Clavulanate

Amoxicillin and Clavulanate Potassium is an antibacterial drug [see Microbiology ( 12.4 )] .

• Amoxicillin and Clavulanate Potassium 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.ICD-10: H66.90

• History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to Amoxicillin and Clavulanate Potassium or to other beta‑lactams (e.g., penicillins or cephalosporins). ( 4.1 ) History of cholestatic jaundice/hepatic dysfunction associated with Amoxicillin and Clavulanate Potassium.contraindicated

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. ( 2.2 , 2.3 ) 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. ( 2.3 ) 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. ( 2.3 ) 2.1 Important Administration Instructions Amoxicillin and Clavulanate Potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium should be taken at the start of a meal. 2.2 Adult Patients See dosing regimens of Amoxicillin and Clavulanate Potassium (based on the amoxicillin component) provided in Table 1 below. Table 1.

Serious (including fatal) hypersensitivity reactions: Discontinue Amoxicillin and Clavulanate Potassium if a reaction occurs. ( 5.1 ) Severe Cutaneous Adverse Reactions (SCAR): Monitor closely. Discontinue if rash progresses. ( 5.2 ) Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests in patients with hepatic impairment. ( 5.3 ) Clostridioides difficile -associated diarrhea (CDAD): Evaluate patients if diarrhea occurs. ( 5.4 ) Patients with mononucleosis who receive Amoxicillin and Clavulanate Potassium develop skin rash. Avoid Amoxicillin and Clavulanate Potassium use in these patients. ( 5.5 ) Overgrowth: The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy. ( 5.6 ) 5.1 Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials, including Amoxicillin and Clavulanate Potassium. 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 Amoxicillin and Clavulanate Potassium, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, Amoxicillin and Clavulanate Potassium should be discontinued, and appropriate therapy instituted.

The following are discussed in more detail in other sections of the labeling: Anaphylactic reactions [see Warnings and Precautions (5.1) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.2 )] Hepatic Dysfunction [see Warnings and Precautions (5.3) ] Clostridioides difficile Associated Diarrhea (CDAD) [see Warnings and Precautions (5.4) ] The most frequently reported adverse effects were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact USAntibiotics, LLC at 1-844-454-5532 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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 (less than 1%) include: Abdominal discomfort, flatulence, and headache.

Pediatric Use: Modify dose in patients 12 weeks or younger. ( 8.4 ) Renal Impairment: Dosage adjustment is recommended for severe renal impairment (GFR less than 30mL/min). ( 2.4 , 8.6 ) Revised 03/2024 8.1 Pregnancy Teratogenic Effects : Pregnancy Category B. Reproduction studies performed in pregnant rats and mice given Amoxicillin and Clavulanate Potassium (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 Amoxicillin and Clavulanate Potassium. 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. 8.2 Labor and Delivery Oral ampicillin‑class antibacterials are poorly absorbed during labor.

Metabolism

Mean amoxicillin and clavulanate potassium pharmacokinetic parameters in normal adults following administration of Amoxicillin and Clavulanate Potassium Tablets are shown in Table 6 and following administration of Amoxicillin and Clavulanate Potassium for Oral Suspension and Chewable Tablets are shown in Table 7. Table 6: Mean (±S.D.) Amoxicillin and Clavulanate Potassium Pharmacokinetic Parameters a,b with Amoxicillin and Clavulanate Potassium Tablets a Mean (± standard deviation) values of 14 normal adults (N equals15 for clavulanate potassium in the low-dose regimens).

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 symptoms 1 . Interstitial nephritis resulting in oliguric renal failure has been reported in patients after overdosage with amoxicillin and clavulanate potassium. Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin and 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 and 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 and clavulanate potassium. Amoxicillin and clavulanate potassium may be removed from circulation by hemodialysis [see Dosage and Administration ( 2.4 )] .

• Aug 6, 1984NDANDA050575Us Antibiotics
• Feb 13, 1996NDANDA050720Us Antibiotics
• Jun 22, 2001NDANDA050755Us Antibiotics
• Mar 14, 2002ANDAANDA065063Sandoz
• Mar 15, 2002ANDAANDA065064Sandoz
• Jun 5, 2002ANDAANDA065066Sandoz
• Sep 25, 2002NDANDA050785Us Antibiotics
• Oct 29, 2002ANDAANDA065096Teva Pharms Usa

1. 1Diarrhoea1,8577.0%
2. 2Drug Hypersensitivity1,8136.8%
3. 3Nausea1,4225.3%
4. 4Pyrexia1,3895.2%
5. 5Dyspnoea1,3795.2%
6. 6Fatigue1,2534.7%
7. 7Vomiting1,1784.4%
8. 8Pneumonia1,1724.4%
9. 9Rash1,0233.8%
10. 10Pain9733.6%
11. 11Headache9153.4%
12. 12Pruritus8483.2%
13. 13Acute Kidney Injury8433.2%
14. 14Drug Ineffective8433.2%
15. 15Asthenia8273.1%

Recent PubMed references pinned to Clavulanate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• The Efficacy of Mumijo Extract in Protecting Against Amoxicillin/Clavulanate-Induced Apoptotic Damage in Renal Tissues of Rats.
  Iranian journal of kidney diseases · 2026 · Durgun HM, Yildizhan E
  PMID 42234886DOI 10.61882/66mbsb92
• Tissue and Serum Concentrations of Time-Dependent Antibiotics in Infected Diabetic Foot Ulcers by Bolus or Continuous Administration: The Randomised DFIATIM Trial.
  Diabetes/metabolism research and reviews · 2026 · Jarošíková R, Sojáková D, Antalová S, et al.
  PMID 42218112DOI 10.1002/dmrr.70185
• Efficacy of Antibiotics for Chronic Low Back Pain With Disc Herniation: A Randomized Clinical Trial.
  JAMA network open · 2026 · Cicuttini FM, Wluka AE, Pan F, et al.
  PMID 42149593DOI 10.1001/jamanetworkopen.2026.12848
• Effectiveness of amoxicillin and amoxicillin-clavulanate for the treatment of community-acquired pneumonia in adults and children: a systematic review and meta-analysis.
  BMJ open · 2026 · Potter-Schwartz L, Swe MM, Sharland M, et al.
  PMID 42097647DOI 10.1136/bmjopen-2025-112219
• [Translated article] Use of 3D printing for the manufacture of antibiotic carriers in the treatment of bone and joint infections.
  Revista espanola de cirugia ortopedica y traumatologia · 2026 · Ortega Yago A, Ezquer Garín C, Medina Bessó P, et al.
  PMID 42024532DOI 10.1016/j.recot.2025.11.035
• Use of 3D printing for the manufacture of antibiotic carriers in the treatment of bone and joint infections.
  Revista espanola de cirugia ortopedica y traumatologia · 2026 · Ortega Yago A, Ezquer Garín C, Medina Bessó P, et al.
  PMID 42024519DOI 10.1016/j.recot.2025.06.017
• Beyond Clavulanic Acid biosynthesis: Exploring the broad regulatory impact of BldD in Streptomyces clavuligerus ATCC 27064.
  PloS one · 2026 · Patiño LF, Caicedo-Montoya C, Ríos-Estepa R, et al.
  PMID 42018526DOI 10.1371/journal.pone.0347564
• Amoxicillin-Clavulanate vs Amoxicillin for Acute Sinusitis in Adults.
  JAMA · 2026 · Savage TJ, Butler AM, Kronman MP, et al.
  PMID 41999289DOI 10.1001/jama.2025.26902

The 10 most recently updated of 334 ClinicalTrials.gov registrations naming Clavulanate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Non-antibiotic Management in Acute Uncomplicated Diverticulitis
  Not yet recruiting · Phase 4 · Interventional · 556 enrolled · Montefiore Medical Center
  NCT07625267updated 2026-06-04
• Gut Microbiota Modulation for Immunotherapy Resensitization in Advanced Renal Cell Carcinoma
  Not yet recruiting · Phase 2 · Interventional · 33 enrolled · Jinling Hospital, China
  NCT07611825updated 2026-05-28
• Efficacy of Non Operative Treatment With Amoxicillin/Clavulanic Acid Versus Surgical Treatment in Acute Uncomplicated Appendicitis in Children
  Not yet recruiting · Phase 3 · Interventional · 724 enrolled · University Hospital, Toulouse
  NCT07587450updated 2026-05-22
• Finnish Children´s Protracted Cough
  Recruiting · Phase 3 · Interventional · 100 enrolled · Tampere University Hospital
  NCT07582549updated 2026-05-13
• Comparative Efficacy of Antibiotics for Small Intestine Bacterial Overgrowth in Bangladeshi Children
  Recruiting · Phase 2 · Interventional · 60 enrolled · University of Virginia
  NCT07451171updated 2026-05-06
• One Versus Five Days of Antibiotics After Appendectomy
  Not yet recruiting · Interventional · 200 enrolled · Ministry of Health and Population, Egypt
  NCT07563933updated 2026-05-04
• Prospective Clinical Investigation on Infection as a Cause of Chronic Subdural Hematoma.
  Recruiting · Phase 2 · Phase 3 · Interventional · 164 enrolled · University of Rostock
  NCT07556991updated 2026-04-29
• The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
  Recruiting · Interventional · 40 enrolled · Semmelweis University
  NCT06533397updated 2026-04-24
• APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)
  Not yet recruiting · Phase 2 · Interventional · 100 enrolled · Vanderbilt University Medical Center
  NCT07492134updated 2026-04-21
• Amoxicillin/Clavulanic Acid Susceptibility in Acute Community-acquired Pneumonia Requiring Intensive Care Management
  Completed · Observational · 104 enrolled · Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
  NCT07322549updated 2026-04-14

Frequently asked questions

How does Clavulanate work?

Amoxicillin and Clavulanate Potassium is an antibacterial drug [see Microbiology ( 12.4 )] .

What is Clavulanate used for?

According to FDA labeling, Clavulanate carries indications including: Amoxicillin and Clavulanate Potassium 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Clavulanate?

Clavulanate is classified as beta Lactamase Inhibitors.

What are the brand names for Clavulanate?

Clavulanate is marketed under brand names including Augmentin, Betacilin, Clavacillin, Clavamox, Kesium, Umbrellin.

What are the contraindications for Clavulanate?

Clavulanate labeling lists contraindications including: History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to Amoxicillin and Clavulanate Potassium or to other beta‑lactams (e.g., penicillins or cephalosporins). ( 4.1 ) History of cholestatic jaundice/hepatic dysfunction associated with Amoxicillin and Clavulanate Potassium.. Always consult the full prescribing information and a clinician.