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 14, 2020; Last Reviewed: April 14, 2020

Ritonavir (RTV, Norvir)
Ritonavir (RTV, Norvir)
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 Formulations:

  • 100 mg tablet
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
When using fixed-dose combination (FDC) tablets, refer to other sections of the Drug Appendix for information about the individual components of the FDC. See also Appendix A, Table 2. Antiretroviral Fixed-Dose Combination Tablets: Minimum Body Weights and Considerations for Use in Children and Adolescents

For additional information, see Drugs@FDA or DailyMed.
Dosing Recommendations Selected Adverse Events
Ritonavir as a Pharmacokinetic Enhancer:
  • Ritonavir (RTV) is used as a pharmacokinetic enhancer of other protease inhibitors (PIs). The recommended dose of RTV varies and is specific to the drug combination selected. See other sections of the Drug Appendix for information about the recommended doses of RTV to use with specific PIs. RTV has antiviral activity, but it is not used as an antiviral agent; instead, it is used as a pharmacokinetic enhancer of other PIs.
Formulation Considerations:
  • The RTV 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 RTV 100 mg, because the oral powder does not contain propylene glycol or ethanol.
  • RTV 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 RTV with food to increase absorption and reduce the likelihood and severity of GI adverse events.
  • Do not administer RTV with cobicistat (COBI) or drugs that contain COBI (e.g., Stribild, Genvoya, Prezcobix, Evotaz).
  • Do not refrigerate RTV oral solution; store at 68°F to 77°F (20°C to 25°C). Shake the solution well before use.
  • RTV 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 or Oral Powder in Children:
  • Mix the solution or powder with milk, chocolate milk, ice cream, or vanilla or chocolate pudding.
  • Before administering RTV, 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 nonallergic child peanut butter or hazelnut chocolate spread to coat the mouth.1
  • After administration, give foods with strong tastes (e.g., maple syrup, cheese).
  • Check a child’s food allergy history before making these recommendations.
  • Counsel caregivers 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. RTV inhibits the intestinal transporter P-glycoprotein.
Ritonavir Dosing in Patients with Hepatic Impairment:
  • RTV is primarily metabolized by the liver.
  • No dose adjustment is necessary in patients with mild or moderate hepatic impairment.
  • There are no data on RTV dosing for adult or pediatric patients with severe hepatic impairment. Use caution when administering RTV to patients with moderate-to-severe hepatic impairment.

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