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Augmentin: Uses, Dosage & Safety Information

Augmentin

Augmentin
augmentin 500/125 mg
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Augmentin

Amoxicillin + Clavulanate potassium
Augmentin is a prescription antibacterial combining amoxicillin with clavulanate potassium, which protects amoxicillin from beta-lactamase enzymes. It treats susceptible respiratory, ear, sinus, skin and urinary infections and is taken at the start of a meal. Forms and strengths differ in their clavulanate content and are not interchangeable.
  • ActiveIngredient: Amoxicillin + Clavulanate potassium
  • DosageForm: Tablet; chewable tablet; powder for oral suspension
  • Dosage: 250 mg/125 mg, 500 mg/125 mg, 875 mg/125 mg (tablets); 125 mg/31.25 mg per 5 mL, 250 mg/62.5 mg per 5 mL (oral suspension)
  • Indications: Lower respiratory tract infections, acute bacterial otitis media, sinusitis, skin and skin structure infections and urinary tract infections caused by designated susceptible bacteria
  • Manufacturer: USAntibiotics (brand); generics also marketed
  • Storage: Reconstituted suspension is refrigerated and discarded after 10 days; tablets stored as directed
  • Drug Status: Prescription Only
Drug Status: Prescription Only
Description

What is Augmentin?

Two drugs, one tablet
Augmentin pairs amoxicillin with clavulanate, an inhibitor of the beta-lactamase enzymes some bacteria use to destroy penicillins. Clavulanate protects the amoxicillin, which is why the labelled indications name beta-lactamase-producing organisms.1

Augmentin is a prescription antibacterial supplied as tablets, chewable tablets and oral suspensions, with doses counted by the amoxicillin component. The strengths differ in their ratio of amoxicillin to clavulanate, so one form cannot simply be swapped for another.12

Augmentin ES-600 is a separate high-strength suspension approved for children with recurrent or persistent ear infections, and it is not interchangeable with other Augmentin suspensions.3

The brand remains marketed alongside generic amoxicillin and clavulanate potassium; plain amoxicillin, without clavulanate, is covered under Amoxil.24

General Instructions

How to Take Augmentin

At the start of a meal

Take each dose at the start of a meal; this reduces stomach upset and improves absorption of the clavulanate.1

How much

Adults and children over 40 kg take 500 mg or 875 mg every 12 hours, or 250 mg or 500 mg every 8 hours, counted as amoxicillin. Children from 3 months take 25 mg to 45 mg per kg a day every 12 hours or 20 mg to 40 mg per kg a day every 8 hours; infants under 3 months take 30 mg per kg a day every 12 hours.1

Check the strength

Use the exact product and strength prescribed; forms are not interchangeable because their clavulanate content differs.

Storage

Store dry powder at or below 25°C (77°F). Keep it out of the reach of children.1

What not to do

Do not stop early when symptoms improve, and do not use it for viral infections such as colds.

Side Effects

What Are the Side Effects of Augmentin?

Diarrhoea or loose stools were the most frequently reported effect, followed by nausea and skin rash.

Most Frequent Reactions
FrequencyEffectNotes
CommonDiarrhoea or loose stools9%
CommonNausea3%
CommonSkin rash or hives3%
CommonVomiting1%
CommonVaginal yeast infection (vaginitis)1%

Source: 1

Seek immediate medical attention if:
  • Swelling of the face or throat, or difficulty breathing
  • A blistering or peeling rash, or rash with fever
  • Severe or bloody diarrhoea
  • Yellowing of the skin or eyes
Uses

What is Augmentin Used For?

Augmentin is indicated for infections caused by susceptible isolates of designated bacteria, and the indications name beta-lactamase producers because that is what clavulanate is for.

  • Lower respiratory tract infections caused by beta-lactamase-producing Haemophilus influenzae and Moraxella catarrhalis
  • Acute bacterial otitis media caused by the same organisms
  • Sinusitis caused by beta-lactamase-producing isolates
  • Skin and skin structure infections, and urinary tract infections, caused by designated susceptible organisms

ES-600 is a separate indication, not a bigger bottle. It covers children aged 3 months to 12 years weighing 40 kg or less with recurrent or persistent acute otitis media, where there has been antibacterial exposure in the preceding three months and the child is either under two or in day care.3

Safety Advice

Interactions Alcohol:

Consult your doctor
The label sets no alcohol restriction for this combination. Alcohol does add to the nausea and diarrhoea that clavulanate already causes, so the practical answer usually follows how the course is being tolerated.

Interactions Other Medications:

Use with caution
Oral anticoagulants may have prothrombin time further prolonged. Allopurinol raises the risk of rash. Probenecid is not recommended alongside. A history of serious hypersensitivity to any beta-lactam is a contraindication rather than a caution.

Special Groups Pregnancy:

Consult your doctor
The prescribing information does not set a blanket recommendation. Penicillins are among the more established antibacterials in pregnancy, but the choice belongs to the clinician treating the infection.

Special Groups Breastfeeding:

Consult your doctor
The label does not establish a breastfeeding recommendation for this combination. Loose stools or thrush in the infant are the practical things to watch and report.

Special Groups Elderly:

Use with caution
No separate geriatric regimen is set. Renal function and anticoagulant use are the two factors that most often change the picture in older patients.

Special Groups Children:

Safe if prescribed
Dosing is established from birth: 30 mg/kg/day divided every 12 hours under 12 weeks, then weight-based bands. ES-600 is a separate product for recurrent or persistent otitis media in children 3 months to 12 years weighing 40 kg or less, and the two suspensions are not interchangeable.

Effects on Activities Driving:

Safe if prescribed
This combination is not sedating. The reason to stop driving would be a reaction rather than the drug itself — a spreading rash or breathlessness means stopping and seeking care.

Effects on Activities Operating Machinery:

Safe if prescribed
The same applies. Nausea and diarrhoea are the common complaints, and neither is a reason to avoid machinery unless they are severe.
Concerns

Augmentin remains an active brand under US Antibiotics, with generics also marketed.2

The concern specific to this product is strength confusion. Augmentin and Augmentin ES-600 share a name but differ in amoxicillin content and in the ratio to clavulanate, and they carry different indications. A prescription for one is not filled with the other.

Warnings

Critical Warnings for Augmentin Use

Serious beta-lactam hypersensitivity

Contraindicated after a serious hypersensitivity reaction, such as anaphylaxis or Stevens-Johnson syndrome, to Augmentin or other beta-lactams.1

Previous Augmentin-related liver injury

Contraindicated after cholestatic jaundice or liver dysfunction associated with Augmentin.1

Liver dysfunction

Hepatitis and cholestatic jaundice have been reported, sometimes appearing weeks after treatment; liver function is monitored in people with liver impairment.

Rash in mononucleosis

A high percentage of people with mononucleosis develop a rash, so it is not used for them.

See Interactions.

Dosage

Dosage

Augmentin Products
FormulationActive IngredientsClinical Note
Oral suspension 125 mg/31.25 mg per 5 mLAmoxicillin; clavulanate potassiumBanana-flavoured
Oral suspension 250 mg/62.5 mg per 5 mLAmoxicillin; clavulanate potassiumOrange-flavoured
Tablets and chewable tabletsAmoxicillin; clavulanate potassiumSeveral strengths; chewables contain phenylalanine
Severe renal impairment (GFR below 30 mL/min)Amoxicillin; clavulanate potassium875 mg dose not used; 250 mg or 500 mg every 12 hours (GFR 10 to 30) or every 24 hours (below 10)
Hepatic impairmentAmoxicillin; clavulanate potassiumLiver function monitored

Source: 12

Exceeding the dose
In an overdose the medicine is stopped and symptoms treated; in one study of children, amoxicillin overdoses under 250 mg per kg caused no significant symptoms. Seek medical help.1
Interactions

What Does Augmentin Interact With?

Interactions by Severity
Interacting SubstanceEffect and RiskSeverityDocumentation
Oral anticoagulants such as warfarinProthrombin time may be prolonged furtherMajorGood — labelled interaction
ProbenecidHigher, longer amoxicillin levels; not advised togetherModerateGood — labelled interaction
AllopurinolHigher risk of rashModerateGood — labelled interaction
Oral contraceptivesPossibly reduced effectivenessMinorFair — labelled interaction

Source: 1

FAQs
Augmentin is amoxicillin plus clavulanate, which blocks the beta-lactamase enzymes some bacteria use to destroy amoxicillin; that is why its indications name beta-lactamase-producing organisms.
Yes. Taking each dose at the start of a meal reduces stomach upset and improves absorption of the clavulanate.
Diarrhoea or loose stools, reported by about 9% of people in clinical trials; severe or bloody diarrhoea needs prompt medical review.
Not after a serious reaction such as anaphylaxis or Stevens-Johnson syndrome to any penicillin or cephalosporin; the prescriber assesses any other past reaction.
Yes, but with severe kidney impairment the 875 mg dose is not used and doses are spaced further apart.
Evidence and Reported Data

Evidence scope

What we know
  • The indications name beta-lactamase-producing organisms specifically, which matches what clavulanate does.
  • Dosing is defined from birth: neonates under 12 weeks at 30 mg/kg/day, older children by weight band, adults by fixed strengths.
  • ES-600 has its own approval, its own indication and its own eligibility criteria.
What remains uncertain
  • How often severe cutaneous reactions occur is not quantified; the label instructs monitoring rather than giving a rate.
  • Drug-induced enterocolitis syndrome is reported with amoxicillin, but its frequency is not stated.
  • The contribution of clavulanate to gastrointestinal intolerance is addressed by dosing with food rather than measured.

Source: 1

Who was this medicine studied in?

The licensed evidence spans adults and children, with paediatric dosing established from birth and a separate ES-600 programme in children aged 3 months to 12 years.13 No Drug Trials Snapshot exists: both approvals predate that programme.25

Who this is and is not appropriate for

It is not appropriate for anyone with a history of anaphylaxis or Stevens-Johnson syndrome to this product or to any penicillin or cephalosporin, nor for anyone who has had cholestatic jaundice or hepatic dysfunction on it before.

It suits an infection where beta-lactamase production is likely or proven — the situation clavulanate exists for. Where plain amoxicillin would work, the added clavulanate brings extra gastrointestinal cost without extra benefit.

Where to report and verify

Routing to Official Registries
What you needWhere to go
Report a side effectFDA MedWatch
Pregnancy-specific dataMotherToBaby
Full prescribing informationDailyMed
Verify a pharmacy websiteFDA BeSafeRx · LegitScript
References

References

  1. FDA Prescribing Information, Augmentin (amoxicillin/clavulanate potassium) (NDA 050575) — Indications and Usage, Dosage and Administration 2.1–2.4, Dosage Forms and Strengths, Contraindications, Warnings and Precautions 5.1–5.9, Adverse Reactions 6.1, Drug Interactions 7, Overdosage
    Label effective 2024-05-16 · Accessed 2026-09-28
    Used for: indications, meal timing, dosing, renal regimens, contraindications, warnings, reaction rates, interactions.
    dailymed.nlm.nih.gov — DailyMed
  2. Drugs@FDA — Augmentin applications (NDA 050564, 050575, 050755)
    Records · Accessed 2026-09-28
    Used for: approved forms and marketing status.
    accessdata.fda.gov — Drugs@FDA
  3. FDA Prescribing Information, Augmentin ES-600 — Indications and Usage
    Label current · Accessed 2026-09-28
    Used for: separate paediatric indication and non-interchangeability.
    dailymed.nlm.nih.gov — DailyMed
  4. FDA Orange Book — amoxicillin and clavulanate potassium
    Current edition · Accessed 2026-09-28
    Used for: reference-standard and generic availability.
    accessdata.fda.gov — Orange Book
  5. FDA — Drug Trials Snapshots programme scope
    Programme current · Accessed 2026-09-28
    Used for: confirmation that Snapshots cover novel drugs approved from 2015.
    fda.gov — Drug Trials Snapshots

FDA adverse event aggregates are not shown for this fixed combination, because reports cannot be attributed to a combination product without misleading attribution.

Review cycle. Clinical review completed 28 September 2026. Next review due by 28 September 2027, or earlier if the labelling is revised.

Disclaimer

Disclaimer: The information on this site is provided for informational purposes only and is not medical advice. It does not replace professional medical consultation, diagnosis, or treatment. Do not self-medicate based on the information presented on this site. Always consult with a doctor or other qualified healthcare professional before making any decisions about your health.