Dosing & UsesAdultPediatric Show
Dosage Forms & Strengthsamoxicillin/clavulanate oral suspension
tablet
tablet, extended release
tablet, chewable
Lower Respiratory Tract Infectionβ-lactamase−producing strains of Haemophilus influenzae and Moraxella catarrhalis Mild to moderate: 500/125 mg PO q12hr or 250/125 mg PO q8hr for 10 days Severe: 875/125 mg PO q12hr or 500/125 mg PO q8hr or 2000 mg (2 extended-release tabs) PO q12hr for 7-10 days Chronic Obstructive Pulmonary Disease500 mg PO q8hr Acute Bacterial Sinusitisβ-lactamase−producing strains of H influenzae and M catarrhalis 2000 mg (2 extended-release tablets) PO q12hr for 10 days Animal/Human Bite Wounds875 mg PO q12hr or 500 mg PO q8hr for 3-5 days Erysipelas875 mg PO q12hr or 500 mg PO q8hr for 7-10 days Pyelonephritisβ-lactamase−producing strains of Escherichia coli, Klebsiella spp, and Enterobacter spp 875 mg PO q12hr or 500 mg PO q8hr Skin Abscessβ-lactamase−producing strains of Staphylococcus aureus, E coli, and Klebsiella spp 875 mg PO q12hr Diabetic FootMild to moderate, localized cellulitis 2000 mg (2 extended-release tablets) PO q12hr for 7-14 days Group A Streptococci, Chronic Carrier40 mg/kg/day PO divided q8hr for 10 days; not to exceed 2000 mg/day Dosing ModificationsRenal impairment
Hepatic impairment
AdministrationTake with meals to avoid GI upset Take suspension at start of meal to enhance absorption Dysphagia: May substitute 250 mg/5 mL suspension for 500/125 mg tablet; may substitute 200 mg/5 mL or 400 mg/5 mL suspension for 875/125 mg tablet Dosage Forms & Strengthsamoxicillin/clavulanate oral suspension
tablet
tablet, chewable
<40 kgDosages based on amoxicillin <3 months old
>3 months old
Acute otitis media
Community-acquired PneumoniaMild to moderate infection
H. influenzae
>40 kgDose according to adult recommendations Dosing ConsiderationsBecause of the different amoxicillin-to-clavulanate ratios in the 250-mg tablet (amoxicillin 250 mg, clavulanate125 mg) and the 250-mg chewable tablet (amoxicillin 250 mg, clavulanate 62.5 mg), the 250-mg tablet should not be used if the pediatric patient weighs <40 kg (adverse reaction, including severe diarrhea, may occur due to excessive clavulonic acid in 250-mg tablet Safety and efficacy of extended-release tablets in children <16 years old have not been established Interaction CheckerEnter a drug name and amoxicillin/clavulanate  No Interactions Found Interactions Found ContraindicatedSerious - Use AlternativeSignificant - Monitor CloselyMinorAll Interactions Sort By: Contraindicated (0)Serious - Use Alternative (13)
Monitor Closely (21)
Minor (10)
Adverse Effects>10%Diarrhea (3-34%; varies upon dose and regimen) 1-10%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%) <1%Hypersensitivity reactions Anaphylaxis Anemia Thrombocytopenia Leukopenia Agranulocytosis Hepatoxicity AST/ALT elevation Pseudomembranous colitis Serum sickness Abdominal discomfort Cholestatic jaundice Flatulence Postmarketing ReportsGastrointestinal: Stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis Immune: Anaphylactic/ anaphylactoid reactions (including shock), angioedema, (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 Renal: Interstitial nephritis, crystalluria Central nervous system: Agitation, anxiety, behavioral changes, aseptic meningitis, confusion, convulsions, dizziness, insomnia, and reversible hyperactivity have been reported rarely WarningsContraindicationsAllergy 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) CautionsAllergy 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 Pregnancy & LactationPregnancyReproduction 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 LactationAmpicillin-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 Pregnancy CategoriesA: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. PharmacologyMechanism of ActionAmoxicillin binds to penicillin-binding proteins, thus inhibiting final transpeptidation step of peptidoglycan synthesis in bacterial cell walls; addition of clavulanate inhibits beta-lactamase-producing bacteria, allowing amoxicillin extended spectrum of action It is a semisynthetic antibiotic with a broad spectrum of bactericidal activity, covering both gram-negative and gram-positive microorganisms Not effective against Mycoplasma and Legionella spp AbsorptionPeak plasma time: 2 hr (amoxicillin); 1.1 hr (clavulanic acid) Peak concentration: 8-22 mcg/mL (amoxicillin); 0.8-2.6 mcg/mL (clavulanic acid) AUC: 40-80 mcg•hr/mL (amoxicillin); 2-6 mcg•hr/mL (clavulanic acid) DistributionProtein bound: 18% (amoxicillin); 25% (clavulanic acid) Widely distributed (except CNS) MetabolismPartially metabolized by liver EliminationHalf-life
Excretion: Urine, unchanged; 50-70% (amoxicillin), 25-40% (clavulanic acid) ImagesNo images available for this drug. Patient HandoutA Patient Handout is not currently available for this monograph. FormularyFormularyPatient Discounts Adding plans allows you to compare formulary status to other drugs in the same class. To view formulary information first create a list of plans. Your list will be saved and can be edited at any time. Adding plans allows you to:
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Amoxicillin and clavulanate potassium 62.5 mg dosage
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