AMOXICILLIN — amoxicillin capsule
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules, USP and other antibacterial drugs, amoxicillin capsules, USP 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. Amoxicillin capsules, USP are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of the designated bacteria in the conditions listed below:
1.1 Infections of the Ear, Nose, and Throat
Due to species (α- and β-hemolytic isolates only), , spp., or . Streptococcus Streptococcus pneumoniae Staphylococcus Haemophilus influenzae
1.2 Infections of the Genitourinary Tract
Due to , or . Escherichia coli, Proteus mirabilis Enterococcus faecalis
1.3 Infections of the Skin and Skin Structure
Due to spp. (α- and β-hemolytic isolates only), spp., or . Streptococcus Staphylococcus E. coli
1.4 Infections of the Lower Respiratory Tract
Due to spp. (α- and β-hemolytic isolates only), spp., or . Streptococcus S. pneumoniae, Staphylococcus H. influenzae
1.5 Gonorrhea, Acute Uncomplicated (ano-genital and urethral infections)
Due to . Because of high rates of amoxicillin resistance, amoxicillin capsules, USP are not recommended for empiric treatment of gonorrhea. Amoxicillin capsules, USP use should be limited to situations where isolates are known to be susceptible to amoxicillin. Neisseria gonorrhoeae N. gonorrhoeae
1.6 Triple Therapy for Helicobacter pylori with Clarithromycin and Lansoprazole
Amoxicillin capsules, USP, in combination with clarithromycin plus lansoprazole as triple therapy, are indicated for the treatment of patients with infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate . Eradication of has been shown to reduce the risk of duodenal ulcer recurrence. H. pylori H. pylori H. pylori
1.7 Dual Therapy for H. pylori with Lansoprazole
Amoxicillin capsules, USP, in combination with lansoprazole delayed-release capsules as dual therapy, are indicated for the treatment of patients with infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) . (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of has been shown to reduce the risk of duodenal ulcer recurrence. H. pylori who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected H. pylori
2 DOSAGE AND ADMINISTRATION
2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
Except for gonorrhea, 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 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. Streptococcus pyogenes
|Infection||Severity a||Usual Adult Dose||Usual Dose for Children > 3 Months b|
|Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. a b|
|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 20 mg/kg/day in divided doses every 8 hours or|
|Severe||875 mg every 12 hours or 500 mg every 8 hours||45 mg/kg/day in divided doses every 12 hours 40 mg/kg/day in divided doses every 8 hours or|
|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 40 mg/kg/day in divided doses every 8 hours or|
|Gonorrhea Acute, uncomplicated ano -genital and urethral infections in males and females||3 grams as single oral dose||children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose. Prepubertal Note: Since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.|
2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks ( ≤ 3 Months)
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 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. Streptococcus pyogenes
2.3 Dosing for H. pylori Infection
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. 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.
2.4 Dosing in Renal Impairment
- Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe.
- Severely impaired patients with a glomerular filtration rate of < 30 mL/min should not receive a 875 mg dose.
- Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection.
- Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
- Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
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