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Dosage adjustment in patients with hepatic disease Return to Top

Dosage adjustment may be required in the presence of hepatic disease for the following medications (consult FDA package insert for details):

Antimicrobial Agent	Category	Recommendation
Abacavir	Antiviral agent	A dose of 200 mg abacavir administered twice daily is recommended for patients with mild liver disease. The safety, efficacy, and pharmacokinetics of abacavir have not been studied in patients with moderate or severe hepatic impairment; therefore, abacavir is contraindicated in these patients.
Atazanavir	Antiviral agent	Mild hepatic impairment (Child-Pugh class A): 400 mg once daily Moderate hepatic impairment (Child-Pugh class B): 300 mg once daily Severe hepatic impairment (Child-Pugh class C): not recommended
Caspofungin	Antifungal agent	Mild hepatic impairment (Child-Pugh score 5 to 6): a dosage adjustment is not required Moderate hepatic impairment (Child-Pugh score 7 to 9): 35 mg once daily following a 70-mg loading dose on day 1 Severe hepatic impairment (Child-Pugh score >9): no clinical experience available Pediatric patients with any degree of hepatic impairment: dosing recommendations are not available
Chloramphenicol	Antibacterial agent	Adults with impairment of hepatic function may have reduced ability to metabolize and excrete the drug. In instances of impaired metabolic processes, dosages should be adjusted accordingly. Precise control of concentration of the drug in the blood should be carefully followed in patients with impaired metabolic processes by the available microtechniques.
Clindamycin	Antibacterial agent	This product contains benzyl alcohol as a preservative and has been associated with gasping syndrome in pediatric patients. The risk of benzyl alcohol toxicity depends on the quantity administered and the hepatic capacity to detoxify the chemical.
Darunavir-Ritonavir	Antiviral agent	No dose adjustment of Darunavir/ritonavir is necessary for patients with either mild or moderate hepatic impairment. No pharmacokinetic or safety data are available regarding the use of Darunavir/ritonavir in subjects with severe hepatic impairment; therefore, Darunavir/ritonavir is not recommended for use in patients with severe hepatic impairment.
Delavirdine	Antiretroviral agent	Delavirdine is metabolized primarily by the liver. Caution should be exercised when administering delavirdine to patients with impaired hepatic function.
Efavirenz	Antiretroviral agent	Patients with mild hepatic impairment may be treated with efavirenz without any adjustment in dose. Because of the extensive cytochrome P450-mediated metabolism of efavirenz and limited clinical experience in patients with hepatic impairment, caution should be exercised in administering efavirenz to these patients. Efavirenz is not recommended for patients with moderate or severe hepatic impairment because there are insufficient data to determine whether dose adjustment is necessary.
Fosamprenavir	Antiretroviral agent	Mild Hepatic Impairment (Child-Pugh Score Ranging From 5 to 6): 700 mg twice daily without ritonavir (therapy-naive) or 700 mg twice daily plus ritonavir 100 mg once daily (therapy-naive or protease inhibitor-experienced) Moderate Hepatic Impairment (Child-Pugh Score Ranging From 7 to 9): 700 mg twice daily without ritonavir (therapy-naive), or 450 mg twice daily plus ritonavir 100 mg once daily (therapy-naive or protease inhibitor-experienced) Severe Hepatic Impairment (Child-Pugh Score Ranging From 10 to 15): 350 mg twice daily without ritonavir (therapy-naive) or 300 mg twice daily plus ritonavir 100 mg once daily (therapy-naive or protease inhibitor-experienced) Pediatric patients with any degree of hepatic impairment: dosing recommendations are not available
Indinavir	Antiretroviral agent	Patients with mild to moderate hepatic insufficiency and clinical evidence of cirrhosis had evidence of decreased metabolism of indinavir resulting in approximately 60% higher mean AUC following a single 400-mg dose. The half-life of indinavir increased to 2.8 ± 0.5 hours. Indinavir pharmacokinetics have not been studied in patients with severe hepatic insufficiency.
Isoniazid	Antimycobacterial agent	Patients with hepatitis attributed to isoniazid should be given appropriate treatment with alternative drugs. If isoniazid must be reinstituted, it should be administered only after symptoms and laboratory abnormalities have cleared. The drug should be restarted in very small and gradually increasing doses and should be withdrawn immediately if there is any indication of recurrent liver involvement. Preventive treatment with isoniazid should be deferred in patients with acute hepatic disease.
Itraconazole	Antifungal agent	Limited data are available on the use of itraconazole in patients with hepatic impairment. Caution should be exercised when this drug is administered in this patient population.
Lopinavir-Ritonavir
Metronidazole
Nafcillin
Nelfinavir
Nevirapine
Quinupristin-Dalfopristin
Rifabutin
Rifampin
Rimantadine
Ritonavir
Telithromycin
Tigecycline
Tinidazole
Voriconazole