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didanosine

Detailed Prescribing Information

October 2005

 

Videx  or Videx-EC = didanosine = ddI

Forms Available

125mg, 200 mg, 250 mg, 400 mg enteric-coated (Videx EC) capsules
100 mg, 125 mg, 150 mg and 200 mg chewable or dispersable wafers

Dosing

Wt. < 60 kg:       

one 250 mg EC capsule daily on an empty stomach*  or
one 125 mg wafer chewed or dispersed twice a day (consider two 125 mg wafers chewed once daily)


Wt. > 60 kg:    

one 400 mg enteric-coated capsule once a day on an empty stomach* or

two 100 mg wafers chewed or dispersed twice a day on an empty stomach*  or

two 200 mg wafers chewed or dispersed daily on an empty stomach*


*An empty stomach is defined as at least one hour before food or at least two hours after food

Renal dosing1 of EC form weight < 60 kg weight > 60 kg
Ccr
(cc/min)
Dose
(mg)
Ccr
(cc/min)
Dose
(mg)
>60 250 >60 400
30-59 125 30-59 250
10-29 125 10-29 125
<10 100
wafer-form
<10 125
Hepatic dosing: unknown - monitor patients carefully for toxicity
Food dependence Take on an empty stomach

Possible exception: when used with tenofovir, this medication (Videx-EC)  may be taken with or without food

Adverse Effects Well tolerated in most patients

Diarrhea and GI upset common with wafer form

5-10% incidence of subclinical to rare fatal pancreatitis

Peripheral neuropathy - less common than zalcitabine or stavudine

Bad taste in mouth from wafer form of didanosine

Rare lactic acidosis and hepatic steatosis especially in setting of hepatitis C, ribavirin therapy, and concomitant stavudine

Didanosine may contribute to fat redistribution

Interactions Ribavirin increased didanosine exposure increasing the risk for lactic acidosis and/or pancreatitis
Ganciclovir raises ddI blood levels significantly: may need ddI dose reduction

Wafer form of didanosine lowers absorption of indinavir (see indinavir dosing below)

Wafer form decreases absorption of delavirdine

Tenofovir increases ddI levels: observe for ddI-related toxicity & reduce ddI-EC to 250 mg daily

Tenofovir and didanosine may produce mitochondrial toxicity and increased nephrotoxicity

Suggested lab follow-up Monitor lipase at baseline and monthly x 3-6 months, then periodically and PRN
Warning Avoid use with ddC/zalcitabine (increased peripheral neuropathy)

Contraindicated with prior history of pancreatitis or elevated lipase / p-amylase

Contraindicated in moderate to heavy alcohol users.
Pancreatitis may be fatal.  Consider pancreatitis first in the differential diagnosis in patients on didanosine with compatible symptoms.

Avoid use with d4T/stavudine if possible
Rare lactic acidosis especially in persons with underlying liver disease: nausea, malaise, anion gap acidosis, renal failure, hepatic steatosis

Contraindications Pancreatitis - clinical or subclinical - in the past
Moderate to heavy alcohol ingestion
Concomitant use of ribavirin
Usage suggestions The extended-release form of didanosine (Videx-EC) has largely supplanted the wafer form (immediate-release) of didanosine due to decreased dose frequency and markedly improved side-effect profile.
Strongly discourage anything more than occasional alcohol use.
Complete prescribing information http://www.videxec.com/

 

 

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Quick Menu / Table of Contents
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PI Info Fusion Inhibitors Drug Summary Investigational Adherence
Lab Evaluation Resistance Tests PEP Antiretroviral Tables OI Prevention
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Updated 10.25.2005

 


 

1. Renal dosing information from: Ian R. McNicholl & Rudolph A. Rodriguez, MD, Dosing of Antiretroviral Drugs in Renal Insufficiency and Hemodialysis, May 2004
http://hivinsite.ucsf.edu/InSite?page=md-rr-18