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Generic Crixivan Indinavir 400mg

Nephrolithiasis/urolithiasis has occurred with Crixivan therapy. The cumulative frequency of nephrolithiasis is substantially higher in pediatric patients (29%) than in adult patients (12.4%; range across individual trials: 4.7% to 34.4%). Do not take this medicine with any of the following:alprazolam , astemizole , atazanavir , amiodarone , cisapride , conivaptan , dofetilide , medicines for headaches like dihydroergotamine, ergonovine, ergotamine, methylergonovine , medicines for high cholesterol like cerivastatin, lovastatin, simvastatin , midazolam , pimozide , ranolazine , rifampin , rifapentine , red yeast rice , St. John's wort , triazolam .This Reports of tubulointerstitial nephritis with medullary calcification and cortical atrophy have been observed in patients with asymptomatic severe leukocyturia (greater than 100 cells/ high power field).

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Crixivan Precautions

Carcinogenicity studies were conducted in mice and rats. In mice, no increased incidence of any tumor type was observed. The highest dose tested in rats was 640 mg/kg/day; at this dose a statistically significant increased incidence of thyroid adenomas was seen only in male rats. Hyperbilirubinemia and nephrolithiasis/urolithiasis occurred more frequently at doses exceeding 2.4 g/day compared to doses less than 2.4 g/day. Nervous System/Psychiatric: oral paresthesia; depression. Skin and Skin Appendage: rash including erythema multiforme and Stevens-Johnson syndrome; hyperpigmentation; alopecia; ingrown toenails and/or paronychia; pruritus.

Clinical Trials In Adults

Indinavir is an inhibitor of the cytochrome P450 isoform CYP3A4. At that dose, daily systemic exposure in rats was approximately 1.3 times higher than daily systemic exposure in humans. No evidence of mutagenicity or genotoxicity was observed in in vitro microbial mutagenesis (Ames) tests, in vitro alkaline elution assays for DNA breakage, in vitro and in vivo chromosomal aberration studies, and in vitro mammalian cell mutagenesis assays. No treatment-related effects on mating, fertility, or embryo survival were seen in female rats and no treatment-related effects on mating performance were seen in male rats at doses providing systemic exposure comparable to or slightly higher than that with the clinical dose.

Crixivan Overdosage Reports

There have been more than 60 reports of acute or chronic human overdosage (up to 23 times the recommended total daily dose of 2400 mg) with Crixivan. Asymptomatic hyperbilirubinemia (total bilirubin greater than 2.5 mg/dL), reported predominantly as elevated indirect bilirubin, has occurred in approximately 14% of patients treated with Crixivan.