Pharmacologic Category
Dosing: Adult
Note: Dose is based on the amoxicillin component. Dose and frequency are product specific; not all products are interchangeable. For adults who have difficulty swallowing the tablets, the 125 mg/5 mL or 250 mg/5 mL suspension (in appropriate amounts) may be given in place of the 500 mg tablet; the 200 mg/5 mL or 400 mg/5 mL suspension (in appropriate amounts) may be given in place of the 875 mg tablet.
Usual dosing range: Oral: Immediate release: 500 mg every 8 to 12 hours or 875 mg every 12 hours; Extended release: 2 g every 12 hours.
Bite wound, prophylaxis or treatment (animal or human bite) (off-label use): Oral: Immediate release: 875 mg every 12 hours (IDSA [Stevens 2014]). Note: For prophylaxis, duration is 3 to 5 days (IDSA [Stevens 2014]); for treatment of established infection, duration is typically 5 to 14 days and varies based on clinical response and patient-specific factors (Baddour 2019a; Baddour 2019b).
Chronic obstructive pulmonary disease, acute exacerbation (off-label use): Note: Some experts reserve for patients with risk factors for poor outcomes (eg, age ≥65 years, FEV1 <50% predicted, frequent exacerbations, major comorbidities), but low risk of Pseudomonas infection (Sethi 2020).
Oral: Immediate release: 500 mg every 8 hours or 875 mg every 12 hours for 3 to 7 days (GOLD 2020; Llor 2012; Sethi 2020; Wilson 2012).
Diabetic foot infection (off-label use): Note: May be used alone for mild infections or after clinical response to parenteral therapy in patients without risk factors or concern for infection caused by Pseudomonas aeruginosa (IDSA [Lipsky 2012]; Weintrob 2018).
Oral: Immediate release: 875 mg every 12 hours (IDSA [Lipsky 2012]; Lipsky 2004; Weintrob 2018). Duration of therapy should be tailored to individual clinical circumstances; most patients with infection limited to skin and soft tissue respond to 1 to 2 weeks of therapy (IDSA [Lipsky 2012]; Weintrob 2018).
Intra-abdominal infection (off-label use):
Diverticulitis, acute (for uncomplicated infection that meets criteria for outpatient therapy or as step-down therapy after clinical improvement on initial parenteral therapy): Oral:
Immediate release: 875 mg every 8 hours (Biondo 2014; Mora Lopez 2013).
Extended release: 2 g every 12 hours (Pemberton 2018).
Other intra-abdominal infection, step-down therapy (when clinically improved and able to tolerate oral therapy): Oral: Immediate release: 875 mg 2 to 3 times daily (Barshak 2018; Lucasti 2008; SIS [Mazuski 2017]; SIS/IDSA [Solomkin 2010]).
Duration of therapy is for 4 to 7 days following adequate source control (SIS/IDSA [Solomkin 2010]); for uncomplicated appendicitis and diverticulitis managed nonoperatively, a longer duration is necessary (Barshak 2018; Pemberton 2018).
Neutropenic fever, low-risk cancer patients (empiric therapy) (off-label use): Oral: Immediate release: 500 mg every 8 hours (Freifeld 1999; Kern 1999) or 1 g every 12 hours (Kern 2013). Combine either dosing regimen with oral ciprofloxacin; continue until resolution of fever and neutropenia. Note: Avoid in patients who have received fluoroquinolone prophylaxis. Administer first dose in the health care setting (after blood cultures are drawn); observe patient for ≥4 hours before discharge (ASCO/IDSA [Taplitz 2018]; IDSA [Freifeld 2011]).
Odontogenic infection (initial therapy for mild infection or step-down therapy after parenteral treatment) (off-label use): Oral: Immediate release: 875 mg twice daily (Tancawan 2015); continue to complete a total of 7 to 14 days of therapy (Chow 2019).
Otitis media, acute: Oral:
Immediate release: 875 mg twice daily (Mira 2001) or 500 mg every 8 hours (WHO 2001).
Extended release: 1 or 2 g twice daily, based on weight and severity of infection; some experts prefer the extended release formulation for patients at high risk of severe infection or resistant S. pneumoniae (Limb 2019).
Duration: 5 to 7 days for mild to moderate infection and 10 days for severe infection (Limb 2019).
Peritonsillar cellulitis or abscess (off-label-use): Note: For step-down therapy after parenteral treatment. Limited data available; dosing based on expert opinion. Reserve for use in regions where Staphylococcus aureus remains susceptible to methicillin or based upon susceptibility results of isolated pathogens, if available. Oral: Immediate release: 875 mg every 12 hours to complete a total of 14 days of therapy (Wald 2018).
Pneumonia:
Aspiration pneumonia (community acquired [mild]): Oral:
Immediate release: 875 mg twice daily (Bartlett 2019).
Extended release: 2 g twice daily (Bartlett 2019).
Duration of therapy: Generally 7 days (Bartlett 2019).
Community acquired, outpatient empiric therapy (patients with comorbidities): Oral:
Immediate release: 500 mg 3 times daily or 875 mg twice daily as part of an appropriate combination regimen (ATS/IDSA [Metlay 2019]).
Extended release: 2 g twice daily as part of an appropriate combination regimen (ATS/IDSA [Metlay 2019]).
Duration of therapy: Minimum of 5 days; patients should be clinically stable with normal vital signs before therapy is discontinued (ATS/IDSA [Metlay 2019]).
Rhinosinusitis, acute bacterial: Note: In uncomplicated acute bacterial rhinosinusitis, initial observation and symptom management without antibiotic therapy is appropriate in most patients (AAO-HNS [Rosenfeld 2015]; Harris 2016).
Standard dose: Oral: Immediate release: 500 mg every 8 hours or 875 mg every 12 hours for 5 to 7 days (IDSA [Chow 2012])
High dose: Oral: Extended release: 2 g every 12 hours. Note: Recommended for patients at risk for poor outcome or pneumococcal resistance based on the following features: age ≥65 years, recent hospitalization, antibiotic use within the past month, immunocompromise, residence in a region with high rates of penicillin-resistant S. pneumoniae, or failure to respond to initial treatment (AAO-HNS [Rosenfeld 2015]; IDSA [Chow 2012]). For initial therapy, the duration is 5 to 7 days; for patients who have failed initial therapy and require re-treatment, the duration is 7 to 10 days (Patel 2018).
Streptococcus (group A), chronic carriage (off-label use): Oral: Immediate release: 40 mg/kg/day in divided doses (eg, 875 mg every 12 hours) (maximum: 2 g/day) for 10 days (IDSA [Shulman 2012]; Mahakit 2006). Note: Most individuals with chronic carriage do not require antibiotics (IDSA [Shulman 2012]).
Urinary tract infection (UTI) (alternative agent): Note: Although evidence is limited, some experts recommend the use of amoxicillin/clavulanate in this setting. Use with caution and only when first-line agents cannot be used (due to decreased efficacy of oral beta-lactams compared to other agents) (ESCMID/IDSA [Gupta 2011]; Hooton 2018a). Closely monitor patient.
Acute uncomplicated cystitis or acute simple cystitis (infection limited to bladder and no signs/symptoms of upper tract or systemic infection): Oral: Immediate release: 500 mg twice daily (Hooton 2005) for 5 to 7 days (ESCMID/IDSA [Gupta 2011]; Hooton 2018a).
Complicated UTI (including pyelonephritis): Oral: Immediate release: 875 mg twice daily for 10 to 14 days (ESCMID/IDSA [Gupta 2011]; Johnson 2018). Note: Oral therapy should follow appropriate parenteral therapy. For outpatient treatment of mild infection, a single dose of a long-acting parenteral agent is acceptable; for outpatients who are more ill or are at risk for more severe illness, consider continuing parenteral therapy until culture and susceptibility results are available (ESCMID/IDSA [Gupta 2011]; Hooton 2018b).
* See Dosage and Administration in AHFS Essentials for additional information.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Renal Impairment: Adult
Note: Renally adjusted dose recommendations are based on the amoxicillin 250 mg/clavulanate 125 mg and amoxicillin 500 mg/clavulanate 125 mg tablets.
CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl 10 to 30 mL/minute: 250 to 500 mg every 12 hours; do not use 875 mg tablet or extended-release tablets
CrCl <10 mL/minute: 250 to 500 mg every 24 hours; do not use 875 mg tablet or extended-release tablets
End-stage renal disease (ESRD) on hemodialysis: 250 to 500 mg every 24 hours; administer dose both during and after dialysis. Do not use 875 mg tablet or extended-release tablets.
Dosing: Hepatic Impairment: Adult
There are no dosage adjustments provided in the manufacturer's labeling; use with caution. Use contraindicated in patients with a history of amoxicillin and clavulanate-associated hepatic dysfunction.
Dosing: Pediatric
Note: Dosing based on amoxicillin component; dose and frequency are product specific; not all products are interchangeable; using a product with the incorrect amoxicillin:clavulanate ratio could result in subtherapeutic clavulanic acid concentrations or severe diarrhea.
Frequency of dosing generally based on ratio of amoxicillin to clavulanate:
• 2:1 formulations are dosed 3 times daily (amoxicillin 250 mg/clavulanate 125 mg). Note: Per the manufacturer, the amoxicillin 250 mg/clavulanate 125 mg tablet should only be used in patients ≥40 kg due to the amoxicillin to clavulanate ratio.
• 4:1 formulations are dosed 3 times daily (amoxicillin 125 mg/clavulanate 31.25 mg; amoxicillin 250 mg/clavulanate 62.5 mg; amoxicillin 500 mg/clavulanate 125 mg).
• 7:1 formulations are dosed 2 times daily (amoxicillin 200 mg/clavulanate 28.5 mg; amoxicillin 400 mg/clavulanate 57 mg; amoxicillin 875 mg/clavulanate 125 mg).
• 14:1 formulations are dosed 2 times daily (amoxicillin 600 mg/clavulanate 42.9 mg).
• 16:1 formulations (extended release) are dosed 2 times daily (amoxicillin 1,000 mg/clavulanate 62.5 mg).
General dosing, susceptible infection: Note: Dosing determined by formulations amoxicillin:clavulanate ratio:
Immediate-release formulations (Red Book [AAP 2018]): Infants, Children, and Adolescents: Oral:
4:1 formulation: 20 to 40 mg amoxicillin/kg/day in divided doses 3 times daily; maximum daily dose: 1,500 mg/day.
7:1 formulation: 25 to 45 mg amoxicillin/kg/day in divided doses twice daily; maximum daily dose: 1,750 mg/day.
14:1 formulation: 90 mg amoxicillin/kg/day in divided doses twice daily; maximum daily dose: 4,000 mg/day.
Extended-release formulation (16:1): Children and Adolescents >40 kg: Oral: 2,000 mg amoxicillin every 12 hours.
Impetigo: Infants, Children, and Adolescents: Oral: 25 mg amoxicillin/kg/day in divided doses twice daily; maximum dose: 875 mg amoxicillin/dose (IDSA [Stevens 2014]).
Otitis media, acute: Infants ≥3 months and Children: Oral suspension (600 mg/5 mL): Oral: 90 mg amoxicillin/kg/day divided every 12 hours for up to 10 days; recommended for use in children with severe illness, who have received amoxicillin in the past 30 days, who have treatment failure at 48 to 72 hours on first-line therapy, and when coverage for beta-lactamase positive H. influenzae and M. catarrhalis is needed. Variable duration of therapy; the manufacturer suggests 10-day course in all patients; however, new data suggests a shorter course in some cases: If <2 years of age or severe symptoms (any age): 10-day course; if 2 to 5 years of age with mild to moderate symptoms: 7-day course; if ≥6 years of age with mild to moderate symptoms: 5- to 7-day course (AAP [Lieberthal 2013]).
Pneumonia, community-acquired (IDSA/PIDS [Bradley 2011]): Infants ≥3 months, Children, and Adolescents:
Empiric therapy: Oral: 90 mg amoxicillin/kg/day in divided doses twice daily; maximum daily dose: 4,000 mg/day.
H. influenzae, beta-lactamase positive strains, mild infection, or step-down therapy: Oral:
Standard dose: 45 mg amoxicillin/kg/day in divided doses 3 times daily.
High dose: 90 mg amoxicillin/kg/day in divided doses twice daily.
Rhinosinusitis, acute bacterial:
Infants ≥3 months: Oral: 45 mg amoxicillin/kg/day divided every 12 hours or 40 mg/kg/day divided every 8 hours.
Children and Adolescents: Oral:
Standard dose: 45 mg amoxicillin/kg/day divided every 12 hours for 10 to 14 days; usual adult dose: 875 mg amoxicillin/dose (IDSA [Chow 2012]).
High dose: 80 to 90 mg amoxicillin/kg/day divided every 12 hours; maximum dose: 2,000 mg/dose (AAP [Wald 2013]; IDSA [Chow 2012]); treatment duration variable: 10 to 28 days, some have suggested discontinuation of therapy 7 days after resolution of signs and symptoms of infection (AAP [Wald 2013]); some experts recommend a duration of 10 to 14 days (IDSA [Chow 2012]). Note: Recommended for patients who live in areas with high endemic rates of penicillin-nonsusceptible S. pneumonia, patients with moderate to severe infections, daycare attendance, age <2 years, recent hospitalization, antibiotic use within the past month, patients who are immunocompromised or if initial therapy fails (second-line therapy) (AAP [Wald 2013]; IDSA [Chow 2012]).
Streptococci, group A; chronic carrier treatment: Children and Adolescents: Oral: 40 mg amoxicillin/kg/day in divided doses every 8 hours for 10 days; maximum daily dose: 2,000 mg amoxicillin/day (IDSA [Shulman 2012]).
Urinary tract infections: Infants ≥2 months and Children ≤2 years: Oral: 20 to 40 mg amoxicillin/kg/day in divided doses 3 times daily (AAP 2011).
Dosing: Renal Impairment: Pediatric
Infants, Children, and Adolescents: There are no dosage adjustments provided in the manufacturer's labeling; however, the following guidelines have been used by some clinicians (Aronoff 2007): Oral:
Mild to moderate infection: Dosing based on 20 to 40 mg amoxicillin/kg/day divided every 8 hours or 25 to 45 mg amoxicillin/kg/day divided every 12 hours:
GFR >30 mL/minute/1.73 m2: No adjustment required
GFR 10 to 29 mL/minute/1.73 m2: 8 to 20 mg amoxicillin/kg/dose every 12 hours
GFR <10 mL/minute/1.73 m2: 8 to 20 mg amoxicillin/kg/dose every 24 hours
Hemodialysis: 8 to 20 mg amoxicillin/kg/dose every 24 hours; give after dialysis
Peritoneal dialysis: 8 to 20 mg amoxicillin/kg/dose every 24 hours
Severe infection (high dose): Dosing based on 80 to 90 mg amoxicillin/kg/day divided every 12 hours:
CrCl >30 mL/minute/1.73 m2: No adjustment required
CrCl 10 to 29 mL/minute/1.73 m2: 20 mg amoxicillin/kg/dose every 12 hours; do not use the 875 mg tablet
CrCl <10 mL/minute/1.73 m2: 20 mg amoxicillin/kg/dose every 24 hours; do not use the 875 mg tablet
Hemodialysis: 20 mg amoxicillin/kg/dose every 24 hours; give after dialysis; do not use the 875 mg tablet
Peritoneal dialysis: 20 mg amoxicillin/kg/dose every 24 hours; do not use the 875 mg tablet
Dosing: Hepatic Impairment: Pediatric
There are no dosage adjustments provided in the manufacturer's labeling; use with caution. Use contraindicated in patients with a history of amoxicillin and clavulanate-associated hepatic dysfunction.
Calculations
Use: Labeled Indications
Otitis media, acute:
Immediate-release tablets, chewable tablets, oral suspension (400/57 mg per 5 mL, 250/62.5 mg per 5 mL, 200/28.5 mg per 5 mL, and 125/31.25 mg per 5 mL only): Treatment of otitis media caused by beta-lactamase-producing strains of H. influenzae and M. catarrhalis.
Oral suspension (600/42.9 mg per 5 mL concentration): Treatment of acute otitis media, recurrent or persistent, caused by S. pneumoniae (penicillin MIC = 2 mcg/mL or less), H. influenzae (including beta-lactamase-producing strains), and M. catarrhalis (including beta-lactamase-producing strains) in pediatric patients with a history of antibiotic exposure for acute otitis media in the preceding 3 months and who are either 2 years or younger or attend day care.
Pneumonia:
Extended-release tablets only: Treatment of patients with community-acquired pneumonia (CAP) caused by confirmed or suspected beta-lactamase-producing pathogens (ie, Haemophilus influenzae, Moraxella catarrhalis, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus) and Streptococcus pneumoniae with reduced susceptibility to penicillin (penicillin minimum inhibitory concentration [MIC] = 2 mcg/mL).
Limitations of use: Augmentin XR is not indicated for the treatment of infections caused by S. pneumoniae with penicillin MIC of 4 mcg/mL or greater (limited data).
Immediate-release tablets, chewable tablets, oral suspension (400/57 mg per 5 mL, 250/62.5 mg per 5 mL, 200/28.5 mg per 5 mL, and 125/31.25 mg per 5 mL only): Treatment of lower respiratory tract infection caused by beta-lactamase-producing strains of H. influenzae and M. catarrhalis.
Rhinosinusitis, acute bacterial:
Extended-release tablets: Treatment of patients with acute bacterial sinusitis caused by confirmed or suspected beta-lactamase-producing pathogens (ie, H. influenzae, M. catarrhalis, H. parainfluenzae, K. pneumoniae, methicillin-susceptible S. aureus) and S. pneumoniae with reduced susceptibility to penicillin (penicillin MIC = 2 mcg/mL).
Limitations of use: Augmentin XR is not indicated for the treatment of infections caused by S. pneumoniae with penicillin MIC of 4 mcg/mL or greater (limited data).
Immediate-release tablets, chewable tablets, oral suspension (400/57 mg per 5 mL, 250/62.5 mg per 5 mL, 200/28.5 mg per 5 mL, and 125/31.25 mg per 5 mL only): Treatment of sinusitis caused by beta-lactamase-producing strains of H. influenzae and M. catarrhalis.
Skin and skin structure infections: Immediate-release tablets, chewable tablets, oral suspension (400/57 mg per 5 mL, 250/62.5 mg per 5 mL, 200/28.5 mg per 5 mL, and 125/31.25 mg per 5 mL only): Treatment of skin and skin structure infections caused by beta-lactamase-producing strains of S. aureus, Escherichia coli, and Klebsiella spp.
Urinary tract infections: Immediate-release tablets, chewable tablets, oral suspension (400/57 mg per 5 mL, 250/62.5 mg per 5 mL, 200/28.5 mg per 5 mL, and 125/31.25 mg per 5 mL only): Treatment of urinary tract infections caused by beta-lactamase-producing strains of E. coli, Klebsiella spp, and Enterobacter spp.
* See Uses in AHFS Essentials for additional information.
Use: Off-Label: Adult
Bite wound, prophylaxis or treatment (animal or human bite)Level of Evidence [G]
Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTIs), amoxicillin/clavulanate is an effective and recommended treatment or prophylaxis of animal or human bite wounds.
Bronchiectasis, acute exacerbationLevel of Evidence [C]
Clinical experience suggests the utility of amoxicillin and clavulanate for the treatment of acute exacerbations of bronchiectasis Ref.
Chronic obstructive pulmonary disease, acute exacerbationLevel of Evidence [A, G]
Data from 2 randomized, double-blind studies support the use of amoxicillin and clavulanate for the treatment of bacterial exacerbations of chronic obstructive pulmonary disease (COPD) Ref.
Based on the Global Initiative for Chronic Obstructive Lung Disease guidelines for the diagnosis, management, and prevention of COPD, amoxicillin and clavulanate is an effective and recommended treatment for COPD exacerbations Ref.
Diabetic foot infectionLevel of Evidence [C, G]
Data from a randomized, open-label trial suggest that amoxicillin and clavulanate may be beneficial for the treatment of diabetic foot infection Ref.
Based on the IDSA clinical practice guideline for the diagnosis and treatment of diabetic foot infections, amoxicillin and clavulanate is an effective and recommended treatment for diabetic foot infection.
Intra-abdominal infectionLevel of Evidence [B, G]
Data from a randomized, multicenter study support the use of amoxicillin and clavulanate for the treatment of acute uncomplicated diverticulitis Ref. Clinical experience also suggests the utility of amoxicillin and clavulanate as oral step-down therapy for the treatment of intra-abdominal infection Ref.
Based on the Surgical Infection Society (SIS)/IDSA clinical practice guideline for the diagnosis and management of complicated intra-abdominal infection in adults and the SIS clinical practice guideline for the management of intra-abdominal infection, amoxicillin and clavulanate is effective and recommended as oral step-down therapy for intra-abdominal infection once clinically improved on parenteral therapy and patient is able to tolerate an oral diet.
Neutropenic fever, low-risk cancer patients (empiric therapy)Level of Evidence [G]
Based on the American Society of Clinical Oncology and IDSA guidelines for treatment of cancer patients with fever and neutropenia, amoxicillin and clavulanate (in combination with ciprofloxacin) is an effective and recommended oral regimen for management of low-risk patients with neutropenic fever.
Odontogenic infectionLevel of Evidence [B]
Data from a prospective, observational study and a prospective, randomized, single-blind study support the use of amoxicillin and clavulanate for the treatment of odontogenic infection Ref.
Peritonsillar cellulitis or abscessLevel of Evidence [C]
Data from 2 prospective, observational studies suggest the utility of amoxicillin and clavulanate for the treatment of peritonsillar abscess Ref. Clinical experience also suggests the utility of amoxicillin and clavulanate for the treatment of peritonsillar cellulitis Ref.
Streptococcus (group A), chronic carriageLevel of Evidence [G]
Based on the IDSA clinical practice guideline for the diagnosis and management of group A streptococcal pharyngitis, amoxicillin and clavulanate is effective and recommended for eradication of group A streptococci in chronic carriers.
Level of Evidence Definitions
Level of Evidence Scale
Class and Related Monographs
Comparative Efficacy
Clinical Practice Guidelines
Chronic Obstructive Pulmonary Disease:
GOLD, “Global Strategy for Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease,” 2020
Diabetic Foot Infection:
IDSA, “The Diagnosis and Treatment of Diabetic Foot Infections,” 2012
Drug-Induced Liver Injury:
American College of Gastroenterology (ACG), “2014 ACG Guideline for Idiosyncratic Drug-induced Liver Injury,” July 2014
Neutropenic Fever:
ASCO/IDSA, "Outpatient Management of Fever and Neutropenia in Adults Treated for Malignancy," February 2018. Note: Information contained within this monograph is pending revision based on these more recent guidelines.
Opportunistic Infections:
DHHS, Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, October 2014 [Note: Information contained within this monograph is pending revision based on these more recent guidelines]
Pharyngitis, Group A Streptococci:
IDSA, “Clinical Practice Guideline for the Diagnosis and Management of Group A Streptococcal Pharyngitis,” September 2012
Pneumonia, Community-Acquired
ATS/IDSA, "Diagnosis and Treatment of Adults With Community-Acquired Pneumonia," 2019.
Prosthetic Joint Infection:
IDSA, “Diagnosis and Management of Prosthetic Joint Infection: Clinical Practice Guideline,” January 2013
Rhinosinusitis:
AAO-HNS, “Clinical Practice Guideline (Update): Adult Sinusitis,” 2015
IDSA, “Clinical Practice Guideline for Acute Bacterial Rhinosinusitis in Children and Adults,” 2012
Skin and Soft-tissue Infection:
IDSA, “Practice Guidelines for the Diagnosis and Management of Skin and Soft Tissue Infections,” June 2014
Urinary Tract Infections:
IDSA, “International Clinical Practice Guidelines for the Treatment of Acute Uncomplicated Cystitis and Pyelonephritis in Women,” March 2011
Administration: Oral
Administer around-the-clock to promote less variation in peak and trough serum levels. Administer with food to increase absorption and decrease stomach upset; shake suspension well before use. ER tablets should be administered with food.
Bariatric surgery: Tablet, extended release: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. Do not cut, crush, or chew. Switch to IR formulation.
Administration: Pediatric
Oral: Can be given without regard to meals. Administer at the start of a meal to decrease the frequency or severity of GI side effects; may mix with milk, formula, or juice; shake suspension well before use
Dietary Considerations
May be taken with meals or on an empty stomach; take with meals to increase absorption and decrease GI upset; may mix with milk, formula, or juice. Extended release tablets should be taken with food. Some products may contain sodium. Some products contain phenylalanine. All dosage forms contain potassium.
Storage/Stability
Powder for oral suspension: Store dry powder at or below 25°C (77°F). Reconstituted oral suspension should be kept in refrigerator. Discard unused suspension after 10 days (consult manufacturer's labeling for specific recommendations). Unit-dose antibiotic oral syringes are stable under refrigeration for 24 hours (Tu 1988).
Tablet: Store at or below 25°C (77°F). Dispense in original container.
Preparation for Administration: Adult
Reconstitute powder for oral suspension with appropriate amount of water as specified in the manufacturer's labeling. Shake vigorously until suspended.
Preparation for Administration: Pediatric
Oral: Reconstitute powder for oral suspension with appropriate amount of water as specified on the bottle. Shake vigorously until suspended.
Medication Patient Education with HCAHPS Considerations
What is this drug used for?
• It is used to treat bacterial infections.
Frequently reported side effects of this drug
• Nausea
• Vomiting
• Diaper rash (children)
• Diarrhea
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
• Liver problems like dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin.
• Vaginal irritation
• Clostridioides (formerly Clostridium) difficile-associated diarrhea like abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools.
• Stevens-Johnson syndrome/toxic epidermal necrolysis like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in mouth, throat, nose, or eyes.
• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
Medication Safety Issues
Sound-alike/look-alike issues:
Contraindications
Hypersensitivity to amoxicillin, clavulanic acid, other beta-lactam antibacterial drugs (eg, penicillins, cephalosporins), or any component of the formulation; history of cholestatic jaundice or hepatic dysfunction with amoxicillin/clavulanate potassium therapy
Augmentin XR: Additional contraindications: Severe renal impairment (creatinine clearance <30 mL/minute) and hemodialysis patients
Canadian labeling: Additional contraindications (not in US labeling): Suspected or confirmed mononucleosis
Warnings/Precautions
Concerns related to adverse effects:
• Anaphylactic/hypersensitivity reactions: Serious and occasionally severe or fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy, especially with a history of beta-lactam hypersensitivity, or history of sensitivity to multiple allergens.
• Diarrhea: Incidence of diarrhea is higher than with amoxicillin alone.
• Hepatic effects: Although rarely fatal, hepatic dysfunction (eg, cholestatic jaundice, hepatitis) has been reported. Patients at highest risk include those with serious underlying disease or concomitant medications. Hepatic toxicity is usually reversible. Monitor liver function tests at regular intervals in patients with hepatic impairment.
• Prolonged therapy: Monitor renal, hepatic, and hematopoietic function if therapy extends beyond approved duration times.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with hepatic impairment and monitor liver function tests at regular intervals.
• Infectious mononucleosis: A high percentage of patients with infectious mononucleosis have developed rash during therapy; ampicillin-class antibiotics not recommended in these patients.
Concurrent drug therapy related issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Dosage form specific issues:
• Clavulanic acid content: Due to differing content of clavulanic acid, not all formulations are interchangeable; use of an inappropriate product for a specific dosage could result in either diarrhea (which may be severe) or subtherapeutic clavulanic acid concentrations leading to decreased clinical efficacy.
• Phenylalanine: Some products contain phenylalanine.
* See Cautions in AHFS Essentials for additional information.
Geriatric Considerations
Expanded coverage of this combination makes it a useful alternative when amoxicillin resistance is present and patients cannot tolerate alternative treatments; consider renal function. Considered one of the drugs of choice in the outpatient treatment of community-acquired pneumonia in elderly.
Warnings: Additional Pediatric Considerations
Epstein-Barr virus infection (infectious mononucleosis), acute lymphocytic leukemia, or cytomegalovirus infection increase risk for penicillin-induced maculopapular rash. Appearance of a rash should be carefully evaluated to differentiate a nonallergic ampicillin rash from a hypersensitivity reaction; rash occurs in 5% to 10% of children and is a generalized dull red, maculopapular rash, generally appearing 3 to 14 days after the start of therapy. It normally begins on the trunk and spreads over most of the body. It may be most intense at pressure areas, elbows, and knees. A high percentage (43% to 100%) of patients with infectious mononucleosis have developed rash during therapy; ampicillin-class antibiotics are not recommended in these patients.
In a meta-analysis of pediatric acute otitis media trials, high-dose amoxicillin regimens were associated with a higher incidence of adverse effects compared to standard-dose; the incidence of diarrhea was 18.9% with high-dose amoxicillin/clavulanate, 13.8% with high-dose amoxicillin, and 8.7% with standard-dose amoxicillin; the incidence of generalized rash was 6.5% with high-dose amoxicillin, 4.9% with high-dose amoxicillin/clavulanate, and 2.9% with standard-dose amoxicillin; however, significant heterogeneity was observed (Hum 2019).
Pregnancy Risk Factor
B
Pregnancy Considerations
Both amoxicillin and clavulanic acid cross the placenta (Weber 1984). Oral ampicillin-class antibiotics are poorly absorbed during labor.
Breast-Feeding Considerations
Amoxicillin is present in breast milk following administration amoxicillin/clavulanate (Weber 1984).
The relative infant dose (RID) of amoxicillin following administration of amoxicillin/clavulanate is 0.02% to 0.07% when calculated using the highest average breast milk concentration located and compared to an infant therapeutic dose of 25 to 90 mg/kg/day. In general, breastfeeding is considered acceptable when the RID is <10% (Anderson 2016; Ito 2000).
Using the highest average milk concentration (0.12 mcg/mL), the estimated daily infant dose via breast milk is 0.018 mg/kg/day. This milk concentration was obtained 4 to 6 hours following maternal administration of oral amoxicillin/clavulanate 250 mg/125 mg (Takase 1982).
Constipation, diarrhea, restlessness, and rash have been reported in breastfeeding infants exposed to amoxicillin and clavulanate; reversible elevations in AST and ALT have been noted in one infant (Benyamini 2005). The manufacturer warns of the potential for allergic sensitization in the infant. In general, antibiotics that are present in breast milk may cause non-dose-related modification of bowel flora. Monitor infants for GI disturbances, such as thrush and diarrhea (WHO 2002).
Although the manufacturer recommends that caution be exercised when administering amoxicillin and clavulanate to breastfeeding women, amoxicillin/clavulanate is considered compatible with breastfeeding when used in usual recommended doses (WHO 2002).
Lexicomp Pregnancy & Lactation, In-Depth
Briggs' Drugs in Pregnancy & Lactation
Adverse Reactions
>10%: Gastrointestinal: Diarrhea (3% to 34%; incidence varies upon dose and regimen used)
1% to 10%:
Dermatologic: Diaper rash, skin rash, urticaria
Gastrointestinal: Abdominal distress, loose stools, nausea, vomiting
Genitourinary: Vaginitis
Infection: Candidiasis, vaginal mycosis
<1%, postmarketing, and/or case reports: Cholestatic jaundice, flatulence, headache, hepatic insufficiency, hepatitis, hepatotoxicity (idiosyncratic) (Chalasani 2014), increased liver enzymes, increased serum alkaline phosphatase, prolonged prothrombin time, thrombocythemia, vasculitis (hypersensitivity)
Additional adverse reactions seen with ampicillin-class antibiotics: Acute generalized exanthematous pustulosis, agitation, agranulocytosis, anaphylaxis, anemia, angioedema, anxiety, behavioral changes, confusion, convulsions, crystalluria, dental discoloration, dizziness, dyspepsia, enterocolitis, eosinophilia, erythema multiforme, exfoliative dermatitis, gastritis, glossitis, hematuria, hemolytic anemia, hemorrhagic colitis, hyperactivity, immune thrombocytopenia, increased serum bilirubin, increased serum transaminases, insomnia, interstitial nephritis, leukopenia, melanoglossia, mucocutaneous candidiasis, pruritus, pseudomembranous colitis, serum sickness-like reaction, Stevens-Johnson syndrome, stomatitis, thrombocytopenia, toxic epidermal necrolysis
* See Cautions in AHFS Essentials for additional information.
Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects
None known.
Drug Interactions Open Interactions
Acemetacin: May increase the serum concentration of Penicillins. Risk C: Monitor therapy
Allopurinol: May enhance the potential for allergic or hypersensitivity reactions to Amoxicillin. Risk C: Monitor therapy
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination
Dichlorphenamide: Penicillins may enhance the hypokalemic effect of Dichlorphenamide. Risk C: Monitor therapy
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy
Methotrexate: Penicillins may increase the serum concentration of Methotrexate. Risk C: Monitor therapy
Mycophenolate: Penicillins may decrease serum concentrations of the active metabolite(s) of Mycophenolate. This effect appears to be the result of impaired enterohepatic recirculation. Risk C: Monitor therapy
Probenecid: May increase the serum concentration of Betalactamase Inhibitors. Management: Coadministration of probenecid with amoxicillin/clavulanate is not recommended per official package labeling. Risk D: Consider therapy modification
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification
Tetracyclines: May diminish the therapeutic effect of Penicillins. Risk C: Monitor therapy
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Penicillins may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy
Test Interactions
May interfere with urinary glucose tests using cupric sulfate (Benedict's solution, Clinitest, Fehling's solution). Glucose tests based on enzymatic glucose oxidase reactions (eg, Clinistix) are recommended.
Ampicillin may transiently interfere with plasma concentrations of total conjugated estriol, estriol-glucuronide, conjugated estrone and estradiol in pregnant women.
Monitoring Parameters
Assess patient at beginning and throughout therapy for infection; with prolonged therapy, monitor renal, hepatic, and hematologic function periodically; in patients with hepatic impairment, monitor liver function tests at regular intervals; monitor for signs of anaphylaxis during first dose
Advanced Practitioners Physical Assessment/Monitoring
Assess culture and sensitivity report and patient’s allergy history prior to starting therapy. Obtain CBC with differential, renal function tests, and liver function tests periodically with prolonged therapy. Screen patients for history of renal impairment, liver impairment, or active mononucleosis. Assess for signs of anaphylaxis during first dose. Assess for signs and symptoms of opportunistic infections. Assess other medication patient may be taking; alternative therapy or dosage adjustment may be needed. Test for Clostridioides (formerly Clostridium) difficile-associated diarrhea if patient develops diarrhea.
Nursing Physical Assessment/Monitoring
Check ordered labs and report any abnormalities. Monitor patients closely for signs and symptoms of hypersensitivity (shortness-of-breath, dyspnea, chest pain, complaints of difficulty swallowing or throat tightness, or change in vital signs). Monitor for severe or bloody diarrhea and send a specimen to the lab for Clostridioides (formerly Clostridium) difficile-associated diarrhea. Educate patients about high likelihood of diarrhea. Educate patients on proper administration (spacing doses evenly around the clock and timing of medication with regard to meals).
Dosage Forms: US
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Suspension Reconstituted, Oral:
Augmentin: Amoxicillin 125 mg and clavulanate potassium 31.25 mg per 5 mL (75 mL [DSC], 100 mL [DSC], 150 mL [DSC]) [contains aspartame, saccharin sodium; banana flavor]
Augmentin: Amoxicillin 250 mg and clavulanate potassium 62.5 mg per 5 mL (75 mL [DSC], 100 mL [DSC], 150 mL [DSC]) [contains aspartame, saccharin sodium; orange flavor]
Augmentin: Amoxicillin 250 mg and clavulanate potassium 62.5 mg per 5 mL (75 mL, 100 mL, 150 mL); Amoxicillin 125 mg and clavulanate potassium 31.25 mg per 5 mL (75 mL, 100 mL, 150 mL) [contains saccharin sodium]
Augmentin ES-600: Amoxicillin 600 mg and clavulanate potassium 42.9 mg per 5 mL (75 mL, 125 mL, 200 mL) [contains aspartame; strawberry cream flavor]
Generic: Amoxicillin 200 mg and clavulanate potassium 28.5 mg per 5 mL (50 mL, 75 mL, 100 mL); Amoxicillin 250 mg and clavulanate potassium 62.5 mg per 5 mL (75 mL, 100 mL, 150 mL); Amoxicillin 400 mg and clavulanate potassium 57 mg per 5 mL (50 mL, 75 mL, 100 mL); Amoxicillin 600 mg and clavulanate potassium 42.9 mg per 5 mL (75 mL, 125 mL, 200 mL)
Tablet, Oral:
Augmentin: Amoxicillin 500 mg and clavulanate potassium 125 mg
Augmentin: Amoxicillin 875 mg and clavulanate potassium 125 mg [DSC] [scored]
Generic: Amoxicillin 250 mg and clavulanate potassium 125 mg, Amoxicillin 500 mg and clavulanate potassium 125 mg, Amoxicillin 875 mg and clavulanate potassium 125 mg
Tablet Chewable, Oral:
Generic: Amoxicillin 200 mg and clavulanate potassium 28.5 mg, Amoxicillin 400 mg and clavulanate potassium 57 mg
Tablet Extended Release 12 Hour, Oral:
Augmentin XR: Amoxicillin 1000 mg and clavulanate potassium 62.5 mg [DSC] [scored]
Generic: Amoxicillin 1000 mg and clavulanate potassium 62.5 mg
Dosage Forms: Canada
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension Reconstituted, Oral:
Clavulin: Amoxicillin 400 mg and clavulanate potassium 57 mg per 5 mL (70 mL); Amoxicillin 200 mg and clavulanate potassium 28.5 mg per 5 mL (70 mL)
Clavulin-125F: Amoxicillin 125 mg and clavulanate potassium 31.25 mg per 5 mL (100 mL, 150 mL)
Clavulin-250F: Amoxicillin 250 mg and clavulanate potassium 62.5 mg per 5 mL (100 mL, 150 mL)
Generic: Amoxicillin 125 mg and clavulanate potassium 31.25 mg per 5 mL (100 mL, 150 mL); Amoxicillin 250 mg and clavulanate potassium 62.5 mg per 5 mL (100 mL, 150 mL); Amoxicillin 400 mg and clavulanate potassium 57 mg per 5 mL (70 mL)
Tablet, Oral:
Clavulin: Amoxicillin 875 mg and clavulanate potassium 125 mg
Clavulin-500F: Amoxicillin 500 mg and clavulanate potassium 125 mg
Generic: Amoxicillin 250 mg and clavulanate potassium 125 mg, Amoxicillin 500 mg and clavulanate potassium 125 mg, Amoxicillin 875 mg and clavulanate potassium 125 mg
Anatomic Therapeutic Chemical (ATC) Classification
Generic Available (US)
Yes
Pricing: US
Chewable (Amoxicillin-Pot Clavulanate Oral)
200-28.5 mg (per each): $2.83
400-57 mg (per each): $5.39
Suspension (reconstituted) (Amoxicillin-Pot Clavulanate Oral)
200-28.5 mg/5 mL (per mL): $0.36 - $0.39
250-62.5 mg/5 mL (per mL): $0.86 - $1.45
400-57 mg/5 mL (per mL): $0.69 - $0.74
600-42.9 mg/5 mL (per mL): $0.49 - $0.66
Suspension (reconstituted) (Augmentin ES-600 Oral)
600-42.9 mg/5 mL (per mL): $0.81
Suspension (reconstituted) (Augmentin Oral)
125-31.25 mg/5 mL (per mL): $6.67
250-62.5 mg/5 mL (per mL): $9.80
Tablet, 12-hour (Amoxicillin-Pot Clavulanate ER Oral)
1000-62.5 mg (per each): $7.67
Tablets (Amoxicillin-Pot Clavulanate Oral)
250-125 mg (per each): $5.92
500-125 mg (per each): $3.78
875-125 mg (per each): $0.72 - $5.05
Tablets (Augmentin Oral)
500-125 mg (per each): $11.57
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Mechanism of Action
Clavulanic acid binds and inhibits beta-lactamases that inactivate amoxicillin resulting in amoxicillin having an expanded spectrum of activity. Amoxicillin inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.
Pharmacodynamics/Kinetics
Amoxicillin pharmacokinetics are not affected by clavulanic acid.
Amoxicillin: See individual Amoxicillin monograph.
Clavulanic acid:
Protein binding: ~25%
Half-life elimination: 1 hour
Time to peak: 1.5 hours
Excretion: Urine (25% to 40% as unchanged drug)
Dental Use
Treatment of orofacial infections when beta-lactamase-producing staphylococci and beta-lactamase-producing Bacteroides are present
* See Uses in AHFS Essentials for additional information.
Local Anesthetic/Vasoconstrictor Precautions
No information available to require special precautions
Dental Health Professional Considerations
In maxillary sinus, anterior nasal cavity, and deep neck infections, beta-lactamase-producing staphylococci and beta-lactamase-producing Bacteroides usually are present. In these situations, antibiotics that resist the beta-lactamase enzyme are indicated. Amoxicillin and clavulanic acid is administered orally for moderate infections. Ampicillin sodium and sulbactam sodium (Unasyn®) is administered parenterally for more severe infections.
Effects on Dental Treatment
Prolonged use of penicillins may lead to development of oral candidiasis (see Dental Health Professional Considerations)
Effects on Bleeding
No information available to require special precautions
Dental Usual Dosing
Orofacial infections: Children >40 kg and Adults: Oral: 250-500 mg every 8 hours or 875 mg every 12 hours
Related Information
Pharmacotherapy Pearls
Two 250 mg tablets are not equivalent to a 500 mg tablet (both tablet sizes contain equivalent clavulanate). Two 500 mg tablets are not equivalent to a single 1000 mg extended release tablet.
Index Terms
Amoxicillin and Clavulanate Potassium; Amoxicillin and Clavulanic Acid; Amoxicillin-Clavulanate; Amoxicillin/Clavulanate; Amoxicillin/Clavulanate K; Amoxicillin/Potassium Clav; Amoxycillin and Clavulanate Potassium; Amoxycillin and Clavulanic Acid; Clavulanic Acid and Amoxicillin; Clavulanic Acid and Amoxycillin; Co-Amoxiclav
FDA Approval Date
August 06, 1984
References
American Academy of Pediatrics (AAP). In: Kimberlin DW, Brady MT, Jackson MA, Long SA, eds. Red Book: 2018 Report of the Committee on Infectious Diseases. 31st ed. Itasca, IL: American Academy of Pediatrics; 2018.
American Academy of Pediatrics (AAP). Pickering LK, Baker CJ, Kimberlin DW, Long SS, eds; Red Book: 2012 Report of the Committee on Infectious Diseases. 29th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2012.
American College of Obstetricians and Gynecologists (ACOG), Committee on Practice Bulletins-Obstetrics. ACOG practice bulletin no. 199: use of Prophylactic antibiotics in labor and delivery. Obstet Gynecol. 2018;132(3):e103-e119.[PubMed 30134425]
American College of Obstetricians and Gynecologists (ACOG). Practice bulletin no. 160: premature rupture of membranes. Obstet Gynecol. 2016;127(1):e39-51.[PubMed 26695586 ]
Amoxicillin and Clavulanate Potassium (powder for oral suspension) [prescribing information]. Memphis, TN: Northstar Rx LLC; December 2018.
Anderson PO, Sauberan JB. Modeling drug passage into human milk. Clin Pharmacol Ther. 2016;100(1):42-52.[PubMed 27060684]
Aronoff GR, Bennett WM, Berns JS, et al, eds. Drug Prescribing in Renal Failure: Dosing Guidelines for Adults and Children. 5th ed. Philadelphia, PA: American College of Physicians; 2007.
Augmentin (amoxicillin/clavulanate potassium) [prescribing information]. Princeton, NJ: Neopharma Inc; January 2019.
Augmentin ES-600 powder (amoxicillin and clavulanate potassium) [prescribing information]. Bridgewater, NJ: Dr Reddys Laboratories Inc; December 2012.
Augmentin XR (amoxicillin and clavulanate potassium) [prescribing information]. Bridgewater, NJ: Dr Reddys Laboratories Inc; April 2014.
Baddour LM, Harper M. Animal bites: evaluation and management. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed March 22, 2019a.
Baddour LM, Harper M. Human bites: evaluation and management. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed March 22, 2019b.
Barker AF. Treatment of bronchiectasis in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 21, 2018.
Barshak MB. Antimicrobial approach to intra-abdominal infections in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed October 11, 2018.
Bartlett JG. Aspiration pneumonia in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed November 7, 2019.
Benyamini L, Merlob P, Stahl B, et al, "The Safety of Amoxicillin/Clavulanic Acid and Cefuroxime During Lactation," Ther Drug Monit, 2005, 27(4):499-502.[PubMed 16044108]
Biondo S, Golda T, Kreisler E, et al. Outpatient versus hospitalization management for uncomplicated diverticulitis: a prospective, multicenter randomized clinical trial (DIVER trial). Ann Surg. 2014;259(1):38-44. doi: 10.1097/SLA.0b013e3182965a11.[PubMed 23732265]
Bradley JS, Byington CL, Shah SS, et al. “The Management of Community-Acquired Pneumonia in Infants and Children Older Than 3 Months of Age: Clinical Practice Guidelines by the Pediatric Infectious Diseases Society and the Infectious Diseases Society of America”, Clin Infect Dis, 2011, 53(7):e25-76.[PubMed 21880587]
Bradley JS. Management of community-acquired pediatric pneumonia in an era of increasing antibiotic resistance and conjugate vaccines. Pediatr Infect Dis J. 2002;21(6):592-598.[PubMed 12182396]
Chalasani NP, Hayashi PH, Bonkovsky HL, et al. ACG Clinical Guideline: the diagnosis and management of idiosyncratic drug-induced liver injury. Am J Gastroenterol. 2014;109(7):950-966.[PubMed 24935270]
Chow AW, Benninger MS, Brook I, et al; Infectious Diseases Society of America. IDSA clinical practice guideline for acute bacterial rhinosinusitis in children and adults. Clin Infect Dis. 2012;54(8):e72-e112.[PubMed 22438350]
Chow AW. Complications, diagnosis, and treatment of odontogenic infections. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 6, 2019.
Clavulin (amoxicillin and clavulanic acid) [product monograph]. Mississauga, Ontario, Canada: GlaxoSmithKline Inc; September 2018.
DHHS Panel on Opportunistic Infections in HIV-Infected Adults and Adolescents. Guidelines for the prevention and treatment of opportunistic infections in HIV-infected adults and adolescents: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. October 2014. Available at http://aidsinfo.nih.gov/contentfiles/lvguidelines/adult_oi.pdf. Accessed November 12, 2014
Freifeld A, Marchigiani D, Walsh T, et al; Infectious Diseases Society of America. A double-blind comparison of empirical oral and intravenous antibiotic therapy for low-risk febrile patients with neutropenia during cancer chemotherapy. N Engl J Med. 1999;341(5):305-311.[PubMed 10423464]
Freifeld AG, Bow EJ, Sepkowitz KA, et al. Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 update by the Infectious Diseases Society of America. Clin Infect Dis. 2011;52(4):e56-93.[PubMed 21258094]
Gerlach KL, Schaal KP, Walz C, Pape HD. Treatment of severe odontogenic infections with amoxicillin/clavulanic acid. J Chemother. 1989;1(4)(suppl):746-747.[PubMed 16312619]
Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: 2020 report. Published 2020. Accessed February 26, 2020. https://goldcopd.org/wp-content/uploads/2019/12/GOLD-2020-FINAL-ver1.2-03Dec19_WMV.pdf
Gupta K, Hooton TM, Naber KG, et al; Infectious Diseases Society of America; European Society for Microbiology and Infectious Diseases. International clinical practice guidelines for the treatment of acute uncomplicated cystitis and pyelonephritis in women: a 2010 update by the Infectious Diseases Society of America and the European Society for Microbiology and Infectious Diseases. Clin Infect Dis. 2011;52(5):e103-e120.[PubMed 21292654]
Harper M. Clinical manifestations and initial management of bite wounds. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 8, 2018.
Harris AM, Hicks LA, Qaseem A; High Value Care Task Force of the American College of Physicians and for the Centers for Disease Control and Prevention. Appropriate antibiotic use for acute respiratory tract infection in adults: advice for high-value care from the American College of Physicians and the Centers for Disease Control and Prevention. Ann Intern Med. 2016;164(6):425-434. doi: 10.7326/M15-1840.[PubMed 26785402]
Hooton TM, Scholes D, Gupta K, Stapleton AE, Roberts PL, Stamm WE. Amoxicillin-clavulanate vs ciprofloxacin for the treatment of uncomplicated cystitis in women: a randomized trial. JAMA 2005;293(8):949-955. doi:10.1001/jama.293.8.949.[PubMed 15728165]
Hooton T, Kalpana G. Acute uncomplicated cystitis in women. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 22, 2018a.
Hooton TM, Gupta K. Acute complicated urinary tract infection (including pyelonephritis) in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed March 27, 2018b.
Hum SW, Shaikh KJ, Musa SS, Shaikh N. Adverse events of antibiotics used to treat acute otitis media in children: a systematic meta-analysis. J Pediatr. 2019;215:139-143.e7.[PubMed 31561959]
Ito S. Drug therapy for breast-feeding women. N Engl J Med. 2000;343(2):118-126.[PubMed 10891521]
Johnson JR, Russo TA. Acute pyelonephritis in adults [published correction appears in N Engl J Med. 2018;378(11):1069]. N Engl J Med. 2018;378(1):48-59.[PubMed 29298155]
Kern WV, Cometta A, De Bock R, Langenaeken J, Paesmans M, Gaya H. Oral versus intravenous empirical antimicrobial therapy for fever in patients with granulocytopenia who are receiving cancer chemotherapy. International Antimicrobial Therapy Cooperative Group of the European Organization for Research and Treatment of Cancer. N Engl J Med. 1999;341(5):312-318.[PubMed 10423465]
Kern WV, Marchetti O, Drgona L, et al. Oral antibiotics for fever in low-risk neutropenic patients with cancer: a double-blind, randomized, multicenter trial comparing single daily moxifloxacin with twice daily ciprofloxacin plus amoxicillin/clavulanic acid combination therapy—EORTC Infectious Diseases Group trial XV. J Clin Oncol. 2013;31(9):1149-1156. doi: 10.1200/JCO.2012.45.8109.[PubMed 23358983]
Lepelletier D, Pinaud V, Le Conte P, et al; French PTA Study Group. Peritonsillar abscess (PTA): clinical characteristics, microbiology, drug exposures and outcomes of a large multicenter cohort survey of 412 patients hospitalized in 13 French university hospitals. Eur J Clin Microbiol Infect Dis. 2016;35(5):867-873. doi: 10.1007/s10096-016-2609-9.[PubMed 26942743]
Lieberthal AS, Carroll AE, Chonmaitree T, et al. The diagnosis and management of acute otitis media [published correction appears in Pediatrics. 2014;133(2):346]. Pediatrics. 2013;131(3):e964-e999.[PubMed 23439909]
Limb CJ, Lustig LR, Durand ML. Acute otitis media in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 6, 2019.
Lipsitz R, Garges S, Aurigemma R, et al. Workshop on treatment of and postexposure prophylaxis for Burkholderia pseudomallei and B. mallei Infection, 2010. Emerg Infect Dis. 2012;18(12):e2.[PubMed 23171644]
Lipsky BA, Itani K, Norden C; Linezolid Diabetic Foot Infections Study Group. Treating foot infections in diabetic patients: a randomized, multicenter, open-label trial of linezolid versus ampicillin-sulbactam/amoxicillin-clavulanate. Clin Infect Dis. 2004;38(1):17-24.[PubMed 14679443]
Lipsky BA, Berendt AR, Cornia PB, et al; Infectious Diseases Society of America. 2012 Infectious Diseases Society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Clin Infect Dis. 2012;54(12):e132-173.[PubMed 22619242]
Llor C, Moragas A, Hernández S, Bayona C, Miravitlles M. Efficacy of antibiotic therapy for acute exacerbations of mild to moderate chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2012;186(8):716-723.[PubMed 22923662]
Lucasti C, Jasovich A, Umeh O, Jiang J, Kaniga K, Friedland I. Efficacy and tolerability of IV doripenem versus meropenem in adults with complicated intra-abdominal infection: a phase III, prospective, multicenter, randomized, double-blind, noninferiority study. Clin Ther. 2008;30(5):868-883. doi: 10.1016/j.clinthera.2008.04.019.[PubMed 18555934]
Mandell LA, Wunderink RG, Anzueto A, et al; Infectious Diseases Society of America; American Thoracic Society. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007;44(suppl 2):S27-S72.[PubMed 17278083]
Mahakit P, Vicente JG, Butt DI, Angeli G, Bansal S, Zambrano D. Oral clindamycin 300 mg BID compared with oral amoxicillin/clavulanic acid 1 g BID in the outpatient treatment of acute recurrent pharyngotonsillitis caused by group a beta-hemolytic streptococci: an international, multicenter, randomized, investigator-blinded, prospective trial in patients between the ages of 12 and 60 years. Clin Ther. 2006;28(1):99-109.[PubMed 16490583]
Mazuski JE, Tessier JM, May AK, et al. The Surgical Infection Society revised guidelines on the management of intra-abdominal infection. Surg Infect (Larchmt). 2017;18(1):1-76. doi: 10.1089/sur.2016.261.[PubMed 28085573]
Metlay JP, Waterer GW, Long AC, et al. Diagnosis and treatment of adults with community-acquired pneumonia. An official clinical practice guideline of the American Thoracic Society and Infectious Diseases Society of America. Am J Resp Crit Care Med. 2019;200(7):e45-e67. doi:10.1164/rccm.201908-1581ST.[PubMed 31573350]
Mira E, Benazzo M. A multicenter study on the clinical efficacy and safety of roxithromycin in the treatment of ear-nose-throat infections: comparison with amoxycillin/clavulanic acid. J Chemother. 2001;13(6):621-627.[PubMed 11806623]
Mora Lopez L, Serra Pla S, Serra-Aracil X, Ballesteros E, Navarro S. Application of a modified Neff classification to patients with uncomplicated diverticulitis. Colorectal Dis. 2013;15(11):1442-1447. doi: 10.1111/codi.12449.[PubMed 24192258]
Osmon DR, Berbari EF, Berendt AR, et al, “Diagnosis and Management of Prosthetic Joint Infection: Clinical Practice Guideline by the Infectious Diseases Society of America,” Clin Infect Dis, 2013, 56(1):e1-25.[PubMed 23223583]
Patel ZM, Hwang PH. Uncomplicated acute sinusitis and rhinosinusitis in adults: treatment. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed October 24, 2018.
Pemberton JH. Acute colonic diverticulitis: medical management. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 8, 2018.
Pherwani N, Ghayad JM, Holle LM, Karpiuk EL. Outpatient management of febrile neutropenia associated with cancer chemotherapy: risk stratification and treatment review. Am J Health Syst Pharm. 2015;72(8):619-613.[PubMed 25825185]
Reed MD, "Clinical Pharmacokinetics of Amoxicillin and Clavulanate," Pediatr Infect Dis J, 1996, 15(10):949-54.[PubMed 8895939]
Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, et al. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015;152(2)(suppl):S1-S39. doi: 10.1177/0194599815572097.[PubMed 25832968]
Sethi S, Murphy TF. Management of infection in exacerbations of chronic obstructive pulmonary disease. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 11, 2020.
Shulman ST, Bisno AL, Clegg HW, et al; Infectious Diseases Society of America. Clinical practice guideline for the diagnosis and management of group A streptococcal pharyngitis: 2012 update by the Infectious Diseases Society of America [published correction appears in Clin Infect Dis. 2014;58(10):1496]. Clin Infect Dis. 2012;55(10):e86-e102.[PubMed 22965026]
Solomkin JS, Mazuski JE, Bradley JS, et al. Diagnosis and management of complicated intra-abdominal infection in adults and children: guidelines by the Surgical Infection Society and the Infectious Diseases Society of America [published correction appears in Clin Infect Dis. 2010;50(12):1695]. Clin Infect Dis. 2010;50(2):133-164. doi: 10.1086/649554.[PubMed 20034345]
Sowerby LJ, Hussain Z, Husein M. The epidemiology, antibiotic resistance and post-discharge course of peritonsillar abscesses in London, Ontario. J Otolaryngol Head Neck Surg. 2013;42:5. doi: 10.1186/1916-0216-42-5.[PubMed 23663820]
Stevens DL, Bisno AL, Chambers HF, et al; Infectious Diseases Society of America. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America. Clin Infect Dis. 2014;59(2):e10-e52. doi: 10.1093/cid/ciu444.[PubMed 24973422]
Subcommittee on Urinary Tract Infection, Steering Committee on Quality Improvement and Management, Roberts KB. Urinary tract infection: clinical practice guideline for the diagnosis and management of the initial UTI in febrile infants and children 2 to 24 months. Pediatrics. 2011;128(3):595-610.[PubMed 21873693]
Takase Z, Shirafuji H, Uchida M. Clinical and Laboratory Studies on BRL25000 (Clavulanic acid-amoxicillin) in the field of obstetrics and gynecology. Japanese Journal of Chemotherapy 1982;30(Suppl 2):579-586.
Tancawan AL, Pato MN, Abidin KZ, et al. Amoxicillin/clavulanic acid for the treatment of odontogenic infections: a randomised study comparing efficacy and tolerability versus clindamycin [published online August 2, 2015]. Int J Dent. doi: 10.1155/2015/472470.[PubMed 26300919]
Taplitz RA, Kennedy EB, Bow EJ, et al. Outpatient management of fever and neutropenia in adults treated for malignancy: American Society of Clinical Oncology and Infectious Diseases Society of America clinical practice guideline update. J Clin Oncol. 2018;36(14):1443-1453. doi: 10.1200/JCO.2017.77.6211.[PubMed 29461916]
Todd PA and Benfield P, "Amoxicillin/Clavulanic Acid. An Update of Its Antibacterial Activity, Pharmacokinetic Properties and Therapeutic Use," Drugs, 1990, 39(2):264-307.[PubMed 2184003]
Tsang KW, Bilton D. Clinical challenges in managing bronchiectasis. Respirology. 2009;14(5):637-650. doi: 10.1111/j.1440-1843.2009.01569.x.[PubMed 19659645]
Tu YH, Stiles ML, Allen LV Jr, et al, “Stability of Amoxicillin Trihydrate-Potassium Clavulanate in Original Containers and Unit Dose Oral Syringes,” Am J Hosp Pharm, 1988, 45(5):1092-9.[PubMed 3400652 ]
Wald ER, Applegate KE, Bordley C, et al; American Academy of Pediatrics. Clinical practice guideline for the diagnosis and management of acute bacterial sinusitis in children aged 1 to 18 years. Pediatrics. 2013;132(1):e262-e280.[PubMed 23796742]
Wald ER. Peritonsillar cellulitis and abscess. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed October 9, 2019.
Weber DJ, Tolkoff-Rubin NE, and Rubin RH, "Amoxicillin and Potassium Clavulanate: An Antibiotic Combination. Mechanism of Action, Pharmacokinetics, Antimicrobial Spectrum, Clinical Efficacy and Adverse Effects," Pharmacotherapy, 1984, 4(3):122-36.[PubMed 6739312]
Weintrob AC, Sexton DJ. Clinical manifestations, diagnosis, and management of diabetic infections of the lower extremities. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed September 7, 2018.
Wilson R, Anzueto A, Miravitlles M, et al. Moxifloxacin versus amoxicillin/clavulanic acid in outpatient acute exacerbations of COPD: MAESTRAL results [published correction appears in Eur Respir J. 2012;40(3):800]. Eur Respir J. 2012;40(1):17-27. doi: 10.1183/09031936.00090311.[PubMed 22135277]
World Health Organization (WHO). WHO Model Prescribing Information: Drugs Used in Bacterial Infections. Geneva, Switzerland: World Health Organization; 2001. http://apps.who.int/medicinedocs/pdf/s5406e/s5406e.pdf. Accessed November 6, 2018.
World Health Organization (WHO). Breastfeeding and maternal medication, recommendations for drugs in the Eleventh WHO Model List of Essential Drugs. 2002. Available at http://www.who.int/maternal_child_adolescent/documents/55732/en/.
Wynn RL and Bergman SA, “Antibiotics and Their Use in the Treatment of Orofacial Infections, Part I and Part II,” Gen Dent, 1994, 42(5):398-402, 498-502.[PubMed 7489869]
Brand Names: International
Acarbixin (MX); Aclam (ID); Aclav (PH); Addex (PH); Alvoclav (SG); Ambilan (CL); Amiclav (ID); AMK (HK, TH); Amobay Cl (MX); Amocla (KR); Amoclan (AE, BH, CY, IQ, IR, JO, KW, LB, LY, OM, SA, SY, TW, YE); Amoclane (BE); Amoclav (DE, IE); Amoksiclav (CN, TH); Amoksixlav (LV); Amotin 1000 (TH); Amoxi Plus (PY); Amoxic Comp (IS); Amoxiclav (BE, LU, MX); Amoxiclav-BID (MX); Amoxiclav-Teva (IL); Amoxicle (KR); Amoxxlin (KR); Amoxyclav (IL); An Qi (CN); Augamox (AE, CY, IQ, IR, JO, KW, LB, LY, OM, SA, SY, YE); AugMaxcil (ZA); Augmentan (DE); Augmentin (AE, AT, AU, BB, BE, BF, BG, BH, BJ, BM, BS, BZ, CH, CI, CN, CR, CY, CZ, EC, EE, EG, ES, ET, FI, FR, GB, GH, GM, GN, GR, GT, GY, HK, HN, HR, HU, IE, IL, IN, IQ, IR, IS, IT, JM, JO, JP, KE, KR, KW, LB, LK, LR, LT, LU, LV, LY, MA, ML, MR, MT, MU, MW, MX, MY, NE, NG, NI, NL, NZ, OM, PA, PE, PK, PL, PT, QA, RO, RU, SA, SC, SD, SI, SK, SL, SN, SR, SV, SY, TH, TN, TR, TT, TZ, UA, UG, UY, VE, VN, YE, ZA, ZM, ZW); Augmentin ES (IL); Augmentin SR (TH); Augmentine (ES); Augmex (VN); Auspilic (ID); Bactiv (PH); Bactoclav (PH, TH); Betaclav (LV); Bioclavid (AE, CY, DE, DK, IQ, IR, JO, KW, LB, LY, OM, PH, SA, SE, SY, YE); Bioclavid Forte (PH); Capsinat (ID); Cavumox (MY, TH); Clacillin Duo Dry Syrup (KR); Clamentin (ZA); Claminat (VN); Clamixin (ID); Clamovid (HK, MY, SG); Clamox (BD); Clamoxin (MX); Clamoxneo (KR); Clamoxyl Duo 400 (AU); Claneksi (ID, PH); Claneksi Forte (ID); Claudia (UA); Clav-K (LK); Clavam (LK, ZW); Clavamel (IE); Clavamox (CH, DE, ID, IN, JP); Clavant (MX); Clavar (AE, CY, IQ, IR, JO, KW, LB, LY, OM, SA, SY, YE); Claventin (IL); Clavicin (MY); Clavinex (CL, EC); Clavipen (MX); Clavmentin (PH); Clavmex (PH); Clavodar (AE, BH, CY, IQ, IR, JO, KW, LB, LY, OM, SA, SY, YE); Clavotec (LK); Clavoxil (BR); Clavucyd (MX); Clavulin (BF, BJ, CI, CO, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, MX, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW); Clavulin C (CR, DO, GT, HN, NI, PA, SV); Clavulox Duo (AR, PY); Clavumox (DE, PE, ZA); Clavuser (MX); Coklav (TH); Comxicla (PH); Cosmox (PH); Cosmox 457 (PH); Coyarin (ID); Cramon Duo (KR); Cramotin (KR); Crasigen Duo (KR); Curam (AE, AU, BH, CO, EG, ET, HK, JO, KW, LB, LK, MY, PE, SA, SG, TH, TW, TZ, VN); Danoclav (ID); Darzitil Plus (AR); Duonasa (ES); E-Moxclav (AE, CY, IQ, IR, JO, KW, LB, LY, OM, SA, SY, YE); Enhancin (ET, LK, PH, ZW); Fengkelin (CN); Fleming (HK, TH, VN); Fullicilina Plus (AR); GA-Amclav (AU); Genclav (PH); Germentin (IE); Gimaclav (MX); Haikela (CN); Hibiotic (AE, CY, IQ, IR, JO, KW, LB, LY, OM, SA, SY, YE); Ind Clav (TH); Julmentin (QA, TH); Klamonex (KR); Klamos Forte (ET); Klavic (PH); Kmoxilin (KR); Koact (SG); Koakt (UA); Lansiclav (ID); Lox (PH); Luvmox (PH); Moxiclav (AE, BF, BJ, CI, CY, ET, GH, GM, GN, IE, IQ, IR, JO, KE, KW, LB, LR, LY, MA, ML, MR, MU, MW, NE, NG, OM, QA, SA, SC, SD, SG, SL, SN, SY, TN, TZ, UG, YE, ZM, ZW); Moxicle (TH); Moxilin CV (BD); Moxlin (MX); Myclav (ET, LK, ZW); Natravox (PH); Neoclav (TZ); Novamox (BR); Nufaclav (ID); Penhance (PH); Quali-Mentin (HK); Ranclav (TH, ZA); Riclasip (MX); Servamox (MX); Sheng Ai (CN); Sinufin (MX); Spektramox (SE); Sullivan (PH); Synclav (TZ); Synermox (NZ); Tyclav (BD); Vestaclav (MY); Viaclav (ID); Viamox (PH); Vulamox (ID); Zeniclav (ID)
Last Updated 4/11/20