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Información de la droga para AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION USP8675 (TEVA PHARMACEUTICALS USA): CLINICAL PHARMACOLOGY
- CLINICAL PHARMACOLOGY
- INDICATIONS AND USAGE
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- DESCRIPTION OF CLINICAL STUDIES
The pharmacokinetics of amoxicillin and clavulanate were determined in a study of 19 pediatric patients, 8 months to 11 years, given amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL suspension at an amoxicillin dose of 45 mg/kg q12h with a snack or meal. The mean plasma amoxicillin and clavulanate pharmacokinetic parameter values are listed in the following table.
Table 1. Mean (± SD) Plasma Amoxicillin and Clavulanate Pharmacokinetic Parameter Values Following Administration of 45 mg/kg of Amoxicillin and Clavulanate Potassium for Oral Suspension, 600 mg/42.9 mg per 5 mL Every 12 Hours to Pediatric Patients
* Arithmetic mean ± standard deviation, except Tmax values which are medians (ranges).
Parameter* Amoxicillin Clavulanate Cmax (mcg/mL) 15.7 ± 7.7 1.7 ± 0.9 Tmax (hr) 2.0 (1.0 to 4.0) 1.1 (1.0 to 4.0) AUC0-t (mcg • hr/mL) 59.8 ± 20.0 4.0 ± 1.9 T1/2 (hr) 1.4 ± 0.3 1.1 ± 0.3 CL/F (L/hr/kg) 0.9 ± 0.4 1.1 ± 1.1
The effect of food on the oral absorption of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL has not been studied.
Approximately 50% to 70% of the amoxicillin and approximately 25% to 40% of the clavulanic acid are excreted unchanged in urine during the first 6 hours after administration of 10 mL of amoxicillin and clavulanate potassium 250 mg/62.5 mg per 5 mL suspension.
Concurrent administration of probenecid delays amoxicillin excretion but does not delay renal excretion of clavulanic acid.
Neither component in amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is highly-protein bound; clavulanic acid has been found to be approximately 25% bound to human serum and amoxicillin approximately 18% bound.
Oral administration of a single dose of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL at 45 mg/kg (based on the amoxicillin component) to pediatric patients, 9 months to 8 years, yielded the following pharmacokinetic data for amoxicillin in plasma and middle ear fluid (MEF):
Table 2. Amoxicillin Concentrations in Plasma and Middle Ear Fluid Following Administration of 45 mg/kg of Amoxicillin and Clavulanate Potassium for Oral Suspension, 600 mg/42.9 mg per 5 mL to Pediatric Patients Timepoint Amoxicillin concentration in plasma (mcg/mL) Amoxicillin concentration in MEF (mcg/mL) 1 hour mean median range 7.7 9.3 1.5 to 14.0 (n = 5) 3.2 3.5 0.2 to 5.5 (n = 4) 2 hour mean median range 15.7 13.0 11.0 to 25.0 (n = 7) 3.3 2.4 1.9 to 6 (n = 5) 3 hour mean median range 13.0 12.0 5.5 to 21.0 (n = 5) 5.8 6.5 3.9 to 7.4 (n = 5)
Dose administered immediately prior to eating.
Amoxicillin diffuses readily into most body tissues and fluids with the exception of the brain and spinal fluid. The results of experiments involving the administration of clavulanic acid to animals suggest that this compound, like amoxicillin, is well distributed in body tissues.
Amoxicillin is a semisynthetic antibiotic with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Amoxicillin is, however, susceptible to degradation by β-lactamases, and therefore, its spectrum of activity does not include organisms which produce these enzymes. Clavulanic acid is a β-lactam, structurally related to penicillin, which possesses the ability to inactivate a wide range of β-lactamase enzymes commonly found in microorganisms resistant to penicillins and cephalosporins. In particular, it has good activity against the clinically important plasmid-mediated β-lactamases frequently found responsible for transferred drug resistance.
The clavulanic acid component of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL protects amoxicillin from degradation by β-lactamase enzymes and effectively extends the antibiotic spectrum of amoxicillin to include many bacteria normally resistant to amoxicillin and other β-lactam antibiotics. Thus, amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL possesses the distinctive properties of a broad-spectrum antibiotic and a β-lactamase inhibitor.
Amoxicillin/clavulanic acid has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.
Aerobic Gram-Positive Microorganisms
Streptococcus pneumoniae (including isolates with penicillin MICs ≤ 2 mcg/mL)
Aerobic Gram-Negative Microorganisms
Haemophilus influenzae (including β-lactamase-producing isolates)
Moraxella catarrhalis (including β-lactamase-producing isolates)
The following in vitro data are available, but their clinical significance is unknown.
At least 90% of the following microorganisms exhibit in vitro minimum inhibitory concentrations (MICs) less than or equal to the susceptible breakpoint for amoxicillin/clavulanic acid. However, the safety and efficacy of amoxicillin/clavulanic acid in treating infections due to these microorganisms have not been established in adequate and well-controlled trials.
Aerobic Gram-Positive Microorganisms
Staphylococcus aureus (including β-lactamase-producing isolates)
NOTE: Staphylococci which are resistant to methicillin/oxacillin must be considered resistant to amoxicillin/clavulanic acid.
NOTE: S. pyogenes do not produce β-lactamase, and therefore, are susceptible to amoxicillin alone. Adequate and well-controlled clinical trials have established the effectiveness of amoxicillin alone in treating certain clinical infections due to S. pyogenes.
Susceptibility Test Methods
When available, the clinical microbiology laboratory should provide cumulative results of in vitro susceptibility test results for antimicrobial drugs used in local hospitals and practice areas to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting the most effective antimicrobial.
Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized procedure.1,2 Standardized procedures are based on dilution methods (broth for S. pneumoniae and H. influenzae) or equivalent with standardized inoculum concentration and standardized concentrations of amoxicillin/clavulanate potassium powder.
The recommended dilution pattern utilizes a constant amoxicillin/clavulanate potassium ratio of 2 to 1 in all tubes with varying amounts of amoxicillin. MICs are expressed in terms of the amoxicillin concentration in the presence of clavulanic acid at a constant 2 parts amoxicillin to 1 part clavulanic acid. The MIC values should be interpreted according to criteria provided in Table 3.
Quantitative methods that require measurement of zone diameters also provides reproducible estimates of the susceptibility of bacteria to antimicrobials. One such standardized technique requires the use of standardized inoculum concentration.2,3 This procedure uses paper disks impregnated with 30 mcg of amoxicillin/clavulanate potassium (20 mcg amoxicillin plus 10 mcg clavulanate potassium) to test susceptibility of microorganisms to amoxicillin/clavulanic potassium. Disk diffusion zone sizes should be interpreted according to criteria provided in Table 3.
Table 3. Susceptibility Test Result Interpretive Criteria for Amoxicillin/Clavulanate Potassium Pathogen Minimum Inhibitory Concentration (mcg/mL) Disk Diffusion (Zone Diameter in mm) S I
NOTE: Susceptibility of S. pneumoniae should be determined using a 1 mcg oxacillin disk. Isolates with oxacillin zone sizes of ≥ 20 mm are susceptible to amoxicillin/clavulanic acid. An amoxicillin/clavulanic acid MIC should be determined on isolates of S. pneumoniae with oxacillin zone sizes of ≤ 19 mm.
NOTE:ß-lactamase-negative, ampicillin-resistant H. influenzae isolates must be considered resistant to amoxicillin/clavulanic acid.
A report of S (“Susceptible”) indicates that the antimicrobial is likely to inhibit growth of the pathogen if the antimicrobial compound in the blood reaches the concentration usually achievable. A report of I (“Intermediate”) indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible antimicrobials, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high doses of antimicrobial can be used. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of R (“Resistant”) indicates that the antimicrobial is not likely to inhibit growth of the pathogen if the antimicrobial compound in the blood reaches the concentration usually achievable; other therapy should be selected.
Standardized susceptibility test procedures require the use of quality control microorganisms to determine the performance of the test procedures.1-3 Standard amoxicillin/clavulanate potassium powder should provide the MIC ranges for the quality control organisms in Table 4. For the disk diffusion technique, the 30 mcg amoxicillin/clavulanate potassium disk should provide the zone diameter ranges for the quality control organisms in Table 4.
Table 4. Acceptable QualityControlRanges for Amoxicillin/Clavulanate Potassium
* ATCC is a trademark of the American Type Culture Collection.
†When using Haemophilus Test Medium (HTM).
Quality Control Organism MinimumInhibitory Concentration Range (mcg/mL) Disk Diffusion (Zone Diameter Range in mm) Escherichia coli ATCC®* 35218† (H. influenzae quality control) 4/2 to 16/8 17 to 22 Haemophilus influenzae ATCC 49247 2/1 to 16/8 15 to 23 Streptococcus pneumoniae ATCC 49619 0.03/0.016 to 0.12/0.06 NA
- Drug Information Provided by National Library of Medicine (NLM).