Ritonavirdosage

Adult patients: 600 mg twice-day with meals Pediatrics patients: Do not exceed 600 mg twice daily dose with meals for children greater than one month of age. The dose is based on body surface area Use NORVIR oral powder only for dosing increments of 100 mg Follow the Instructions for Use for preparation and administration of NORVIR oral powder Dose modification for NORVIR is necessary when used with other protease inhibitors

2.1 General

Administration Recommendations NORVIR must be used in combination with other antiretroviral agents. Administer NORVIR orally. Swallow NORVIR tablets whole. Do not chew, break or crush NORVIR tablets. Take NORVIR with meals. Mix NORVIR oral powder with soft food such as apple sauce or vanilla pudding, or with liquid such as water, chocolate milk, or infant formula. When administered with food, the bitter aftertaste of NORVIR oral powder may be lessened. 2. 2 Dosage Recommendations in Adults Recommended Dosage for Treatment of HIV-1: The recommended dosage of NORVIR is 600 mg twice daily by mouth to be taken with meals. Use of a dose titration schedule may help to reduce treatment-emergent adverse events while maintaining appropriate ritonavir plasma levels. Start NORVIR at no less than 300 mg twice daily and increase at 2 to 3 day intervals by 100 mg twice daily. Do not exceed the maximum dose of 600 mg twice daily upon completion of the titration. 2. 3 Dosage Recommendations in Pediatric Patients NORVIR must be used in combination with other antiretroviral agents. The recommended dosage of NORVIR in pediatric patients older than 1 month is 350 to 400 mg per m 2 twice daily by mouth to be taken with meals. Do not exceed 600 mg twice daily. Start NORVIR at 250 mg per m 2 twice daily and increase at 2 to 3 day intervals by 50 mg per m 2 twice daily. If patients do not tolerate 400 mg per m 2 twice daily due to adverse events, use the highest tolerated dose for maintenance therapy in combination with other antiretroviral agents, or consider using alternative therapy. NORVIR powder should not be used for doses less than 100 mg or for incremental doses between 100 mg intervals. 2. 4 Preparation of NORVIR Oral Powder For details on the preparation and administration of NORVIR oral powder see Instructions for Use. NORVIR oral powder should only be used for dosing increments of 100 mg. Prepare the dose using the required number of packets. For example, use one packet for doses of 100 mg and two packets for doses of 200 mg. Pour and mix the entire contents of each packet over soft food or liquid. Administer all of the powder mixed with soft food or liquid within 2 hours of preparation. If not administered within 2 hours of preparation, discard the mixture and prepare a new dose. The prescribed dose of NORVIR oral powder can be administered via a feeding tube after being mixed with water (see Instructions for Use ). Follow the instructions for the feeding tube to administer the medicine. 2. 5 Dose Modification due to Drug Interaction Reduce dose of NORVIR when used with other protease inhibitors: atazanavir, darunavir, fosamprenavir, saquinavir, and tipranavir. Consult the full prescribing information and clinical study information of these protease inhibitors when they are co-administered with a reduced dose of ritonavir.