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Amoxicillin and Clavulanate

Pronunciation

Pronunciation

(a moks i SIL in & klav yoo LAN ate)

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

Dosage Forms

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

Powder for suspension, oral:

Augmentin:

125: Amoxicillin 125 mg and clavulanate potassium 31.25 mg per 5 mL (75 mL, 100 mL, 150 mL) [contains potassium 0.16 mEq/5 mL; banana flavor]

200: Amoxicillin 200 mg and clavulanate potassium 28.5 mg per 5 mL (50 mL, 75 mL, 100 mL) [contains phenylalanine 7 mg/5 mL and potassium 0.14 mEq/5 mL; orange flavor] [DSC]

250: Amoxicillin 250 mg and clavulanate potassium 62.5 mg per 5 mL (75 mL, 100 mL, 150 mL) [contains potassium 0.32 mEq/5 mL; orange flavor]

400: Amoxicillin 400 mg and clavulanate potassium 57 mg per 5 mL (50 mL, 75 mL, 100 mL) [contains phenylalanine 7 mg/5 mL and potassium 0.29 mEq/5 mL; orange flavor] [DSC]

Augmentin ES-600:

600: Amoxicillin 600 mg and clavulanate potassium 42.9 mg per 5 mL (75 mL, 125 mL, 200 mL) [contains phenylalanine 7 mg/5 mL, potassium 0.23 mEq/5 mL; strawberry cream flavor]

Generic: 200: Amoxicillin 200 mg and clavulanate potassium 28.5 mg per 5 mL (50 mL, 75 mL, 100 mL); 250: Amoxicillin 250 mg and clavulanate potassium 62.5 mg per 5 mL (75 mL, 100 mL, 150 mL); 400: Amoxicillin 400 mg and clavulanate potassium 57 mg per 5 mL (50 mL, 75 mL, 100 mL); 600: Amoxicillin 600 mg and clavulanate potassium 42.9 mg per 5 mL (75 mL, 125 mL, 200 mL)

Tablet, oral:

Augmentin:

250: Amoxicillin 250 mg and clavulanate potassium 125 mg [contains potassium 0.63 mEq/tablet] [DSC]

500: Amoxicillin 500 mg and clavulanate potassium 125 mg [contains potassium 0.63 mEq/tablet]

875: Amoxicillin 875 mg and clavulanate potassium 125 mg [contains potassium 0.63 mEq/tablet]

Generic: 250: Amoxicillin 250 mg and clavulanate potassium 125 mg; 500: Amoxicillin 500 mg and clavulanate potassium 125 mg; 875: Amoxicillin 875 mg and clavulanate potassium 125 mg

Tablet, chewable, oral:

Generic: 200: Amoxicillin 200 mg and clavulanate potassium 28.5 mg [contains phenylalanine]; 400: Amoxicillin 400 mg and clavulanate potassium 57 mg [contains phenylalanine]

Tablet, extended release, oral:

Augmentin XR: 1000: Amoxicillin 1000 mg and clavulanate acid 62.5 mg [contains potassium 12.6 mg (0.32 mEq) and sodium 29.3 mg (1.27 mEq) per tablet; packaged in either a 7-day or 10-day package]

Generic: 1000: Amoxicillin 1000 mg and clavulanate acid 62.5 mg

Brand Names: U.S.

  • Augmentin
  • Augmentin ES-600
  • Augmentin XR

Pharmacologic Category

  • Antibiotic, Penicillin

Pharmacology

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.

Excretion

Clavulanic acid: Urine (25% to 40% as unchanged drug)

Time to Peak

Clavulanic acid: Serum: 1.5 hours

Half-Life Elimination

Clavulanic acid: 1 hour

Protein Binding

Clavulanic acid: ~25%

Use: Labeled Indications

Pneumonia, community-acquired: 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).

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; treatment of otitis media caused by beta-lactamase-producing strains of H. influenzae and M. catarrhalis.

Respiratory tract infections, lower: 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.

Sinusitis, 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.

Use: Unlabeled

Chronic antimicrobial suppression of prosthetic joint infection

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

Dosing: Adult

Note: Dose is based on the amoxicillin component; see “Augmentin Product-Specific Considerations" table.

Susceptible infections: Oral: 250 mg every 8 hours or 500 mg every 8 to 12 hours or 875 mg every 12 hours or 2,000 mg every 12 hours

Augmentin Product-Specific Considerations

Strength

Form

Consideration

Legend: CT = chewable tablet, S = suspension, T = tablet, XR = extended release.

125 mg

S

q8h dosing

S

For adults having difficulty swallowing tablets, 125 mg/5 mL suspension may be substituted for 500 mg tablet.

200 mg

CT, S

q12h dosing

CT

Contains phenylalanine

S

For adults having difficulty swallowing tablets, 200 mg/5 mL suspension may be substituted for 875 mg tablet.

250 mg

S, T

q8h dosing

T

Not for use in patients <40 kg; two 250 mg tablets are not equivalent to one 500 mg tablet

S

For adults having difficulty swallowing tablets, 250 mg/5 mL suspension may be substituted for 500 mg tablet.

400 mg

CT, S

q12h dosing

CT

Contains phenylalanine

S

For adults having difficulty swallowing tablets, 400 mg/5 mL suspension may be substituted for 875 mg tablet.

500 mg

T

q8h or q12h dosing

600 mg

S

q12h dosing

Not for use in adults, adolescents, or children ≥40 kg

600 mg/5 mL suspension is not equivalent to or interchangeable with 200 mg/5 mL or 400 mg/5 mL due to differences in clavulanic acid.

875 mg

T

q12h dosing; not for use in CrCl <30 mL/minute

1,000 mg

XR

q12h dosing

Not for use in children or adolescents <40 kg

Not interchangeable with two 500 mg tablets

Not for use if CrCl <30 mL/minute or hemodialysis

Table has been converted to the following text.

Augmentin Product-Specific Considerations

125 mg:

• Suspension:

– q8h dosing

– For adults having difficulty swallowing tablets, 125 mg/5 mL suspension may be substituted for 500 mg tablet.

200 mg:

• Chewable tablet:

– q12h dosing

– Contains phenylalanine

• Suspension:

– q12h dosing

– For adults having difficulty swallowing tablets, 200 mg/5 mL suspension may be substituted for 875 mg tablet.

250 mg:

• Suspension:

– q8h dosing

– For adults having difficulty swallowing tablets, 250 mg/5 mL suspension may be substituted for 500 mg tablet.

• Tablet:

– q8h dosing

– Not for use in patients <40 kg; two 250 mg tablets are not equivalent to one 500 mg tablet

400 mg:

• Chewable tablet:

– q12h dosing

– Contains phenylalanine

• Suspension:

– q12h dosing

– For adults having difficulty swallowing tablets, 400 mg/5 mL suspension may be substituted for 875 mg tablet.

500 mg:

• Tablet: q8h or q12h dosing

600 mg:

• Suspension:

– q12h dosing

– Not for use in adults, adolescents, or children ≥40 kg

– 600 mg/5 mL suspension is not equivalent to or interchangeable with 200 mg/5 mL or 400 mg/5 mL due to differences in clavulanic acid.

875 mg:

• Tablet:

– q12h dosing

– Not for use in Clcr <30 mL/minute

1,000 mg:

• Extended release tablet:

– q12h dosing

– Not for use in children or adolescents <40 kg

– Not interchangeable with two 500 mg tablets

– Not for use if Clcr <30 mL/minute or hemodialysis

Bite wounds (animal/human) (off-label use): Oral: Immediate release: 875 mg every 12 hours (IDSA [Stevens 2014])

Chronic obstructive pulmonary disease (COPD) (off-label use): Oral: Immediate release: 500 mg every 8 hours (Llor 2012)

Impetigo (off-label use): Oral: Immediate release: 875 mg every 12 hours for 7 days, depending on response (IDSA [Stevens 2014])

Pneumonia, community-acquired (CAP): Oral:

Manufacturer’s labeling:

Immediate release: 875 mg every 12 hours or 500 mg every 8 hours

Extended release: 2,000 mg every 12 hours for 7 to 10 days

Alternate dosing:

Outpatient empiric therapy: Extended release: 2,000 mg every 12 hours for a minimum of 5 days (patients should be afebrile for ≥48 hours and clinically stable before discontinuation of therapy); use in combination with a macrolide (preferred) or doxycycline (Mandell 2007)

Prosthetic joint infection, chronic antimicrobial suppression, oxacillin-susceptible Staphylococci (alternative to cephalexin or cefadroxil) (off-label use): Oral: Immediate release: 500 mg 3 times daily (IDSA [Osmon 2013])

Respiratory tract infections, lower: Oral

Immediate release: 875 mg every 12 hours or 500 mg every 8 hours

Sinusitis, acute bacterial: Oral:

Manufacturer’s labeling:

Immediate release: 500 mg every 8 hours or amoxicillin 875 mg every 12 hours

Extended release: Amoxicillin 2,000 mg every 12 hours for 10 days

Alternate dosing: IDSA recommendations:

Standard dose: Immediate release: 500 mg every 8 hours or 875 mg every 12 hours for 5 to 7 days

High dose: Extended release: 2,000 mg every 12 hours for 10 days. Note: Recommended for patients with any of the following: If initial therapy fails (as second-line therapy), in areas with high endemic rates of penicillin-nonsusceptible S. pneumoniae, those with severe infections, age >65 years, recent hospitalization, antibiotic use within the past month, or who are immunocompromised (AAO-HNS [Rosenfeld 2015]; IDSA [Chow 2012]).

Streptococci, group A, chronic carrier treatment (off-label use): Oral: Immediate release: Amoxicillin 40 mg/kg/day divided every 8 hours (maximum: amoxicillin 2,000 mg daily) for 10 days (IDSA [Shulman 2012])

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: Dose is based on the amoxicillin component; see “Augmentin Product-Specific Considerations” table.

Usual dosage range:

Infants <3 months: Oral: Amoxicillin 30 mg/kg/day divided every 12 hours using the 125 mg per 5 mL suspension only

Infants ≥3 months, Children, and Adolescents <40 kg: Oral: Immediate release:

Mild to moderate infections: Amoxicillin 25 mg/kg/day in divided doses twice daily (using the 200 mg per 5 mL or 400 mg per 5 mL suspension or 200 mg or 400 mg chewable tablets) or amoxicillin 20 mg/kg/day in divided doses 3 times daily (using the 125 mg per 5 mL or 250 mg per 5 mL suspension) (maximum single dose: 500 mg amoxicillin)

Severe infections: Amoxicillin 45 mg/kg/day in divided doses twice daily (using the 200 mg per 5 mL or 400 mg per 5 mL suspension or 200 mg or 400 mg chewable tablets) (maximum single dose: amoxicillin 875 mg) or amoxicillin 40 mg/kg/day in divided doses 3 times daily (using the 125 mg per 5 mL or 250 mg per 5 mL suspension) (maximum single dose: amoxicillin 500 mg)

Children and Adolescents ≥40 kg: Oral:

Mild to moderate infections: Immediate release: Amoxicillin 500 mg every 12 hours (using the 500 mg tablet; if difficulty swallowing the 125 mg per 5 mL or 250 mg per 5 mL suspension may be used) or 250 mg amoxicillin every 8 hours (using the 250 mg tablet)

Severe infections:

Immediate release: Amoxicillin 875 mg every 12 hours (using the 875 mg tablet; if difficulty swallowing, the 200 mg per 5 mL or 400 mg per 5 mL suspension may be used) or amoxicillin 500 mg every 8 hours (using the 500 mg tablet; if difficulty swallowing, the 125 mg per 5 mL or 250 mg per 5 mL suspension may be used).

Extended release: Amoxicillin 2,000 mg every 12 hours

Indication-specific dosing:

Impetigo (off-label use): Infants ≥3 months, Children, and Adolescents: Oral: Immediate release: Amoxicillin 25 mg/kg/day in divided doses twice daily (using the 200 mg per 5 mL or 400 mg per 5 mL oral suspension or the 200 mg or 400 mg chewable tablets) (maximum single dose: 875 mg amoxicillin) (IDSA [Stevens 2014])

Otitis media, acute: Infants ≥6 months and Children: Oral: Immediate release: Amoxicillin 90 mg/kg/day divided every 12 hours (using the 600 mg per 5 mL suspension only) Note: Use for severe illness, those 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’s labeling suggests 10-day course in all patients; however, new data suggest 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]). Note: Per the manufacturer, the 600 mg/5 mL formulation should only be used for patients weighing <40 kg.

Pneumonia, community-acquired (CAP) and respiratory tract infections, lower: Infants ≥3 months, Children, and Adolescents: Oral:

Manufacturer's labeling:

Patients weighing <40 kg: Immediate release: Amoxicillin 45 mg/kg/day in divided doses twice daily (using the 200 mg per 5 mL or 400 mg per 5 mL suspension or the 200 mg or 400 mg chewable tablets) (maximum single dose: Amoxicillin 875 mg) or amoxicillin 40 mg/kg/day in divided doses 3 times daily (using the 125 mg per 5 mL or 250 mg per 5 mL suspension) (maximum single dose: Amoxicillin 500 mg)

Patients weighing ≥40 kg:

Immediate release: Amoxicillin 875 mg every 12 hours using the 875 mg tablet or if difficulty swallowing, the 200 mg/5 mL or the 400 mg/5 mL oral suspension may be used or 500 mg amoxicillin every 8 hours using the 500 mg tablet or if difficulty swallowing, the 125 mg/5 mL or 250 mg/5 mL oral suspension may be used

Extended release: 2,000 mg amoxicillin every 12 hours

Alternate dosing (off-label dosing): Beta-lactamase positive H. influenzae strains (IDSA/PIDS [Bradley 2011]): Immediate release:

Standard dose: Amoxicillin 45 mg/kg/day in divided doses 3 times daily (using the 125 mg per 5 mL or 250 mg per 5 mL suspension) (maximum single dose: Amoxicillin 500 mg)

High dose: Amoxicillin 90 mg/kg/day in divided doses 2 times daily (using the 600 mg per 5 mL suspension). Note: A wider dosing range of 80 to 100 mg/kg/day divided every 8 hours has also been used (Bradley 2002).

Sinusitis, acute bacterial: Oral:

IDSA recommendations:

Infants ≥3 months, Children, and Adolescents <40 kg: Immediate release:

Standard dose: Amoxicillin 45 mg/kg/day divided every 12 hours for 10 to 14 days (using the 200 mg per 5 mL or 400 mg per 5 mL suspension or 200 mg or 400 mg chewable tablets only) (IDSA [Chow 2012])

High dose (off-label dose): Amoxicillin 90 mg/kg/day divided every 12 hours for 10 to 14 days (using the 600 mg per 5 mL suspension only). Note: Use recommended in the following: If initial therapy fails (as second-line therapy), in areas with high endemic rates of penicillin-nonsusceptible S. pneumoniae, those with severe infections, daycare attendance, age <2 years, recent hospitalization, antibiotic use within the past month, or who are immunocompromised (IDSA [Chow 2012]).

Children and Adolescents ≥40 kg: Refer to adult dosing.

AAP recommendations: Children and Adolescents: Immediate release:

High dose (off-label dose): Amoxicillin 80 to 90 mg/kg/day divided every 12 hours (using the 600 mg per 5 mL oral suspension only); treatment duration variable: 10 to 28 days, some have suggested discontinuation of therapy 7 days after resolution of signs and symptoms of infection. Note: Recommended for patients with any of the following: moderate to severe infection, age <2 years, childcare attendance, or recent antibiotic treatment. (Wald 2013)

Streptococci, group A, chronic carrier treatment (off-label use): Infants ≥3 months, Children, and Adolescents: Oral: Immediate release: Amoxicillin 40 mg/kg/day divided every 8 hours for 10 days (using the 125 mg per 5 mL or 250 mg per 5 mL suspension) (IDSA [Shulman 2012])

Urinary tract infections: Infants and Children 2 to 24 months: Oral: Immediate release: Amoxicillin 20 to 40 mg/kg/day in divided doses 3 times daily (using the 125 mg per 5 mL or 250 mg per 5 mL suspension); (maximum single dose: Amoxicillin 500 mg) (AAP 2011)

Dosing: Renal Impairment

Adults: 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 amoxicillin every 24 hours; administer dose both during and after dialysis. Do not use 875 mg tablet or extended-release tablets.

Infants, Children, and Adolescents: There are no dosage adjustments provided in the manufacturer's labeling; however, the following adjustments have been recommended (Aronoff 2007):

Mild to moderate infection: Dosing based on amoxicillin 25 to 50 mg/kg/day divided every 8 hours:

GFR ≥30 mL/minute/1.73 m2: No dosage adjustment necessary

GFR 10 to 29 mL/minute/1.73 m2: Amoxicillin 8 to 20 mg/kg/dose every 12 hours

GFR <10 mL/minute/1.73 m2: Amoxicillin 8 to 20 mg/kg/dose every 24 hours

End-stage renal disease (ESRD):

Hemodialysis: Amoxicillin 8 to 20 mg/kg/dose every 24 hours; give after dialysis

Peritoneal dialysis: Amoxicillin 8 to 20 mg/kg/dose every 24 hours

Severe infection (high dose): Dosing based on amoxicillin 80 to 90 mg/kg/day divided every 12 hours:

CrCl ≥30 mL/minute/1.73 m2: No dosage adjustment necessary

CrCl 10 to 29 mL/minute/1.73 m2: Amoxicillin 20 mg/kg/dose every 12 hours; do not use the 875 mg tablet

CrCl <10 mL/minute/1.73 m2: Amoxicillin 20 mg/kg/dose every 24 hours; do not use the 875 mg tablet

End-stage renal disease (ESRD):

Hemodialysis: Amoxicillin 20 mg/kg/dose every 24 hours; give after dialysis; do not use the 875 mg tablet

Peritoneal dialysis: Amoxicillin 20 mg/kg/dose every 24 hours; do not use the 875 mg tablet

Dosing: Hepatic Impairment

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.

Reconstitution

Reconstitute powder for oral suspension with appropriate amount of water as specified in the manufacturer’s labeling. Shake vigorously until suspended.

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. Extended release tablets should be administered with food.

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; if you have phenylketonuria or PKU, avoid use. All dosage forms contain potassium.

Storage

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.

Drug Interactions

Allopurinol: May enhance the potential for allergic or hypersensitivity reactions to Amoxicillin. Monitor therapy

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Avoid combination

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy

Methotrexate: Penicillins may increase the serum concentration of Methotrexate. 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. Monitor therapy

Probenecid: May increase the serum concentration of Penicillins. Management: Avoid the routine use of penicillins and probenecid, but this combination may be used advantageously in select cases with careful monitoring. Monitor for toxic effects of penicillins if probenecid is initiated or the dose is increased. 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. Consider therapy modification

Tetracycline Derivatives: May diminish the therapeutic effect of Penicillins. Consider therapy modification

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. Consider therapy modification

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

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% (Limited to important or life-threatening): 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

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.

Monitoring Parameters

Assess patient at beginning and throughout therapy for infection; with prolonged therapy, monitor renal, hepatic, and hematologic function periodically; monitor for signs of anaphylaxis during first dose

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies. Both amoxicillin and clavulanic acid cross the placenta. Maternal use of amoxicillin/clavulanate has generally not resulted in an increased risk of birth defects. A possible increased risk of necrotizing enterocolitis in neonates or bowel disorders in children exposed to amoxicillin/clavulanate in utero has been observed. In women with acute infections during pregnancy, amoxicillin/clavulanate may be given if an antibiotic is required and appropriate based on bacterial sensitivity; however, use is not recommended in the management of preterm premature rupture of membranes. Oral ampicillin-class antibiotics are poorly absorbed during labor.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea. Have patient report immediately to prescriber signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools), signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes), bruising, bleeding, or thrush (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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