From the Guidelines
Terbinafine tablets can likely be taken with an ALT of 46 and albumin of 54 in a healthy 24-year-old with no underlying conditions, though caution is warranted. The ALT level is only mildly elevated (normal range typically 7-45 IU/L), and the albumin level is within normal limits (normal range typically 35-55 g/L) 1. Terbinafine is primarily metabolized by the liver, and baseline liver function tests are recommended before starting therapy, as indicated in the British Association of Dermatologists' guidelines for the management of onychomycosis 2014 1. For fungal nail infections, the typical dosage is 250 mg once daily for 6 weeks for fingernails or 12 weeks for toenails. During treatment, it's advisable to monitor for signs of liver dysfunction such as persistent nausea, vomiting, abdominal pain, fatigue, dark urine, or jaundice. If these occur, discontinue the medication and consult a healthcare provider immediately. Follow-up liver function tests may be recommended after 4-6 weeks of treatment. The mild ALT elevation should be rechecked, but it's not necessarily a contraindication to therapy in an otherwise healthy young adult without risk factors for liver disease, as suggested by the guidelines for detection, assessment, and management of suspected acute drug-induced liver injury during clinical trials in patients with nonalcoholic steatohepatitis 1. Key considerations include:
- Monitoring liver function tests before and during treatment
- Being aware of the potential for liver dysfunction and discontinuing the medication if symptoms occur
- Rechecking the mild ALT elevation before starting therapy
- Following the recommended dosage and treatment duration for fungal nail infections. Given the most recent and highest quality study available, the patient can likely take terbinafine tablets with caution and close monitoring 1.
From the FDA Drug Label
Measurement of serum transaminases (ALT and AST) is advised for all patients before taking terbinafine tablets
The patient's ALT is 46 and albumin is 54. There is no specific guidance in the drug label regarding the acceptable range of ALT levels for taking terbinafine tablets. However, it is advised to measure serum transaminases (ALT and AST) before taking terbinafine tablets.
- The patient should consult their doctor to determine if their ALT level is acceptable for taking terbinafine tablets.
- It is recommended to exercise caution and consult a doctor before taking terbinafine tablets 2.
From the Research
Terbinafine Tablets and Liver Function
- The patient's ALT level is 46 and albumin level is 54, which are within normal limits for a healthy 24-year-old individual.
- According to the study by 3, many physicians monitor liver function tests during terbinafine therapy, but the study suggests that monitoring of liver function tests on terbinafine is not recommended, and patients should be advised to discontinue treatment and seek medical care when symptoms of DILI occur.
- However, the study by 4 recommends liver function assessment before treatment and periodic monitoring 4-6 weeks after initiation of treatment.
Risk of Hepatotoxicity
- Terbinafine has been associated with severe acute liver injury, although this is a rare complication 4, 5.
- The study by 6 compared the hepatotoxicity of different antifungal agents, including terbinafine, and found that ketoconazole had the highest risk of causing liver injury, followed by itraconazole, fluconazole, terbinafine, and griseofulvin.
- However, histopathological changes revealed that fluconazole was the most hepatotoxic, followed by ketoconazole, itraconazole, terbinafine, and griseofulvin 6.
Patient-Specific Considerations
- The patient is fit and healthy with no underlying conditions, which suggests that the risk of hepatotoxicity may be lower.
- However, it is still important for the patient to be aware of the potential risks and to monitor for symptoms of DILI, such as jaundice, abdominal pain, and general malaise 3, 4.