Amoxicillin

1. INDICATIONS AND USAGE Adults and Pediatric Patients Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species. (α-and ​ ​ β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae. Infections of the Genitourinary Tract: Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. Infections of the Skin and Skin Structure: Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α-and ​ β-hemolytic isolates only), Staphylococcus spp., or E. coli.

Amoxicillin is an antibacterial drug.

In Adults, 750-1750 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. The upper dose for neonates and infants age 3 months or younger is 30 mg/kg/day divided every 12 hours. 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. Reduce the dose in patients with severe renal impairment (GFR greater than 30 mL/min).

AMOXIL is contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to AMOXIL or to other β-lactam antibacterial drugs (e.g., penicillins and cephalosporins). 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).

Anaphylactic reactions: Serious and occasionally fatal anaphylactic reactions have been reported in patients on penicillin therapy, including amoxicillin. Discontinue Amoxicillin if a reaction occurs. Severe cutaneous adverse reactions (SCAR): Monitor closely. Discontinue if rash progresses. Drug-induced enterocolitis syndrome (DIES) has been reported with amoxicillin use. If this occurs, discontinue Amoxicillin and institute appropriate therapy. Clostridioides difficile -associated diarrhea (CDAD)(ranging from mild diarrhea to fatal colitis): Evaluate if diarrhea occurs.

The following are discussed in more detail in other sections of the labeling: Anaphylactic reactions Severe Cutaneous Adverse Reactions Drug-Induced Enterocolitis Syndrome (DIES) Clostridioides difficile -Associated Diarrhea (CDAD) The most common adverse reactions (greater than 1%) observed in clinical trials of amoxicillin tablets or oral suspension were diarrhea, rash, vomiting, and nausea.

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

Store at or below 25° C (77° F).