Augmentin ES-600

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Augmentin ES-600

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Augmentin ES-600

Property Description
Active Ingredients Amoxicillin, Clavulanic Acid
Form Powder for Oral Suspension
Pharmacological Class beta-Lactam Antibiotic / beta-Lactamase Inhibitor Combination
General Purpose Combats susceptible bacterial infections
Origin Semisynthetic

What Type of Medicine is Amoxicillin and Clavulanate Potassium (Augmentin ES-600)?

Augmentin ES-600 is a prescription-only (Rx status) semisynthetic combination product classified as an anti-infective agent within the beta-lactam antibiotic / beta-lactamase inhibitor combination class. The drug is a penicillin derivative, and its dual-component nature is characteristic of therapeutic strategies designed to address evolving microbial resistance patterns.

The drug entity, Amoxicillin and Clavulanate Potassium, is prepared for administration via the oral route as a Powder for Oral Suspension. This particular physical form must be reconstituted with water before use, a design choice intended to ensure accurate and tailored dosing.


What Active Ingredients are in Augmentin ES-600 and How Does it Differ?

The composition includes the two active ingredients: amoxicillin (the primary antibiotic) and clavulanic acid (the potassium salt). These are combined in a fixed 14:1 ratio of amoxicillin to clavulanate. This high-concentration formula is specifically designed for pediatric patients (children weighing less than 40 kg), providing high-dose amoxicillin therapy when indicated for this age group.

The high concentration of amoxicillin, specifically 600 mg/5 mL, is a key differentiating factor, offering treatment levels optimized for pediatric body weights while managing the overall exposure to the clavulanate component. This combination is a standard therapeutic option for treating common bacterial infections.


What is the General Purpose of the Amoxicillin/Clavulanate Combination?

The general purpose of the Amoxicillin and Clavulanate Potassium combination is to treat bacterial infections by actively overcoming bacterial resistance. The clavulanic acid component functions as a protective agent—a beta-lactamase inhibitor—that chemically neutralizes the bacterial enzymes (beta-lactamases) that would otherwise destroy the amoxicillin. This protective action ensures the primary antibiotic remains intact to stop the growth of drug-resistant bacteria.

What side effects are possible with Augmentin ES-600?

Possible side effects and safety information

The official safety profile for Amoxicillin and Clavulanate Potassium is structured around frequencies and the affected System-Organ Class (SOC) as defined by regulatory authorities.


Frequency-Classified Adverse Reactions

Adverse reactions are categorized by incidence rate, with the most frequently reported events being gastrointestinal in nature:

  • Common (occur in 1 to 10 out of 100 people): Diarrhea, nausea, vomiting, and mucocutaneous candidiasis.
  • Uncommon (occur in 1 to 10 out of 1,000 people): Dizziness, headache, indigestion, skin rash, pruritus (itching), urticaria, and a reversible increase in liver enzymes (ALT/AST).

Serious Adverse Reactions and Key Safety Constraints

Regulatory documents highlight rare but clinically critical safety concerns. Severe hypersensitivity reactions, including anaphylaxis, angioedema, and serious skin conditions like Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), are documented as potentially life-threatening. The medication is restricted from use in individuals with a history of prior severe immediate hypersensitivity to any penicillin or beta-lactam agent.

Hepatic dysfunction, including cholestatic jaundice and hepatitis, is a documented serious adverse event that can lead to hepatic failure, particularly in older adults or those with underlying disease. The medication is explicitly contraindicated in patients who have a history of hepatic dysfunction associated with previous use of this combination. Hepatic events may manifest during treatment or shortly after cessation, sometimes weeks later.

Other serious events include Clostridioides difficile-associated diarrhea (CDAD), which must be considered in patients presenting with severe diarrhea after treatment. Safety notes also state that use is contraindicated in patients with infectious mononucleosis due to the high risk of rash.

Overdose and Emergency Response

The official regulatory profile for Amoxicillin and Clavulanate Potassium overdose is defined by specific gastrointestinal, neurological, and renal manifestations. Documented symptoms following high exposure include severe gastrointestinal irritation, such as stomach pain and diarrhea, as well as central nervous system effects like sleepiness, agitation, and confusion. Seizures (convulsions) have been reported rarely as a serious potential outcome.

The most critical concern is the dose-related risk of amoxicillin crystalluria, which presents as cloudy or greatly decreased urination and can potentially lead to acute renal failure. Patients with existing impaired renal function or reduced fluid intake are noted to be at increased risk for this complication.

If a suspected overdose occurs or if severe symptoms such as seizures or markedly decreased urine output are observed, immediate medical attention must be sought. Official regulatory management involves the immediate discontinuation of the medication and the provision of supportive care and symptomatic treatment. No specific antidote is documented; however, maintaining adequate fluid intake is necessary to mitigate crystalluria risk, and hemodialysis may be used to effectively remove both the amoxicillin and clavulanate components in severe cases.

Therapeutic Uses of Augmentin ES-600

What Augmentin ES-600 Treats: Main Uses and Benefits

This specialized formulation is commonly used to help manage acute bacterial infections of the middle ear, known as acute otitis media (AOM). This product is generally applied when supportive symptom management is appropriate for pediatric patients, especially when dealing with infections that may involve specific beta-lactamase–producing organisms.

Management of Recurrent and Drug-Resistant Pathogens

This medication is relevant in clinical settings that involve acute or unstable symptom patterns, specifically when patients experience recurrent or persistent AOM. It is applied across domains where additional symptomatic support is needed because of established risk factors, such as recent antibacterial drug exposure or daycare attendance. The combination is used to help ease the overall symptom burden by addressing these difficult-to-treat organisms.

Pediatric Therapeutic Support

This formulation provides targeted antibacterial support for pediatric patients. Indications for use include AOM associated with the presence of specific bacterial pathogens. By design, this formulation is intended for use in situations where symptoms related to organ-specific functional stress are present, and may assist with easing discomfort and supports improved day-to-day comfort during episodes of acute bacterial illness.

Quick Fact: Managing Acute Otalgia
This medication is commonly used to help manage the acute ear pain (otalgia) and fever associated with bacterial middle ear infections.

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Augmentin ES-600

Official regulatory information strictly defines the patient populations eligible for Augmentin ES-600 Powder for Oral Suspension.

Category Eligibility Status as Per Official Labels
Contraindicated Patients with a history of serious allergic reaction to any penicillin, cephalosporin, or other beta-lactam drugs. The medicine is also strictly prohibited for patients with a previous history of cholestatic jaundice or liver dysfunction linked to prior amoxicillin/clavulanate use.
Age and Weight Use is strictly limited to pediatric patients ge 3 months of age who weigh 40 kg or less. Safety and effectiveness have not been established for children under 3 months or for patients over 40 kg (including adults).
Organ Function The formulation is not recommended for patients with severe renal impairment (Creatinine Clearance < 30 mL/min). Patients with existing hepatic dysfunction should use the medicine with caution and require regular monitoring.
Comorbidity Use should be avoided in patients with suspected infectious mononucleosis. Patients with Phenylketonuria (PKU) must use with caution as the product contains aspartame.
Pregnancy/Lactation The medicine should generally be avoided during pregnancy unless considered essential. Caution is advised during lactation, as the active ingredients are known to be excreted into breast milk.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section describes officially documented interaction patterns for Amoxicillin and Clavulanate Potassium (Augmentin ES-600) as established in government regulatory documents.


Documented Pharmacokinetic and Pharmacodynamic Interactions

Entity Interaction Outcome and Restriction
Probenecid This substance is officially not recommended for co-administration. It increases and prolongs the plasma concentration of amoxicillin by inhibiting its renal tubular secretion, thereby altering exposure.
Oral Anticoagulants Co-administration may increase the International Normalized Ratio (INR) or prothrombin time. Close monitoring of coagulation parameters is required.
Methotrexate The penicillin component may reduce the excretion of Methotrexate, creating the potential for increased Methotrexate toxicity.
Mycophenolate Mofetil (MMF) A significant reduction (approximately 50%) in the pre-dose concentration of the active metabolite, Mycophenolic Acid (MPA), has been reported.
Allopurinol Concomitant use increases the documented likelihood of developing a generalized allergic skin reaction or rash.

Administration and Component-Specific Notes

The absorption of the clavulanate component is enhanced when the medication is administered at the start of a meal. The product contains aspartame (a source of phenylalanine) and requires specific caution for use in patients with phenylketonuria (PKU). The medicine should be avoided if Infectious Mononucleosis is suspected due to the high risk of rash associated with amoxicillin use in that population.

Mechanism of Action

The action of Amoxicillin and Clavulanic Acid exerts its pharmacodynamic action through a dual mechanistic process targeting bacterial cell physiology. The primary action involves Amoxicillin acting as an irreversible inhibitor against Penicillin-Binding Proteins (PBPs), the bacterial transpeptidases necessary for constructing the cell wall. Amoxicillin prevents the final cross-linking step of peptidoglycan synthesis, leading to a fundamental structural failure. This molecular disruption causes the bacterial cell to become osmotically unstable, triggering autolytic enzymes and resulting in rapid cell lysis and death (a bactericidal mechanism).

This bactericidal process is crucially supported by Clavulanic Acid, which functions as an irreversible suicide inhibitor specifically targeting beta-lactamase enzymes produced by resistant bacteria. By forming a stable, inactive complex with these defense enzymes, clavulanic acid shields the beta-lactam ring of amoxicillin from hydrolysis. This pharmacodynamic protection restores amoxicillin's ability to engage its PBP targets, thereby ensuring its bactericidal mechanism is executed against susceptible, enzyme-producing strains, resulting in a diminished concentration of viable pathogens.

Dosage and Administration Information

Instruction Map: How to use Augmentin ES-600 — Administration Guidelines


Administration Scope

Instruction Detail
Route of administration Oral, as a reconstituted powder for oral suspension.
Dosing schedule The regimen is 90 mg/kg/day of amoxicillin, administered in two equally divided doses.
Timing in relation to meals (if applicable) Must be administered at the start of a meal to enhance absorption of the clavulanate component.
Preparation requirements (if applicable) The supplied powder requires reconstitution with a specific volume of water; the prepared suspension must be shaken well before each use.
Age-group administration rules Intended for pediatric patients weighing less than 40 kg; this formulation is not established for use in adults or children ge 40 kg.
Missed-dose rules If a dose is missed, administer it as soon as remembered; if it is near the time of the next dose, the missed dose should be skipped. Do not take two doses at one time.
Special procedural conditions The reconstituted suspension requires refrigeration and must be discarded after 10 days. This 14:1 product is not interchangeable with other Augmentin suspensions.

Instruction Classifications (High-Level)

Classification Detail
Administration method type Oral suspension.
Frequency pattern Twice daily (dose divided and taken every 12 hours).
Use-context constraints Must be used for a fixed duration of 10 days. Dose calculation is weight-based.

Resulting Procedural Structure

Step sequence:

  • The dry powder is reconstituted with the proper amount of water at the time of dispensing.
  • The appropriate, weight-based volume of the suspension is measured and administered every 12 hours.
  • Each dose must be taken at the start of a meal.
  • The bottle must be shaken well prior to measuring each individual dose.
  • Any remaining refrigerated product is discarded after 10 days of use.

Connection to the overall use protocol:

The usage protocol structures the administration around a calculated, weight-based dose specific to the pediatric population (le 40 kg). This protocol mandates a fixed 10-day treatment duration with a twice-daily frequency and explicitly links administration to meal-timing to enhance absorption. These explicit conditions define the standardized approach for using this unique 14:1 formulation.

Recent Clinical Evidence

Augmentin ES-600: Recent Clinical Evidence


Evidence for Use in Acute Otitis Media with Risk Factors

The specialized combination of amoxicillin and clavulanate has been studied for the treatment of recurrent or persistent acute otitis media (AOM), especially in pediatric patients with risk factors suggesting the infection may involve beta-lactamase–producing bacteria. The core research consists of Randomized Controlled Trials (RCTs) and pivotal clinical studies. Researchers assessed measured shifts in clinical response and Bacteriological Assessments, which monitor the status of target bacteria at the end of treatment. This evidence contributes to understanding symptom patterns in studies observing patients with conditions involving periods of heightened symptoms.


Types of Trials and Follow-up Duration

The evidence base is supported by Comparative trials (against active comparators or placebo) and non-comparative trials. Systematic reviews and meta-analyses are also relevant in evidence describing how outcomes are measured across studies. The available research primarily monitored outcomes over short, defined periods. Follow-up durations were limited, typically assessed 10 to 12 days after treatment, with extended observation periods lasting up to one month post-treatment. Long-term effects are not fully established, and there is limited information regarding whether outcomes were maintained over time.


Research in Specific Patient Groups and Evidence Gaps

Clinical trials observed pediatric patients (children) exclusively, spanning the ages of 3 months to 12 years and weighing 40 kg or less. Crucially, the results apply only to the populations studied. Data for other groups remain limited; there is no clinical research available for this specific formulation in the adult population. Additionally, measured outcomes have not been established in children younger than 3 months of age.

Evidence gaps remain concerning clinical activity against certain strains of S. pneumoniae that are highly resistant to penicillin, and research exploring this specific formulation is limited. Furthermore, certainty remains low for some findings because sample sizes were modest in some initial trials. Research does not determine whether an individual will respond similarly to the patterns observed.

Frequently Asked Questions (FAQ)

Common questions about Augmentin ES-600 (FAQ)


Q: Can adults use Augmentin ES-600 suspension?

A: According to the official product prescribing information, the safety and effectiveness of Augmentin ES-600 have not been established for use in adult patients. This formulation is only indicated for use in pediatric patients who weigh less than 40 kilograms.


Q: Why is Augmentin ES-600 often prescribed for children?

A: Official information indicates this product is specifically formulated for pediatric patients and is indicated for treating infections like recurrent or persistent acute otitis media (ear infection). It provides a high concentration of amoxicillin and is used when the prescribing clinician determines that a higher concentration may be appropriate to address certain resistant bacteria.


Q: Is it normal to feel tired while taking Augmentin ES-600?

A: A general feeling of tiredness or weakness has been reported as a side effect associated with taking the medication. The feeling of tiredness may also be related to the underlying condition itself.


Q: Is the 'ES' in Augmentin ES-600 related to extra strength?

A: Yes, the 'ES' in Augmentin ES-600 stands for Extra Strength. This designation is used to identify the specific formulation which has a high amoxicillin concentration (600 mg per 5 mL) and a unique 14:1 amoxicillin-to-clavulanate ratio, designed for high-dose pediatric therapy.


Q: Is Augmentin ES-600 indicated for sinus infections?

A: Regulatory documents from international health authorities state that Augmentin ES-600 is indicated for treating certain upper respiratory tract infections in children, including sinusitis (sinus infection) caused by susceptible bacteria.


Q: Is it true that Augmentin ES-600 has a bitter taste?

A: Official administration instructions address patient compliance concerns regarding the taste. Instructions for adding commercial flavoring are provided, reflecting that taste is a known consideration during administration.


Q: Does alcohol interact with Augmentin ES-600?

A: Official regulatory sources do not list a known direct interaction between alcohol and the active ingredients in Augmentin ES-600. However, there is a theoretical possibility that alcohol consumption could worsen side effects associated with the drug, such as nausea or dizziness.


Q: Is there a generic version of Augmentin ES-600?

A: Augmentin ES-600 is the brand name. The generic drug name for the combination of active ingredients is amoxicillin and clavulanate potassium. The product is generally referred to by the active ingredients at the specific 600 mg/42.9 mg per 5 mL concentration.


Q: Can Augmentin ES-600 cause dizziness?

A: Official safety data lists dizziness as an uncommon side effect that has been reported by patients using this medication. The uncommon designation means it is not one of the most frequently reported side effects.


Q: Is there a weight limit for prescribing Augmentin ES-600?

A: Yes, the official prescribing information states that this product is intended only for pediatric patients who weigh less than 40 kilograms (kg). The key eligibility is determined by weight, as safety and effectiveness are not established for patients who weigh 40 kg or more.


Q: Has there been any research on long-term effects of taking Augmentin ES-600?

A: Studies on this medication primarily tracked patient outcomes over short, defined treatment periods, such as 10 to 12 days. Official documents state that long-term effects are not fully established beyond these initial observation periods.


Q: Does Augmentin ES-600 contain sulfa?

A: The active ingredients in Augmentin ES-600 are amoxicillin (a penicillin-class antibiotic) and clavulanate potassium. Official chemical information indicates that the product does not contain any sulfonamide (sulfa) antibiotics.


Q: Is it okay to mix Augmentin ES-600 with juice or formula?

A: Official prescribing information defines the reconstitution process for the powder using water. The label does not provide instruction for mixing the suspension with juice, formula, or other liquids.


Q: Does taking Augmentin ES-600 affect sleep?

A: Official safety documents indicate that adverse reactions affecting the central nervous system have been reported. This includes sleep disturbances (insomnia), which are listed as a rare side effect of the medication.


Q: Does Augmentin ES-600 lose effectiveness if it gets warm?

A: The stability of the medicine requires specific temperature controls. The reconstituted liquid suspension is required to be stored under refrigeration to maintain its stated potency and must be discarded after 10 days, even if refrigerated.


Q: Are there different brand names for the same combination as Augmentin ES-600?

A: The combination of the two active ingredients, amoxicillin and clavulanate potassium, may be sold under other brand names. However, Augmentin ES-600 is a specific brand formulation with a unique ratio and concentration (14:1 and 600 mg/42.9 mg per 5 mL).


Q: What is the typical age range for a child to be prescribed Augmentin ES-600?

A: The medicine is indicated for use in pediatric patients 3 months of age and older. The key eligibility is determined by weight, and the product is indicated for children weighing less than 40 kilograms.


Q: Why did my doctor prescribe the ES-600 version instead of a tablet?

A: The ES-600 suspension is a specialized, high-dose formula created for pediatric patients who weigh under 40 kg. This formulation provides high amoxicillin concentration for specific pediatric needs and official documents state it is not interchangeable with other formulations due to the unique ratio.


Q: What is the official designation for the use of Augmentin ES-600?

A: The official designation for use, as defined by regulatory agencies, is the treatment of pediatric patients with recurrent or persistent acute otitis media (AOM). This indication addresses cases where the infection is recurrent or persistent, suggesting involvement of bacteria that may be resistant.

How should Augmentin ES-600 be stored and disposed of?

Storage and Disposal of Augmentin ES-600

The storage requirements for Augmentin ES-600 Powder for Oral Suspension differ before and after mixing.

Product State Temperature and Condition
Dry Powder Store at controlled room temperature (20 C to 25 C or 68 F to 77 F) in the original container.
Reconstituted Suspension Store under refrigeration (2 C to 8 C or 36 F to 46 F). Do not freeze.

The reconstituted suspension is stable for a maximum of 10 days when refrigerated. Any unused portion must be discarded after this period. The medicine must be kept out of the sight and reach of children. Disposal of unused or expired product must be done according to local requirements, and it should not be discarded via household waste or wastewater.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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