500 mg, film-coated tablet, human medicine
Assessed clinical scopeDog · Adjunctive ursodeoxycholic-acid therapy for selected diagnosed canine cholestatic or inflammatory hepatobiliary disease after exclusion of complete extrahepatic obstruction · By mouth
Care settingVeterinarian-directed outpatient adjunct after hepatobiliary diagnosis and imaging, with accurate formulation selection, laboratory/ultrasound monitoring and urgent surgical escalation when obstruction, leakage or progression is suspected.
vetman score
5.6/10
Weak evidence support
Evidence confidence: Medium
Georgia: Yes, human · № რ-037741 · Verified on 23 Oct 2026
Off-label use
A plausible guideline-supported adjunct for selected non-obstructed cholestatic disease, but exact-product veterinary evidence is limited and the 500 mg tablet is a poor dosing unit for many dogs.
Regulatory and scientific credibility5.5/10
Exact 500 mg identity, full human instruction, manufacturer and current Georgian human registration are traceable, but no veterinary authorisation or exact-product target-animal dossier exists; veterinary support comes from ingredient guidance and limited animal evidence.
Clinical efficacy5.5/10
Consensus and disease-specific guidance support a biologically coherent adjunct in cholestatic chronic hepatitis and selected non-obstructed biliary disease, but efficacy is little investigated, direct canine evidence includes a single case and it cannot replace surgery or cause-specific care.
Safety and tolerability6.5/10
UDCA is generally tolerated and the exact human label is detailed, but complete obstruction can make choleresis dangerous; diarrhoea, interaction-related underexposure, worsening biliary disease and unestablished canine reproductive/long-term exact-product safety require monitoring.
Clinical practicality4.5/10
Once-daily oral treatment can be simple in a large dog, but one 500 mg whole tablet fits about 33.3 kg at 15 mg/kg and the score is not validated for equal halves; most dogs require a lower strength or accurately prepared formulation plus repeated monitoring.
Full-course cost-effectiveness-
No verified current Georgian patient-adjusted full-course price is available, so cost is excluded.
Important safety and use flags
- Human medicine registered in Georgia; dog/cat use is off-label and no veterinary authorisation or exact Ursovef target-animal dossier exists.
- Adjunct only. Establish the hepatobiliary diagnosis and treat the cause; do not replace nutrition, antimicrobials, copper-directed or immune therapy, drainage, decompression or surgery when indicated.
- Exclude complete extrahepatic bile-duct obstruction before use. Worsening pain, jaundice, fever, vomiting, effusion, gallbladder leakage/rupture or imaging progression requires urgent escalation, not more choleretic.
- Use in gallbladder mucocele only when leakage/obstruction is absent and monitoring is close; progression makes surgery necessary, and cholecystectomy remains essential for most clinically significant obstruction/inflammation/rupture.
- Veterinary reference dose is 15 mg/kg PO every 24 hours, while disease-specific schedules differ. Never transfer a human indication schedule or increase dose without diagnosis-specific evidence.
- One intact 500 mg tablet approximates 33.3 kg at 15 mg/kg. The one-sided score is not documented to yield equal doses; do not claim half-tablet accuracy, crush or create visual fragments. Use a validated lower strength or accurately prepared formulation.
- Monitor appetite, stool/diarrhoea, vomiting, pain, jaundice, liver enzymes, bilirubin and disease-appropriate ultrasound. Define response and stop/escalate if clinical, biochemical or imaging disease progresses.
- Cholestyramine, colestipol and aluminium-containing antacids/smectite bind UDCA; separate by at least two hours. Review ciclosporin levels and possible ciprofloxacin underexposure when co-administered.
- Avoid in known bile-acid/excipient hypersensitivity and reassess acute gallbladder/biliary inflammation, frequent biliary colic, calcified stones or impaired gallbladder contractility before exposing an animal.
- Exact safety in pregnancy, lactation, breeding animals, puppies/kittens and prolonged or repeated dog/cat courses is not established; use only after individual benefit-risk review.
Assessment sources+