Amoxicillin/​Clavulanic Acid

Amoxicillin/Clavulanate

DEA Class; Rx

Common Brand Names; Augmentin, Augmentin XR, Augmentin ES-600

Indicated for Lower Respiratory Tract Infection β-lactamase−producing strains of Haemophilus influenzae and Moraxella catarrhalis

For the treatment of acute otitis media.

Allergy to penicillins

Previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin/clavulanate

Extended release: Hemodialysis patients and severe renal impairment (CrCl <30 mL/min)

• Diarrhea (3-34%; varies upon dose and regimen)
• Diaper rash (3.5%)
• Mycosis (3.3%)
• Nausea (2-3%)
• Rash (1-3%)
• Vomiting (1-2.2%)
• Loose stool (1.6%)
• Candidiasis (1.4%)
• Vaginitis (1%)
• Hypersensitivity reactions
• Anaphylaxis
• Anemia
• Thrombocytopenia
• Leukopenia
• Agranulocytosis
• Hepatoxicity
• AST/ALT elevation
• Pseudomembranous colitis
• Serum sickness
• Abdominal discomfort
• Cholestatic jaundice
• Flatulence

Allergy to cephalosporins, carbapenems

Different tablets are not interchangeable, because ratios of amoxicillin to clavulanate are different

Extended release tablets not for use in renal impairment (CrCl <30 mL/min)

Incidence of diarrhea is higher than with amoxicillin alone

Unknown safety and efficacy of extended-release tablets in patients <16 years old

Risk of Clostridium difficile-associated diarrhea (CDAD); consider in patients who present with diarrhea after antibiotic use; CDAD has been known to occur over 2 months after antibiotic therapy; if suspected, discontinue drug immediately and administer appropriate fluid/electrolyte therapy, protein supplementation, and C difficile antibiotic treatment

Prescribing treatment in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to patient and increases risk of development of drug-resistant bacteria; risk of bacterial or fungal superinfections; if suspected, discontinue drug immediately and administer appropriate therapy

High percentage of patients with mononucleosis reported to develop rash during therapy; ampicillin-class antibiotics not recommended in these patients

Use caution in hepatic impairment; hypatic dysfunction (rare) is more common in elderly and/or males and prolonged therapy may increase risk; may occur after completing therapy

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions reported; these reactions are more likely to occur in individuals with history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens; before initiating therapy, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens; if allergic reaction occurs, discontinue treatment and institute appropriate therapy

Therapy may cause severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP); if patients develop a skin rash, they should be monitored closely, and discontinued if lesions progress

Reproduction studies in animals (mice and rats at doses up to 10 times the human dose) with orally and parenterally administered drugs have shown no teratogenic effects; in a single study in women with preterm, premature rupture of the fetal membrane (pPROM), it was reported that prophylactic treatment with this drug may be associated with an increased risk of necrotizing enterocolitis in neonates; as with all medications, use should be avoided in pregnancy, unless considered essential by the physician

Ampicillin-class antibiotics are excreted in human milk; therefore caution should be exercised when the drug is administered to a nursing mother; however, the drug may be administered during the period of lactation; with the exception of risk of sensitization, associated with excretion of trace quantities in breast milk, there are no known detrimental effects for the breastfed infant