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 |
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Dosing |
Wt. < 60 kg:
one 250 mg EC capsule daily on an empty stomach* or 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 |
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Renal dosing1 of EC form | weight < 60 kg | weight > 60 kg | |||
Ccr (cc/min) |
Dose (mg) |
Ccr (cc/min) |
Dose (mg) |
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>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 |
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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 |
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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 |
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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.
Avoid
use with d4T/stavudine if possible |
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Contraindications |
Pancreatitis - clinical or
subclinical - in the past Moderate to heavy alcohol ingestion Concomitant use of ribavirin |
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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. |
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Complete prescribing information | http://www.videxec.com/ |
Links to Antiretroviral Sections (click on anything) |
Nucleoside & Nucleotide Reverse Transcriptase Inhibitors (NRTI) |
AZT | ddC | ddI | d4T | 3TC | ABC | FTC | TDF | Combivir | Trizivir | Epzicom | Truvada |
Nonnucleoside Reverse Transcriptase Inhibitors (NNRTI) |
efavirenz | nevirapine | delavirdine |
Protease Inhibitors (PI) | Boosted Protease Inhibitors |
saquinavir | indinavir | ritonavir | nelfinavir | amprenavir | lopinavir + ritonavir | atazanavir | fosamprenavir | tipranavir |
Fusion Inhibitors |
enfuvirtide |
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