Cautions
Contraindications
Warnings/Precautions
Warnings
Superinfection/Clostridium difficile-associated Colitis
Possible emergence and overgrowth of nonsusceptible bacteria or fungi. Discontinue and institute appropriate therapy if superinfection occurs.
Treatment with anti-infectives may permit overgrowth of clostridia. Consider Clostridium difficile-associated diarrhea and colitis (antibiotic-associated pseudomembranous colitis) if diarrhea develops and manage accordingly.
Some mild cases of C. difficile-associated diarrhea and colitis may respond to discontinuance alone. Manage moderate to severe cases with fluid, electrolyte, and protein supplementation; appropriate anti-infective therapy (e.g., oral metronidazole or vancomycin) recommended if colitis is severe.
Sensitivity Reactions
Hypersensitivity Reactions
Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis, reported with penicillins.
Prior to initiation of therapy, make careful inquiry regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other drugs. Partial cross-allergenicity occurs among penicillins and other β-lactam antibiotics including cephalosporins and cephamycins.
If a severe hypersensitivity reaction occurs, discontinue immediately and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway and oxygen).
General Precautions
Selection and Use of Anti-infectives
To reduce development of drug-resistant bacteria and maintain effectiveness of amoxicillin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.
When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing. In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.
Hepatic Effects
Moderate increases in serum AST and/or ALT reported.
Hepatic dysfunction, including cholestatic jaundice, hepatic cholestasis, and acute cytolytic hepatitis reported.
Assess hepatic function periodically during prolonged therapy.
Renal Effects
Assess renal function periodically during prolonged therapy.
Hematologic Effects
Adverse hematologic effects (e.g., anemia, hemolytic anemia, leukopenia, agranulocytosis, thrombocytopenia, thrombocytopenic purpura) reported with penicillins. Usually reversible when drug discontinued; may be a hypersensitivity reaction.
Assess hematologic function periodically during prolonged therapy.
Mononucleosis
Possible increased risk of rash in patients with mononucleosis; use in these patients not recommended.
Phenylketonuria
200- and 400-mg chewable tablets contain aspartame (NutraSweet®), which is metabolized in the GI tract to provide 1.82 or 3.64 mg of phenylalanine, respectively.
Oral suspensions do not contain aspartame and can be used in individuals with phenylketonuria (i.e., homozygous genetic deficiency of phenylalanine hydroxylase) and other individuals who must restrict their intake of phenylalanine.
Use of Fixed Combination
When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.
Specific Populations
Pregnancy
Category B.
Recommended as an alternative for various indications in pregnant women (e.g., treatment of chlamydial infections†, treatment of Lyme disease†, postexposure prophylaxis or treatment of anthrax†).
Lactation
Distributed into milk; use with caution.
Use in a breast-feeding woman may result in sensitization of infants.
Recommended as an alternative for postexposure prophylaxis or treatment of anthrax† in women who are breast-feeding.
Pediatric Use
Renal clearance of amoxicillin may be delayed in neonates and young infants because of incompletely developed renal function.
Neonates and infants ≤12 weeks (3 months) of age should receive no more than 30 mg/kg daily given in divided doses every 12 hours.
Tooth discoloration (brown, yellow, gray) reported rarely, most frequently in pediatric patients. Brushing or dental cleaning reduces or eliminates discoloration in most cases.
Geriatric Use
Renal clearance may be decreased.
Hepatic Impairment
Assess hepatic function periodically during prolonged therapy.
Renal Impairment
Assess renal function periodically during prolonged therapy.
Dosage adjustments necessary in severe renal impairment.
Common Adverse Effects
Adverse GI effects (e.g., nausea, vomiting, diarrhea), hypersensitivity reactions (e.g., rash).
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