From the FDA Drug Label
Liver: Hepatic dysfunction, including hepatitis and cholestatic jaundice, increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been reported with amoxicillin and clavulanate potassium. It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment The histologic findings on liver biopsy have consisted of predominantly cholestatic, hepatocellular, or mixed cholestatic-hepatocellular changes. The onset of signs/symptoms of hepatic dysfunction may occur during or several weeks after therapy has been discontinued. The hepatic dysfunction, which may be severe, is usually reversible. Deaths have been reported [see Contraindications (4. 2), Warnings and Precautions (5. 2)]. 5. 2 Hepatic Dysfunction Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of amoxicillin and clavulanate potassium. Hepatic toxicity is usually reversible; however, deaths have been reported. Hepatic function should be monitored at regular intervals in patients with hepatic impairment. 4.2 Cholestatic Jaundice/Hepatic Dysfunction Amoxicillin and clavulanate potassium tablets are contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium tablets.
Key Points:
- Hepatic dysfunction, including hepatitis and cholestatic jaundice, has been reported with amoxicillin and clavulanate potassium.
- The risk of hepatic dysfunction is higher in patients with a history of hepatic impairment.
- Hepatic function should be monitored at regular intervals in patients with hepatic impairment.
- Amoxicillin and clavulanate potassium are contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with the drug.
Given your past history of hepatitis B, which is now inactive, caution should be exercised when using amoxicillin and clavulanate potassium, as the drug can cause hepatic dysfunction. It is essential to monitor liver function during treatment. However, the decision to use the drug should be made on a case-by-case basis, considering the potential benefits and risks 1, 1, 1.
From the Research
Co-amoxiclav should be used with caution in patients with a history of hepatitis B, even if it's currently inactive, due to the potential risk of liver injury. This antibiotic combination (amoxicillin plus clavulanic acid) can potentially cause liver injury in some patients, with the clavulanic acid component being primarily responsible for this side effect, as reported in a case study 2. For someone with previous liver disease like hepatitis B, the risk of drug-induced liver problems may be somewhat higher. If your doctor has prescribed co-amoxiclav, they've likely determined that the benefits outweigh the risks in your specific situation. During treatment, be alert for warning signs of liver problems such as yellowing of the skin or eyes, dark urine, pale stools, unusual fatigue, loss of appetite, or abdominal pain. If any of these symptoms develop, contact your doctor immediately. Regular liver function monitoring through blood tests might be recommended during your treatment course, as suggested by guidelines for evaluating abnormal liver chemistries 3. Alternative antibiotics with less potential for liver effects could be considered if appropriate for your infection, so discussing your hepatitis B history with your prescribing doctor is essential. Recent studies have highlighted the importance of careful management of patients with chronic hepatitis B, including those in the indeterminate phase, to reduce the risk of transitioning to active phase and developing hepatocellular carcinoma (HCC) and cirrhosis 4. However, the most recent and highest quality study on the topic of co-amoxiclav use in patients with a history of hepatitis B is not directly available, but based on the available evidence, caution is advised when using co-amoxiclav in these patients.