Components:
Method of action:
Treatment option:
Medically reviewed by Militian Inessa Mesropovna, PharmD. Last updated on 13.03.2022
Attention! Information on this page is intended only for medical professionals! Information is collected in open sources and may contain significant errors! Be careful and double-check all the information on this page!
Dosage Forms And Strengths
Tablets
- 250 mg/125-mg Tablets: Each white oval film-coated tablet, debossed with AUGMENTIN on one side and 250/125 on the other side, contains 250 mg of amoxicillin and 125 mg clavulanic acid as the potassium salt.
- 500 mg/125-mg Tablets: Each white oval film-coated tablet, debossed with AUGMENTIN on one side and 500/125 on the other side, contains 500 mg amoxicillin and 125 mg of clavulanic acid as the potassium salt.
- 875 mg/125-mg Tablets: Each scored white capsule shaped tablet, debossed with AUGMENTIN 875 on one side and scored on the other side, contains 875 mg amoxicillin and 125 mg clavulanic acid as the potassium salt.
Powder For Oral Suspension
- 125 mg/31.25 mg per 5 mL: Banana-flavored powder for oral suspension (each 5 mL of reconstituted suspension contains 125 mg amoxicillin and 31.25 mg of clavulanic acid as the potassium salt).
- 200 mg/28.5 mg per 5 mL: Orange-favored powder for oral suspension (each 5 mL of reconstituted suspension contains 200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt).
- 250 mg/62.5 mg per 5 mL: Orange-flavored powder for oral suspension (each 5 mL of reconstituted suspension contains 250 mg amoxicillin and 62.5 mg of clavulanic acid as the potassium salt).
- 400 mg/57 mg per 5 mL Orange-flavored powder for oral suspension (each 5 mL of reconstituted suspension contains 400 mg amoxicillin and 57.0 mg of clavulanic acid as the potassium salt).
Chewable Tablets
- 125-mg/31.25-mg Chewable Tablets: Each mottled yellow, round, lemon-lime-flavored tablet, debossed with BMP 189 contains 125 mg amoxicillin and 31.25 mg clavulanic acid as the potassium salt.
- 200-mg/28.5 mg Chewable Tablets: Each mottled pink, round, biconvex cherry-banana-flavored tablet, debossed with AUGMENTIN 200 contains 200 mg amoxicillin and 28.5 mg clavulanic acid as the potassium salt.
- 250-mg/62.5-mg Chewable Tablets: Each mottled yellow, round, lemon-lime-flavored tablet, debossed with BMP 190 contains 250 mg amoxicillin and 62.5 mg clavulanic acid as the potassium salt.
- 400-mg/57-mg Chewable Tablets: Each mottled pink, round, biconvex cherry-banana-flavored tablet, debossed with AUGMENTIN 400 contains 400 mg amoxicillin and 57.0 mg clavulanic acid as the potassium salt.
The 250-mg tablet of AUGMENTIN and the 250-mg chewable tablet should NOT be substituted for each other, as they are not interchangeable and the 250-mg tablet should not be used in children weighing less than 40 kg. The 250-mg tablet of AUGMENTIN and the 250-mg chewable tablet do not contain the same amount of clavulanic acid. The 250-mg tablet of AUGMENTIN contains 125 mg of clavulanic acid whereas the 250-mg chewable tablet contains 62.5 mg of clavulanic acid.
Two 250 mg tablets of AUGMENTIN should NOT be substituted for one 500 mg tablet of AUGMENTIN. Since both the 250 mg and 500 mg tablets of AUGMENTIN contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg tablets of AUGMENTIN are not equivalent to one 500 mg tablet of AUGMENTIN.
Storage And Handling
Tablets
250 mg/125-mg Tablets: Each white oval film-coated tablet, debossed with AUGMENTIN on one side and 250/125 on the other side, contains 250 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt.
NDC 43598-018-30 bottles of 30
NDC 43598-018-78 Unit Dose (10x10) 100 tablets
500 mg/125-mg Tablets: Each white oval film-coated tablet, debossed with AUGMENTIN on one side and 500/125 on the other side, contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt.
NDC 43598-006-14 bottles of 20
NDC 43598-006-78 Unit Dose (10x10) 100 tablets
875 mg/125-mg Tablets: Each scored white capsule shaped tablet, debossed with AUGMENTIN 875 on one side and scored on the other side, contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt.
NDC 43598-021-14 bottles of 20
NDC 43598-021-78 Unit Dose (10x10) 100 tablets
Powder for Oral Sus pens ion:125 mg/31.25 mg per 5 mL: Banana-flavored powder for oral suspension (each 5 mL of reconstituted suspension contains 125 mg amoxicillin and 31.25 mg of clavulanic acid as the potassium salt).
NDC 43598-012-51 75 mL bottle
NDC 43598-012-52 100 mL bottle
NDC 43598-012-53 150 mL bottle
200 mg/28.5 mg per 5 mL: Orange-favored powder for oral suspension (each 5 mL of reconstituted suspension contains 200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt).
NDC 43598-013-50 50 mL bottle
NDC 43598-013-51 75 mL bottle
NDC 43598-013-52 100 mL bottle
250 mg/62.5 mg per 5 mL: Orange-flavored powder for oral suspension (each 5 mL of reconstituted suspension contains 250 mg amoxicillin and 62.5 mg of clavulanic acid as the potassium salt).
NDC 43598-004-51 75 mL bottle
NDC 43598-004-52 100 mL bottle
NDC 43598-004-53 150 mL bottle
400 mg/57 mg per 5 mL Orange-flavored powder for oral suspension (each 5 mL of reconstituted suspension contains 400 mg amoxicillin and 57.0 mg of clavulanic acid as the potassium salt).
NDC 43598-008-50 50 mL bottle
NDC 43598-008-51 75 mL bottle
NDC 43598-008-52 100 mL bottle
Chewable Tablets:125-mg/31.25-mg Chewable Tablets: Each mottled yellow, round, lemon-limeflavored tablet, debossed with BMP 189, contains 125 mg amoxicillin and 31.25 mg clavulanic acid as the potassium salt.
NDC 43598-014-31 carton of 30 (5x6) tablets
200-mg/28.5 mg Chewable Tablets: Each mottled pink, round, biconvex, cherry-banana-flavored tablet, debossed with AUGMENTIN 200, contains 200 mg amoxicillin and 28.5 mg clavulanic acid as the potassium salt.
NDC 43598-015-14 carton of 20 tablets
250-mg/62.5-mg Chewable Tablets: Each mottled yellow, round, lemon-lime-flavored tablet, debossed with BMP 190, contains 250 mg amoxicillin and 62.5 mg clavulanic acid as the potassium salt.
NDC 43598-016-31 carton of 30 (5x6) tablets
400-mg/57-mg Chewable Tablets: Each mottled pink, round, biconvex, cherry-banana-flavored tablet, debossed with AUGMENTIN 400, contains 400 mg amoxicillin and 57.0 mg clavulanic acid as the potassium salt.
NDC 43598-017-14 carton of 20 tablets
Dispense in original container.
Store tablets and dry powder at or below 25°C (77°F).
Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Keep out of the reach of children.
REFERENCES
1. Swanson-Biearman B, Dean BS, Lopez G, Krenzelok EP. The effects of penicillin and cephalosporin ingestions in children less than six years of age.Vet Hum Toxicol. 1988; 30: 66 67.
2. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – 8thed. CLSI Document M7-A9. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA, 19087, 2012.
3. Clinical and Laboratory Standards Institute (CLSI). Performance Standard for Antimicrobial Disk Susceptibility Tests;Approved Standard – 11thed. CLSI Document M2-A11. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA, 19087, 2012.
4. CLSI. Performance Standards for Antimicrobial Susceptibility Testing: 22nd Informational Supplement. CLSI document M100-S22. CLSI, Wayne, PA, 2012.
Distributed by: Dr. Reddy’s Laboratories Inc.Bridgewater, NJ 08807. Revised: March 2013
Serious Hypersensitivity Reactions
AUGMENTIN is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate or to other beta lactam antibacterial drugs (e.g., penicillins and cephalosporins).
Cholestatic Jaundice/Hepatic Dysfunction
AUGMENTIN is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with AUGMENTIN.
WARNINGS
Included as part of the "PRECAUTIONS" Section
PRECAUTIONS
Hypersensitivity Reactions
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials, including AUGMENTIN. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Before initiating therapy with AUGMENTIN, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, AUGMENTIN should be discontinued and appropriate therapy instituted.
Hepatic Dysfunction
Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of AUGMENTIN. Hepatic toxicity is usually reversible; however, deaths have been reported. Hepatic function should be monitored at regular intervals in patients with hepatic impairment.
Clostridium Difficile Associated Diarrhea (CDAD)
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including AUGMENTIN, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxinproducing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Skin Rash In Patients With Mononucleosis
A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash. Thus, AUGMENTIN should not be administered to patients with mononucleosis.
Potential For Microbial Overgrowth
The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy. If superinfection occurs, amoxicillin/clavulanate potassium should be discontinued and appropriate therapy instituted.
Phenylketonurics
AUGMENTIN Chewable tablets and AUGMENTIN Powder for Oral Solution contain aspartame which contains phenylalanine. Each 200-mg chewable tablet of AUGMENTIN contains 2.1 mg phenylalanine; each 400-mg chewable tablet contains 4.2 mg phenylalanine; each 5 mL of either the 200 mg/5 mL or 400 mg/5 mL oral suspension contains 7 mg phenylalanine. The other formulations of AUGMENTIN do not contain phenylalanine.
Development Of Drug-Resistant Bacteria
Prescribing AUGMENTIN in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient, and increases the risk of the development of drug resistant bacteria.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Long term studies in animals have not been performed to evaluate carcinogenic potential.
AUGMENTIN (4:1 ratio formulation of amoxicillin:clavulanate) was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. AUGMENTIN was weakly positive in the mouse lymphoma assay, but the trend toward increased mutation frequencies in this assay occurred at doses that were also associated with decreased cell survival. AUGMENTIN was negative in the mouse micronucleus test, and in the dominant lethal assay in mice. Potassium clavulanate alone was tested in the Ames bacterial mutation assay and in the mouse micronucleus test, and was negative in each of these assays.
AUGMENTIN (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses of up to 1,200 mg/kg/day was found to have no effect on fertility and reproductive performance in rats. Based on body surface area, this dose of amoxicillin is approximately 4 times the maximum recommended adult human oral dose (875 mg every 12 hours). For clavulanate, the dose multiple is approximately 9 times higher than the maximum recommended adult human oral dose (125 mg every 8 hours), also based on body surface area.
Use In Specific Populations
Pregnancy
Teratogenic Effects
Pregnancy Category B. Reproduction studies performed in pregnant rats and mice given AUGMENTIN (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to AUGMENTIN. The amoxicillin doses in rats and mice (based on body surface area) were approximately 4 and 2 times the maximum recommended adult human oral dose (875 mg every 12 hours). For clavulanate, these dose multiples were approximately 9 and 4 times the maximum recommended adult human oral dose (125 mg every 8 hours). There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Labor And Delivery
Oral ampicillin class antibiotics are poorly absorbed during labor. It is not known whether use of amoxicillin/clavulanate potassium in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood of the necessity for an obstetrical intervention.
Nursing Mothers
Amoxicillin has been shown to be excreted in human milk. Amoxicillin/clavulanate potassium use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin/clavulanate potassium is administered to a nursing woman.
Pediatric Use
The safety and effectiveness of AUGMENTIN Powder for Oral Suspension and Chewable Tablets have been established in pediatric patients. Use of AUGMENTIN in pediatric patients is supported by evidence from studies of AUGMENTIN Tablets in adults with additional data from a study of AUGMENTIN Powder for Oral Suspension in pediatric patients aged 2 months to 12 years with acute otitis media.
Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed; clavulanate elimination is unaltered in this age group. Dosing of AUGMENTIN should be modified in pediatric patients aged <12 weeks (<3 months).
Geriatric Use
Of the 3,119 patients in an analysis of clinical studies of AUGMENTIN, 32% were ≥65 years old, and 14% were ≥75 years old. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Dosing In Renal Impairment
Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR <30 mL/min). See Patients with Renal Impairment for specific recommendations in patients with renal impairment.
SIDE EFFECTS
The following are discussed in more detail in other sections of the labeling:
- Anaphylactic reactions
- Hepatic Dysfunction
- CDAD
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). Less than 3% of patients discontinued therapy because of drug related adverse reactions. The overall incidence of adverse reactions, and in particular diarrhea, increased with the higher recommended dose. Other less frequently reported adverse reactions (<1%) include: Abdominal discomfort, flatulence, and headache.
In pediatric patients (aged 2 months to 12 years), 1 US/Canadian clinical trial was conducted which compared 45/6.4 mg/kg/day (divided every 12 hours) of AUGMENTIN for 10 days versus 40/10 mg/kg/day (divided every 8 hours) of AUGMENTIN for 10 days in the treatment of acute otitis media. A total of 575 patients were enrolled, and only the suspension formulations were used in this trial. Overall, the adverse reactions seen were comparable to that noted above; however, there were differences in the rates of diarrhea, skin rashes/urticaria, and diaper area rashes.
Postmarketing Experience
In addition to adverse reactions reported from clinical trials, the following have been identified during postmarketing use of AUGMENTIN. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to AUGMENTIN.
Gastrointestinal
Indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment.
Hypersensitivity Reactions
Pruritus, angioedema, serum sickness–like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), erythema multiforme, Stevens Johnson syndrome, acute generalized exanthematouspustulosis, hypersensitivity vasculitis, and cases of exfoliative dermatitis (including toxic epidermal necrolysis) have been reported.
Liver
Hepatic dysfunction, including hepatitis and cholestatic jaundice, increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been reported with AUGMENTIN. It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment. The histologic findings on liver biopsy have consisted of predominantly cholestatic, treatment. The histologic findings on liver biopsy have consisted of predominantly cholestatic, hepatocellular, or mixed cholestatic hepatocellular changes. The onset of signs/symptoms of hepatic dysfunction may occur during or several weeks after therapy has been discontinued. The hepatic dysfunction, which may be severe, is usually reversible. Deaths have been reported.
Renal
Interstitial nephritis, hematuria, and crystalluria have been reported.
Hemic And Lymphatic Systems
Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosishave been reported. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Thrombocytosis was noted in less than 1% of the patients treated with AUGMENTIN. There have been reports of increased prothrombin time in patients receiving AUGMENTIN and anticoagulant therapy concomitantly.
Central Nervous System
Agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, insomnia, and reversible hyperactivity have been reported.
Miscellaneous
Tooth discoloration (brown, yellow, or gray staining) has been reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.
DRUG INTERACTIONS
Probenecid
Probenecid decreases the renal tubular secretion of amoxicillin but does not delay renal excretion of clavulanic acid. Concurrent use with AUGMENTIN may result in increased and prolonged blood concentrations of amoxicillin. Coadministration of probenecid is not recommended.
Oral Anticoagulants
Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently with AUGMENTIN. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
Allopurinol
The concurrent administration of allopurinol and amoxicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients.
Oral Contraceptives
AUGMENTIN may affect intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Effects On Laboratory Tests
High urine concentrations of amoxicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST®, Benedict’s Solution, or Fehling’s Solution. Since this effect may also occur with AUGMENTIN, it is recommended that glucose tests based on enzymatic glucose oxidase reactions be used.
Following administration of amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted.
Teratogenic Effects
Pregnancy Category B. Reproduction studies performed in pregnant rats and mice given AUGMENTIN (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to AUGMENTIN. The amoxicillin doses in rats and mice (based on body surface area) were approximately 4 and 2 times the maximum recommended adult human oral dose (875 mg every 12 hours). For clavulanate, these dose multiples were approximately 9 and 4 times the maximum recommended adult human oral dose (125 mg every 8 hours). There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
The following are discussed in more detail in other sections of the labeling:
- Anaphylactic reactions
- Hepatic Dysfunction
- CDAD
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). Less than 3% of patients discontinued therapy because of drug related adverse reactions. The overall incidence of adverse reactions, and in particular diarrhea, increased with the higher recommended dose. Other less frequently reported adverse reactions (<1%) include: Abdominal discomfort, flatulence, and headache.
In pediatric patients (aged 2 months to 12 years), 1 US/Canadian clinical trial was conducted which compared 45/6.4 mg/kg/day (divided every 12 hours) of AUGMENTIN for 10 days versus 40/10 mg/kg/day (divided every 8 hours) of AUGMENTIN for 10 days in the treatment of acute otitis media. A total of 575 patients were enrolled, and only the suspension formulations were used in this trial. Overall, the adverse reactions seen were comparable to that noted above; however, there were differences in the rates of diarrhea, skin rashes/urticaria, and diaper area rashes.
Postmarketing Experience
In addition to adverse reactions reported from clinical trials, the following have been identified during postmarketing use of AUGMENTIN. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to AUGMENTIN.
Gastrointestinal
Indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment.
Hypersensitivity Reactions
Pruritus, angioedema, serum sickness–like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), erythema multiforme, Stevens Johnson syndrome, acute generalized exanthematouspustulosis, hypersensitivity vasculitis, and cases of exfoliative dermatitis (including toxic epidermal necrolysis) have been reported.
Liver
Hepatic dysfunction, including hepatitis and cholestatic jaundice, increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been reported with AUGMENTIN. It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment. The histologic findings on liver biopsy have consisted of predominantly cholestatic, treatment. The histologic findings on liver biopsy have consisted of predominantly cholestatic, hepatocellular, or mixed cholestatic hepatocellular changes. The onset of signs/symptoms of hepatic dysfunction may occur during or several weeks after therapy has been discontinued. The hepatic dysfunction, which may be severe, is usually reversible. Deaths have been reported.
Renal
Interstitial nephritis, hematuria, and crystalluria have been reported.
Hemic And Lymphatic Systems
Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosishave been reported. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Thrombocytosis was noted in less than 1% of the patients treated with AUGMENTIN. There have been reports of increased prothrombin time in patients receiving AUGMENTIN and anticoagulant therapy concomitantly.
Central Nervous System
Agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, insomnia, and reversible hyperactivity have been reported.
Miscellaneous
Tooth discoloration (brown, yellow, or gray staining) has been reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.
In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. A prospective study of 51 pediatric patients at a poison-control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms1.
Interstitial nephritis resulting in oliguric renal failure has been reported in patients after overdosage with amoxicillin/clavulanate potassium.
Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin/clavulanate potassium overdosage in adult and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin/clavulanate potassium crystalluria. Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin/clavulanate potassium. Amoxicillin/clavulanate potassium may be removed from circulation by hemodialysis.
Mean amoxicillin and clavulanate potassium pharmacokinetic parameters in normal adults following administration of AUGMENTIN Tablets are shown in Table 3 and following administration of AUGMENTIN Powder for Oral Suspension and Chewable Tablets are shown in Table 4.
Table 3: Mean (±S.D.) Amoxicillin and Clavulanate Potassium Pharmacokinetic Parametersa,b
with AUGMENTIN Tablets
| Dose and Regimen | Cmax (mcg/mL) | AUC0-24(mcg*h/mL) | ||
| Amoxicillin/Clavulanate potassium |
Amoxicillin | Clavulanate potassium |
Amoxicillin | Clavulanate potassium |
| 250/125 mg every 8 hours | 3.3 ± 1.12 | 1.5 ± 0.70 | 26.7 ± 4.56 | 12.6 ± 3.25 |
| 500/125 mg every 12 hours | 6.5 ± 1.41 | 1.8 ± 0.61 | 33.4 ± 6.76 | 8.6 ± 1.95 |
| 500 125 mg every 8 hours | 7.2 ± 2.26 | 2.4 ± 0.83 | 53.4 ± 8.87 | 15.7 ± 3.86 |
| 875/125 mg every 12 hours | 11.6 ± 2.78 | 2.2 ± 0.99 | 53.5 ± 12.31 |
10.2 ± 3.04 |
| aMean (± standard deviation) values of 14 normal adults (N=15 for clavulanate potassium in the lowdose
regimens). Peak concentrations occurred approximately 1.5 hours after the dose. bAmoxicillin/clavulanate potassium administered at the start of a light meal. |
Table 4: Mean (±S.D.) Amoxicillin and Clavulanate Potassium Pharmacokinetic Parametersa,b
with AUGMENTIN Powder for Oral Suspension and Chewable Tablets
| Dose | Cmax (mcg/mL) | AUC0-24(mcg*h/mL) | ||
| Amoxicillin/Clavulanate potassium |
Amoxicillin | Clavulanate potassium |
Amoxicillin | Clavulanate potassium |
| 400/57 mg(5 mL of suspension) |
6.94 ± 1.24 | 1.10 ± 0.42 | 17.29 ± 2.28 |
2.34 ± 0.94 |
| 400/57 mg(1 chewable tablet) |
6.67 ± 1.37 | 1.03 ± 0.33 | 17.24 ± 2.64 |
2.17 ± 0.73 |
| aMean (± standard deviation) values of 28 normal adults. Peak concentrations occurred approximately 1
hour after the dose. bAmoxicillin/clavulanate potassium administered at the start of a light meal. |
Oral administration of 5 mL of 250 mg/5 mL suspension of AUGMENTIN or the equivalent dose of 10 mL of 125 mg/5 mL suspension of AUGMENTIN provides average peak serum concentrations approximately 1 hour after dosing of 6.9 mcg/mL for amoxicillin and 1.6 mcg/mL for clavulanic acid. The areas under the serum concentration curves obtained during the first 4 hours after dosing were 12.6 mcg*h/mL for amoxicillin and 2.9 mcg*h/mL for clavulanic acid when 5 mL of 250 mg/5 mL suspension of AUGMENTIN or equivalent dose of 10 mL of 125 mg/5 mL suspension of AUGMENTIN were administered to normal adults. One 250-mg chewable tablet of AUGMENTIN or two 125-mg chewable tablets of AUGMENTIN are equivalent to 5 mL of 250 mg/5 mL suspension of AUGMENTIN and provide similar serum concentrations of amoxicillin and clavulanic acid.
Amoxicillin serum concentrations achieved with AUGMENTIN are similar to those produced by the oral administration of equivalent doses of amoxicillin alone. Time above the minimum inhibitory concentration of 1 mcg/mL for amoxicillin has been shown to be similar after corresponding every 12 hour and every 8 hour dosing regimens of AUGMENTIN in adults and children.
Absorption
Dosing in the fasted or fed state has minimal effect on the pharmacokinetics of amoxicillin. While AUGMENTIN can be given without regard to meals, absorption of clavulanate potassium when taken with food is greater relative to the fasted state. In one study, the relative bioavailability of clavulanate was reduced when AUGMENTIN was dosed at 30 and 150 minutes after the start of a high fat breakfast.
Distribution
Neither component in AUGMENTIN is highly protein bound; clavulanic acid is approximately 25% bound to human serum and amoxicillin approximately 18% bound. Amoxicillin diffuses readily into most body tissues and fluids with the exception of the brain and spinal fluid.
Two hours after oral administration of a single 35 mg/kg dose of suspension of AUGMENTIN to fasting children, average concentrations of 3 mcg/mL of amoxicillin and 0.5 mcg/mL of clavulanic acid were detected in middle ear effusions.
Metabolism And Excretion
The half life of amoxicillin after the oral administration of AUGMENTIN is 1.3 hours and that of clavulanic acid is 1 hour.
Approximately 50% to 70% of the amoxicillin and approximately 25% to 40% of the clavulanic acid are excreted unchanged in urine during the first 6 hours after administration of a single 250 mg or 500 mg tablet of AUGMENTIN.
Augmentin Oral Suspension is indicated for the treatment of the following infections in adults and children :
- Acute bacterial sinusitis
- Acute otitis media
- Acute streptococcal tonsillitis and pharyngitis
- Acute exacerbations of chronic bronchitis
- Community acquired pneumonia
- Acute cystitis
- Asymptomatic bacteriuria in pregnancy
- Acute pyelonephritis
- Typhoid and paratyphoid fever
- Dental abscess with spreading cellulitis
- Prosthetic joint infections
- Helicobacter pylori eradication
- Lyme disease
.
Augmentin Oral Suspension is also indicated for the prophylaxis of endocarditis.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Amoxil is indicated for the treatment of the following infections in adults and children :
- Acute bacterial sinusitis
- Acute otitis media
- Acute streptococcal tonsillitis and pharyngitis
- Acute exacerbations of chronic bronchitis
- Community acquired pneumonia
- Acute cystitis
- Asymptomatic bacteriuria in pregnancy
- Acute pyelonephritis
- Typhoid and paratyphoid fever
- Dental abscess with spreading cellulitis
- Prosthetic joint infections
- Helicobacter pylori eradication
- Lyme disease
Amoxil is also indicated for the prophylaxis of endocarditis.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Posology
The dose of Augmentin Oral Suspension that is selected to treat an individual infection should take into account:
- The expected pathogens and their likely susceptibility to antibacterial agents
- The severity and the site of the infection
- The age, weight and renal function of the patient; as shown below
The duration of therapy should be determined by the type of infection and the response of the patient, and should generally be as short as possible.).
Adults and children > 40kg
| Indication* | Dose* |
| Acute bacterial sinusitis | 250 mg to 500 mg every 8 hours or 750 mg to 1 g every 12 hours |
| Asymptomatic bacteriuria in pregnancy | |
| Acute pyelonephritis | For severe infections 750 mg to 1 g every 8 hours |
| Dental abscess with spreading cellulitis | |
| Acute cystitis | Acute cystitis may be treated with 3 g twice daily for one day |
| Acute otitis media Acute streptococcal tonsillitis and pharyngitis Acute exacerbations of chronic bronchitis | 500 mg every 8 hours, 750 mg to 1 g every 12 hours For severe infections 750 mg to 1 g every 8 hours for 10 days |
| Community acquired pneumonia | 500 mg to 1 g every 8 hours |
| Typhoid and paratyphoid fever | 500 mg to 2 g every 8 hours |
| Prosthetic joint infections | 500 mg to 1 g every 8 hours |
| Prophylaxis of endocarditis | 2 g orally, single dose 30 to 60 minutes before procedure |
| Helicobacter pylori eradication | 750 mg to 1 g twice daily in combination with a proton pump inhibitor (e.g. omeprazole, lansoprazole) and another antibiotic (e.g. clarithromycin, metronidazole) for 7 days |
| Lyme disease | Early stage: 500 mg to 1 g every 8 hours up to a maximum of 4 g/day in divided doses for 14 days (10 to 21 days) Late stage (systemic involvement): 500 mg to 2 g every 8 hours up to a maximum of 6 g/day in divided doses for 10 to 30 days |
| *Consideration should be given to the official treatment guidelines for each indication | |
Children < 40 kg
Children may be treated with Augmentin Capsules, dispersible tablets suspensions or sachets
Augmentin Paediatric Suspension is recommended for children under six months of age.
Children weighing 40 kg or more should be prescribed the adult dosage.
Recommended doses:
| Indication+ | Dose+ |
| Acute bacterial sinusitis | 20 to 90 mg/kg/day in divided doses* |
| Acute otitis media | |
| Community acquired pneumonia | |
| Acute cystitis | |
| Acute pyelonephritis | |
| Dental abscess with spreading cellulitis | |
| Acute streptococcal tonsillitis and pharyngitis | 40 to 90 mg/kg/day in divided doses* |
| Typhoid and paratyphoid fever | 100 mg/kg/day in three divided doses |
| Prophylaxis of endocarditis | 50 mg/kg orally, single dose 30 to 60 minutes before procedure |
| Lyme disease | Early stage: 25 to 50 mg/kg/day in three divided doses for 10 to 21 days Late stage (systemic involvement): 100 mg/kg/day in three divided doses for 10 to 30 days |
| +Consideration should be given to the official treatment guidelines for each indication. *Twice daily dosing regimens should only be considered when the dose is in the upper range. | |
Elderly
No dose adjustment is considered necessary.
Renal impairment
| GFR (ml/min) | Adults and children > 40 kg | Children < 40 kg# |
| greater than 30 | No adjustment necessary | No adjustment necessary |
| 10 to 30 | Maximum 500 mg twice daily | 15 mg/kg given twice daily (maximum 500 mg twice daily) |
| less than 10 | Maximum 500mg/day. | 15 mg/kg given as a single daily dose (maximum 500 mg) |
| # In the majority of cases, parenteral therapy is preferred. | ||
In patients receiving haemodialysis
Augmentin may be removed from the circulation by haemodialysis.
| Haemodialysis | |
| Adults and children over 40 kg | 500mg every 24 h Prior to haemodialysis one additional dose of 500mg should be administered. In order to restore circulating drug levels, another dose of 500 mg should be administered after haemodialysis. |
| Children under 40kg | 15 mg/kg/day given as a single daily dose (maximum 500 mg). Prior to haemodialysis one additional dose of 15 mg/kg should be administered. In order to restore circulating drug levels, another dose of 15 mg/kg should be administered after haemodialysis. |
In patients receiving peritoneal dialysis
Augmentin maximum 500 mg/day.
Hepatic impairment
Dose with caution and monitor hepatic function at regular intervals.
Method of administration
Augmentin Oral Suspension is for oral use.
Absorption of Augmentin Oral Suspension is unimpaired by food.
Therapy can be started parenterally according to the dosing recommendations of the intravenous formulation and continued with an oral preparation.
Posology
The dose of Amoxil that is selected to treat an individual infection should take into account:
- The expected pathogens and their likely susceptibility to antibacterial agents
- The severity and the site of the infection
- The age, weight and renal function of the patient; as shown below
The duration of therapy should be determined by the type of infection and the response of the patient, and should generally be as short as possible.).
Adults and children >40 kg
| Indication* | Dose* |
| Acute bacterial sinusitis | 250 mg to 500 mg every 8 hours or 750 mg to 1 g every 12 hours For severe infections 750 mg to 1 g every 8 hours Acute cystitis may be treated with 3 g twice daily for one day |
| Asymptomatic bacteriuria in pregnancy | |
| Acute pyelonephritis | |
| Dental abscess with spreading cellulitis | |
| Acute cystitis | |
| Acute otitis media | 500 mg every 8 hours, 750 mg to 1 g every 12 hours For severe infections 750 mg to 1 g every 8 hours for 10 days |
| Acute streptococcal tonsillitis and pharyngitis | |
| Acute exacerbations of chronic bronchitis | |
| Community acquired pneumonia | 500 mg to 1 g every 8 hours |
| Typhoid and paratyphoid fever | 500 mg to 2 g every 8 hours |
| Prosthetic joint infections | 500 mg to 1 g every 8 hours |
| Prophylaxis of endocarditis | 2 g orally, single dose 30 to 60 minutes before procedure |
| Helicobacter pylori eradication | 750 mg to 1 g twice daily in combination with a proton pump inhibitor (e.g. omeprazole, lansoprazole) and another antibiotic (e.g. clarithromycin, metronidazole) for 7 days |
| Lyme disease | Early stage: 500 mg to 1 g every 8 hours up to a maximum of 4 g/day in divided doses for 14 days (10 to 21 days) Late stage (systemic involvement): 500 mg to 2 g every 8 hours up to a maximum of 6 g/day in divided doses for 10 to 30 days |
| *Consideration should be given to the official treatment guidelines for each indication | |
Children <40 kg
Children may be treated with Amoxil capsules, dispersible tablets suspensions or sachets.
Amoxil Paediatric Suspension is recommended for children under six months of age.
Children weighing 40 kg or more should be prescribed the adult dosage.
Recommended doses:
| Indication+ | Dose+ |
| Acute bacterial sinusitis | 20 to 90 mg/kg/day in divided doses* |
| Acute otitis media | |
| Community acquired pneumonia | |
| Acute cystitis | |
| Acute pyelonephritis | |
| Dental abscess with spreading cellulitis | |
| Acute streptococcal tonsillitis and pharyngitis | 40 to 90 mg/kg/day in divided doses* |
| Typhoid and paratyphoid fever | 100 mg/kg/day in three divided doses |
| Prophylaxis of endocarditis | 50 mg/kg orally, single dose 30 to 60 minutes before procedure |
| Lyme disease | Early stage: 25 to 50 mg/kg/day in three divided doses for 10 to 21 days Late stage (systemic involvement): 100 mg/kg/day in three divided doses for 10 to 30 days |
| + Consideration should be given to the official treatment guidelines for each indication. *Twice daily dosing regimens should only be considered when the dose is in the upper range. | |
Elderly
No dose adjustment is considered necessary.
Renal impairment
| GFR (ml/min) | Adults and children > 40 kg | Children < 40 kg# |
| greater than 30 | no adjustment necessary | no adjustment necessary |
| 10 to 30 | maximum 500 mg twice daily | 15 mg/kg given twice daily (maximum 500 mg twice daily) |
| less than 10 | maximum 500 mg/day. | 15 mg/kg given as a single daily dose (maximum 500 mg) |
| # In the majority of cases, parenteral therapy is preferred. | ||
In patients receiving haemodialysis
Amoxicillin may be removed from the circulation by haemodialysis.
| Haemodialysis | |
| Adults and children over 40 kg | 500 mg every 24 h Prior to haemodialysis one additional dose of 500 mg should be administered. In order to restore circulating drug levels, another dose of 500 mg should be administered after haemodialysis. |
| Children under 40 kg | 15 mg/kg/day given as a single daily dose (maximum 500 mg). Prior to haemodialysis one additional dose of 15 mg/kg should be administered. In order to restore circulating drug levels, another dose of 15 mg/kg should be administered after haemodialysis. |
In patients receiving peritoneal dialysis
Amoxicillin maximum 500 mg/day.
Hepatic impairment
Dose with caution and monitor hepatic function at regular intervals.
Method of administration
Amoxil is for oral use.
Absorption of Amoxil is unimpaired by food.
Therapy can be started parenterally according to the dosing recommendations of the intravenous formulation and continued with an oral preparation.
Swallow with water without opening capsule.
No studies on the effects on the ability to drive and use machines have been performed. However, undesirable effects may occur (e.g. allergic reactions, dizziness, convulsions), which may influence the ability to drive or use machines.
No studies on the effects on the ability to drive and use machines have been performed. However, undesirable effects may occur (e.g. allergic reactions, dizziness, convulsions), which may influence the ability to drive and use machines.
Pharmacotherapeutic group: penicillins with extended spectrum; ATC code: J01CA04.
Mechanism of action
Augmentin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins, PBPs) in the biosynthetic pathway of bacterial peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, which is usually followed by cell lysis and death.
Augmentin is susceptible to degradation by beta-lactamases produced by resistant bacteria and therefore the spectrum of activity of Augmentin alone does not include organisms which produce these enzymes.
Pharmacokinetic/pharmacodynamic relationship
The time above the minimum inhibitory concentration (T>MIC) is considered to be the major determinant of efficacy for Augmentin.
Mechanisms of resistance
The main mechanisms of resistance to Augmentin are:
- Inactivation by bacterial beta-lactamases.
- Alteration of PBPs, which reduce the affinity of the antibacterial agent for the target.
Impermeability of bacteria or efflux pump mechanisms may cause or contribute to bacterial resistance, particularly in Gram-negative bacteria.
Breakpoints
MIC breakpoints for Augmentin are those of the European Committee on Antimicrobial Susceptibility Testing (EUCAST) version 5.0.
| Organism | MIC breakpoint (mg/L) | |
| Susceptible ≤ | Resistant > | |
| Enterobacteriaceae | 81 | 8 |
| Staphylococcus spp. | Note2 | Note 2 |
| Enterococcus spp.3 | 4 | 8 |
| Streptococcus groups A, B, C and G | Note 4 | Note 4 |
| Streptococcus pneumoniae | Note 5 | Note 5 |
| Viridans group steprococci | 0.5 | 2 |
| Haemophilus influenzae | 26 | 26 |
| Moraxella catarrhalis | Note 7 | Note 7 |
| Neisseria meningitidis | 0.125 | 1 |
| Gram positive anaerobes except Clostridium difficile8 | 4 | 8 |
| Gram negative anaerobes8 | 0.5 | 2 |
| Helicobacter pylori | 0.1259 | 0.1259 |
| Pasteurella multocida | 1 | 1 |
| Non- species related breakpoints10 | 2 | 8 |
| 1Wild type Enterobacteriaceae are categorised as susceptible to aminopenicillins. Some countries prefer to categorise wild type isolates of E. coli and P. mirabilis as intermediate. When this is the case, use the MIC breakpoint S ≤ 0.5 mg/L 2Most staphylococci are penicillinase producers, which are resistant to Augmentin. Methicillin resistant isolates are, with few exceptions, resistant to all beta-lactam agents. 3Susceptibility to Augmentin can be inferred from ampicillin 4The susceptibility of streptococcus groups A, B, C and G to penicillins is inferred from the benzylpenicillin susceptibility. 5Breakpoints relate only to non-meningitis isolates. For isolates categorised as intermediate to ampicillin avoid oral treatment with Augmentin. Susceptibility inferred from the MIC of ampicillin. 6Breakpoints are based on intravenous administration. Beta-lactamase positive isolates should be reported resistant. 7Beta lactamase producers should be reported resistant 8Susceptibility to Augmentin can be inferred from benzylpenicillin. 9The breakpoints are based on epidemiological cut-off values (ECOFFs), which distinguish wild-type isolates from those with reduced susceptibility. 10The non-species related breakpoints are based on doses of at least 0.5 g x 3or 4 doses daily (1.5 to 2 g/day) | ||
The prevalence of resistance may vary geographically and with time for selected species, and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
| In vitro susceptibility of micro-organisms to Augmentin |
| Commonly Susceptible Species |
| Gram-positive aerobes: |
| Enterococcus faecalis Beta-hemolytic streptococci (Groups A, B, C and G) Listeria monocytogenes |
| Species for which acquired resistance may be a problem |
| Gram-negative aerobes: Escherichia coli Haemophilus influenzae Helicobacter pylori Proteus mirabilis Salmonella typhi Salmonella paratyphi Pasteurella multocida |
| Gram-positive aerobes: Coagulase negative staphylococcus Staphylococcus aureus£ Streptococcus pneumoniae Viridans group streptococcus |
| Gram-positive anaerobes: Clostridium spp. |
| Gram-negative anaerobes: Fusobacterium spp. |
| Other: Borrelia burgdorferi |
| Inherently resistant organisms†|
| Gram-positive aerobes: Enterococcus faecium†|
| Gram-negative aerobes: Acinetobacter spp. Enterobacter spp. Klebsiella spp. Pseudomonas spp. |
| Gram-negative anaerobes: Bacteroides spp. (many strains of Bacteroides fragilis are resistant). |
| Others: Chlamydia spp. Mycoplasma spp. Legionella spp. |
| †Natural intermediate susceptibility in the absence of acquired mechanism of resistance. £ Almost all S.aureus are resistant to Augmentin due to production of penicillinase. In addition, all methicillin-resistant strains are resistant to Augmentin. |
Pharmacotherapeutic group: penicillins with extended spectrum; ATC code: J01CA04.
Mechanism of action
Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins, PBPs) in the biosynthetic pathway of bacterial peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, which is usually followed by cell lysis and death.
Amoxicillin is susceptible to degradation by beta-lactamases produced by resistant bacteria and therefore the spectrum of activity of amoxicillin alone does not include organisms which produce these enzymes.
Pharmacokinetic/pharmacodynamic relationship
The time above the minimum inhibitory concentration (T>MIC) is considered to be the major determinant of efficacy for amoxicillin.
Mechanisms of resistance
The main mechanisms of resistance to amoxicillin are:
- Inactivation by bacterial beta-lactamases.
- Alteration of PBPs, which reduce the affinity of the antibacterial agent for the target.
Impermeability of bacteria or efflux pump mechanisms may cause or contribute to bacterial resistance, particularly in Gram-negative bacteria.
Breakpoints
MIC breakpoints for amoxicillin are those of the European Committee on Antimicrobial Susceptibility Testing (EUCAST) version 5.0.
| Organism | MIC breakpoint (mg/L) | |
| Susceptible ≤ | Resistant > | |
| Enterobacteriaceae | 81 | 8 |
| Staphylococcus spp. | Note2 | Note 2 |
| Enterococcus spp.3 | 4 | 8 |
| Streptococcus groups A, B, C and G | Note 4 | Note 4 |
| Streptococcus pneumoniae | Note 5 | Note 5 |
| Viridans group steprococci | 0.5 | 2 |
| Haemophilus influenzae | 26 | 26 |
| Moraxella catarrhalis | Note 7 | Note 7 |
| Neisseria meningitidis | 0.125 | 1 |
| Gram positive anaerobes except Clostridium difficile8 | 4 | 8 |
| Gram negative anaerobes8 | 0.5 | 2 |
| Helicobacter pylori | 0.1259 | 0.1259 |
| Pasteurella multocida | 1 | 1 |
| Non- species related breakpoints10 | 2 | 8 |
| 1Wild type Enterobacteriaceae are categorised as susceptible to aminopenicillins. Some countries prefer to categorise wild type isolates of E. coli and P. mirabilis as intermediate. When this is the case, use the MIC breakpoint S ≤ 0.5 mg/L 2Most staphylococci are penicillinase producers, which are resistant to amoxicillin. Methicillin resistant isolates are, with few exceptions, resistant to all beta-lactam agents. 3Susceptibility to amoxicillin can be inferred from ampicillin 4The susceptibility of streptococcus groups A, B, C and G to penicillins is inferred from the benzylpenicillin susceptibility. 5Breakpoints relate only to non-meningitis isolates. For isolates categorised as intermediate to ampicillin avoid oral treatment with amoxicillin. Susceptibility inferred from the MIC of ampicillin. 6Breakpoints are based on intravenous administration. Beta-lactamase positive isolates should be reported resistant. 7Beta lactamase producers should be reported resistant 8Susceptibility to amoxicillin can be inferred from benzylpenicillin. 9The breakpoints are based on epidemiological cut-off values (ECOFFs), which distinguish wild-type isolates from those with reduced susceptibility. 10The non-species related breakpoints are based on doses of at least 0.5 g x 3or 4 doses daily (1.5 to 2 g/day). | ||
The prevalence of resistance may vary geographically and with time for selected species, and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
| In vitro susceptibility of micro-organisms to Amoxicillin |
| Commonly Susceptible Species |
| Gram-positive aerobes: Enterococcus faecalis Beta-hemolytic streptococci (Groups A, B, C and G) Listeria monocytogenes |
| Species for which acquired resistance may be a problem |
| Gram-negative aerobes: Escherichia coli Haemophilus influenzae Helicobacter pylori Proteus mirabilis Salmonella typhi Salmonella paratyphi Pasteurella multocida |
| Gram-positive aerobes: Coagulase negative staphylococcus Staphylococcus aureus£ Streptococcus pneumoniae Viridans group streptococcus |
| Gram-positive anaerobes: Clostridium spp. |
| Gram-negative anaerobes: Fusobacterium spp. |
| Other: Borrelia burgdorferi |
| Inherently resistant organisms†|
| Gram-positive aerobes: Enterococcus faecium†|
| Gram-negative aerobes: Acinetobacter spp. Enterobacter spp. Klebsiella spp. Pseudomonas spp. |
| Gram-negative anaerobes: Bacteroides spp. (many strains of Bacteroides fragilis are resistant). |
| Others: Chlamydia spp. Mycoplasma spp. Legionella spp. |
| †Natural intermediate susceptibility in the absence of acquired mechanism of resistance. £ Almost all S.aureus are resistant to amoxilcillin due to production of penicillinase. In addition, all methicillin-resistant strains are resistant to amoxicillin. |
Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development.
Carcinogenicity studies have not been conducted with Augmentin.
Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development.
Carcinogenicity studies have not been conducted with amoxicillin.
Not applicable.
Check cap seal is intact before use.
Invert and shake bottle to loosen powder.
To prepare add 64ml of potable water and shake until all contents are dispersed
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
