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Norvir (Ritonavir) - Indications and Dosage

 
 



INDICATIONS AND USAGE

NORVIR is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

DOSAGE AND ADMINISTRATION

NORVIR is administered orally in combination with other antiretroviral agents. It is recommended that NORVIR be taken with meals if possible.

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.

Dose modification for NORVIR

Dose reduction of NORVIR is necessary when used with other protease inhibitors: atazanavir, darunavir, fosamprenavir, saquinavir, and tipranavir.

Prescribers should consult the full prescribing information and clinical study information of these protease inhibitors if they are co-administered with a reduced dose of ritonavir [see Warnings and Precautions (5) , and Drug Interactions (7) ].

Adult Patients

Recommended Dosage for treatment of HIV-1

The recommended dosage of ritonavir 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. Ritonavir 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.

Pediatric Patients

The recommended dosage of ritonavir in children greater than 1 month is 350 to 400 mg per m2 twice daily by mouth and should not exceed 600 mg twice daily. Ritonavir 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.

DOSAGE FORMS AND STRENGTHS

  • NORVIR (ritonavir) capsules, soft gelatin

White soft gelatin capsules imprinted with the “a” logo, 100 and the code DS, providing 100 mg of ritonavir.

HOW SUPPLIED/STORAGE AND HANDLING

NORVIR (ritonavir) soft gelatin capsules are white capsules imprinted with the “a” logo, 100 and the code DS, available in the following package size:

Bottles of 120 capsules each (NDC 0074-6633-22).

Bottles of 30 capsules each (NDC 0074-6633-30).

Recommended Storage

Store NORVIR soft gelatin capsules in the refrigerator between 2°-8°C (36°-46°F) until dispensed. Refrigeration of NORVIR soft gelatin capsules by the patient is recommended, but not required if used within 30 days and stored below 25°C (77°F). Protect from light. Avoid exposure to excessive heat.

Product should be stored and dispensed in the original container.

Keep cap tightly closed.

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