Indinavir

Indinavir is an antiviral or antiretroviral medicine. It is used in the treatment of HIV infection. It stops the virus from producing new viruses and clears up your infection. Indinavir should be taken with food, as this increases the absorption of the medicine into the body. You should take it in the dose and duration as advised by your doctor. Taking it at the same time every day will help you to remember to take it. Do not stop taking it until you have finished the complete course, even when you feel better. If you stop taking this medicine too early then infection may return or worsen. Some people may experience headache, dizziness, nausea, vomiting, and diarrhea as side effects of this medicine. Please consult your doctor if these side effects persist for a longer duration. Inform your doctor if you have diabetes as it can increase sugar levels in the blood. Before using it, you should tell your doctor if you are allergic to any antibiotics or have any kidney or liver problems. Inform your doctor before taking this drug if you are an elderly patient, of, or above 65 years of age, if you have a history of liver disease including hepatitis B or C or have hemophilia or if you are allergic to sulfa drugs. Indinavir is an anti-HIV medication. It works by interfering with an enzyme (protease), which is required by HIV-infected cells to make new viruses. This stops the production of new viruses.

• HIV infection

Indinavir binds reversibly to HIV-protease which prevents cleavage of the viral precursor polyproteins. As a result, immature viral particles incapable of infecting other cells are formed.

Adult Dose: Oral HIV infection Adult: 800 mg PO q8hr With ritonavir: 800 mg PO q12hr plus ritonavir 100-200 mg q12hr Dosage Modifications Concomitant CYP3A4 inhibitor: 600 mg PO q8hr Concomitant administration with itraconazole, delavirdine, ketoconazole: 600 mg PO q8hr Concomitant administration with efavirenz: 1000 mg PO q8hr Concomitant administration with lopinavir and ritonavir: 600 mg PO q12hr Concomitant administration with nelfinavir: 1200 mg PO q12hr Concomitant administration with nevirapine: 1000 mg PO q8hr Concomitant administration with rifabutin: Reduce rifabutin dose to half of standard dose plus increase indinavir to 1000 mg PO q8hr Hepatic impairment: Mild-moderate (due to cirrhosis): 600 mg every 8 hr. Child Dose: HIV-1 Infection Neonates/infants: Safety and efficacy not established; should not be administered to neonates due to the risks associated with hyperbilirubinemia 4-15 years (investigational): 500 mg/m² PO q8hr Renal Dose: Dose adjustment not studied

Take this medicine in the dose and duration as advised by your doctor. Do not chew, crush or break it. Indinavir is to be taken empty stomach.

If you miss a dose of Indinavir, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.

Common: • Blood in urine • Crystals in urine • Diarrhea • Dizziness • Dry skin • Headache • Increased liver enzymes • Nausea • Protein in urine • Rash • Vomiting • Kidney stone

[UNSAFE] Indinavir may decrease alertness, affect your vision or make you feel sleepy and dizzy. Do not drive if these symptoms occur. Indinavir should be taken at least 1 hour before meals or 2 hours after meals. Do not skip any doses and finish the full course of treatment even if you feel better. It may cause dizziness or sleepiness. Do not drive or do anything that requires concentration until you know how it affects you. Your doctor may check your liver function regularly. Inform your doctor if you develop abdominal pain, loss of appetite darkened urine or yellowing of the eyes or skin (jaundice). Inform your doctor if you are pregnant, planning pregnancy or breastfeeding.

Hypersensitivity. Severe hepatic impairment.

Reduced absorption with antacids. Increased concentrations with ketoconazole, delavirdine, nelfinavir and ritonavir. Reduced efficacy with nevirapine, efavirenz or rifampicin. Increased risk of myopathy with statins. Increased concentrations of phosphodiesterase-5 inhibitors. Potentially Fatal: Increased risk of cardiac arrhythmias with amiodarone, pimozide or cisapride. Increased sedation and respiratory depression with midazolam, alprazolam and triazolam. Increased risk of ergotism with ergot derivatives. Increased toxicity of drugs with narrow therapeutic index.

[CAUTION] Caution is advised when consuming alcohol with Indinavir. Please consult your doctor.

[CONSULT YOUR DOCTOR] Indinavir may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.

[SAFE IF PRESCRIBED] Indinavir is probably safe to use during breastfeeding. Limited human data suggests that the drug does not represent any significant risk to the baby.

[SAFE IF PRESCRIBED] Indinavir is probably safe to use in patients with kidney disease. Limited data available suggests that dose adjustment of Indinavir may not be needed in these patients. Please consult your doctor. [CAUTION] Indinavir should be used with caution in patients with liver disease. Dose adjustment of Indinavir may be needed. Please consult your doctor. Limited information is available on the use of Indinavir in patients with severe liver disease.

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