Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection

The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.

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Nucleoside and Nucleotide Analogue Reverse Transcriptase Inhibitors (NRTIs)

Didanosine

Last Updated: May 22, 2018; Last Reviewed: May 22, 2018

Didanosine (ddI, Videx)
Didanosine (ddI, Videx)
For additional information see Drugs@FDA: http://www.accessdata.fda.gov/scripts/cder/daf/
Formulations
Pediatric Oral Solution:10 mg/mL
Enteric-Coated (EC) Delayed-Release Capsules (EC Beadlets): 125 mg, 200 mg, 250 mg, and 400 mg

Generic Formulations
Delayed-Release Capsules: 125 mg, 200 mg, 250 mg, and 400 mg
Dosing Recommendations Selected Adverse Events

Note: Didanosine is no longer recommended by the Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV for use in children due to higher rates of adverse effects than other NRTIs.

Neonatal/Infant Dose (Aged 2 Weeks to <3 Months):

  • 50 mg/m2 of body surface area every 12 hours. See dosing section below for justification of this dose.
Infant Dose (Aged ≥3 Months to 8 Months):
  • 100 mg/m2 body surface area every 12 hours
Pediatric Dose of Oral Solution (Aged >8 Months):
  • 120 mg/m2 body surface area every 12 hours
  • Dose range: 90–150 mg/m2 of body surface area every 12 hours. Do not exceed maximum adult dose; see table below. 
  • In treatment-naive children aged 3 years to 21 years, 240 mg/m2 of body surface area once daily (oral solution or capsules) has resulted in viral suppression.
     
Pediatric Dose of Videx EC or Generic Capsules (Aged 6–18 Years and Weighing ≥20 kg)
Body Weight Dose 
20 kg to <25 kg 200 mg once daily
25 kg to <60 kg 250 mg once daily
≥60 kg 400 mg once daily

Adolescent and Adult Dose
Body Weight Dose
<60 kg 250 mg once daily
≥60 kg 400 mg once daily


Pediatric and Adolescent Dose of Didanosine when Combined with Tenofovir Disoproxil Fumarate:
  • This combination should be avoided because of enhanced didanosine toxicity, reports of immunologic nonresponse, high rates of early virologic failure, and rapid selection of resistance mutations (see the Adult and Adolescent Guidelines)
  • Peripheral neuropathy
  • Diarrhea, abdominal pain, nausea, and vomiting
  • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported (the risk is increased when didanosine is used in combination with stavudine).
  • Pancreatitis (less common in children than in adults, more common when didanosine is used in combination with tenofovir disoproxil fumarate or stavudine)
  • Non-cirrhotic portal hypertension
  • Retinal changes, optic neuritis
  • Insulin resistance/diabetes mellitus
Special Instructions
  • Administer didanosine on an empty stomach (30 minutes before or 2 hours after a meal). To improve adherence, some practitioners administer didanosine without regard to timing of meals (see text below).
  • Didanosine powder for oral solution contains antacids that may interfere with the absorption of other medications, including protease inhibitors (PIs). See individual PI for instructions on timing of administration. 
  • Shake didanosine oral solution well before use. Keep refrigerated; solution is stable for 30 days.
Metabolism/Elimination
  • Renal excretion 50%
  • Decrease dosage in patients with impaired renal function. Consult manufacturer’s prescribing information for adjustment of dosage in accordance with creatinine clearance.

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