (See WARNINGS.)

Liver:   A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted in patients treated with ampicillin class antibiotics but the significance of these findings is unknown. Hepatic dysfunction, including increases in serum transaminases (AST and/or ALT), serum bilirubin and/or alkaline phosphatase, has been infrequently reported with Augmentin . It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment. The histologic findings on liver biopsy have consisted of predominantly cholestatic, hepatocellular, or mixed cholestatic-hepatocellular changes. The onset of signs/symptoms of hepatic dysfunction may occur during or several weeks after therapy has been discontinued. The hepatic dysfunction, which may be severe, is usually reversible. On rare occasions, deaths have been reported (less than 1 death reported per estimated 4 million prescriptions worldwide). These have generally been cases associated with serious underlying diseases or concomitant medications.

Renal:   Interstitial nephritis and hematuria have been reported rarely.

Hemic and Lymphatic Systems:   Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. A slight thrombocytosis was noted in less than 1% of the patients treated with Augmentin . There have been reports of increased prothrombin time in patients receiving Augmentin and anticoagulant therapy concomitantly.

Central Nervous System:   Agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, insomnia, and reversible hyperactivity have been reported rarely.

Miscellaneous:   Tooth discoloration has been reported very rarely in children. Good oral hygiene may help to prevent tooth discoloration as it can usually be removed by brushing.

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with Augmentin ES-600 may result in increased and prolonged blood levels of amoxicillin. Co-administration of probenecid cannot be recommended.

The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients. There are no data with Augmentin ES-600 and allopurinol administered concurrently.

In common with other broad-spectrum antibiotics, amoxicillin/clavulanate may reduce the efficacy of oral contraceptives.