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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Archived Drugs

Indinavir

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

Indinavir (IDV, Crixivan)
Indinavir (IDV, Crixivan)
For additional information see Drugs@FDA: https://www.accessdata.fda.gov/scripts/cder/daf/
Formulations
Capsules: 100 mg, 200 mg, and 400 mg
Dosing Recommendations Selected Adverse Events
Neonate and Infant Dose:
  • Not approved for use in neonates/infants
  • Should not be administered to neonates because of the risks associated with hyperbilirubinemia (kernicterus)
Pediatric Dose:
  • Not approved for use in children
  • A range of indinavir doses (234–500 mg/m2 body surface area) boosted with low-dose ritonavir has been studied in children (see text below).
Adolescent and Adult Dose:
  • 800 mg indinavir plus 100 or 200 mg ritonavir every 12 hours
  • The Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV does not recommend the use of indinavir in adolescents.
  • Nephrolithiasis
  • Gastrointestinal intolerance, nausea
  • Hepatitis
  • Indirect hyperbilirubinemia
  • Hyperlipidemia
  • Hyperglycemia
  • Fat maldistribution
  • Possible increased bleeding episodes in patients with hemophilia
Special Instructions
  • When indinavir is given in combination with ritonavir, meal restrictions are not necessary.
  • Adequate hydration is required to minimize risk of nephrolithiasis (≥48 oz of fluid daily in adult patients).
  • Indinavir capsules are sensitive to moisture; store at room temperature (59–86ºF) in original container with desiccant.
Metabolism/Elimination
  • Cytochrome P450 3A4 (CYP3A4) inhibitor and substrate
Indinavir Dosing in Patients with Hepatic Impairment:
  • Dose should be decreased in patients with mild-to-moderate hepatic impairment (recommended dose for adults is 600 mg indinavir every 8 hours). No dosing information is available for children with any degree of hepatic impairment or for adults with severe hepatic impairment.

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