Amoxicilin

Adverse Effects
Frequency Not Defined
Anaphylaxis
Anemia
AST/ALT elevation
Mucocutaneous candidiasis
Diarrhea
Headache
Nausea
Vomiting
Rash
Pseudomembranous colitis
Serum sickness-like reactions
Postmarketing Reports
Mucocutaneous candidiasis
Gastrointestinal (eg, black hairy tongue and hemorrhagic/pseudomembranous colitis, which may
occur during or after treatment)
Hypersensitivity reactions (eg, anaphylaxis, serum sickness–like reactions, erythematous
maculopapular rashes, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis,
toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis,
urticaria)
Moderate increase in AST and/or ALT; hepatic dysfunction (eg, cholestatic jaundice, hepatic
cholestasis and acute cytolytic hepatitis have been reported)
Renal (eg, crystalluria)
Anemia (eg, hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia,
leukopenia, agranulocytosis)
CNS reactions (eg, reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions,
behavioral changes, dizziness)
Tooth discoloration (brown, yellow, or gray staining); may be reduced or eliminated with brushing
or dental cleaning
Pharmacology
Mechanism of Action
Derivative of ampicillin and has similar antibacterial spectrum (certain gram-positive and gram-
negative organisms); similar bactericidal action as penicillin; acts on susceptible bacteria during
multiplication stage by inhibiting cell wall mucopeptide biosynthesis; superior bioavailability and
stability to gastric acid and has broader spectrum of activity than penicillin; less active than
penicillin against Streptococcus pneumococcus; penicillin-resistant strains also resistant to
amoxicillin, but higher doses may be effective; more effective against gram-negative organisms (eg,
N meningitidis, H influenzae) than penicillin
Absorption
Rapidly absorbed
Bioavailability: 74-92%
Peak plasma time: 2hr (capsule); 3.1 hr (extended release tab); 1 hr (suspension)
Distribution
Most body fluids and bone, CSF <1%
Protein bound: 17-20%
Metabolism
Hepatic
Elimination
Excretion: Urine
Half-life: 3.7 hr (full-term neonates); 1-2 hr (infants and children); 0.7-1.4 hr (adults)
Warnings
Contraindications
Documented hypersensitivity to penicillins, cephalosporins, imipenem
Cautions
Anaphylaxis has been reported rarely but is more likely to occur following parenteral therapy with
penicillins
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all
antibacterial agents; severity may range from mild diarrhea to fatal colitis; CDAD may occur over 2
months after discontinuation of therapy; if CDAD is suspected or confirmed, discontinue
immediately and begin appropriate fluid and electrolyte management, protein supplementation,
antibiotic treatment of C difficile, and surgical evaluation
Do not administer in patients with infectious mononucleosis because of risk of development of
erythematous skin rash
Do not administer to patients in the absence of a proven or suspected bacterial infection because of
risk of development of drug-resistant bacteria
Superinfections with bacterial or fungal pathogens may occur during therapy; if suspected,
discontinue immediately and begin appropriate treatment
Chewable tablets contain aspartame, which contains phenylalanine
Use caution in patients with allergy to cephalosporins, carbapenems
Endocarditis prophylaxis: use for only high-risk patients, as per recent AHA guidelines
High doses may cause false urine glucose test by some methods