Amoxicillinside effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Anaphylactic reactions Severe Cutaneous Adverse Reactions Drug-Induced Enterocolitis Syndrome (DIES) Hepatic Dysfunction Clostridioides difficile -associated diarrhea (CDAD) Skin Rash in Patients with Mononucleosis The most frequently reported adverse reactions were (incidence >2%) diarrhea, vaginal mycosis, nausea, and loose stools. To report SUSPECTED ADVERSE REACTIONS, contact USAntibiotics, LLC at 1-844-454-5532 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical

Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, 5,643 patients have been treated with Amoxicillin and Clavulanate Potassium Extended Release Tablets. The most frequently reported adverse reactions were diarrhea (15%), vaginal mycosis (3%), nausea (2%), and loose stools (2%). Amoxicillin and Clavulanate Potassium Extended Release Tablets had a higher rate of diarrhea which required corrective therapy (4% versus 3% for Amoxicillin and Clavulanate Potassium Extended Release Tablets and all comparators, respectively). Two percent of patients discontinued therapy due to adverse reactions.

6.2 Postmarketing

Experience The following adverse reactions have been identified during postmarketing use of Amoxicillin and Clavulanate products, including Amoxicillin and Clavulanate Potassium Extended Release Tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal: Drug-induced enterocolitis syndrome (DIES), 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 antibacterial treatment.

Immune: Hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock), angioedema, serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), hypersensitivity vasculitis.

Skin and Appendages: Rashes, pruritus, urticaria, erythema multiforme, SJS, TEN, DRESS, AGEP, exfoliative dermatitis, and linear IgA bullous dermatosis.

Liver: A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted in patients treated with ampicillin-class antibacterials, but the significance of these findings is unknown. Hepatic dysfunction, including hepatitis and cholestatic jaundice,, increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been reported with Amoxicillin and Clavulanate. 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. Deaths have been reported.

Renal: Interstitial nephritis, hematuria, and crystalluria have been reported.

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. There have been reports of increased prothrombin time in patients receiving Amoxicillin and Clavulanate and anticoagulant therapy concomitantly.

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

Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) has been reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.