"The U.S. Food and Drug Administration today approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection.
Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. "...
NORVIR is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
DOSAGE AND ADMINISTRATION
NORVIR is administered orally. NORVIR tablets should be swallowed whole, and not chewed, broken or crushed. Take NORVIR with meals. Patients may improve the taste of NORVIR oral solution by mixing with chocolate milk, Ensure®, or Advera® within one hour of dosing.
General Dosing Guidelines
Patients who take the 600 mg twice daily soft gel capsule NORVIR dose may experience more gastrointestinal side effects such as nausea, vomiting, abdominal pain or diarrhea when switching from the soft gel capsule to the tablet formulation because of greater maximum plasma concentration (Cmax) achieved with the tablet formulation relative to the soft gel capsule [see CLINICAL PHARMACOLOGY]. Patients should also be aware that these adverse events (gastrointestinal or paresthesias) 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, and DRUG INTERACTIONS].
Recommended Dosage for Treatment of HIV-1:
The recommended dosage of ritonavir 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. 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.
Ritonavir should be used in combination with other antiretroviral agents [see DOSAGE AND ADMINISTRATION]. The recommended dosage of ritonavir in children greater than 1 month is 350 to 400 mg per m² twice daily by mouth to be taken with meals 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. When possible, dose should be administered using a calibrated dosing syringe.
NORVIR oral solution should not be administered to neonates before a postmenstrual age (first day of the mother's last menstrual period to birth plus the time elapsed after birth) of 44 weeks has been attained [see WARNINGS AND PRECAUTIONS].
NORVIR oral solution contains 43.2% (v/v) alcohol and 26.57% (w/v) propylene glycol. Special attention should be given to accurate calculation of the dose of NORVIR, transcription of the medication order, dispensing information and dosing instructions to minimize the risk for medication errors, and overdose. This is especially important for young children. Total amounts of alcohol and propylene glycol from all medicines that are to be given to pediatric patients 1 to 6 months of age should be taken into account in order to avoid toxicity from these excipients [see WARNINGS AND PRECAUTIONS and OVERDOSAGE].
Table 1: Pediatric Dosage Guidelines
|Body Surface Area
|Twice Daily Dose 250 mg per m²||Twice Daily Dose 300 mg per m²||Twice Daily Dose 350 mg per m²||Twice Daily Dose 400 mg per m²|
Body surface area (BSA) can be calculated as follows1:
BSA (m²) = √Ht (Cm) x Wt (kg) / 3600
Dosage Forms And Strengths
- NORVIR Tablets
White film-coated ovaloid tablets debossed with the “a” logo and the code NK providing 100 mg ritonavir.
- NORVIR Oral Solution
Orange-colored liquid containing 600 mg ritonavir per 7.5 mL marked dosage cup (80 mg per mL).
Storage And Handling
NORVIR (ritonavir) tablets and NORVIR (ritonavir) oral solution are available in the following strengths and package sizes:
NORVIR Tablets, 100 mg Ritonavir
NORVIR (ritonavir) tablets are white film-coated ovaloid tablets debossed with the “a” logo and the code NK.
Bottles of 30 tablets each (NDC 0074-3333-30).
Store at or below 30°C (86°F). Exposure to temperatures up to 50°C (122°F) for seven days permitted. Dispense in original container or USP equivalent tight container (60 mL or less). For patient use: exposure of this product to high humidity outside the original or USP equivalent tight container (60 mL or less) for longer than 2 weeks is not recommended.
NORVIR Oral Solution, 80 mg per mL Ritonavir
NORVIR (ritonavir) oral solution is an orange-colored liquid, supplied in amber-colored, multi-dose bottles containing 600 mg ritonavir per 7.5 mL marked dosage cup (80 mg per mL).
240 mL bottles (NDC 0074-1940-63).
Store NORVIR oral solution at room temperature 20°-25°C (68°-77°F). Do not refrigerate. Shake well before each use. Use by product expiration date.
Product should be stored and dispensed in the original container.
Avoid exposure to excessive heat. Keep cap tightly closed.
AbbVie Inc. North Chicago, IL 60064 USA. Revised: November 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/23/2015
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