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Amoxicillin and Clavulanate Potassium Drug Information Provided by Lexi-Comp

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Pronunciation

(a moks i SIL in & klav yoo LAN ate poe TASS ee um)

Generic Available (U.S.)

Yes

Index Terms

  • Amoxicillin and Clavulanic Acid
  • Clavulanic Acid and Amoxicillin

U.S. Brand Names

  • Amoclan
  • Augmentin ES-600® [DSC]
  • Augmentin XR®
  • Augmentin®

Canadian Brand Names

  • Amoxi-Clav
  • Apo-Amoxi-Clav®
  • Clavulin®
  • Novo-Clavamoxin
  • ratio-Aclavulanate

Pharmacologic Category

  • Antibiotic, Penicillin

Pharmacologic Category Synonyms

  • Penicillin Derivative Antibiotic

Use: Labeled Indications

Treatment of otitis media, sinusitis, and infections caused by susceptible organisms involving the lower respiratory tract, skin and skin structure, and urinary tract; spectrum same as amoxicillin with additional coverage of beta-lactamase producing B. catarrhalis, H. influenzae, N. gonorrhoeae, and S. aureus (not MRSA). The expanded coverage of this combination makes it a useful alternative when amoxicillin resistance is present and patients cannot tolerate alternative treatments.

Use: Dental

Treatment of orofacial infections when beta-lactamase-producing staphylococci and beta-lactamase-producing Bacteroides are present

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events have not been observed in animal studies; therefore, amoxicillin/clavulanate is classified as pregnancy category B. Both amoxicillin and clavulanic acid cross the placenta. There is no documented increased risk of teratogenic effects caused by amoxicillin/clavulanate. A potential increased risk of necrotizing enterocolitis in the newborn has been noted after maternal use of amoxicillin/clavulanate for preterm labor or premature prolonged rupture of membranes. When used during pregnancy, pharmacokinetic changes have been observed with amoxicillin alone (refer to the Amoxicillin monograph for details).

Lactation

Enters breast milk/use caution

Breast-Feeding Considerations

Amoxicillin is found in breast milk. The manufacturer recommends that caution be used if administered to breast-feeding women. The use of amoxicillin/clavulanate may be safe while breast-feeding; however, the risk of adverse events in the infant may be increased when compared to the use of amoxicillin alone. The risk of adverse events may be related to maternal dose. Nondose-related effects could include modification of bowel flora and allergic sensitization of the infant.

Contraindications

Hypersensitivity to amoxicillin, clavulanic acid, penicillin, or any component of the formulation; history of cholestatic jaundice or hepatic dysfunction with amoxicillin/clavulanate potassium therapy; Augmentin XR™: severe renal impairment (Clcr <30 mL/minute) and hemodialysis patients

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Serious and occasionally severe or fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy, especially with a history of beta-lactam hypersensitivity, history of sensitivity to multiple allergens, or previous IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria). Use with caution in asthmatic patients. Low incidence of cross-allergy with cephalosporins exists.

• Diarrhea: Incidence of diarrhea is higher than with amoxicillin alone.

• Hepatic effects: Although rare, hepatic dysfunction is more common in elderly and/or males, and occurs more frequently with prolonged treatment, and may occur after therapy is complete.

• 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.

• Infectious mononucleosis: A high percentage of patients with infectious mononucleosis have developed rash during therapy; ampicillin-class antibiotics not recommended in these patients.

• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment recommended.

Dosage form specific issues:

• Clavulanic acid content: Due to differing content of clavulanic acid, not all formulations are interchangeable.

• Phenylalanine: Some products contain phenylalanine.

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 discomfort, loose stools, nausea, vomiting

Genitourinary: Vaginitis, vaginal mycosis

Miscellaneous: Moniliasis

<1%: Alkaline phosphatase increased, cholestatic jaundice, flatulence, headache, hepatic dysfunction, hepatitis, liver function tests increased, prothrombin time increased, thrombocytosis, vasculitis (hypersensitivity)

Additional adverse reactions seen with ampicillin-class antibiotics: Agitation, agranulocytosis, alkaline phosphatase increased, anaphylaxis, anemia, angioedema, anxiety, behavioral changes, bilirubin increased, black “hairy” tongue, confusion, convulsions, crystalluria, dizziness, enterocolitis, eosinophilia, erythema multiforme, exanthematous pustulosis, exfoliative dermatitis, gastritis, glossitis, hematuria, hemolytic anemia, hemorrhagic colitis, indigestion, insomnia, hyperactivity, interstitial nephritis, leukopenia, mucocutaneous candidiasis, pruritus, pseudomembranous colitis, serum sickness-like reaction, Stevens-Johnson syndrome, stomatitis, transaminases increased, thrombocytopenia, thrombocytopenic purpura, tooth discoloration, toxic epidermal necrolysis

Drug Interactions

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

BCG: Antibiotics may diminish the therapeutic effect of BCG. Risk X: Avoid combination

Fusidic Acid: May diminish the therapeutic effect of Penicillins. Risk D: Consider therapy modification

Methotrexate: Penicillins may decrease the excretion 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 Penicillins. Risk C: Monitor therapy

Tetracycline Derivatives: May diminish the therapeutic effect of Penicillins. Risk D: 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 24 hours after cessation of antibacterial agents. Risk D: Consider therapy modification

Storage

Powder for oral suspension: Store dry powder at room temperature of 25°C (77°F). Reconstituted oral suspension should be kept in refrigerator. Unit-dose antibiotic oral syringes are stable under refrigeration for 24 hours (Tu, 1988).

Tablet: Store at room temperature of 25°C (77°F).

Reconstitution

Reconstitute powder for oral suspension with appropriate amount of water as specified on the bottle. Shake vigorously until suspended. Discard unused suspension after 10 days.

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 Amoxicillin monograph.

Clavulanic acid:

Protein binding: ~25%

Metabolism: Hepatic

Half-life elimination: 1 hour

Time to peak: 1 hour

Excretion: Urine (30% to 40% as unchanged drug)

Dosage

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

Usual dosage range:

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

Children ≥3 months and <40 kg: Oral: 20-90 mg/kg/day divided every 8-12 hours

Children >40 kg and Adults: Oral: 250-500 mg every 8 hours or 875 mg every 12 hours

Indication-specific dosing:

Children ≥3 months and <40 kg: Oral:

Lower respiratory tract infections, severe infections, sinusitis: 45 mg/kg/day divided every 12 hours or 40 mg/kg/day divided every 8 hours

Mild-to-moderate infections: 25 mg/kg/day divided every 12 hours or 20 mg/kg/day divided every 8 hours

Otitis media (Augmentin ES-600®): 90 mg/kg/day divided every 12 hours for 10 days in children with severe illness and when coverage for β-lactamase-positive H. influenzae and M. catarrhalis is needed.

Children ≥16 years and Adults: Oral:

Acute bacterial sinusitis: Extended release tablet: Two 1000 mg tablets every 12 hours for 10 days

Bite wounds (animal/human): 875 mg every 12 hours or 500 mg every 8 hours

Chronic obstructive pulmonary disease: 875 mg every 12 hours or 500 mg every 8 hours

Diabetic foot: Extended release tablet: Two 1000 mg tablets every 12 hours for 7-14 days

Diverticulitis, perirectal abscess: Extended release tablet: Two 1000 mg tablets every 12 hours for 7-10 days

Erysipelas: 875 mg every 12 hours or 500 mg every 8 hours

Febrile neutropenia: 875 mg every 12 hours

Pneumonia:

Aspiration: 875 mg every 12 hours

Community-acquired: Extended release tablet: Two 1000 mg tablets every 12 hours for 7-10 days

Pyelonephritis (acute, uncomplicated): 875 mg every 12 hours or 500 mg every 8 hours

Skin abscess: 875 mg every 12 hours

Dosing interval in renal impairment:

Clcr <30 mL/minute: Do not use 875 mg tablet or extended release tablets

Clcr 10-30 mL/minute: 250-500 mg every 12 hours

Clcr <10 mL/minute: 250-500 every 24 hours

Hemodialysis: Moderately dialyzable (20% to 50%)

250-500 mg every 24 hours; administer dose during and after dialysis. Do not use extended release tablets.

Peritoneal dialysis: Moderately dialyzable (20% to 50%)

Amoxicillin: Administer 250 mg every 12 hours

Clavulanic acid: Dose for Clcr <10 mL/minute

Continuous arteriovenous or venovenous hemofiltration effects:

Amoxicillin: ~50 mg of amoxicillin/L of filtrate is removed

Clavulanic acid: Dose for Clcr <10 mL/minute

Augmentin® Product-Specific Considerations Strength Form Consideration 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 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 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 Clcr <30 mL/minute 1000 mg XR q12h dosing Not for use in children <16 years of age Not interchangeable with two 500 mg tablets Not for use if Clcr <30 mL/minute or hemodialysis Legend: CT = chewable tablet, S = suspension, T = tablet, XR = extended release. 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 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 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 1000 mg: • Extended release tablet: – q12h dosing – Not for use in children <16 years of age – Not interchangeable with two 500 mg tablets – Not for use if Clcr <30 mL/minute or hemodialysis

Dental Usual Dosing

Orofacial infections: Children >40 kg and Adults: Oral: 250-500 mg every 8 hours or 875 mg every 12 hours

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.

Some penicillins (eg, carbenicillin, ticarcillin, and piperacillin) have been shown to inactivate aminoglycosides in vitro. This has been observed to a greater extent with tobramycin and gentamicin, while amikacin has shown greater stability against inactivation. Concurrent use of these agents may pose a risk of reduced antibacterial efficacy in vivo, particularly in the setting of profound renal impairment. However, definitive clinical evidence is lacking. If combination penicillin/aminoglycoside therapy is desired in a patient with renal dysfunction, separation of doses (if feasible), and routine monitoring of aminoglycoside levels, CBC, and clinical response should be considered.

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

Test Interactions

May interfere with urinary glucose tests using cupric sulfate (Benedict's solution, Clinitest®, Fehling's solution); may inactivate aminoglycosides in vitro.

Some penicillin derivatives may accelerate the degradation of aminoglycosides in vitro, leading to a potential underestimation of aminoglycoside serum concentration.

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.

Patient Education

See individual agents.

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.

Additional Information

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.

Dental Health: Effects on Dental Treatment

Prolonged use of penicillins may lead to development of oral candidiasis (see Dental Health Professional Considerations)

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Dental Comment

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.

Infectious Diseases Comment

A well-documented reaction can occur between beta-lactam and aminoglycoside antibiotics in vitro, leading to complexation, opening of the beta-lactam ring and presumably, loss of antibacterial activity for one or both agents. However, the conditions under which this reaction occurs are variable and influenced by (but not limited to) assay methodology, sampling time and storage, and drug selection and concentration. In general, many of the in vitro studies employed artificial conditions that tested high concentrations of the penicillin derivative (equating to serum levels most likely observed only in severe renal impairment) in combination with gentamicin or tobramycin. Incubation of the agents at conditions of 37°C for up to 48 hours has definitely demonstrated inactivation and loss of bactericidal activity. However, some of these studies permitted a considerable time lapse prior to assaying the medium, or stored the samples at higher temperatures (-20°C or greater), which may have allowed continued chemical degradation prior to assay. In general, amikacin was the most resistant to penicillin-mediated chemical degradation, and cephalosporins were much less likely than penicillins to inactivate the aminoglycosides.

The more robust studies have been those which evaluated in vivo effects via rapid and frequent blood sampling during concomitant dosing. In vivo, there are a number of studies documenting significant changes in the half-life of gentamicin in combination with primarily ticarcillin and carbenicillin, but usually only in the setting of end-stage renal disease. A number of literature reports suggest that despite documented changes in gentamicin kinetics, this is not likely to lead to clinically-significant differences in outcomes in patients with normal renal function. Furthermore, there are no published, prospective, outcomes-based studies that provide compelling evidence of changes in rates of clinical or microbiological response as a function of dosing separation.

Based on the weight of evidence to date, coadministration of (but not coadmixture of) a penicillin or cephalosporin antibiotic with an aminoglycoside should not pose a significant concern in patients with even mild renal impairment. However, specific circumstances exist in which this approach should be undertaken with caution. Concurrent administration of either gentamicin or tobramycin with piperacillin, carbenicillin, or ticarcillin (including combinations with beta-lactamase inhibitors), particularly in the face of moderate-to-severe renal failure, would warrant careful monitoring of aminoglycoside serum levels, CBCs, and clinical response to avoid potentially reduced efficacy due to chemical inactivation.

Mental Health: Effects on Mental Status

Penicillins have been reported to cause apprehension, illusions, agitation, insomnia, depersonalization, and encephalopathy

Mental Health: Effects on Psychiatric Treatment

Disulfiram may increase amoxicillin levels

Nursing: Physical Assessment/Monitoring

See individual agents.

Dosage Forms

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

Powder for oral suspension, oral: 200: Amoxicillin 200 mg and clavulanate potassium 28.5 mg per 5 mL (50 mL, 75 mL, 100 mL) [contains phenylalanine]; 250: Amoxicillin 250 mg and clavulanate potassium 62.5 mg per 5 mL (75 mL, 100 mL, 150 mL) [contains phenylalanine]; 400: Amoxicillin 400 mg and clavulanate potassium 57 mg per 5 mL (50 mL, 75 mL, 100 mL) [contains phenylalanine]; 600: Amoxicillin 600 mg and clavulanate potassium 42.9 mg per 5 mL (75 mL, 125 mL, 200 mL)

Amoclan:

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; fruit 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; fruit flavor]

600: Amoxicillin 600 mg and clavulanate potassium 42.9 mg per 5 mL (75 mL, 125 mL) [contains phenylalanine 7 mg/5 mL, potassium 0.248 mEq/5 mL; orange flavor]

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

Tablet: 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

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]

Tablet, chewable: 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: Amoxicillin 1000 mg and clavulanate acid 62.5 mg

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]

Pricing: U.S. (www.drugstore.com)

Chewable (Amoxicillin-Pot Clavulanate)

400-57 mg (20): $60.99

Suspension (reconstituted) (Amoxicillin-Pot Clavulanate)

250-62.5 mg/5 mL (75): $65.99

250-62.5 mg/5 mL (100): $85.99

250-62.5 mg/5 mL (150): $115.99

600-42.9 mg/5 mL (75): $35.99

Tablet, 12-hour (Augmentin XR)

1000-62.5 mg (28): $116.69

Tablets (Amoxicillin-Pot Clavulanate)

250-125 mg (30): $149.99

500-125 mg (20): $45.99

875-125 mg (20): $31.99

Tablets (Augmentin)

250-125 mg (30): $118.99

500-125 mg (30): $166.71

875-125 mg (20): $145.98

References

American Academy of Pediatrics Subcommittee on Management of Acute Otitis Media, "Diagnosis and Management of Acute Otitis Media," Pediatrics, 2004, 113(5):1451-65.

American Thoracic Society, “Guidelines for the Initial Management of Adults With Community-Acquired Pneumonia: Diagnosis, Assessment of Severity, and Initial Antimicrobial Therapy,” Am Rev Respir Dis, 1993, 148(5):1418-26.

Ancill RJ, Ballard JH, and Capewell MA, “Urinary Tract Infections in Geriatric Inpatients: A Comparative Study of Amoxicillin-Clavulanic Acid and Co-trimoxazole,” Curr Ther Res Clin Exp, 1987, 41(4):444-8.

Chow MS, Quintiliani R, and Nightingale CH, "In Vivo Inactivation of Tobramycin by Ticarcillin. A Case Report," JAMA, 1982, 247(5):658-9.

Daly JS, Dodge RA, Glew RH, et al, "Effect of Time and Temperature on Inactivation of Aminoglycosides by Ampicillin at Neonatal Dosages," J Perinatol, 1997, 17(1):42-5.

Donowitz GR and Mandell GL, “Beta-Lactam Antibiotics,” N Engl J Med, 1988, 318(7):419-26 and 318(8):490-500.

Dowell JA, Korth-Bradley J, Milisci M, et al, “Evaluating Possible Pharmacokinetic Interactions Between Tobramycin, Piperacillin, and a Combination of Piperacillin and Tazobactam in Patients With Various Degrees of Renal Impairment,” J Clin Pharmacol, 2001, 41:979-86.

Farchione LA, “Inactivation of Aminoglycosides by Penicillins,” J Antimicrob Chemother, 1982, 8(Suppl A):27-36.

Fuchs PC, Stickel S, Anderson PH, et al, “In Vitro Inactivation of Aminoglycosides by Sulbactam, Other Beta-Lactams, and Sulbactam-Beta-Lactam Combinations,” Antimicrob Agents Chemother, 1991, 35(1):182-4.

Gan VN, Kusmiesz H, Shelton S, et al, “Comparative Evaluation of Loracarbef and Amoxicillin-Clavulanate for Acute Otitis Media,” Antimicrob Agents Chemother, 1991, 35(5):967-71.

Halstenson CE, Wong MO, Herman CS, et al, “Effect of Concomitant Administration of Piperacillin on the Dispositions on Isepamicin and Gentamicin in Patients With End-Stage Renal Disease,” Antimicrob Agents Chemother, 1992, 36(9):1832-36.

Hitt CM, Patel KB, Nicolau DP, et al, “Influence of Piperacillin-Tazobactam on Pharmacokinetics of Gentamicin Given Once Daily,” Am J Health Syst Pharm, 1997, 54(23):2704-8.

Hoberman A, Paradise JL, Burch DJ, et al, “Equivalent Efficiency and Reduced Occurrence of Diarrhea From a New Formulation of Amoxicillin/Clavulanate Potassium (Augmentin®) for Treatment of Acute Otitis Media in Children,” Pediatr Infect Dis J, 1997, 16(5):463-70.

Konishi H, Goto M, Nakamoto Y, et al, "Tobramycin Inactivation by Carbenicillin, Ticarcillin, and Piperacillin," Antimicrob Agents Chemother, 1983, 23(5):653-57.

Lau A, Lee M, Flascha S, et al, "Effect of Piperacillin on Tobramycin Pharmacokinetics in Patients With Normal Renal Function," Antimicrob Agents Chemother, 1983, 24(4):533-37.

Mandell LA, Bartlett JG, Dowell SF, et al, “Update of Practice Guidelines for the Management of Community-Acquired Pneumonia in Immunocompetent Adults,” Clin Infect Dis, 2003, 37(11):1405-33.

Reed MD, “Clinical Pharmacokinetics of Amoxicillin and Clavulanate,” Pediatr Infect Dis J, 1996, 15(10):949-54.

Russoe ME and Atkins-Thor E, "Gentamicin and Ticarcillin in Subjects With End-Stage Renal Disease. Comparison of Two Assay Methods and Evaluation of Inactivation Rate," Clin Nephrol, 1981, 15(4):175-80.

Swanson-Biearman B, Dean DS, Lopez G, et al, "The Effects of Penicillin and Cephalosporin Ingestions in Children Less Than Six Years of Age," Vet Hum Toxicol, 1988, 30(1):66-7.

Thoene DE and Johnson CE, “Pharmacotherapy of Otitis Media,” Pharmacotherapy, 1991, 11(3):212-21.

Thompson MIB, Russo ME, Saxon BJ, et al, "Gentamicin Inactivation by Piperacillin or Carbenicillin in Patients With End-Stage Renal Disease," Antimicrob Agents Chemother, 1982, 21(2):268-73.

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.

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.

Viollier AF, Standiford HC, Drusano GL, et al, "Comparative Pharmacokinetics and Serum Bactericidal Activity of Mezlocillin, Ticarcillin and Piperacillin, With and Without Gentamicin," J Antimicrob Chemother, 1985, 15(5):597-606.

Walterspiel JN, Feldman S, Van R, et al, "Comparative Inactivation of Isepamicin, Amikacin, and Gentamicin by Nine Beta-Lactams and Two Beta-Lactamase Inhibitors, Cilastatin and Heparin," Antimicrob Agents Chemother, 1991, 35(9):1875-8.

Wright AJ, “The Penicillins,” Mayo Clin Proc, 1999, 74(3):290-307.

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.

International Brand Names

  • Acarbixin (MX)
  • Aclam (ID)
  • Ambilan (PE)
  • AMK (TH)
  • Amobay Cl (MX)
  • Amoclan (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE)
  • Amoclav (DE)
  • Amoksiclav (TH)
  • Amoksiklav (CL, PL)
  • Amoxi Plus (PY)
  • Amoxiclav (MX)
  • Amoxiclav-BID (MX)
  • Amoxiclav-Teva (IL)
  • Amoxxlin (KP)
  • Amoxyclav (IL)
  • Augamox (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE)
  • AugMaxcil (ZA)
  • Augmentan (DE)
  • Augmentin (AE, AT, BB, BE, BF, BG, BH, BJ, BM, BS, BZ, CI, CY, CZ, EC, EG, ES, ET, FI, FR, GB, GH, GM, GN, GR, GY, HK, HN, IE, IN, IQ, IR, IT, JM, JO, JP, KE, KP, KW, LB, LR, LY, MA, ML, MR, MU, MW, MX, MY, NE, NG, NL, NO, OM, PE, PK, PL, PT, QA, RU, SA, SC, SD, SL, SN, SR, SY, TH, TN, TR, TT, TZ, UG, UY, VE, YE, ZM, ZW)
  • Augmentin SR (TH)
  • Augmentine (ES)
  • Augmex (PH)
  • Augurcin (PH)
  • Auspilic (ID)
  • Bactiv (PH)
  • Bactoclav (PH)
  • Bioclavid (AE, BH, CY, DE, DK, EG, IQ, IR, JO, KW, LB, LY, OM, PH, QA, SA, SE, SY, YE)
  • Bioclavid Forte (PH)
  • Capsinat (ID)
  • Cavumox (MY, TH)
  • Clacillin Duo Dry Syrup (KP)
  • Clamax (KP)
  • Clamentin (ZA)
  • Clamohexal (AU)
  • Clamovid (HK, MY, SG)
  • Clamoxin (MX)
  • Clamoxyl (AU)
  • Clamoxyl Duo 400 (AU)
  • Clamoxyl DuoForte (AU)
  • Clavamox (CH, DE, ID, IN)
  • Clavant (MX)
  • Clavar (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE)
  • Claventin (IL)
  • Clavinex (CN, EC)
  • Clavipen (MX)
  • Clavmex (PH)
  • Clavodar (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE)
  • 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 Duo Forte (AU)
  • Clavulox Duo (AR, PY)
  • Clavumox (DE, PE, ZA)
  • Clavuser (MX)
  • Cramon Duo (KP)
  • Cramotin (KP)
  • Crasigen Duo (KP)
  • Curam (AU, CO, CR, DO, GT, HK, MY, NI, PA, PE, PL, SG, SV, TH, TW)
  • Danoclav (ID)
  • Darzitil Plus (AR)
  • E-Moxclav (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE)
  • Enhancin (PH)
  • Fleming (HK)
  • Forcid (PL)
  • Fugentin (SG)
  • Fullicilina Plus (AR)
  • GA-Amclav (AU)
  • Gimaclav (MX)
  • Hibiotic (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE)
  • Ind Clav (TH)
  • Klamonex (KP)
  • Klavic (PH)
  • Klavocin (PL)
  • Kmoxilin (KP)
  • Lansiclav (ID)
  • Luvmox (PH)
  • Moxiclav (AE, BF, BH, BJ, CI, CY, EG, ET, GH, GM, GN, 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, TW, TZ, UG, YE, ZM, ZW)
  • Moxicle (KP, TH)
  • Moxlin (MX)
  • Natravox (PH)
  • Novamox (BR)
  • Nufaclav (ID)
  • Penhance (PH)
  • Quali-Mentin (HK)
  • Ramoclav (PL)
  • Ranclav (TH, ZA)
  • Riclasip (MX)
  • Servamox (MX)
  • Sinufin (MX)
  • Spektramox (SE)
  • Sullivan (PH)
  • Synermox (NZ)
  • Taromentin (PL)
  • Velamox CL (PE)
  • Vestaclav (MY)
  • Viaclav (ID)
  • Vulamox (ID)

Lexi-Comp.com

Last full review/revision June 2011

Content last modified June 2011

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