These highlights do not include all the information needed to use amoxicillin capsules safely and effectively. See full prescribing information for amoxicillin capsules, USP.Amoxicillin Capsules, USPInitial U.S. Approval: 1974
1 INDICATIONS AND USAGE
1.1 Infections of the Ear, Nose, and Throat
1.2 Infections of the Genitourinary Tract
1.3 Infections of the Skin and Skin Structure
1.4 Infections of the Lower Respiratory Tract
1.5 Gonorrhea, Acute Uncomplicated (ano-genital and urethral infections in males and females)
1.6 Triple Therapy for Helicobacter pylori with Clarithromycin and Lansoprazole
1.7 Dual Therapy for H. pylori with Lansoprazole
2 DOSAGE AND ADMINISTRATION
2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
| 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 |
| Gonorrhea Acute, uncomplicated ano -genital and urethral infections in males and females | 3 grams as single oral dose | Prepubertal children: 50 mg/kg amoxicillin capsules, combined with 25 mg/kg probenecid as a single dose. 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)
2.3 Dosing for H. pylori Infection
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.
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Anaphylactic Reactions
5.2 Clostridium difficile Associated Diarrhea
5.3 Potential for Microbial Overgrowth or Bacterial Resistance
5.4 Use in Patients With Mononucleosis
6 ADVERSE REACTIONS
- Anaphylactic reactions [see Warnings and Precautions (5.1)]
- CDAD [see Warnings and Precautions (5.2)]
6.1 Clinical Trials Experience
6.2 Postmarketing or Other Experience
- Infections and Infestations: Mucocutaneous candidiasis.
- Gastrointestinal: Black hairy tongue, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions (5.2)].
- Hypersensitivity Reactions: Anaphylaxis [see Warnings and Precautions (5.1)]. Serum sickness–like reactions, erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis, and urticaria have been reported.
- Liver: A moderate rise in AST and/or ALT has been noted, but the significance of this finding is unknown. Hepatic dysfunction including cholestatic jaundice, hepatic cholestasis and acute cytolytic hepatitis have been reported.
- Renal: Crystalluria has been reported [see Overdosage (10)].
- Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.
- Central Nervous System: Reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, and/or dizziness have been reported.
- Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) has been reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.
7 DRUG INTERACTIONS
7.1 Probenecid
7.2 Oral Anticoagulants
7.3 Allopurinol
7.4 Oral Contraceptives
7.5 Other Antibacterials
7.6 Effects on Laboratory Tests
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Dosing in Renal Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
| Amoxicillin | Amoxicillin (±S.D.) | Amoxicillin (±S.D.) |
| 400 mg (5 mL of suspension) | 17.1 (3.1) | 5.92 (1.62) |
| 400 mg (1 chewable tablet) | 17.9 (2.4) | 5.18 (1.64) |
12.4 Microbiology
Susceptibility Testing for Helicobacter pylori: Amoxicillin in vitro susceptibility testing methods for determining minimum inhibitory concentrations (MICs) and zone sizes have not been standardized, validated, or approved for testing H. pylori. Specimens for H. pylori and clarithromycin susceptibility test results should be obtained on isolates from patients who fail triple therapy. If clarithromycin resistance is found, a non-clarithromycin-containing regimen should be used.
| Gram-Positive Bacteria | Gram-Negative Bacteria |
| Enterococcus faecalis Staphylococcus spp. Streptococcus pneumoniae Alpha and β-hemolytic streptococci. | Escherichia coli Haemophilus influenzae Neisseria gonorrhoeae Proteus mirabilis Helicobacter pylori |
| Enterococcus spp. | ≤ 8 | - | ≥ 16 | ≥ 17 | - | ≤ 16 |
| Staphylococcus spp. | ≤ 0.25 | ≥ 0.5 | ≥ 29 | ≤ 28 | ||
| Streptococci, viridians group (alpha-hemolytic streptococci) | ≤ 0.25 | 0.5 to 4 | ≥ 8 | - | - | - |
| β-hemolytic streptococci | ≤ 0.25 | - | - | ≥ 24 | - | - |
| Streptococcus pneumoniae (non-meningitis isolates)* | ≤ 2 | 4 | ≥ 8 | - | - | - |
| Enterobacteriaceae | ≤ 8 | 16 | ≥ 32 | ≥ 17 | 14 to 16 | ≤ 13 |
| Haemophilus influenzae | ≤ 1 | 2 | ≥ 4 | ≥ 22 | 19 to 21 | ≤ 18 |
| Neisseria gonorrhoeae** | - | - | - | - | - | - |
| Escherichia coli | 25922 | 2 to 8 | 16 to 22 |
| Enterococcus faecalis | 29212 | 0.5 to 2 | |
| Haemophilus influenzae | 49247 | 2 to 8 | 13 to 21 |
| Staphylococcus aureus | 29213 | 0.5 to 2 | |
| 25923 | 27 to 35 | ||
| Streptococcus pneumoniae | 49619 | 0.06 to 0.25 |
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
| Study 1 | 92 [80 - 97.7] (n = 48) | 86 [73.3 - 93.5] (n = 55) |
| Study 2 | 86[75.7 - 93.6] (n = 66) | 83 [72 - 90.8] (n = 70) |
| Study 1 | 77 [62.5 - 87.2] (n = 51) | 70 [56.8 - 81.2] (n = 60) |
| Study 2 | 66 [51.9 - 77.5] (n = 58) | 61 [48.5 - 72.9] (n = 67) |
15 REFERENCES
- Swanson-Biearman B, Dean BS, Lopez G, Krenzelok EP. The effects of penicillin and cephalosporin ingestions in children less than six years of age. Vet Hum Toxicol. 1988; 30: 66-67.
- Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – 8th ed. CLSI Document M7-A8, Vol. 29, No.2. CLSI, Wayne, PA, Jan. 2009.
- Clinical and Laboratory Standards Institute (CLSI). Performance Standard for Antimicrobial Disk Susceptibility Tests; Approved Standard – 10th ed. CLSI Document M2-A10, Vol. 29, No. 1. CLSI, Wayne, PA, 2009.
- Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing: 21st Informational Supplement. Approved Standard CLSI Document M100-S21 CLSI, Wayne, PA, January 2011.
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Information for Patients
- Patients should be advised that amoxicillin may be taken every 8 hours or every 12 hours, depending on the dose prescribed.
- Patients should be counseled that antibacterial drugs, including amoxicillin, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When amoxicillin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by amoxicillin or other antibacterial drugs in the future.
- Patients should be counseled that diarrhea is a common problem caused by antibiotics, and it usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken their last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
- Patients should be aware that amoxicillin contains a penicillin class drug product that can cause allergic reactions in some individuals.