General Administration Recommendations

• NORVIR must be used in combination with other antiretroviral agents.
• NORVIR is administered orally in combination with other antiretroviral agents. It is recommended that NORVIR be taken with meals.

General Dosing Guidelines

Patients should be aware that frequently observed adverse events, such as mild to moderate gastrointestinal disturbances and paraesthesias, may diminish as therapy is continued.

Dosage Recommendations in Adults

Recommended Dosage for treatment of HIV-1

The recommended dosage of NORVIR is 600 mg twice daily by mouth. Use of a dose titration schedule may help to reduce treatment-emergent adverse events while maintaining appropriate ritonavir plasma levels. NORVIR should be started at no less than 300 mg twice daily and increased at 2 to 3 day intervals by 100 mg twice daily. The maximum dose of 600 mg twice daily should not be exceeded upon completion of the titration.

Dosage Recommendations in Pediatric Patients

NORVIR must be used in combination with other antiretroviral agents [see Dosage and Administration (2)]. The recommended dosage of NORVIR in pediatric patients older than 1 month is 350 to 400 mg per m2 twice daily by mouth and should not exceed 600 mg twice daily. NORVIR should be started at 250 mg per m2 twice daily and increased at 2 to 3 day intervals by 50 mg per m2 twice daily. If patients do not tolerate 400 mg per m2 twice daily due to adverse events, the highest tolerated dose may be used for maintenance therapy in combination with other antiretroviral agents, however, alternative therapy should be considered. The use of NORVIR oral solution is recommended for children greater than 1 month who cannot swallow capsules. Please refer to the NORVIR oral solution full prescribing information for pediatric dosage and administration.