Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUM- amoxicillin and clavulanate potassium tablet, film coated
American Health Packaging
1 INDICATIONS AND USAGE
Amoxicillin and clavulanate potassium tablets are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below:
- Lower Respiratory Tract Infections – caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis.
- Acute Bacterial Otitis Media – caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis.
- Sinusitis – caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis.
- Skin and Skin Structure Infections – caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species .
- Urinary Tract Infections – caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species , and Enterobacter species.
Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets should not be used.
Usage To reduce the development of drug‑resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible 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.
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
Amoxicillin and clavulanate potassium tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets should be taken at the start of a meal.
2.2 Adult Patients
See dosing regimens of amoxicillin and clavulanate potassium tablets (based on the amoxicillin component) provided in Table 1 below.
| |
TYPE OF INFECTION | DOSING REGIMEN OF AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS |
Severe infections and infections of the respiratory tract | one 875 mg/125 mg tablet *of amoxicillin and clavulanate potassium tablets every 12 hours or one 500 mg/125 mg tablet †‡of amoxicillin and clavulanate potassium tablets every 8 hours |
Less severe infections | one 500 mg/125 mg tablet †, ‡of amoxicillin and clavulanate potassium tablets every 12 hours or one 250 mg/125 mg tablet §of amoxicillin and clavulanate potassium tablets every 8 hours |
2.3 Pediatric Patients
Based on the amoxicillin component, amoxicillin and clavulanate potassium tablets should be dosed as follows:
Neonates and Infants Aged less than 12 weeks (less than 3 months): See dosing regimens of amoxicillin and clavulanate potassium tablets provided in Table 2 below.
| |
PATIENT POPULATION | DOSING REGIMEN |
Amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL for oral suspension * | |
Neonates and Infants aged less than 12 weeks (less than 3 months) | 30 mg/kg/day every 12 hours |
Patients Aged 12 weeks (3 months) and Older and Weighing Less than 40 kg: See dosing regimens provided in Table 3 below.
- The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies (14.2)] .
INFECTION | DOSING REGIMEN | |
Every 12 hours | Every 8 hours | |
Amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL or Amoxicillin and clavulanate potassium tablets 400 mg/57 mg per 5 mL for oral suspension * | Amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL or Amoxicillin and clavulanate potassium tablets 250 mg/62.5 mg per 5 mL for oral suspension * | |
Otitis media †, sinusitis, lower respiratory tract infections, and more severe infections | 45 mg/kg/day every 12 hours | 40 mg/kg/day every 8 hours |
Less severe infections | 25 mg/kg/day every 12 hours | 20 mg/kg/day every 8 hours |
Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
- The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium should NOT be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250 mg/125 mg tablet of amoxicillin and clavulanate potassium versus the 250 mg/62.5 mg chewable tablet of amoxicillin and clavulanate potassium.
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.
https://medlibrary.org/lib/rx/meds/amoxicillin-and-clavulanate-potassium-50/