Classes
DEA Class; Rx
Common Brand Names; Videx, Videx EC
- HIV, NRTIs
Description
Synthetic guanosine nucleoside reverse transcriptase inhibitor (NRTI)
Indicated for the treatment of human immunodeficiency virus (HIV) infection
Associated with fatal hypersensitivity reactions during initial treatment and with reintroduction of therapy
Indications
Indicated for the treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents.
Contraindications
Hypersensitivity
Coadministration with allopurinol (may increase didanosine toxicity)
Coadministration with ribavirin (increases actrive metabolite dideoxyadenosine 5’-triphosphate levels, causing fatal hepatic failure, peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis)
Coadministration with stavudine
Adverse Effects
- Diarrhea (19-28%)
- Peripheral neuropathy (17-20%)
- Increased amylase (15-17%)
- Abdominal pain (7-13%)
- 1-10%
- Increased LFT
- Increased uric acid
- Pancreatitis (patients >65 years had higher frequency of pancreatitis than younger patients)
- Pruritus
- Rash
- Noncirrhotic portal hypertension
Warnings
(All NRTIs): Risk of potentially fatal lactic acidosis & severe hepatomegaly with steatosis when used alone or in combination with other antiretrovirals
Risk of potentially fatal pancreatitis, increases if used in combo with stavudine
Risk of potentially fatal bleeding from esophageal varices in patients with non-cirrhotic portal hypertension
Discontinue if pancreatitis occurs; reduce dose for other ADR’s
Risk of immune reconstitution syndrome if used in combination w/ other antiretroviral drugs
Risk of retinal changes and optic neuritis
Rapidly degrades in acidic pH, however, EC is protected from stomach acids
Noncirrhotic portal hypertension reported; discontinue if signs/symptoms occur (eg, elevated liver enzymes, esophageal varices, hematemesis, ascites, splenomegaly)
Coadministration of methadone with Videx pediatric powder may significant decrease didanosine concentrations
Patients treated in combination with stavudine may be at increased risk for pancreatitis, lactic acidosis, and hepatic toxicity; coadministration is contraindicated
Treatment has been associated with loss of subcutaneous fat, which is most evident in the face, limbs, and buttocks; incidence and severity of lipoatrophy are related to cumulative exposure, and is often not reversible when treatment is stopped; patients receiving therapy should be frequently examined and questioned for signs of lipoatrophy, and if feasible, therapy should be switched to an alternative regimen if there is suspicion of lipoatrophy
Pregnancy and Lactation
There are no adequate and well-controlled studies of didanosine in pregnant women; drug should be used during pregnancy only if potential benefit justifies potential risk
The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed infants to avoid risking postnatal transmission of HIV
Maximum Dosage
weight 60 kg or more: 400 mg/day PO.
weight less than 60 kg: 250 mg/day PO.
weight 60 kg or more: 400 mg/day PO.
weight less than 60 kg: 250 mg/day PO.
weight 60 kg or more: 400 mg/day PO for extended-release capsules; 240 mg/m2/day PO for pediatric powder for oral solution is the FDA-approved maximum dosage; however, doses as high as 300 mg/m2/day (Max: 400 mg/day) have been used off-label.
weight 25 to 59 kg: 250 mg/day PO for extended-release capsules; 240 mg/m2/day PO for pediatric powder for oral solution is the FDA-approved maximum dosage; however, doses as high as 300 mg/m2/day (Max: 250 mg/day) have been used off-label.
weight 20 to 24 kg: 200 mg/day PO for extended-release capsules; 240 mg/m2/day PO for pediatric powder for oral solution is the FDA-approved maximum dosage; however, doses as high as 300 mg/m2/day (Max: 250 mg/day) have been used off-label.
6 to 12 years and weight 60 kg or more: 400 mg/day PO for extended-release capsules; 240 mg/m2/day PO for pediatric powder for oral solution is FDA-approved maximum dosage; however, doses as high as 300 mg/m2/day (Max: 400 mg/day) have been used off-label.
6 to 12 years and weight 25 to 59 kg: 250 mg/day PO for extended-release capsules; 240 mg/m2/day PO for pediatric powder for oral solution is FDA-approved maximum dosage; however, doses as high as 300 mg/m2/day (Max: 250 mg/day) have been used off-label.
6 to 12 years and weight 20 to 24 kg: 200 mg/day PO for extended-release capsules; 240 mg/m2/day PO for pediatric powder for oral solution is FDA-approved maximum dosage; however, doses as high as 300 mg/m2/day (Max: 250 mg/day) have been used off-label.
1 to 5 years or weight less than 20 kg: 240 mg/m2/day PO for pediatric powder for oral solution is FDA-approved maximum dosage; however, doses as high as 300 mg/m2/day have been used off-label; safety and efficacy of extended-release capsules have not been established.
9 to 12 months: 240 mg/m2/day PO for oral solution is FDA-approved maximum dosage; however, doses as high as 300 mg/m2/day have been used off-label; safety and efficacy of other formulations have not been established.
3 to 8 months: 200 mg/m2/day PO for oral solution; safety and efficacy of other formulations have not been established.
1 to 2 months: 200 mg/m2/day PO for oral solution is FDA-approved maximum dosage; however, many limit dosage to 100 mg/m2/day in this age group to decrease toxicity; safety and efficacy of other formulations have not been established.
14 to 29 days: 200 mg/m2/day PO for pediatric powder for oral solution is FDA-approved maximum dosage; however, many limit dosage to 100 mg/m2/day in this age group to decrease toxicity; safety and efficacy of other formulations have not been established.
0 to 13 days: Safety and efficacy have not been established.
How supplied
Didanosine
capsule, extended release
- 125mg
- 200mg
- 250mg
- 400mg
powder for oral solution
- 2 g
- 4 g
