Amoxicillin 500 mg Capsules — Generic For Amoxil — Aurobindo

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

AMOXICILLIN capsules, for oral use

Initial U.S. Approval: 1974

Recent Major Changes

Warnings and Precautions, Drug-Induced Enterocolitis Syndrome

(dies) (5.3) 01/2024

Indications And Usage

Amoxicillin capsules are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. (1)

Adults and Pediatric Patients (1)

Upper Respiratory Tract Infections of the Ear, Nose, and Throat

Infections of the Genitourinary Tract

Infections of the Skin and Skin Structure

Infections of the Lower Respiratory Tract

Adult Patients only (1)

Helicobacter pylori Infection and Duodenal Ulcer Disease

Usage

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

Dosage And Administration

In Adults, 750 to 1750 mg/day in divided doses every 8 to 12 hours.

In Pediatric Patients over 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. (2.2, 2.3)

The upper dose for neonates and infants aged 3 months or younger is 30 mg/kg/day divided every 12 hours. (2.3)

Dosing for H. pylori Infection (in Adults): 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. (2.4)

Reduce the dose in patients with severe renal impairment (GFR greater than 30 mL/min). (2.5)

Dosage Forms And Strengths

Capsules: 250 mg and 500 mg (3)

Contraindications

History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin capsules or to other beta-lactams (e.g., penicillins or cephalosporins). (4)

Warnings And Precautions

• , Drug-Induced Enterocolitis Syndrome (DIES) (5.3) 01/2024 INDICATIONS AND USAGE Amoxicillin capsules are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. (1) Adults and Pediatric Patients (1)
• Upper Respiratory Tract Infections of the Ear, Nose, and Throat
• Infections of the Genitourinary Tract
• Infections of the Skin and Skin Structure
• Infections of the Lower Respiratory Tract Adult Patients only (1)
• Helicobacter pylori Infection and Duodenal Ulcer Disease Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1) DOSAGE AND ADMINISTRATION
• In Adults, 750 to 1750 mg/day in divided doses every 8 to 12 hours.
• In Pediatric Patients over 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. (2.2, 2.3)

• , Drug-Induced Enterocolitis Syndrome (DIES) (5.3) 01/2024 INDICATIONS AND USAGE Amoxicillin capsules are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. (1) Adults and Pediatric Patients (1)
• Upper Respiratory Tract Infections of the Ear, Nose, and Throat
• Infections of the Genitourinary Tract
• Infections of the Skin and Skin Structure
• Infections of the Lower Respiratory Tract Adult Patients only (1)
• Helicobacter pylori Infection and Duodenal Ulcer Disease Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1) DOSAGE AND ADMINISTRATION
• In Adults, 750 to 1750 mg/day in divided doses every 8 to 12 hours.
• In Pediatric Patients over 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. (2.2, 2.3)

Anaphylactic reactions: Serious and occasionally fatal anaphylactic reactions have been reported in patients on penicillin therapy, including amoxicillin. Discontinue amoxicillin 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 amoxicillin use. If this occurs, discontinue amoxicillin and institute appropriate therapy. (5.3)

Clostridioides difficile-associated diarrhea (CDAD) (ranging from mild diarrhea to fatal colitis): Evaluate if diarrhea occurs. (5.4)

Adverse Reactions

The most common adverse reactions (greater than 1%) observed in clinical trials of amoxicillin capsules, tablets or for oral suspension were diarrhea, rash, vomiting, and nausea. (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 probenicid is not recommended. (7.1)

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

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

Amoxicillin may reduce the efficacy of oral contraceptives. (7.4)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 1/2024