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Topic: Hepatic impairment

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	Caution Recommended in Use of Lopinavir/Ritonavir in HIV-HCV Coinfected Patients with Hepatic Impairment
		Twenty-four HIV-1-infected subjects received lopinavir 400 mg/ritonavir 100 mg twice daily prior to and during the study: 6 each with mild or moderate hepatic impairment (and hepatitis C virus coinfected) and 12 with normal hepatic function.
		The effect of hepatic impairment on low-dose ritonavir pharmacokinetics was more pronounced in the moderate impairment group (181% and 221% increase in AUC(12) and C(max), respectively) than in the mild impairment group (39% and 61% increase in AUC(12) and C(max), respectively).
		Pharmacokinetics of Lopinavir/Ritonavir in HIV/Hepatitis C Virus-Coinfected Subjects With Hepatic Impairment.
	www.hivandhepatitis.com /hiv_hcv_co_inf/2006/031706_a.html (201 words)

	The Pharmacokinetics of Escitalopram in Patients With Hepatic Impairment
		The effect of hepatic impairment on the pharmacokinetics of escitalopram was determined by means of nonlinear mixed effect modeling, considering both the Child-Pugh classification (and its components) and cytochrome P450 2C19 (CYP2C19) activity.
		and is generally altered in a population with hepatic impairment.
		The subjects were stratified according to the Child-Pugh classification of hepatic function (Child-Pugh Score of 5 or 6 for mild hepatic impairment and 7 to 9 for moderate hepatic impairment).
	www.aapsj.org /view.asp?art=aapsj080102 (3126 words)

	Pharmacokinetics of Telbivudine in Subjects with Various Degrees of Hepatic Impairment -- Zhou et al. 50 (5): 1721 -- ...
		Tenofovir pharmacokinetics in hepatic impairment and drug interaction potential with agents used to treat viral hepatitis, abstr.
		Dosing guidelines for adefovir dipivoxil in the treatment of chronic hepatitis B patients with renal or hepatic impairment.
		Clinical pharmacokinetics of telbivudine, a potent antiviral for hepatitis B, in subjects with impaired hepatic or renal function.
	aac.asm.org /cgi/content/full/50/5/1721 (3617 words)

	Guidance for Industry: Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design
		Given the small numbers of subjects usually entered into hepatic impairment studies, FDA recognizes that documentation that a PK parameter remains within a certain no effect boundary at a certain level of confidence is unlikely.
		The half-life of _______/metabolite is prolonged by ____ in patients with moderate hepatic impairment.
		The dosage should be reduced in patients with mild and moderate hepatic impairment receiving _______.
	www.fda.gov /cder/guidance/2629dft.htm (4411 words)

	Agenerase 50mg Soft Capsules , SPC from the eMC
		Hepatic impairment: the principal route of metabolism of amprenavir is via the liver.
		Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse events.
		Hepatic impairment: the pharmacokinetics of amprenavir are significantly altered in patients with moderate to severe hepatic impairment.
	emc.medicines.org.uk /emc/assets/c/html/displaydoc.asp?documentid=3820 (7428 words)

	The Pharmacokinetics of Escitalopram in Patients With Hepatic Impairment
		The effect of hepatic impairment on the pharmacokinetics of escitalopram was determined by means of nonlinear mixed effect modeling, considering both the Child-Pugh classification (and its components) and cytochrome P450 2C19 (CYP2C19) activity.
		The aim of the present study was to determine the effect of hepatic impairment on the pharmacokinetics of escitalopram, by means of nonlinear mixed effect modeling, considering both the Child-Pugh classification (and its components) and CYP2C19 activity (S/R-mephenytoin ratio).
		The subjects were stratified according to the Child-Pugh classification of hepatic function (Child-Pugh Score of 5 or 6 for mild hepatic impairment and 7 to 9 for moderate hepatic impairment).
	www.aapspharmsci.org /view.asp?art=aapsj080102 (3119 words)

	Liver Disease
		Nevertheless, there does tend to be impairment of many kinds of hepatic function, including impaired amino acid metabolism, impaired storage and release of glycogen, impaired lipid metabolism, some impairment of formation of coagulation factors, and some impairment of the liver's ability to modify and excrete toxic substances (including drugs).
		Hepatitis B is more likely than hepatitis A to be somewhat insidious in onset, and may not present with the sequential symptomatology just described.
		Impairment of glycogen storage and of glycogen release may be seen in moderate acute hepatitis and in moderate cirrhotic disease.
	www.ece.ncsu.edu /imaging/MedImg/SIMS/Module2/GE2_3.html (11539 words)

	Casodex 150mg International prescribing information
		Data suggest that its elimination may be slower in subjects with severe hepatic impairment and this could lead to increased accumulation of bicalutamide.
		Hepatic changes (elevated levels of transaminases, jaundice), which are rarely severe, have been observed with Casodex 150 mg.
		The pharmacokinetics of the (R)-enantiomer are unaffected by age, renal impairment or mild to moderate hepatic impairment.
	www.prostateline.com /prostatelinehcp/9898_9981_8_1_2.aspx (1363 words)

	eMedicine - Congenital Hepatic Fibrosis : Article by Hisham Nazer, MD, FRCP
		CHF is associated with an impairment of renal functions, usually caused by an autosomal recessive polycystic kidney disease, which is a severe form of polycystic kidney disease.
		Commonly, the hepatic lesion is associated with renal involvement characterized by cystic tubular dilatations affecting both the cortical and medullary portions of the kidney.
		When hepatic lesions dominate the clinical expression of the disease, the affected child may remain asymptomatic for years before evidence of hepatic involvement manifests as a sequel of portal hypertension with repeated episodes of gastrointestinal bleeding of varying severity.
	www.emedicine.com /ped/topic459.htm (4342 words)

	AstraZeneca Clinical Trials
		The primary objective of this trial was to compare the pharmacokinetics of ZD4522 in subjects with hepatic impairment with those in healthy subjects with normal liver function.
		The secondary objectives were to assess the pharmacodynamics and safety and tolerability of ZD4522 in subjects with hepatic impairment and in healthy subjects with normal liver function.
		The etiology of hepatic impairment of all subjects with CP-A and CP-B was alcohol-induced cirrhosis of the liver.
	www.astrazenecaclinicaltrials.com /Article/511262.aspx (1220 words)

	CELEBREX PACKAGE INSERT SCHEDULING STATUS
		Hepatic impairment: Plasma concentrations of celecoxib in patients with mild hepatic impairment are not significantly different from those of age and sex matched controls.
		Patients with severe hepatic impairment have not been studied but can be expected to show accumulation of parent drug as the main route of metabolism is via the liver.
		Hepatic impairment: No dosage adjustment is necessary in patients with mild or moderate hepatic impairment.
	www.drdoc.co.za /celebrex_package.html (1440 words)

	Anticoagulant Therapy Argatroban Safety Profile
		Caution should be exercised when administering Argatroban to patients with hepatic disease, by starting with a lower dose and carefully titrating until the desired level of anticoagulation is achieved.
		[2,6] Hepatic impairment is associated with a decrease in clearance and increased elimination half-life of Argatroban (to 1.9 mL/kg/min and 181 minutes, respectively, for patients with a Child-Pugh score >6).
		Patients with hepatic impairment were not studied in PCI trials.
	www.argatroban.com /argatroban_safety.htm (1999 words)

	AEGiS-11CROI: Tenofovir Pharmacokinetics in Hepatic Impairment and Drug Interaction Potential with Agents Used to Treat ...
		Hepatic impairment is a frequent co-morbidity in patients with HIV, particularly when co-infection with HBV or hepatitis C virus (HCV) is present.
		In all 3 studies adverse events were generally mild, except for 1 subject in the RBV study who developed a serious adverse event (cholecystitis/pancreatitis) that was unrelated to study drug.
		CONCLUSIONS: Tenofovir pharmacokinetics are not significantly altered with hepatic impairment.
	www.aegis.com /conferences/croi/2004/600.html (401 words)

	Data Sheet
		Hepatic impairment: Agenerase oral solution should be used with caution in patients with hepatic impairment (see Special Warnings and Special Precautions for Use).
		For adults with severe hepatic impairment the dose should be reduced to 342mg (23mLs) twice a day (see Pharmacokinetic Properties).
		As the principal route of metabolism of amprenavir and the propylene glycol excipient is via the liver, Agenerase oral solution should be used with caution in patients with hepatic impairment.
	www.medsafe.govt.nz /Profs/datasheet/a/Ageneraseoralsoln.htm (3988 words)

	RAYZON 40 MG IV/IM
		In patients with moderate hepatic impairment (Child-Pugh scale 7-9), treatment should be initiated with half the usual recommended dose of parecoxib injection and the maximum daily dose should be reduced to 40 mg since valdecoxib exposures were more than doubled (130%) in these patients.
		Patients with severe hepatic impairment have not been studied and therefore the use of parecoxib injection in patients with severe hepatic impairment is not recommended.
		Hepatic Impairment: No dosage adjustment is generally necessary in patients with mild hepatic impairment (Child-Pugh scale 5-6).
	home.intekom.com /pharm/pharmaca/rayzon.html (2094 words)

	Zithromax hepatic impairment (Site not responding. Last check: 2007-10-27)
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	zithromax-effectiveness.supapharm.com /zithromax-hepatic-impairment.html (457 words)

	Casodex Combination 50mg prescribing information
		Data suggest that its elimination may be slower in subjects with severe hepatic impairment and this could lead to increased accumulation of Casodex.
		Therefore, Casodex should be used with caution in patients with moderate to severe hepatic impairment.
		Hepatic changes are rarely severe and were frequently transient, resolving or improving with continued therapy or following cessation of therapy (see Special warnings and special precautions for use)
	www.prostateline.com /prostatelinehcp/9898_10138_10_1_1.aspx (840 words)

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