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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Pharmacokinetic Enhancers

Ritonavir

Last Updated: April 16, 2019; Last Reviewed: April 16, 2019

Ritonavir (RTV, Norvir)
Ritonavir (RTV, Norvir)
For additional information see Drugs@FDA: https://www.accessdata.fda.gov/scripts/cder/daf/
Formulations
Oral Powder: 100 mg per packet
Oral Solution: 80 mg/mL. Oral solution contains 43% (v/v) ethanol and approximately 27% (w/v) propylene glycol.
Tablets: 100 mg

Generic Formulation
Tablets: 100 mg

Fixed-Dose Combination Solution:
  • [Kaletra] Lopinavir 80 mg/ritonavir 20 mg/mL. Oral solution contains 42.4% (v/v) ethanol and 15.3% (w/v) propylene glycol.
Fixed-Dose Combination Tablets:
  • [Kaletra] Lopinavir 100 mg/ritonavir 25 mg
  • [Kaletra] Lopinavir 200 mg/ritonavir 50 mg
Dosing Recommendations Selected Adverse Events
Ritonavir as a Pharmacokinetic Enhancer:a
  • Ritonavir is used as a pharmacokinetic enhancer of other protease inhibitors (PIs). The recommended dose of ritonavir varies and is specific to the drug combination selected. See other sections of the Drug Appendix for information about the recommended doses of ritonavir to use with specific PIs.
Formulation Considerations:
  • The oral solution contains propylene glycol and ethanol.
  • The oral powder is preferred over the oral solution for children who cannot swallow the tablets and who need a dose of at least 100 mg, because the oral powder does not contain propylene glycol or ethanol.
  • Ritonavir oral powder should be used only for dosing increments of 100 mg and cannot be used for doses <100 mg.
[Kaletra] Lopinavir/Ritonavir
Infant, Child, Adolescent, and Adult Dose:
  • Gastrointestinal (GI) intolerance, nausea, vomiting, diarrhea
  • Hyperlipidemia, especially hypertriglyceridemia
  • Hepatitis
  • Hyperglycemia
  • Fat maldistribution
Special Instructions
  • Administer ritonavir with food to increase absorption and reduce the likelihood and severity of GI adverse events.
  • Do not administer ritonavir with cobicistat or drugs that contain cobicistat (e.g., Stribild, Genvoya, Prezcobix, Evotaz).
  • Do not refrigerate ritonavir oral solution; store at 68°F to 77°F (20°C to 25°C). Shake the solution well before use.
  • Ritonavir oral powder should be mixed with a soft food (e.g., apple sauce, vanilla pudding) or a liquid (e.g., water, chocolate milk, infant formula) to help mitigate the bitter taste. Administer or discard the mixture within 2 hours of mixing.
To Increase Tolerability of Ritonavir Oral Solution in Children:
  • Mix the solution with milk, chocolate milk, ice cream, or vanilla or chocolate pudding.
  • Before administering ritonavir, give a child ice chips, a Popsicle, or spoonfuls of partially frozen orange or grape juice concentrate to dull the taste buds. Another option is to give a child peanut butter to coat the mouth.
  • After administration, give strong-tasting foods (e.g., maple syrup, cheese).
  • Check a child’s food allergy history before making these recommendations.
  • Counsel parents or patients that the bad taste will not be completely masked.
Metabolism/Elimination
  • Cytochrome P450 (CYP) 3A and CYP2D6 inhibitor; CYP1A2, CYP2B6, CYP2C9, CYP2C19, and glucuronidation inducer. Ritonavir inhibits the intestinal transporter P glycoprotein.
Ritonavir Dosing in Patients with Hepatic Impairment:
  • Ritonavir is primarily metabolized by the liver. No dose adjustment is necessary in patients with mild or moderate hepatic impairment. There are no data on ritonavir dosing for adult or pediatric patients with severe hepatic impairment. Use caution when administering ritonavir to patients with moderate-to-severe hepatic impairment.
a Ritonavir has antiviral activity, but it is not used as an antiviral agent (see text).

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