Generic Crixivan

INDINAVIR SULFATE
Capsules: 200 and 400 mg (Rx) Crixivan (Merck)
Warning:
Indinavir is indicated for the treatment of HIV infection in adults when antiretroviral therapy is warranted. This indication is based on analyses of surrogate end-points in studies of up to 24 weeks in duration. At present, there are no results from controlled clinical trials evaluating the effect of therapy with indinavir on clinical progression of HIV infection, such as survival or the incidence of opportunistic infections.

Indications
HIV infection: Treatment of HIV infection in adults when antiretroviral therapy is warranted.

Administration and Dosage
The recommended dosage is 800 mg (two 400 mg capsules) orally every 8 hours. The dosage is the same whether indinavir is used alone or in combination with other antiretroviral agents. The antiretroviral activity of indinavir may be increased when used in combination with approved reverse transcriptase inhibitors.
Administer at intervals of 8 hours. For optimal absorption, administer without food but with water 1 hour before or 2 hours after a meal or administer with other liquids such as skim milk, juice, coffee, or tea, or with a light meal (e.g., dry toast with jelly, juice, and coffee with skim milk and sugar; or corn flakes, skim milk, and sugar).
If indinavir and didanosine are administered concomitantly, they should be administered at least 1 hour apart on an empty stomach.
In addition to adequate hydration, medical management in patients who experience nephrolithiasis may include temporary interruption of therapy (e.g., 1 to 3 days) during the acute episode of nephrolithiasis or therapy discontinuation.
Cirrhosis: Reduce the dosage of indinavir to 600 mg every 8 hours in patients with mild to moderate hepatic insufficiency caused by cirrhosis.

Actions
Pharmacology: Indinavir is an inhibitor of the HIV protease. HIV protease is an enzyme required for the proteolytic cleavage of the viral polyprotein precursors into the individual functional proteins found in infectious HIV. Indinavir binds to the protease active site and inhibits the activity of the enzyme. This inhibition prevents cleavage of the viral polyproteins resulting in the formation of immature noninfectious viral particles. The relationship between in vitro susceptibility of HIV to indinavir and inhibition of HIV replication in humans has not been established.
Drug resistance - Isolates of HIV with reduced susceptibility to the drug have been recovered from some patients treated with indinavir.
Cross-resistance between indinavir and HIV reverse transcriptase inhibitors is unlikely because the enzyme targets involved are different. Cross-resistance was noted between indinavir and the protease inhibitor ritonavir. Varying degrees of cross-resistance have been observed between indinavir and other HIV-protease inhibitors.
Pharmacokinetics:
Absorption - Indinavir was rapidly absorbed in the tasted state with a time to peak plasma concentration (Tmax) of 0.8 hours. A greater than dose-proportional increase in indinavir plasma concentrations was observed over the 200 to 1000 mg dose range. At a dosing regimen of 800 mg every 8 hours, steady-state AUC was 30,691 nM-hour, Cmax was 12,617 nM, and plasma concentration 8 hours post-dose (trough) was 251 nM.
Distribution - Indinavir was about 60% bound to human plasma proteins over a concentration range of 81 to 16,300 nM.
Metabolism - Following à 400 mg dose of 14C-indinavir, 83% and 19% of the total radioactivity was recovered in feces and urine, respectively; radioactivity caused by parent drug in feces and urine was 19.1% and 9.4%, respectively. Seven metabolites have been identified, 1 glucuronide conjugate and 6 oxidative metabolites. In vitro studies indicate that cytochrome P450 3A4 (CYP3A4) is the major enzyme responsible for formation of the oxidative metabolites.
Excretion - Indinavir is excreted (

Contraindications
Hypersensitivity to any component of the product.

Warnings
Concomitant agents: Do not administer indinavir concurrently with terfenadine, astemizole, cisapride, triazolam, and midazolam because competition for CYP3A4 by indinavir could result in inhibition of the metabolism of these drugs and create the potential for serious or life-threatening events.
Renal function impairment: Nephrolithiasis, including flank pain with or without hematuria (including microscopic hematuria), has been reported in about 4% of patients. In general, these events were not associated with renal dysfunction and resolved with hydration and temporary interruption of therapy (e.g., 1 to 3 days). Following the acute episode, 9.2% of patients discontinued therapy.
To ensure adequate hydration, it is recommended that the patient drink at least 1.5 liters (~ 48 ounces) of liquids during the course of 24 hours.
Hepatic function impairment: Patients with mild to moderate hepatic insufficiency and clinical evidence of cirrhosis had evidence of decreased metabolism of indinavir resulting in about 60% higher mean AUC following a single 400 mg dose. The half-life increased to 2.8 hours.
Pregnancy: Category C.
Lactation: Although it is not known whether indinavir is excreted in breast milk, there exists the potential for adverse effects from indinavir in nursing infants. Instruct mothers to discontinue nursing if they are receiving indinavir. This is consistent with the recommendation by the CDC that HIV-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV.
Children: Safety and efficacy have not been established.

Precautions
Hyperbilirubinemia: Asymptomatic hyperbilirubinemia (total bilirubin > 2.5 mg/dL), reported predominantly as elevated indirect bilirubin, has occurred in about 10% of patients. In

Drug Interactions
Drugs that may affect indinavir include clarithromycin, didanosine, fluconazole, ketoconazole, quinidine, rifampin, rifabutin, and zidovudine.
Drugs that may be affected by indinavir include astemizole, cisapride, midazolam, terfenadine, triazolam, clarithromycin, isoniazid, lamivudine, oral contraceptives, rifabutin, stavudine, TMP-SMZ, and zidovudine.
Drug/Food interactions: Administration of indinavir with a meal high in calories, fat, and protein (784 kcal, 48.6 g fat, 31.3 g protein) resulted in a 77% reduction in AUC and an 84% reduction in Cmax. Administration with lighter meals resulted in little or no change in AUC, Cmax, or trough concentration. A single 400 mg dose of indinavir with 8 oz of grapefruit juice resulted in a decrease in indinavir AUC (26%).

Adverse Reactions
Adverse reactions occurring in > 3% of patients include abdominal pain; asthenia/ fatigue; nausea; diarrhea; vomiting; headache; insomnia.
HIV

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