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# Amoxicillin/Clavulanate Potassium (Augmentin) ## Overview Amoxicillin/clavulanate potassium is a combination antibiotic consisting of amoxicillin, a penicillin-class beta-lactam antibiotic, and clavulanate potassium, a beta-lactamase inhibitor. Clavulanate potassium irreversibly binds to and inactivates bacterial beta-lactamase enzymes, thereby protecting amoxicillin from degradation and expanding its spectrum of activity against beta-lactamase-producing bacteria. ## Primary Indications * **Acute bacterial sinusitis:** In patients with signs and symptoms of bacterial sinusitis, and where clinical judgment suggests that the patient is likely to benefit from amoxicillin-clavulanate. * **Acute otitis media:** In pediatric patients (if criteria met) and adults with acute otitis media, particularly in cases thought to be caused by beta-lactamase-producing *Haemophilus influenzae* or *Moraxella catarrhalis*. * **Lower respiratory tract infections:** Such as community-acquired pneumonia (CAP), acute exacerbations of chronic bronchitis. * **Uncomplicated urinary tract infections:** For patients who are unable to take or have failed other appropriate therapy. * **Uncomplicated skin and skin structure infections.** ## Adult Dosing Dosing is based on the amoxicillin component. * **Standard Strength Tablets:** 500 mg amoxicillin/125 mg clavulanate every 8 to 12 hours. * **High-Strength Tablets (875/125):** 875 mg amoxicillin/125 mg clavulanate every 12 hours. * **Oral Suspension:** Dosing varies by concentration, typically dosed every 8 or 12 hours. **Maximum Dose:** Generally, no more than 875 mg of amoxicillin every 12 hours for the high-strength tablets. ## Pediatric Dosing Dosing is weight-based and depends on the severity of infection and formulation. * **Oral Suspension:** Typically dosed in mg/kg/day divided every 8 or 12 hours. * **Mild to Moderate Infections:** 25 mg/kg/day to 45 mg/kg/day. * **Severe Infections:** 45 mg/kg/day to 60 mg/kg/day. * **Chewable Tablets (for children who can chew):** Dosing is tablet-based; consult product labeling for specific mg/kg recommendations for age/weight. **Dosing Limits:** * For infections requiring higher doses (e.g., otitis media, sinusitis, lower respiratory tract infections), the maximum dose should not exceed 45 mg/kg/day (for mild to moderate) or 60 mg/kg/day (for severe) of amoxicillin component, divided every 8 or 12 hours, not to exceed adult maximums. * For the 875 mg/125 mg tablet, pediatric use is generally not recommended due to difficulty in administering appropriate doses. ## Dose Adjustments * **Renal Impairment:** * **CrCl > 30 mL/min:** No dose adjustment needed. * **CrCl 10-30 mL/min:** Standard strength: 500 mg amoxicillin/125 mg clavulanate every 12 hours. High strength: 875 mg amoxicillin/125 mg clavulanate every 24 hours. Oral suspension: Reduce dose frequency as per prescribing information. * **CrCl < 10 mL/min:** Standard strength: 500 mg amoxicillin/125 mg clavulanate every 24 hours. Oral suspension: Reduce dose frequency as per prescribing information. * **Hemodialysis:** Standard strength: 500 mg amoxicillin/125 mg clavulanate every 24 hours, plus 500 mg amoxicillin/125 mg clavulanate after dialysis. Oral suspension: Reduce dose frequency as per prescribing information. ## Contraindications * Hypersensitivity to amoxicillin, clavulanate potassium, penicillins, or components. * History of cholestatic jaundice or hepatic dysfunction associated with amoxicillin/clavulanate use. ## Adverse Effects * **Common:** Diarrhea, nausea, vomiting, rash, yeast infections (vaginal and oral). * **Serious:** *Clostridioides difficile*-associated diarrhea (CDAD), hypersensitivity reactions (including anaphylaxis, Stevens-Johnson syndrome), liver toxicity (hepatitis, cholestatic jaundice), seizures (especially with high doses or renal impairment). ## Key Drug Interactions * **Probenecid:** May increase and prolong amoxicillin serum levels by decreasing renal tubular secretion. * **Oral Contraceptives:** May decrease the efficacy of oral contraceptives. Advise patients to use an alternative non-hormonal method of contraception. * **Warfarin:** May increase INR and risk of bleeding. Monitor INR closely. * **Allopurinol:** May increase the incidence of rash. ## Monitoring * **Renal function:** Assess periodically, especially in patients with known renal impairment. * **Liver function:** Monitor for signs and symptoms of hepatic dysfunction. * **Signs of Superinfection:** Monitor for development of fungal or bacterial superinfections. * **Prothrombin time/INR:** If co-administered with warfarin. * **Diarrhea:** Assess for *Clostridioides difficile* infection. ## Clinical Pearls * Amoxicillin/clavulanate is available in various formulations (tablets, chewable tablets, powder for oral suspension) and strengths. Ensure correct formulation and strength are selected based on indication, patient age, weight, and renal function. * Dosing is based on the amoxicillin component. Clavulanate is added to increase stability against beta-lactamase. * Diarrhea is a common side effect. While often mild, patients should be advised to report severe or persistent diarrhea, which could indicate *C. difficile* infection. * Reconstitute oral suspension with the amount of water specified on the label and shake well before each use. Store reconstituted suspension in the refrigerator and discard after the specified period (usually 10 days). * Always advise patients to complete the full course of therapy even if they feel better, unless directed otherwise by a healthcare provider. *** **Disclaimer:** This information is intended for healthcare professionals and is not a substitute for professional medical advice. Always consult the current prescribing information and relevant clinical guidelines for complete and up-to-date details before making any treatment decisions.