Amoxicillin - Amoxicillin capsule

Warnings and Precautions, Drug-Induced Enterocolitis Syndrome

(DIES) (

• Upper Respiratory Tract Infections of the Ear, Nose, and Throat:
    Amoxicillin capsules  are 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 capsules  are 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 capsules are 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
  .

• Infections of the Lower Respiratory Tract:
   Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of
  Streptococcus
  spp. (α- and β-hemolytic isolates only),
  S. pneumoniae, Staphylococcus
  spp., or
  H. influenzae
  .

• Helicobacter pylori
  Infection
   
  and Duodenal Ulcer Disease:

Amoxicillin capsules in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with

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 infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

• 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 Dosage for Adults and Pediatric Patients Aged 3 Months (12 weeks) and Older

  • Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic, or evidence of bacterial eradication has been obtained.
  • It is recommended that there be at least 10 days’ treatment for any infection caused by
    Streptococcus pyogenes
    to prevent the occurrence of acute rheumatic fever.
  • In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

  Table 1. Dosage Recommendations for Adult and Pediatric Patients Aged 3 Months (12 weeks) and Older

  Infection	Severitya	Recommended Dosage for Adults and Pediatric Patients Aged 3 Months and Older and Weight Greater than 40 kg	Recommended Dosage for Pediatric Patients Aged 3 Months and Older and Weight Less than 40 kg
  Ear/Nose/Throat Skin/Skin Structure Genitourinary Tract	Mild/Moderate	500 mg every 12 hours or 250 mg every 8 hours	25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours
  	Severe	875 mg every 12 hours or 500 mg every 8 hours	45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
  Lower Respiratory Tract	Mild/Moderate or Severe	875 mg every 12 hours or 500 mg every 8 hours	45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours

  ^aDosage for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
  ,
  2.3 Dosage in Pediatric Patients Aged Less than 12 Weeks (3 months)

  • It is recommended that there be at least 10 days’ treatment for any infection caused by
    Streptococcus pyogenes
    to prevent the occurrence of acute rheumatic fever.
  • Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin capsules is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.
  • Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic, or evidence of bacterial eradication has been obtained.
  )
• The upper dose for neonates and infants aged 3 months or younger is 30 mg/kg/day divided every 12 hours. (
  2.3 Dosage in Pediatric Patients Aged Less than 12 Weeks (3 months)

  • It is recommended that there be at least 10 days’ treatment for any infection caused by
    Streptococcus pyogenes
    to prevent the occurrence of acute rheumatic fever.
  • Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin capsules is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.
  • Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic, or evidence of bacterial eradication has been obtained.
  )
• 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 Dosage for

  H. pylori

  Infection in Adults

  Triple therapy:

  The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

  
  
  

  Dual therapy:

  The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

  
  
  

  Please refer to clarithromycin and lansoprazole full prescribing information.
  )
• Reduce the dose in patients with severe renal impairment (GFR greater than 30 mL/min). (2.5)