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Fixed-dose combination

Amoxicillin and Clavulanate

Also known as amoxicillin, amoxicillin sodium, clavulanate potassium
Available on request
Presentations
15
Brands
2
Manufacturers
2
Available from stock
0

Amoxicillin and Clavulanate is a fixed-dose combination of a penicillin-class antibacterial and a beta lactamase inhibitor indicated for the treatment of infections in adults and pediatric patients, among other approved uses. MedsAcross supplies Amoxicillin and Clavulanate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Penicillin-class Antibacterial, Beta Lactamase Inhibitor, Beta Lactamase Inhibitors
US FDA first approval
6 August 1984
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet, Powder for oral suspension, Oral suspension, Extended-release tablet, Chewable tablet
Fixed-dose combination of
Amoxicillin, Clavulanate

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

AUGMENTIN is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: Lower Respiratory Tract Infections - caused by beta‑lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis. Acute Bacterial Otitis Media - caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis. Sinusitis - caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis. Skin and Skin Structure Infections - caused by beta‑lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species. Urinary Tract Infections - caused by beta‑lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species.

Source: US FDA prescribing information

Dosing overview

Adults and Pediatric Patients greater than 40 kg: 500 or 875 mg every 12 hours or 250 or 500 mg every 8 hours, based on the amoxicillin component. Pediatric patients aged 12 weeks (3 months) and older: 25 to 45 mg/kg/day every 12 hours or 20 to 40 mg/kg/day every 8 hours, up to the adult dose. Neonates and infants less than 12 weeks of age: 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Use of the 125 mg/5 mL oral suspension is recommended.

Source: US FDA prescribing information

Contraindications

History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to AUGMENTIN or to other beta‑lactams (e.g., penicillins or cephalosporins). History of cholestatic jaundice/hepatic dysfunction associated with AUGMENTIN.

Source: US FDA prescribing information

Warnings and precautions

Serious (including fatal) hypersensitivity reactions: Discontinue AUGMENTIN if a reaction occurs. Severe Cutaneous Adverse Reactions (SCAR): Monitor closely. Discontinue if rash progresses. Drug-induced enterocolitis syndrome (DIES) has been reported with use of Amoxicillin, A componet of Augmentin. If this occures, discontinue AUGMENIN and institute appropriate therapy. Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests in patients with hepatic impairment. Clostridioides difficile -associated diarrhea (CDAD): Evaluate patients if diarrhea occurs. Patients with mononucleosis who receive AUGMENTIN develop skin rash. Avoid AUGMENTIN use in these patients. (

Source: US FDA prescribing information

Side effects

The following are discussed in more detail in other sections of the labeling: Anaphylactic reactions Severe Cutaneous Adverse Reactions Drug-Induced Enterocolitis Syndrom (DIES) Hepatic Dysfunction Clostridioides difficile Associated Diarrhea (CDAD)

Source: US FDA prescribing information

Interactions

Co‑administration with probenecid is not recommended. Concomitant use of AUGMENTIN and oral anticoagulants may increase the prolongation of prothrombin time. Co-administration with allopurinol increases the risk of rash. AUGMENTIN may reduce efficacy of oral contraceptives.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

15 presentations of Amoxicillin and Clavulanate, sorted by availability.

MedicineActive ingredientManufacturerRegisterAvailability
Amoxicillin and Clavulanate 875 mg/125 mg tabletOralGeneric nameAmoxicillin and Clavulanate—US FDAAvailable on request
Amoxicillin and Clavulanate 500 mg/125 mg tabletOralGeneric nameAmoxicillin and Clavulanate—US FDAAvailable on request
Amoxicillin and Clavulanate 400 mg/57 mg per 5 mL powder for oral suspensionOralGeneric nameAmoxicillin and Clavulanate—US FDAAvailable on request
Amoxicillin and Clavulanate 600 mg/42.9 mg per 5 mL powder for oral suspensionOralGeneric nameAmoxicillin and Clavulanate—US FDAAvailable on request
Amoxicillin and Clavulanate 200 mg/28.5 mg per 5 mL powder for oral suspensionOralGeneric nameAmoxicillin and Clavulanate—US FDAAvailable on request
Amoxicillin and Clavulanate 250 mg/125 mg tabletOralGeneric nameAmoxicillin and Clavulanate—US FDAAvailable on request
Amoxicillin and Clavulanate 600 mg/42.9 mg per 5 mL oral suspensionOralGeneric nameAmoxicillin and Clavulanate—US FDAAvailable on request
Amoxicillin and Clavulanate 250 mg/62.5 mg per 5 mL powder for oral suspensionOralGeneric nameAmoxicillin and Clavulanate—US FDAAvailable on request
Amoxicillin and Clavulanate 125 mg/31.25 mg per 5 mL powder for oral suspensionOralGeneric nameAmoxicillin and Clavulanate—US FDAAvailable on request
Amoxicillin and Clavulanate 562.5 mg/437.5 mg/62.5 mg extended-release tabletOralGeneric nameAmoxicillin and Clavulanate—US FDAAvailable on request
Amoxicillin and Clavulanate 250 mg/62.5 mg per 5 mL oral suspensionOralGeneric nameAmoxicillin and Clavulanate—US FDAAvailable on request
Augmentin 125 mg/31.25 mg per 5 mL powder for oral suspensionOralAmoxicillin and ClavulanateAllegis HoldingsUS FDAAvailable on request
Augmentin ES-600 600 mg/42.9 mg per 5 mL powder for oral suspensionOralAmoxicillin and ClavulanateUSAntibioticsUS FDAAvailable on request
Amoxicillin and Clavulanate 200 mg/28.5 mg chewable tabletOralGeneric nameAmoxicillin and Clavulanate—US FDAAvailable on request
Amoxicillin and Clavulanate 400 mg/57 mg chewable tabletOralGeneric nameAmoxicillin and Clavulanate—US FDAAvailable on request

Brands by market

2 brand names across 1 markets.

Brand names by country

United States

AugmentinAugmentin ES-600

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 6 August 1984Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Amoxicillin and Clavulanate available for export from India?

Yes, on request. MedsAcross lists 15 presentations of Amoxicillin and Clavulanate and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Amoxicillin and Clavulanate have?

The catalogue lists 2 brand names for Amoxicillin and Clavulanate, including Augmentin, Augmentin ES-600.

Is Amoxicillin and Clavulanate approved by the US FDA?

Yes. The US FDA first approved Amoxicillin and Clavulanate on 6 August 1984, according to Drugs@FDA.

Does Amoxicillin and Clavulanate need cold chain shipping?

No listed presentation of Amoxicillin and Clavulanate is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

References

  1. Augmentin prescribing information (Allegis Holdings). U.S. National Library of Medicine, DailyMed. Retrieved 26 October 2026

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