Generic Norvir

RITONAVIR
Tablets: 100 mg (Rx) Norvir (Abbott)
Oral solution: 80 mg/mL (Rx)

Warning:
Co-administration of ritonavir with certain non-sedating antihistamines, sedative hypnotics, or antiarrhythmics may result in potentially serious or life-threatening adverse events because of possible effects of ritonavir on the hepatic metabolism of certain drugs.

Indications
HIV infection: Combination with nucleoside analogs or as monotherapy for the treatment of HIV infection when therapy is warranted.

Administration and Dosage
The recommended dosage is 600 mg twice daily. If possible, take with food. Some Patients experience nausea upon initiation of 600 mg twice daily dosing; dose escalation may provide some relief: 300 mg twice daily for 1 day, 400 mg twice daily for 2 days, 500 mg twice daily for 1 day and then 600 mg twice daily thereafter. In addition, patients initiating combination regimens with ritonavir and nucleosides may improve GI tolerance by initiating ritonavir alone and subsequently adding nucleosides before completing 2 weeks of ritonavir monotherapy.

Actions
Pharmacology: Ritonavir is an inhibitor of HIV protease with activity against HIV. Ritonavir is a petidomimetic inhibitor of the HIV-1 and HIV-2 ptoteases. Inhibition of HIV protease renders the enzyme incapable of processing the gag-pol poly-protein precursor which leads to production of noninfectious immature HIV particles. Cross-resistance between ritonavir and reverse transcriptase inhibitors is unlikely because of the different enzyme targets involved.
Pharmacokinetics: After a 600 mg dose of oral solution, peak concentrations of ritonavir were achieved about 2 and 4 hours after dosing under fasting and non-fasting conditions, respectively. When the oral solution was given under non-fasting conditions, peak ritonavir concentrations decreased 23% and the extent of absorption deceased 7% relative to fasting conditions. Dilution of the oral solution, within 1 hour of administration, with 240 mL of chocolate milk, Advera or Ensure did not significantly affect the extent and rate of ritonavir absorption. After a single 600 mg dose under non-fasting conditions, in 2 separate studies, the capsule and oral solution formulations yielded mean areas under the plasma concentration-time curve (AUCs) of 129.5 and 129 mcg-hr/mL, respectively. Relative to fasting conditions, the extent of absorption of ritonavir from the capsule formulation was 15% higher when administered with a meal.
Nearly all of the plasma radioactivity after a single oral 600 mg dose of 14C-ritonavitr oral solution was attributed to unchanged ritonavir. Five ritonavir metabolites have been identified in urine and feces. The isopropylthiazole oxidation metabolite (M-2) is the major metabolite and has antiviral activity similar to that of the patent drug; however, the concentrations of this metabolite in plasma are low. Studies utilizing human liver microsomes demonstrate that cytochrome P450 ÇÀ (CYP3A) is a major isoform involved in ritonavir metabolism, although CYP2D6 also contributes to the formation of M-2.

Contraindications
Hypersensitivity to the drug or any of its ingredients.
Ritonavir is expected to produce large increases in the plasma concentrations of amiodarone, astemizole, bepridil, bupropion, cisapride, clozapine, encainide, flecainide, meperidine, piroxicam, propafenone, propoxyphene, quinidine, rifabutin, and terfenadine. These agents have recognized risks of arrhythmias, hematologic abnormalities, seizures, or other potentially serious adverse effects. Do not administer these drugs concomitantly with ritonavir.
Co-administration is likely to produce large increases in the following highly metabolized sedatives and hypnotics: Alprazolam, clorazepate, diazepam, estazolam, flurazepam, midazolam, triazolam, and Zolpidem. Because of the potential for extreme sedation and respiratory depression from these agents, do not administer with ritonavir.

Warnings
Hepatic function impairment: Ritonavir is principally metabolized by the liver. Exercise caution when administering this drug to patients with impaired hepatic function. Pregnancy: Category B.
Lactation: It is not known whether this drug is excreted in breast milk. The CDC advises HIV-infected women not to breastfeed to avoid postnatal transmission of HIV to a child who may not be infected.
Children: Safety and efficacy in children

Precautions
Lab test abnormalities: Ritonavir has been associated with alterations in triglycerides, AST, ALT, GGT, CPK, and uric acid. Perform appropriate laboratory testing prior to initiating ritonavir therapy and at periodic intervals or if any clinical signs and symptoms occur during therapy.

Drug Interactions
Drags that may affect ritonavir include clarithromycin, didanosine, fluconazole, fluoxetine, and rifampin.
Drugs that may be affected by ritonavir include clarithromycin, didanosine, desipramine, disulfiram, metronidazole, ethinyl estradiol, narcotic analgesics, rifabutin, saquinavir, sulfamethoxazole, theophylline, trimethoprim, and zidovudine.
Drug/Food interactions: When the oral solution was given under non-fasting conditions, peak ritonavir concentrations decreased 23% and extent of absorption decreased 7% relative to fasting conditions. Extent of absorption or ritonavir from the capsule was 15% higher when given with a meal relative to fasting conditions. If possible, take ritonavir with meals.

Adverse Reactions
The most frequent clinical adverse events, other than asthenia, among patients receiving ritonavir were GI and neurological disturbances including nausea, diarrhea, vomiting, anorexia, abdominal pain, taste perversion, and circumoral and peripheral paresthesias.
HIV

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