Amoxicillin, Clavulanate Potassium: what the FDA reviewed for dog products
1 Freedom of Information summary from the FDA Center for Veterinary Medicine for products containing Amoxicillin, Clavulanate Potassium, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs and cats.
Products
- Kesium® (NADA/ANADA 200-749)
Kesium® NADA 200-749, Original approval, February 22, 2024; sponsor Ceva Sante Animale; species: Dogs and cats; foi_id 15070; FDA PDF
Indication
Dogs: skin and soft tissue infections (wounds, abscesses, cellulitis, superficial/juvenile and deep pyoderma) due to susceptible Staphylococcus aureus (beta-lactamase producing and non-producing), Staphylococcus spp., Streptococcus spp. and E. coli; periodontal infections due to susceptible aerobic and anaerobic bacteria. (Cats: skin/soft tissue infections and urinary tract infections.)
Dose regimen
6.25 mg/lb body weight, Oral, Twice a day, Skin/soft tissue and periodontal infections 5-7 days or 48 hours after symptoms subside; deep pyoderma may require 21 days; maximum 30 days
Dogs: The recommended dosage is 6.25 mg/lb of body weight twice a day.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | 21414.0 hr*ng/mL | Amoxicillin, generic Kesium® 125 mg tablet, geometric mean; single oral dose, 22 fasted intact male beagles, 4-period crossover (Table II.3 columns: generic, RLNAD, ratio, lower 90% CI, upper 90% CI) | AUC (hr*ng/mL) 21414.0† 20801.9† 1.03 0.98 1.08 |
| auc | 20801.9 hr*ng/mL | Amoxicillin, RLNAD CLAVAMOX® CHEWABLE 125 mg tablet, geometric mean; fasted dogs | AUC (hr*ng/mL) 21414.0† 20801.9† 1.03 0.98 1.08 |
| cmax | 7564.3 ng/mL | Amoxicillin, generic 125 mg tablet, geometric mean; fasted dogs | CMAX (ng/mL) 7564.3† 7398.3† 1.02 0.95 1.10 |
| cmax | 7398.3 ng/mL | Amoxicillin, RLNAD 125 mg tablet, geometric mean; fasted dogs | CMAX (ng/mL) 7564.3† 7398.3† 1.02 0.95 1.10 |
| tmax | 1.4 hours (SD 0.5) | Amoxicillin, generic 125 mg tablet, arithmetic mean; fasted dogs (RLNAD 1.50 h) | TMAX (hours) (SD)‡ 1.4 (0.5)‡ 1.50 (0.4)‡ NE NE NE |
| auc | 3575.3 hr*ng/mL | Clavulanic acid, generic 125 mg tablet, geometric mean; fasted dogs (Table II.4 columns: sWR, generic, RLNAD, ratio, 95% upper bound; RLNAD 3741.3) | AUC (hr*ng/mL) 0.53 3575.3† 3741.3† 0.96 -0.139 |
| cmax | 2555.0 ng/mL | Clavulanic acid, generic 125 mg tablet, geometric mean; fasted dogs (RLNAD 2585.1) | CMAX (ng/mL) 0.48 2555.0† 2585.1† 0.99 -0.118 |
| tmax | 1.0 hours (SD 0.4) | Clavulanic acid, generic 125 mg tablet, arithmetic mean; fasted dogs (RLNAD 1.0 h) | TMAX (hours) (SD)‡ NE 1.0 (0.4)‡ 1.0 (0.3)‡ NE NE |
Effectiveness
Blood-level bioequivalence study in dogs (US/BEQ/C662/2006), labelled as such: randomized, masked, four-period, two-sequence, single-dose crossover of generic 125 mg Kesium® vs RLNAD 125 mg CLAVAMOX® CHEWABLE in fasted intact male beagles, 7-day washout; average bioequivalence for amoxicillin, RSABE for clavulanic acid; n = 22; primary endpoint: CMAX and AUC (90% CI of geometric mean ratio within 0.80-1.25; RSABE criteria for clavulanic acid); result: Bioequivalent: amoxicillin AUC ratio 1.03 (0.98-1.08), CMAX 1.02 (0.95-1.10); clavulanic acid AUC ratio 0.96, CMAX 0.99 with 95% upper bounds < 0
Study Animals: 22 intact male beagle dogs, approximately 15 months to 4 years of age
Extraction notes: Generic ANADA (Ceva, 2024). No target animal safety or field effectiveness studies (not required); effectiveness field records the dog bioequivalence study. PK values are from flattened bioequivalence tables (column order described in conditions). Adverse reactions: 'There were no serious adverse events reported during the study.' Cat bioequivalence study (34 cats, 62.5 mg) and biowaiver for 62.5/250/375 mg dog strengths not extracted.
Reproduce: foi_structured_search(query="Amoxicillin, Clavulanate Potassium") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).