RITONAVIR — ritonavir tablet
Camber Pharmaceuticals, Inc.
WARNING: DRUG-DRUG INTERACTIONS LEADING TO POTENTIALLY SERIOUS AND/OR LIFE THREATENING REACTIONS
Co-administration of ritonavir with several classes of drugs including sedative hypnotics, antiarrhythmics, or ergot alkaloid preparations may result in potentially serious and/or life-threatening adverse events due to possible effects of ritonavir on the hepatic metabolism of certain drugs. Review medications taken by patients prior to prescribing ritonavir or when prescribing other medications to patients already taking ritonavir [see Contraindications ( 4), Warnings and Precautions ( 5.1)].
1 INDICATIONS AND USAGE
Ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
2 DOSAGE AND ADMINISTRATION
2.1 General Administration Recommendations
• Ritonavir must be used in combination with other antiretroviral agents.
• Ritonavir is administered orally. Ritonavir tablets should be swallowed whole, and not chewed, broken or crushed. Take ritonavir with meals.
General Dosing Guidelines Patients who take the 600 mg twice daily soft gel capsule ritonavir 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 (C max ) achieved with the tablet formulation relative to the soft gel capsule [see Clinical Pharmacology ( 12.3)]. Patients should also be aware that these adverse events (gastrointestinal or paresthesias) may diminish as therapy is continued.
2.3 Dosage Recommendations in Adults
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 [see Dosage and Administration ( 2.6)].
Ritonavir oral solution is not recommended during pregnancy due to its alcohol content. Ritonavir oral solution contains the excipients alcohol and propylene glycol [see Use in Specific Populations ( 8.1)].
2.4 Dosage Recommendations in Pediatric Patients
Ritonavir must be used in combination with other antiretroviral agents
[see Dosage and Administration (
The recommended dosage of ritonavir in pediatric patients older than 1 month is 350 to 400 mg per m
2 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 m
2 twice daily and increased 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, the highest tolerated dose may be used for maintenance therapy in combination with other antiretroviral agents, however, alternative therapy should be considered
[see Dosage and Administration (
Pediatric Dosage Guidelines for Oral Solution
Ritonavir 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 ( 5.2)].
Ritonavir oral solution contains the excipients alcohol and propylene glycol. Special attention should be given to accurate calculation of the dose of ritonavir, 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 ( 5.2) and Overdosage ( 10)]. When possible, dose should be administered using a calibrated dosing syringe. Table 1. Pediatric Dosage Guidelines for Oral Solution*
|Body Surface Area (m 2)||Twice Daily Dose 250 mg per m 2||Twice Daily Dose 300 mg per m 2||Twice Daily Dose 350 mg per m 2||Twice Daily Dose 400 mg per m 2|
|0.20||0.6 mL (50 mg)||0.75 mL (60 mg)||0.9 mL (70 mg)||1 mL (80 mg)|
|0.25||0.8 mL (62.5 mg)||0.9 mL (75 mg)||1.1 mL (87.5 mg)||1.25 mL (100 mg)|
|0.50||1.6 mL (125 mg)||1.9 mL (150 mg)||2.2 mL (175 mg)||2.5 mL (200 mg)|
|0.75||2.3 mL (187.5 mg)||2.8 mL (225 mg)||3.3 mL (262.5 mg)||3.75 mL (300 mg)|
|1||3.1 mL (250 mg)||3.75 mL (300 mg)||4.4 mL (350 mg)||5 mL (400 mg)|
|1.25||3.9 mL (312.5 mg)||4.7 mL (375 mg)||5.5 mL (437.5 mg)||6.25 mL (500 mg)|
|1.50||4.7 mL (375 mg)||5.6 mL (450 mg)||6.6 mL (525 mg)||7.5 mL (600 mg)|
|*The concentration of the oral solution is 80 mg per mL.|
Body surface area (BSA) can be calculated as follows 1:
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