Amoxicillin 500 mg / Clavulanate 125 mg Combination Tablets — Generic For Augmentin — Aurobindo

These highlights do not include all the information needed to use AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS.

AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use

Initial U.S. Approval: 1984

Recent Major Changes

Warnings and Precautions, Drug-Induced Enterocolitis Syndrome (DIES) (5.3) 5/2024

Indications And Usage

Amoxicillin and clavulanate potassium tablets are a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor indicated for treatment of the following infections in adults and pediatric patients: (1)

Lower respiratory tract infections

Acute bacterial otitis media

Sinusitis

Skin and skin structure infections

Urinary tract infections

Limitations of Use

When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets should not be used. (1)

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1)

Dosage And Administration

Adults and Pediatric Patients greater than 40 kg: 500 mg/125 mg or 875 mg/125 mg every 12 hours or 250 mg/125 mg or 500 mg/125 mg every 8 hours, based on 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/31.25 mg per 5 mL oral suspension is recommended. (2.3)

Dosage Forms And Strengths

Tablets: 250 mg/125 mg, 500 mg/125 mg, 875 mg/125 mg; 875 mg/125 mg tablets are scored. (3)

Contraindications

History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin and clavulanate potassium tablets or to other beta-lactams (e.g., penicillins or cephalosporins). (4.1)

History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium tablets. (4.2)

Warnings And Precautions

• , Drug-Induced Enterocolitis Syndrome (DIES) (5.3) 5/2024 INDICATIONS AND USAGE Amoxicillin and clavulanate potassium tablets are a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor indicated for treatment of the following infections in adults and pediatric patients: (1)
• Lower respiratory tract infections
• Acute bacterial otitis media
• Sinusitis
• Skin and skin structure infections
• Urinary tract infections Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets should not be used. (1) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1) DOSAGE AND ADMINISTRATION
• Adults and Pediatric Patients greater than 40 kg: 500 mg/125 mg or 875 mg/125 mg every 12 hours or 250 mg/125 mg or 500 mg/125 mg every 8 hours, based on 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)

• , Drug-Induced Enterocolitis Syndrome (DIES) (5.3) 5/2024 INDICATIONS AND USAGE Amoxicillin and clavulanate potassium tablets are a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor indicated for treatment of the following infections in adults and pediatric patients: (1)
• Lower respiratory tract infections
• Acute bacterial otitis media
• Sinusitis
• Skin and skin structure infections
• Urinary tract infections Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets should not be used. (1) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1) DOSAGE AND ADMINISTRATION
• Adults and Pediatric Patients greater than 40 kg: 500 mg/125 mg or 875 mg/125 mg every 12 hours or 250 mg/125 mg or 500 mg/125 mg every 8 hours, based on 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)

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)

Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of amoxicillin and clavulanate potassium tablets. If this occurs, discontinue amoxicillin and clavulanate potassium and institute appropriate therapy. (5.3)

Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests in patients with hepatic impairment. (5.4)

Clostridioides difficile-associated diarrhea (CDAD): Evaluate patients if diarrhea occurs. (5.5)

Patients with mononucleosis who receive amoxicillin and clavulanate potassium develop skin rash. Avoid amoxicillin and clavulanate potassium use in these patients. (5.6)

Overgrowth: The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy. (5.7)

Adverse Reactions

The most frequently reported adverse reactions 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 Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Co-administration with probenecid is not recommended. (7.1)

Concomitant use of amoxicillin and clavulanate potassium and oral anticoagulants may increase the prolongation of prothrombin time. (7.2)

Co-administration with allopurinol increases the risk of rash. (7.3)

Amoxicillin and clavulanate potassium may reduce efficacy of oral contraceptives. (7.4)

Use In Specific Populations

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 30 mL/min). (2.4, 8.6)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 6/2024