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Call your doctor or other health care provider if you develop kidney pains middle to lower stomach or back pain or blood in the urine. Some patients treated with CRIXIVAN have had rapid breakdown of red blood cells hemolytic anemia which in some cases was severe or resulted in death. Some patients treated with CRIXIVAN have had liver problems including liver failure and death.
Some patients had other illnesses or were taking other drugs. It is uncertain if CRIXIVAN caused these liver problems. Diabetes and high blood sugar hyperglycemia have occurred in patients taking protease inhibitors. In some of these patients, this led to ketoacidosis, a serious condition caused by poorly controlled blood sugar.
Some patients had diabetes before starting protease inhibitors, others did not. Some patients required adjustments to their diabetes medication.
Read full chapter Chapter:29 Antiviral drugs Christoph Fux, John Evison, Matthias Schlegel, Christine Thurnheer, Hansjakob Furrer, in Side Effects of Drugs Annual, 2007.
Tissue plasminogen activator and plasminogen activator inhibitor antigen are both markedly increased in patients with impaired glucose tolerance. Both markers have been linked to impaired thrombolysis, which is associated with an increased cardiovascular risk. Amprenavir had no significant effect on glucose concentrations or insulin sensitivity but increased total cholesterol, triglycerides, and free fatty acids.
Susceptibility factors Sex Variability in the systemic availability of indinavir has been studied in 239 patients 52c. Concomitant use of ritonavir and female sex both predicted increased availability. They also encouraged drug concentration monitoring. However, close attention has to be paid to adverse effects for example nephrolithiasis when exposing patients to regimens with higher dosages than have previously been recommended.
The bioavailability of indinavir is decreased by the presence of food in the gastrointestinal tract. TerfenadineIndinavir inhibition of CYP3A4 can cause elevated plasma levels of terfenadine, resulting in potentially life-threatening reactions. CisaprideIndinavir inhibition of CYP3A4 can cause elevated plasma levels of cisapride, resulting in potentially life-threatening reactions. AstemizoleIndinavir inhibition of CYP3A4 can cause elevated plasma levels of astemizole, resulting in potentially life-threatening reactions.
TriazolamIndinavir inhibition of CYP3A4 can cause elevated plasma levels of triazolam, resulting in potentially life-threatening reactions.
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Indinavir inhibits the HIV viral protease enzyme which prevents cleavage of the gag-pol polyprotein, resulting in noninfectious, immature viral particles. Maintenance, support, and commercial licensing is provided by OMx Personal Health Analytics, Inc.
TargetKindPharmacological actionActionsOrganismUniProt IDPol polyproteinQ72874 Hepatic. SubstrateEnzymesProductIndinavir Cytochrome P450 3A4DrugInteractionDrug group16-BromoepiandrosteroneThe serum concentration of 16-Bromoepiandrosterone can be increased when it is combined with Indinavir.
The serum concentration of 19-norandrostenedione can be increased when it is combined with Indinavir. The therapeutic efficacy of Acetohexamide can be decreased when used in combination with Indinavir.
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Grapefruit juice: Concurrent grapefruit juice may decrease indinavir levels by 26 percent. Individuals should not drastically alter their intake of grapefruit juice or should avoid concurrent use unless advised differently by their healthcare professional. Guanfacine: Indinavir may significantly increase guanfacine plasma concentrations. FDA-approved labeling for extended-release ER guanfacine recommends that, if these agents are taken together, the guanfacine dosage should be decreased to half of the recommended dose.
Specific recommendations for immediate-release IR guanfacine are not available. Monitor patients closely for alpha-adrenergic effects including hypotension, drowsiness, lethargy, and bradycardia. If indinavir is discontinued, the guanfacine ER dosage should be increased back to the recommended dose. Guanfacine is primarily metabolized by CYP3A4, and indinavir is a strong CYP3A4 inhibitor.
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Usually you will have blood tests done in the first month to look for the beneficial effects of atazanavir and any side effects. Many minor side effects will either stay constant or get better with time. It is mainly the side effects that are severe or get worse that may cause significant health risks for you. Far and away the most common side effect of indinavir is elevated blood bilirubin levels.
Bilirubin is a pigment that the liver secretes to help it digest food. When bilirubin is elevated in the blood due to atazanavir, it can be seen early on and in milder forms only in blood tests.
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But despite this tragedy and numerous other difficulties along the way, it took just four years from first synthesis to the approved drug reaching the market, something of a miracle in this often slow-moving industry.
Methadone: Administration of indinavir 800 mg every 8 hours with methadone 20 mg to 60 mg daily for one week in subjects on methadone maintenance resulted in no change in methadone AUC.
It is unknown whether CRIXIVAN administered to the mother in the perinatal period will exacerbate physiologic hyperbilirubinemia in neonates.
Isavuconazole serum concentrations were increased 5-fold when coadministered with ketoconazole, another strong CYP3A4 inhibitor.
In addition, plasma concentrations of indinavir also a CYP3A substrate may be increased when given with grazoprevir a weak CYP3A inhibitor.
Eletriptan: Eletriptan is contraindicated for use within 72 hours of using any drug that is a potent CYP3A4 inhibitor as described in the prescribing information of the interacting drug including protease inhibitors. Eletriptan is metabolized via CYP3A4, and coadministration with protease inhibitors may cause increased eletriptan concentrations and thus toxicity.
Eliglustat: Coadministration of indinavir and eliglustat is contraindicated in intermediate or poor CYP2D6 metabolizers IMs or PMs.
Where can I get more information?
Protease inhibitor: atazanavir Both CRIXIVAN and atazanavir are associated with indirect unconjugated hyperbilirubinemia.
Patients on antidiabetic therapy, such as linagliptin, should be closely monitored for changes in glycemic control, specifically hyperglycemia, if protease inhibitor therapy is initiated.