Amoxicillin 500 mg Capsules — Generic For Amoxil — Aurobindo

These highlights do not include all the information needed to use AMOXICILLIN capsules and AMOXICILLIN for oral suspension safely and effectively. See full prescribing information for AMOXICILLIN capsules and AMOXICILLIN for oral suspension.

AMOXICILLIN capsules, for oral use

AMOXICILLIN for oral suspension

Initial U.S. Approval: 1974

Recent Major Changes

Warnings and Precautions,

Drug-Induced Enterocolitis Syndrome (DIES) (5.2)

05/2024

Indications And Usage

Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms.

Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract.

1.1to

1.4)

In combination for treatment of

H. pyloriinfection and duodenal ulcer disease.

1.5)

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

1.6)

Dosage And Administration

In adults, 750-1750 mg/day in divided doses every 8 to 12 hours. In Pediatric Patients > 3 Months of Age, 20 to 45 mg/kg/day in divided doses every 8 to 12 hours. Refer to full prescribing information for specific dosing regimens.

2.1,

2.2,

2.3)

The upper dose for neonates and infants ≤ 3 months is 30 mg/kg/day divided every 12 hours.

2.2)

Dosing for H.

pylori Infection: Triple therapy: 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual therapy: 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

2.3)

Reduce the dose in patients with severe renal impairment (GFR <30 mL/min).

2.4)

Dosage Forms And Strengths

(3)

Capsules: 250 mg, 500 mg

For Oral Suspension: 125 mg/5 mL, 250 mg/5 mL

(3)

Contraindications

History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to Amoxicillin or to other beta-lactams (e.g., penicillins or cephalosporins)

4)

Warnings And Precautions

• , Drug-Induced Enterocolitis Syndrome (DIES) (5.2) 05/2024 INDICATIONS AND USAGE Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms.
• Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1to 1.4)
• In combination for treatment of H. pyloriinfection and duodenal ulcer disease. ( 1.5) To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.6) DOSAGE AND ADMINISTRATION
• In adults, 750-1750 mg/day in divided doses every 8 to 12 hours. In Pediatric Patients > 3 Months of Age, 20 to 45 mg/kg/day in divided doses every 8 to 12 hours. Refer to full prescribing information for specific dosing regimens. ( 2.1, 2.2, 2.3)
• The upper dose for neonates and infants ≤ 3 months is 30 mg/kg/day divided every 12 hours. ( 2.2)
• Dosing for H. pylori Infection: Triple therapy: 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual therapy: 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. ( 2.3)
• Reduce the dose in patients with severe renal impairment (GFR <30 mL/min). ( 2.4) DOSAGE FORMS AND STRENGTHS (3)
• Capsules: 250 mg, 500 mg

• , Drug-Induced Enterocolitis Syndrome (DIES) (5.2) 05/2024 INDICATIONS AND USAGE Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms.
• Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1to 1.4)
• In combination for treatment of H. pyloriinfection and duodenal ulcer disease. ( 1.5) To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.6) DOSAGE AND ADMINISTRATION
• In adults, 750-1750 mg/day in divided doses every 8 to 12 hours. In Pediatric Patients > 3 Months of Age, 20 to 45 mg/kg/day in divided doses every 8 to 12 hours. Refer to full prescribing information for specific dosing regimens. ( 2.1, 2.2, 2.3)
• The upper dose for neonates and infants ≤ 3 months is 30 mg/kg/day divided every 12 hours. ( 2.2)
• Dosing for H. pylori Infection: Triple therapy: 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual therapy: 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. ( 2.3)
• Reduce the dose in patients with severe renal impairment (GFR <30 mL/min). ( 2.4) DOSAGE FORMS AND STRENGTHS (3)
• Capsules: 250 mg, 500 mg

Anaphylactic reactions: Serious and occasionally fatal anaphylactic reactions have been reported in patients on penicillin therapy. Serious anaphylactic reactions require immediate emergency treatment with supportive measures.

5.1)

Drug-induced enterocolitis syndrome (DIES) has been reported with amoxicillin use. If this occurs, discontinue Amoxicillin and institute appropriate therapy.

5.2)

Clostridium difficile-associated diarrhea (ranging from mild diarrhea to fatal colitis): Evaluate if diarrhea occurs.

5.3)

Adverse Reactions

The most common adverse reactions (> 1%) observed in clinical trials of amoxicillin capsules, tablets or oral suspension were diarrhea, rash, vomiting, and nausea.

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.

Drug Interactions

Probenicid decreases renal tubular secretion of amoxicillin which may result in increased blood levels of amoxicillin.

7.1)

Concomitant use of amoxicillin and oral anticoagulants may increase the prolongation of prothrombin time.

7.2)

Coadministration with allopurinol increases the risk of rash.

7.3)

Amoxicillin may reduce the efficacy of oral contraceptives.

7.4)

Use In Specific Populations

Pediatric: Modify dose in patients 12 weeks or younger (≤ 3 months).

8.4)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 5/2025