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indinavir (Rx)Brand and Other Names:Crixivan, IDV

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsules

  • 100mg
  • 200mg
  • 400mg
more...

HIV Infection

800 mg PO q8hr

With ritonavir: 800 mg PO q12hr plus ritonavir 100-200 mg q12hr

Dose 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

Renal Impairment

Dose adjustment not studied

Hepatic Impairment

Mild-to-moderate: 600 mg PO q8hr

Administration

Take on empty stomach, with water, 1 hr prior or 2 hr after meal

May take with skim milk or low-fat meal

If taking with ritonavir, may take without regard to meals

Dosage Forms & Strengths

capsules

  • 100mg
  • 200mg
  • 400mg
more...

HIV-1 Infection (Off-label)

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 

Administration

Take on empty stomach, with water, 1 hr prior or 2 hr after meal

May take with skim milk or low-fat meal

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Interactions

Interaction Checker

indinavir and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Nephrolithiasis/urolithiasis (29%, peds)

            Hyperbilirubinemia (14%)

            Nausea (12%)

            Pain (17%)

            Nephrolithiasis/urolithiasis (12%, adults)

            1-10%

            Abdominal pain (9%)

            Thrombocytopenia (1%)

            Back pain (8%)

            Dysuria (2%)

            Headache (6%)

            Fever (2%)

            Dizziness (3%)

            Diarrhea/vomiting (4-5%)

            Weakness (4%)

            Malaise (2%)

            Insomnia (3%)

            Fatigue (2%)

            Taste perversion (3%)

            Flank pain (3%)

            Pruritus (4%)

            Neutropenia (2%)

            Cough (2%)

            <1%

            Angina

            Erythema multiforme

            Hepatitis

            Crystaluria

            Angina

            Postmarketing Reports

            Body as a whole: Redistribution/accumulation of body fat

            Cardiovascular system: Cardiovascular disorders including myocardial infarction and angina pectoris; cerebrovascular disorder

            Digestive system: Liver function abnormalities; hepatitis including reports of hepatic failure; pancreatitis; jaundice; abdominal distention; dyspepsia

            Hematologic: Increased spontaneous bleeding in patients with hemophilia, acute hemolytic anemia

            Endocrine/metabolic: New onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, hyperglycemia

            Hypersensitivity: Anaphylactoid reactions; urticaria; vasculitis

            Musculoskeletal system: Arthralgia, periarthritis

            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

            Urogenital system: Nephrolithiasis/urolithiasis, in some cases resulting in renal insufficiency or acute renal failure, pyelonephritis with or without bacteremia; nephritis sometimes with indinavir crystal deposits; renal insufficiency; renal failure; leukocyturia, crystalluria; dysuria

            Laboratory abnormalities: Increased serum triglycerides; increased serum cholesterol

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            Warnings

            Contraindications

            Hypersensitivity

            Drugs that are contraindicated with indinavir include alpha1-adrenoreptor agonists (eg, alfuzosin), antiarrhythmics (amiodarone, bepridil, flecainide, propafenone, quinidine), rifampin, voriconazole, ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), cisapride, St. John’s wort, lovastatin, simvastatin, pimozide, sildenafil (when used for pulmonary artery hypertension), midazolam, and triazolam

            Cautions

            Proper hydration required (1.5 L liquids/day) to counter risk of nephrolithiasis/urolithiasis (much higher in children)

            Risks of fat redistribution, hemolytic anemia, hyperglycemia, hyperbilirubinemia, immune reconstitution syndrome if used in combination w/ other antiretroviral drugs

            Separate from didanosine by 1 hr

            Monitor: LFTs q6-12week

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: excretion in milk unknown; contraindicated

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            Protease Inhibitor; inhibits cleavage of Gag-Pol polyprotein precursors, which in turn causes the formation of immature, noninfectious viral particles; combination use recommended

            Pharmacokinetics

            Absorption: administration with high fat, high calorie diet resulted in a reduction in AUC & in maximum serum concentration (77% & 84% respectively); lighter meal resulted in little or no change in these parameters

            Protein Bound: 60%

            Metabolism: hepatic via CYP3A4; 7 metabolites of indinavir identified

            Bioavailability: good

            Half-life, elimination: 1.8±0.4 hr

            Peak Plasma Time: 0.8±0.3 hr

            Excretion: Urine (19%); feces (83%)

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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