Child-Pugh class

Premenopausal use There is no indication for premenopausal use of raloxifene. Hepatic function impairment Raloxifene was studied, as a single dose, in Child-Pugh class A patients with cirrhosis and serum total bilirubin ranging from 0.6 to 2 mg/dL. Plasma raloxifene concentrations were approximately 2.5 times higher than in controls and correlated with total bilirubin concentrations. Safety and efficacy have not been evaluated further in patients with severe hepatic insufficiency. Carcinogenesis In long term carcinogenicity studies in animals there was an increased incidence of ovarian tumors, testicular interstitial cell tumors, and prostatic adenocarcinomas. 

Hepatic function impairment Because iloprost elimination is reduced in patients with impaired liver function, exercise caution during iloprost therapy in patients with at least Child-Pugh class B hepatic impairment. 

Hepatic function impairment- In mild or moderate hepatic impairment (Child-Pugh class A or B), do not exceed 10 mg once daily. In severe hepatic impairment (Child-Pugh class C), the use of tadalafil is not recommended. 

Hepatic function impairment For patients with moderate hepatic function impairment (Child-Pugh Class B), reduce initial and target doses to 50% of the normal dose. For patients with severe hepatic function impairment (Child-Pugh Class C), reduce initial and target doses to 25% of normal. 

Hepatic function impairment Atomoxetine exposure (AUC) is increased, compared with normal subjects, in EM subjects with moderate (Child-Pugh Class B) (2-fold increase) and severe (Child-Pugh Class C) (4-fold increase) hepatic insufficiency. Dosage adjustment is recommended for patients with moderate or severe hepatic insufficiency (see Administration and Dosage). 

Hepatic function impairment In patients with severe hepatic impairment (Child-Pugh class C), the initial dose of tigecycline should be 100 mg, followed by a reduced maintenance dose of 25 mg every 12 hours. Patients with severe hepatic impairment should be treated with caution and monitored for treatment response. 

It is recommended that the standard loading dose regimens be used but that the maintenance dose be halved in patients with mild to moderate hepatic cirrhosis (Child-Pugh class A and B). 

Evaluate liver function tests at the start of and during the course of voriconazole therapy. Monitor patients who develop abnormal liver function tests during voriconazole therapy for the development of more severe hepatic injury. Discontinuation of voriconazole must be considered if clinical signs and symptoms consistent with liver disease develop that may be attributable to voriconazole. Hepatic function impairment It is recommended that the standard loading dose regimens be used but that the maintenance dose be halved in patients with mild to moderate hepatic cirrhosis (Child-Pugh class A and B) receiving voriconazole. 

Chronic HCV- In combination with peginterferon alfa-2a for the treatment of adults with chronic HCV infection who have compensated liver disease and have not been previously treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A). 

Known hypersensitivity to any of the ingredients of the product moderate to severe (Child-Pugh class B and C, respectively) hepatic insufficiency. 

Hepatic function impairment Give with caution in patients with mild to moderate hepatic insufficiency. Consider a dosage reduction to 300 mg once daily for patients with moderate hepatic insufficiency (Child-Pugh class B) who have not experienced virologic failure. Do not use atazanavir in patients with severe hepatic insufficiency (Child-Pugh class C). 

Dosaye in renal impairment For patients with a creatinine clearance of 31-50 ml/min, the starting dose is 5 mg before sexual activity once a day and the maximum dose is 10 mg no more frequently than once q48h. For patients with a creatinine clearance of less than 31 ml/min, the starting dose is 5 mg before sexual activity once a day. Dosaye in mild or moderate hepatic impairment Patients with Child-Pugh Class A or B hepatic impairment should take no more than 10 mg once a day. 

Dosage in moderate hepatic impairment PO Forpatients with Child-Pugh Class B hepatic impairment, dosage is 5 mg 60 min before sexual activity. 

Decompensated hepatic disease (e.g., Child-Pugh class B or C) should not he treated with PEG-interferon a-2a... 

Drug Metabolism Child-Pugh class (n) PK observation Study recommendations References... 

Raloxifene undergoes extensive first-pass metabolism to glucuronide conjugates. It is then eliminated by biliary excretion. The pharmacokinetics of raloxifene have been studied in patients with mild hepatic impairment (Child-Pugh class A) and concentrations were found to be approximately 2.5 times higher than in controls, correlating with the patient s bilirubin concentration [8]. 

For RF ablation of HCC, patients must be Child-Pugh class A or B because in cases with end-stage liver cirrhosis (class C), treatment of tumor probably does not increase patient survival. In patients with hepatic metastases, the rationale for RF tumor ablation is based on the demonstration that in certain types of malignancies, surgical removal of hepatic tumor burden improves survival (Selzner et al. 2000 Benevento et al. 2000). 

Celecoxib is ehminated predominantly by hepatic metabolism with httle imchanged drug recovered in the urine and feces. Fifty-seven percent of the dose was excreted in the feces and 27% was excreted in the urine. As a result, the daily recommended dose of celecoxib should be reduced by 50% in patients with moderate hepatic impairment (Child-Pugh Class B) [1]. 

Child-Pugh class A or B cirrhosis Treatment refractory ascites... 

Maluf-Filho F, Sakai P, Ishioka S, Matuguma SE. Endoscopic sclerosis versus cyanoacrylate endoscopic injection for the first episode of variceal bleeding a prospective, controlled, and randomized study in Child-Pugh class C patients. Endoscopy. 2001 33 421-427. 

---