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تعداد ایتم قابل مشاهده باقیمانده : 4 مورد

Amoxicillin and clavulanate: Drug information

Amoxicillin and clavulanate: Drug information
(For additional information see "Amoxicillin and clavulanate: Patient drug information" and see "Amoxicillin and clavulanate: Pediatric drug information")

For abbreviations and symbols that may be used in Lexicomp (show table)
Brand Names: US
  • Augmentin;
  • Augmentin ES-600;
  • Augmentin XR [DSC]
Brand Names: Canada
  • Amoxi-Clav [DSC];
  • APO-Amoxi Clav;
  • Clavulin;
  • Clavulin-125F;
  • Clavulin-250F;
  • Clavulin-500F;
  • RATIO-Aclavulanate 250F [DSC];
  • RATIO-Aclavulanate [DSC];
  • RATIO-Aclavulanate-125F [DSC];
  • SANDOZ Amoxi-Clav
Pharmacologic Category
  • Antibiotic, Penicillin
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.

IV [Canadian product]: 1 g every 8 hours or 2 g every 8 to 12 hours; surgical prophylaxis: 1 to 2 g at induction of anesthesia for procedures <1 hour (for procedures >1 hour may administer up to 2 additional doses in 24 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 2021a; Baddour 2021b).

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 2021; 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, mild to moderate, community acquired in patients without risk factors for resistance or treatment failure (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):

Note: Some experts suggest deferring antibiotics in otherwise healthy immunocompetent patients with mild disease; however, data on this approach in outpatients are limited (AGA [Stollman 2015]; Desai 2019; Shah 2017; SIS [Mazuski 2017]; van Dijk 2020).

Immediate release: Oral: 875 mg every 8 hours (Biondo 2014; Mora Lopez 2013).

Extended release: Oral: 2 g every 12 hours (Pemberton 2021).

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 2021; Lucasti 2008; SIS [Mazuski 2017]; SIS/IDSA [Solomkin 2010]).

Duration: Total duration of therapy is 4 to 5 days following adequate source control (Sawyer 2015; SIS [Mazuski 2017]); for diverticulitis or uncomplicated appendicitis managed without intervention, duration is 7 to 10 days (Barshak 2021; Pemberton 2021).

Neutropenic fever, low-risk cancer patients (empiric therapy) (off-label use): Oral: Immediate release: 500 mg every 8 hours (Freifeld 1999; Kern 1999) or 875 mg 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 2021).

Duration: 5 to 7 days for mild to moderate infection and 10 days for severe infection (Limb 2021).

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 (Klompas 2021).

Extended release: 2 g twice daily (Klompas 2021).

Duration of therapy: Generally 5 days (Klompas 2021).

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. Reserve antibiotic therapy for poor follow-up or lack of improvement over the observation period (AAO-HNS [Rosenfeld 2015]; ACP/CDC [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 for 5 to 7 days. Note: Recommended for patients at risk for poor outcome or pneumococcal resistance based on the following features: ≥65 years of age, recent hospitalization or antibiotic use, multiple comorbidities, high endemic resistance (AAO-HNS [Rosenfeld 2015]; IDSA [Chow 2012]).

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 (alternative agent):

Note: Use only when first-line agents cannot be used; limited evidence suggests inferior efficacy of oral beta-lactams (Hooton 2021a; IDSA/ESCMID [Gupta 2011]).

Cystitis, acute uncomplicated or acute simple cystitis (infection limited to the bladder without signs/symptoms of upper tract, prostate, or systemic infection) : Oral: Immediate release: 500 mg twice daily (Hooton 2005) for 5 to 7 days (Hooton 2021a; IDSA/ESCMID [Gupta 2011]).

Urinary tract infection, complicated (including pyelonephritis) : Oral: Immediate release: 875 mg twice daily for 10 to 14 days (IDSA/ESCMID [Gupta 2011]; Johnson 2018). Note: Oral beta-lactam therapy should generally follow appropriate parenteral therapy (Hooton 2021b; IDSA/ESCMID [Gupta 2011]).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Renal Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Oral:

Note: Renally adjusted dose recommendations are based on the amoxicillin 250 mg/clavulanate 125 mg and amoxicillin 500 mg/clavulanate 125 mg tablets. Avoid IR 875 mg tablet or ER tablets in patients with CrCl <30 mL/minute.

Altered kidney function: Note: Although the manufacturer's labeling for some products utilizes the term GFR to present dose adjustment cutoffs, pharmacokinetic studies utilized CrCl measurements (Arancibia 1982; Horber 1986; Ksiazek 1983; Lawson 1974).

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl 10 to <30 mL/minute: 250 to 500 mg every 12 hours.

CrCl <10 mL/minute: 250 to 500 mg every 12 to 24 hours (expert opinion; manufacturer's labeling).

Hemodialysis, intermittent (thrice weekly): Dialyzable (30% to 47% [amoxicillin component], 34% [clavulanic acid] with low-flux filters [Davies 1988; Francke 1979]): 250 to 500 mg every 12 to 24 hours (Hui 2017; manufacturer's labeling). If utilizing a 24-hour dosing interval, administer dose after dialysis or give an additional dose after dialysis on dialysis days.

Peritoneal dialysis: 250 to 500 mg every 12 hours (expert opinion).

IV [Canadian product]: Note: Dose based on amoxicillin component.

Altered kidney function:

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl 10 to 30 mL/minute: Initial: 1 g followed by 500 mg every 12 hours.

CrCl <10 mL/minute: Initial: 1 g followed by 500 mg every 12 to 24 hours (expert opinion).

Hemodialysis, intermittent (thrice weekly): Dialyzable (30% to 47% [amoxicillin component] with low-flux filters [Davies 1988; Francke 1979]): Initial: 1 g followed by 500 mg every 12 to 24 hours. If utilizing a 24-hour dosing interval, administer dose after dialysis or give an additional 500 mg dose after dialysis on dialysis days (expert opinion; manufacturer's labeling).

Peritoneal dialysis: Initial: 1 g followed by 500 mg every 12 hours (expert opinion).

Dosing: Hepatic Impairment: Adult

Oral, IV [Canadian product]: 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

(For additional information see "Amoxicillin and clavulanate: Pediatric drug information")

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).

IV dosing (Canadian labeling; not available in US):

Note: Choice of formulation depends upon desired dosages of amoxicillin and clavulanate; for higher daily doses of amoxicillin (as may be used in the empiric coverage of Streptococcus pneumoniae), the 10:1 formulation is preferred to avoid unnecessary high clavulanate exposure.

5:1 formulation:

Infants <3 months or weighing <4 kg: IV: 25 mg amoxicillin/kg/dose every 12 hours.

Infants ≥3 months weighing ≥4 kg, Children, and Adolescents: IV: 25 mg amoxicillin/kg/dose every 8 hours; maximum dose: 1,000 mg amoxicillin/dose.

10:1 formulation:

Infants <3 months or weighing <4 kg: IV: 50 mg amoxicillin/kg/dose every 12 hours.

Infants ≥3 months, Children, and Adolescents weighing 4 to <40 kg: 50 mg amoxicillin/kg/dose every 8 hours; maximum dose: 2,000 mg amoxicillin/dose.

Children and Adolescents weighing ≥40 kg: 2,000 mg amoxicillin every 8 to 12 hours.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Renal Impairment: Pediatric

Oral:

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):

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.

IV [Canadian product]:

5:1 formulation:

Infants, Children, and Adolescents weighing <40 kg:

CrCl >30 mL/minute: No dosage adjustment necessary.

CrCl 10 to 30 mL/minute: 25 mg amoxicillin/kg every 12 hours.

CrCl <10 mL/minute: 25 mg amoxicillin/kg every 24 hours.

Hemodialysis: 25 mg amoxicillin/kg every 24 hours; give an additional dose of 12.5 mg amoxicillin/kg at the end of each dialysis session.

Children and Adolescents weighing ≥40 kg:

CrCl >30 mL/minute: No dosage adjustment necessary.

CrCl 10 to 30 mL/minute: 1,000 mg amoxicillin followed by 500 mg amoxicillin every 12 hours.

CrCl <10 mL/minute: 1,000 mg amoxicillin followed by 500 mg amoxicillin every 24 hours.

Hemodialysis: 1,000 mg amoxicillin followed by 500 mg amoxicillin every 24 hours; give an additional 500 mg at the end of each dialysis session.

10:1 formulation:

Infants, Children, and Adolescents:

CrCl >30 mL/minute: No dosage adjustment necessary.

CrCl <30 mL/minute: Use not recommended due to lack of data; preferred formulation is 5:1 with this level of kidney impairment.

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.

Dosing: Geriatric

Refer to adult dosing.

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 [DSC], 150 mL [DSC]); Amoxicillin 125 mg and clavulanate potassium 31.25 mg per 5 mL (75 mL [DSC], 100 mL [DSC], 150 mL [DSC]) [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

Generic Equivalent Available: US

Yes

Dosage Forms Considerations

IV [Canadian product]: 500 mg, 1 g, and 2 g vials contain 31.4 mg (1.4 mmoL), 62.9 mg (2.7 mmoL), and 125.9 mg (5.5 mmoL) of sodium and 19.6 (0.5 mmoL), 39.3 mg (1 mmoL) and 39.3 mg (1 mmoL) of potassium, respectively.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution Reconstituted, Intravenous:

Generic: Amoxicillin 1000 mg and clavulanate potassium 200 mg (1 ea); Amoxicillin 2000 mg and clavulanate potassium 200 mg (1 ea); Amoxicillin 500 mg and clavulanate potassium 100 mg (1 ea)

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 ([DSC]); 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

Administration: Adult

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.

IV [Canadian product]: Administer by slow IV injection over 3 to 4 minutes (1 g dose only) or as an infusion over 30 to 40 minutes.

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.

IV [Canadian product]: Administer as an infusion over 30 to 40 minutes. In infants ≥3 months, children, and adolescents, 5:1 formulations (500/100 mg and 1,000/200 mg) may also be administered by slow IV injection over 3 to 4 minutes.

Use: Labeled Indications

Oral:

Otitis media, acute:

IR 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 Haemophilus influenzae and Moraxella catarrhalis.

Oral suspension (600/42.9 mg per 5 mL concentration): Treatment of acute otitis media, recurrent or persistent, caused by Streptococcus 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 of age or attend day care.

Pneumonia:

ER tablets only: Treatment of patients with community-acquired pneumonia (CAP) caused by confirmed or suspected beta-lactamase–producing pathogens (ie, H. influenzae, M. catarrhalis, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus) and S. 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 (limited data).

IR 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:

ER 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 (limited data).

IR 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: IR 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 infection: IR 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 infection caused by beta-lactamase–producing strains of E. coli, Klebsiella spp, and Enterobacter spp.

IV [Canadian product]: Treatment of severe upper respiratory infections, chronic bronchitis (acute exacerbation), CAP, cystitis, pyelonephritis, skin and soft tissue infections, osteomyelitis, intra-abdominal infections, and female genital infections caused by susceptible organisms in adults and pediatric patients; surgical prophylaxis in procedures involving the GI tract, pelvic cavity, head and neck, or biliary tract in adults.

Use: Off-Label: Adult

Bite wound, prophylaxis or treatment (animal or human bite); Bronchiectasis, acute exacerbation; Chronic obstructive pulmonary disease, acute exacerbation; Diabetic foot infection; Intra-abdominal infection, mild to moderate, community acquired in patients without risk factors for resistance or treatment failure; Neutropenic fever, low-risk cancer patients (empiric therapy); Odontogenic infection; Peritonsillar cellulitis or abscess; Streptococcus (group A), chronic carriage

Medication Safety Issues
Sound-alike/look-alike issues:

Augmentin may be confused with amoxicillin, Azulfidine

Adverse Reactions (Significant): Considerations
Clostridioides difficile infection

Clostridioides difficile infection (CDI) has occurred, includingClostridioides difficile associated diarrhea and Clostridioides difficile colitis. (Ref)

Onset: Varied; may start on the first day of antibiotic therapy or up to 3 months postantibiotic (Ref).

Risk factors:

• Antibiotic exposure (highest risk factor), especially prolonged use (Ref)

• Type of antibiotic (penicillin combination antibiotics, including amoxicillin and clavulanate, have been associated with increased risk) (Ref)

• Long durations in a hospital or other healthcare setting (recent or current) (Ref)

• Older adults (Ref)

• Immunocompromised conditions (Ref)

• A serious underlying condition (Ref)

• GI surgery/manipulation (Ref)

• Antiulcer medications (eg, proton pump inhibitors and H2 blockers) (Ref)

• Chemotherapy (Ref)

• In pediatric patients, community-acquired CDI was associated with amoxicillin/clavulanate, cephalosporins, or clindamycin use in the prior 12 weeks, as well as non-Hispanic race, more health care visits, and prior positive Clostridioides difficile test in the past 6 months (Ref).

Diarrhea

Antibiotic-associated diarrhea (AAD) ranges from "nuisance diarrhea" (frequent loose and watery stools with no other complications) to colitis in adult and pediatric patients (Ref). Most cases of AAD are mild and self-limiting (Ref). However, Clostridioides difficile may account for nearly one-third of cases (discussed separately) (Ref).

Mechanism: In addition to antibiotic disruption of indigenous gut microbiota, clavulanic acid appears to stimulate small-bowel motility (Ref).

Onset: Varied; mean time to onset of AAD is 3 to 18 days for adult patients and 2 to 6 days for pediatric patients. The majority of AAD cases occur during (versus after) antibiotic therapy in pediatric patients (Ref).

Risk factors:

• More common with amoxicillin/clavulanic acid than with amoxicillin or ampicillin alone (Ref)

• More frequent dosing (eg, 3 times daily versus twice daily) and higher amounts of clavulanic acid (eg, high-dose amoxicillin/clavulanate) may increase risk in pediatric patients (Ref)

• Length of therapy (Ref)

• Age (pediatric patients 1 to 2 years of age and older adults) (Ref)

• Length of hospitalization (Ref)

• Duration of proton pump inhibitor use (Ref)

Drug-induced liver injury

Although rarely fatal, drug-induced liver injury has been reported. The most frequent presentation is cholestatic hepatitis (Ref). Most patients recover after drug discontinuation, but there are reports of death or patients who require liver transplantation (Ref)

Mechanism: Non-dose-related; primarily immunologic, mediated by T-cells (Ref). Genetic variation at human leukocyte antigen class I & II loci has been shown to be associated with amoxicillin/clavulanic acid induced liver jury (Ref). Unknown whether the liver injury is due to amoxicillin or clavulanic acid or both (Ref).

Onset: Variable; most cases occur within 12 weeks after initial drug exposure (Ref).

Risk factors:

• Older male patients, most often of Caucasian race, are at greater risk (Ref)

• Serious underlying disease

• Concomitant medications (Ref)

• Repeated courses of therapy (Ref)

Hypersensitivity (immediate and delayed)

Immediate, including urticaria, angioedema and anaphylaxis (Ref), and delayed hypersensitivity reactions have been reported in all ages (Ref). Delayed hypersensitivity reactions range from maculopapular skin rash to rare severe cutaneous adverse reactions (SCARs), including acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, and toxic epidermal necrolysis in all ages (Ref).

Mechanism: Non-dose-related; immunologic. Immediate hypersensitivity reactions (eg, anaphylaxis, urticaria) are IgE-mediated. Delayed hypersensitivity reactions, including maculopapular rash and SCARs are T-cell-mediated (Ref). In patients with reactions to amoxicillin/clavulanic acid, the reaction can be mediated by the amoxicillin or clavulanic acid component (Ref), or some patients may be sensitized independently to both amoxicillin and clavulanic acid (Ref). Approximately 30% of patients have selective reactions to clavulanic acid (Ref).

Onset: Immediate hypersensitivity reactions: Rapid; generally occur within 1 hour of administration but may occur up to 6 hours after exposure (Ref). Delayed hypersensitivity reactions: Maculopapular reactions: Intermediate; occur 7 to 10 days after initiation. Other reactions (including SCARs): Variable; occur after 7 to 14 days up to 3 months) (Ref) .

Risk factors:

• Rash may develop in 9% to 23% of patients with Epstein-Barr virus (EBV) infection (infectious mononucleosis) who are not on antibiotics. Although previous studies indicated that concomitant administration of an aminopenicillin, specifically ampicillin or amoxicillin, may increase the risk of rash in these patients, more recent studies suggest that amoxicillin/clavulanic acid may not increase the risk of rash. In one study, 12.5% of EBV-infected patients who used amoxicillin/clavulanic acid developed a rash (Ref).

• Cross-reactivity between beta-lactams (related to side chain similarity) (Ref). No cross-reactivity reported between clavulanic acid and penicillins, likely due to differences in chemical structures (Ref).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Gastrointestinal: Diarrhea (3% to 34%)

1% to 10%:

Dermatologic: Candidal diaper rash (4% to 6%), diaper rash (4%), skin rash (≤3%), urticaria (≤3%)

Gastrointestinal: Nausea (2% to 3%), vomiting (1% to 2%)

Genitourinary: Vaginitis (1%)

Infection: Candidiasis (1%), vaginal mycosis (3%)

<1%:

Gastrointestinal: Abdominal distress, flatulence

Hematologic & oncologic: Thrombocythemia

Nervous system: Headache

Postmarketing:

Cardiovascular: Hypersensitivity angiitis

Dermatologic: Acute generalized exanthematous pustulosis (Hioki 2019), bullous dermatitis (linear IgA) (Panasiti 2009), erythema multiforme, exfoliative dermatitis (Barni 2018), fixed drug eruption (Perez-Ezquerra 2010), pruritus, Stevens-Johnson syndrome (Mori 2017), toxic epidermal necrolysis (Rodriguez-Martin 2019)

Gastrointestinal: Clostridioides difficile associated diarrhea (Brown 2020; Slimings 2014), Clostridioides difficile colitis, dyspepsia, enterocolitis, gastritis, glossitis, hemorrhagic colitis (Youn 2018), melanoglossia, mucocutaneous candidiasis, staining of tooth (Garcia-Lopez 2001), stomatitis

Genitourinary: Crystalluria (van Noord 2012), hematuria

Hematologic & oncologic: Agranulocytosis (Armas Villalba 2019), anemia, eosinophilia, hemolytic anemia, immune thrombocytopenia, leukopenia, thrombocytopenia (Mansour 2014)

Hepatic: Cholestatic hepatitis (Chalasani 2014; deLemos 2016), hepatocellular hepatitis (Chalasani 2014; deLemos 2016)

Hypersensitivity: Anaphylaxis, angioedema, serum sickness-like reaction (Patterson-Fortin 2016)

Immunologic: Drug reaction with eosinophilia and systemic symptoms (van Kester 2018)

Nervous system: Agitation, anxiety, behavioral changes (Macknin 1987), confusion, dizziness, hyperactive behavior (reversible), insomnia, myoclonus (Viloria-Alebesque 2020)

Renal: Interstitial nephritis

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 (CrCl <30 mL/minute) and hemodialysis patients.

Canadian labeling: Additional contraindications (not in the US labeling): Oral: Suspected or confirmed mononucleosis.

Warnings/Precautions

Concerns related to adverse effects:

• Superinfection: Prolonged use may result in fungal or bacterial superinfection.

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.

Metabolism/Transport Effects

None known.

Drug 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

Aminoglycosides: Penicillins may decrease the serum concentration of Aminoglycosides. Primarily associated with extended spectrum penicillins, and patients with renal dysfunction. 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: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification

Vitamin K Antagonists (eg, warfarin): Penicillins may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy

Pregnancy Considerations

Both amoxicillin and clavulanic acid cross the placenta (Muller 2009; Weber 1984). An increased risk of necrotizing enterocolitis in neonates or bowel disorders in children may be associated with amoxicillin/clavulanate when exposure occurs near delivery (Kenyon 2001).

Oral ampicillin-class antibiotics are poorly absorbed during labor. Clavulanate does not appear to influence maternal amoxicillin pharmacokinetics following IV administration of amoxicillin/clavulanate prior to delivery (Muller 2009).

As a class, penicillin antibiotics are widely used in pregnant women. Based on available data, penicillin antibiotics are generally considered compatible for use during pregnancy (Ailes 2016; Bookstaver 2015; Crider 2009; Damkier 2019; Lamont 2014; Muanda 2017a; Muanda 2017b).

Untreated urinary tract infections (UTI) during pregnancy are associated with an increased risk of developing pyelonephritis, low birth weight, and preterm labor. Amoxicillin/clavulanate may be an option for the treatment of UTI during pregnancy (Betschart 2020; de Rossi 2020; IDSA [Nicolle 2019]; Usta 2011).

Antibiotics are used in the management of preterm prelabor rupture of membranes (PROM) to prolong pregnancy and reduce the risk of infection. However, due to the possible increased risk of necrotizing enterocolitis, amoxicillin/clavulanate is not recommended for this indication (ACOG 217 2020).

Amoxicillin/clavulanate is considered compatible for the of treatment airway diseases in pregnant women. Use should be avoided in women at risk for preterm delivery (due to association with necrotizing enterocolitis) (ERS/TSANZ [Middleton 2020]).

The routine use of antibiotics prior to an operative vaginal delivery (vacuum or forceps delivery) is not currently recommended. However, amoxicillin/clavulanate IV administered after an operative vaginal delivery may decrease the risk of a maternal infection occurring within 6 weeks postpartum. A single dose may be appropriate in specific cases (Knight 2019; Liabsuetrakul 2020).

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).

The RID of amoxicillin was calculated using a milk concentration of 0.12 mcg/mL, providing an estimated daily infant dose via breast milk of 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).

A group of 14 breastfeeding mothers taking amoxicillin/clavulanate were given a specially designed record sheet to monitor possible antibiotic-induced side effects in their infants for 15 days postdelivery. These infants were compared to a control group of 45 breastfed infants whose mothers were not taking antibiotics. There were no significant differences between the groups (Campbell 1991). 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).

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.

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

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 and Pharmacokinetics

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)

Pharmacodynamics and Pharmacokinetics: Additional Considerations

Anti-infective considerations:

Parameters associated with efficacy:

Amoxicillin: Refer to Amoxicillin monograph.

Clavulanate (in combination with amoxicillin): Not defined.

Expected drug exposure in normal renal function:

Pediatric patients, Cmax (peak):

Oral suspension (4:1 ratio); single dose:

Children 2 to 5 years of age: Amoxicillin 125 mg/clavulanate 31.25 mg per 5 mL: Mean dose amoxicillin 9.11 ± 1.83 mg/kg: Amoxicillin 3.45 ± 1.14 mg/L; clavulanate: 1.18 ± 0.63 mg/L (van Niekerk 1985).

Children 6 to 10 years of age: Amoxicillin 250 mg/clavulanate 62.5 mg per 5 mL: Mean dose amoxicillin 12.35 ± 3.11 mg/kg: Amoxicillin: 4 ± 1.65 mg/L; clavulanate: 1.31 ± 0.79 mg/L (van Niekerk 1985).

Oral suspension (14:1 ratio), amoxicillin 600 mg/clavulanate 42.9 mg per 5 mL; steady state:

Infants ≥8 months of age and children ≤11 years of age: Amoxicillin 45 mg/kg/dose every 12 hours: Amoxicillin: 15.7 ± 7.7 mg/L; clavulanate: 1.7 ± 0.9 mg/L.

Oral tablet, extended release; steady state:

Children ≥7 years of age and adolescents ≤15 years of age (weighing ≥40 kg): Amoxicillin 2,000 mg/clavulanate 125 mg every 12 hours: Amoxicillin: 11 ± 3.34 mg/L; clavulanate: 1.17 ± 0.67 mg/L.

IV (5:1 ratio) [Canadian product]; single dose, 2-minute infusion:

Children ≥2 years of age and adolescents ≤14 years of age: Amoxicillin 25 mg/kg/dose: Amoxicillin: 89.4 mg/L; clavulanate: 19.5 mg/L (Schaad 1983).

Adults, Cmax (peak):

Oral tablet; steady state:

Amoxicillin 250 mg/clavulanate 125 mg every 8 hours: Amoxicillin: 3.3 ± 1.12 mg/L; clavulanate: 1.5 ± 0.7 mg/L.

Amoxicillin 500 mg/clavulanate 125 mg every 12 hours: Amoxicillin: 6.5 ± 1.41 mg/L; clavulanate: 1.8 ± 0.61 mg/L.

Amoxicillin 500 mg/clavulanate 125 mg every 8 hours: Amoxicillin: 7.2 ± 2.26 mg/L; clavulanate: 2.4 ± 0.83 mg/L.

Amoxicillin 875 mg/clavulanate 125 mg every 12 hours: Amoxicillin: 11.6 ± 2.78 mg/L; clavulanate: 2.2 ± 0.99 mg/L.

Oral tablet, chewable; single dose:

Amoxicillin 250 mg/clavulanate 62.5 mg: Amoxicillin: 6.9 mg/L; clavulanate: 1.6 mg/L.

Amoxicillin 400 mg/clavulanate 57 mg: Amoxicillin: 6.67 ± 1.37 mg/L; clavulanate: 1.03 ± 0.33 mg/L.

Oral tablet, extended release; single dose:

Amoxicillin 2 g/clavulanate 125 mg: Amoxicillin: 17 ± 4 mg/L; clavulanate: 2.05 ± 0.8 mg/L.

IV [Canadian product]; single dose:

Amoxicillin 500 mg/clavulanate 100 mg, bolus: Amoxicillin: 32.2 mg/L; clavulanate: 10.5 mg/L.

Amoxicillin 1 g/clavulanate 200 mg, bolus: Amoxicillin: 105.4 mg/L; clavulanate: 28.5 mg/L.

Amoxicillin 2 g/clavulanate 200 mg, 30-minute infusion: Amoxicillin: 108 mg/L; clavulanate: 13.9 mg/L.

Postantibiotic effect:

H. influenzae: 0 to <2 hours; S. pneumoniae: 0 to <3 hours; Streptococcus pyogenes: 0 to 3.9 hours; methicillin-susceptible S. aureus: 0 to 2.55 hours; Enterobacterales: 0 to <1 hour (Dubois 2000; Neuhauser 2001; Thorburn 1996).

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): $0.08 - $0.66

Suspension (reconstituted) (Augmentin ES-600 Oral)

600-42.9 mg/5 mL (per mL): $0.81

Suspension (reconstituted) (Augmentin Oral)

250-62.5 mg/5 mL (per mL): $9.79

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.

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)


For country abbreviations used in Lexicomp (show table)

REFERENCES

  1. Agamennone V, Krul CAM, Rijkers G, Kort R. A practical guide for probiotics applied to the case of antibiotic-associated diarrhea in The Netherlands. BMC Gastroenterol. 2018;18(1):103. doi:10.1186/s12876-018-0831-x [PubMed 30078376]
  2. Ailes EC, Gilboa SM, Gill SK, et al. Association between antibiotic use among pregnant women with urinary tract infections in the first trimester and birth defects, National Birth Defects Prevention Study 1997 to 2011. Birth Defects Res A Clin Mol Teratol. 2016;106(11):940-949. doi:10.1002/bdra.23570 [PubMed 27891788]
  3. Akanbi O, Saleem N, Soliman M, Pannu BS. Antibiotic-associated haemorrhagic colitis: not always Clostridium difficile. BMJ Case Rep. 2017;2017:bcr2017219915. doi:10.1136/bcr-2017-219915 [PubMed 28619975]
  4. 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. American Academy of Pediatrics; 2018.
  5. 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. American Academy of Pediatrics; 2012.
  6. American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins-Obstetrics. Prelabor rupture of membranes: ACOG practice bulletin, number 217. Obstet Gynecol. 2020;135(3):e80-e97. doi:10.1097/AOG.0000000000003700 [PubMed 32080050]
  7. Amoxicillin-Clavulanate. LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. https://www.ncbi.nlm.nih.gov/books/NBK548517/. Updated March 30, 2016.
  8. Amoxicillin and clavulanate potassium (powder for oral suspension) [prescribing information]. Memphis, TN: Northstar Rx LLC; December 2018.
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