Regulatory product record
CLAVASEPTIN 50 MG
Product identity, ingredients and source provenance from the regulatory catalogue. Linked clinical evidence has a separate review status.
Owner information handout
Plain-language medication information to review with the owner. Open the handout to print it or download a PDF.
Product identity
- Brand name
- CLAVASEPTIN 50 MG
- DIN
- 02316900
- DPD drug code
- 80240
- Regulatory category
- APPROVED_VET_DRUG
- Market status
- MARKETED
- Route(s)
- ORAL
- Pharmaceutical form(s)
- TABLET (CHEWABLE)
- Ingredients
- CLAVULANIC ACID (CLAVULANATE POTASSIUM) (10 MG), AMOXICILLIN (AMOXICILLIN TRIHYDRATE) (40 MG)
- Species (DPD record)
- DOGS, CATS
- Company
- VETOQUINOL N A INC (DIN owner)
Source and provenance
- Source dataset
- health_canada_dpd_marketed
- Source snapshot date
- Not available in this source
- Source record key
- 80240
- Archive fingerprint (SHA-256)
- 85cc3ce208af3aa57018c3d14d83f90220c436baef7455384b6d48d9774e1c88
Linked clinical reference
Clinical entries are linked through the active molecule. Check their species, formulation, source and review status separately from this product record.
Clinical evidence
Pending clinical review (PROPOSED)Rule-based (RULE_BASED)— applies to the facts and dose entries in this species selection; individual source records retain their own status.
Indications2
UTI, soft tissue infection, susceptible gram-positive infections, Lyme disease (dog)
DogCatExtra-label (EXTRA_LABEL)2 source records · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 84–86; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 37–38 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: UTI, soft tissue infection, susceptible gram-positive infections, Lyme disease (dog) — Extra-label (no veterinary FDA approval per Plumb's)
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 84–86; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 37–38 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: UTI, soft tissue infection, susceptible gram-positive infections, Lyme disease (dog) — Extra-label (no veterinary FDA approval per Plumb's)
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 84–86; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 37–38 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Dose regimens5
This calculator performs arithmetic only on the sourced dosing field shown for each result — it does not verify the field's accuracy, does not select which field to use for a patient, and does not replace a veterinarian's order. Not for clinical use. Confirm every result against the primary source before dispensing.
Select a species above to calculate a dose.
Adverse effects405
GI (vomiting, diarrhea, anorexia) — Most common
DogCatNot applicable (NOT_APPLICABLE)2 source records · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 84–86; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 37–38 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 84–86; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 37–38 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Hypersensitivity (rash, fever, anaphylaxis) — Uncommon, not dose-related
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 84–86; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 37–38 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Neurotoxicity (ataxia) — High-dose/prolonged use
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 84–86; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 37–38 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Gut flora shift toward resistant gram-negatives — Documented in healthy dogs
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 84–86; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 37–38 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
These are counts of spontaneously reported events, not proven adverse effects, causal relationships, or incidence rates.
Bars compare report counts within each species; they do not show incidence.
More reportsFewer reportsDog
- Vomiting1,418 reports
- Anorexia801 reports
- Lethargy (see also Central nervous system depression in 'Neurological')720 reports
- Elevated alanine aminotransferase (ALT)597 reports
- Diarrhoea569 reports
- Death by euthanasia538 reports
- Lack of efficacy (bacteria) - NOS532 reports
- Other abnormal test result NOS528 reports
- Death522 reports
- Lack of efficacy - NOS510 reports
- Elevated serum alkaline phosphatase (SAP)478 reports
- Leucocytosis NOS438 reports
Cat
- Vomiting756 reports
- Anorexia435 reports
- Diarrhoea370 reports
- Lack of efficacy (bacteria) - NOS272 reports
- Death267 reports
- Lethargy (see also Central nervous system depression in 'Neurological')240 reports
- Death by euthanasia226 reports
- Depression206 reports
- Weight loss177 reports
- Ataxia160 reports
- Lack of efficacy - NOS153 reports
- Fever147 reports
Monitoring1
Clinical response; false-positive urine glucose with copper-reduction methods (Clinitest) — use glucose oxidase methods instead
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 84–86; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 37–38 — Monitoring Parameters · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Contraindications1
Known penicillin/beta-lactam hypersensitivity; do not give penicillins/cephalosporins/macrolides to rabbits, guinea pigs, chinchillas, hamsters — risk of fatal enterotoxemia
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 84–86; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 37–38 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Precautions4
Do not give oral antibiotics in septicemia/shock (use parenteral)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 84–86; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 37–38 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Reasonable first-line empiric choice for feline abscesses per Trepanier 2009.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 84–86; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 37–38 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Do not use in adult horses orally — poor absorption; foals absorb better (36–43%).
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 84–86; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 37–38 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Never give to rabbits/rodents/guinea pigs — fatal enterotoxemia risk shared across penicillins/cephalosporins/macrolides.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 84–86; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 37–38 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Interactions3
Bacteriostatic antimicrobials (chloramphenicol, macrolides, tetracyclines) — Theoretical in vitro antagonism — significance unclear
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 84–86; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 37–38 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Methotrexate — ↓ renal MTX excretion — ↑ toxicity risk
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 84–86; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 37–38 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Probenecid — ↑ amoxicillin levels/half-life (blocks tubular secretion)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 84–86; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 37–38 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pharmacokinetics5
Bioavailability — 50–92% (varies by source); poor in adult horses (<10%)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 84–86; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 37–38 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Protein binding — ~13% (dog)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 84–86; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 37–38 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Half-life — 45–90 min (dog, cat); 1.3–1.4h (Papich)
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 84–86; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 37–38 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Metabolism — Partial hepatic hydrolysis to inactive penicilloic acid
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 84–86; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 37–38 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Elimination — Renal (tubular secretion)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 84–86; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 37–38 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pregnancy / lactation considerations1
Crosses placenta; considered relatively safe. Papich canine/feline class A (probably safe). Low levels in milk.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 84–86; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 37–38 — Pregnancy & Lactation · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Literature references32
References are linked to this drug. Species applicability is not recorded here, so the species filter does not narrow this list. Imported dates do not retain their original precision; confirm dates in the original citation.
- Heat-Stress Alters the Effects of Antibiotics on Fish Behavior.
Study summary not available in the imported record. Open the original citation to review the study.
- Pharmacokinetic-pharmacodynamic evaluation of therapeutic efficacy of intramuscular amoxicillin-florfenicol in olive flounder.
Study summary not available in the imported record. Open the original citation to review the study.
- Long Noncoding RNA PCALRx Interacts with Pyruvate Carboxylase to Drive Multi-Organ Developmental Toxicity in Zebrafish Embryos Exposed to Amoxicillin.
Study summary not available in the imported record. Open the original citation to review the study.
- Dynamics of archaeal diversity and functionality in the piglet gut microbiome under common antimicrobial treatments.
Study summary not available in the imported record. Open the original citation to review the study.
- Silver nanoparticle hydrogen peroxide composite mitigates resistant Escherichia coli dissemination driven by poultry waste biosecurity failures.
Study summary not available in the imported record. Open the original citation to review the study.
Sources: PubMed, National Library of Medicine; openFDA, U.S. Food and Drug Administration; Plumb DC. Plumb's Veterinary Drug Handbook. 7th ed. PharmaVet Inc; 2011.