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Ritonavir

    Brands

    DEA Class; Rx

    Common Brand Names; Norvir

    • HIV, Protease Inhibitors

    Protease inhibitor (PI)
    Used in combination with other antiretroviral agents for treatment of human immunodeficiency virus (HIV) infection
    Commonly used to boost or enhance plasma concentrations of other PIs; many drug interactions

    Not typically used as sole protease inhibitor (PI), but as pharmacokinetic enhancer of other PIs

    Indicated in combination with other antiretroviral agents for the treatment of HIV-infection

    Known hypersensitivity to ritonavir (eg, toxic epidermal necrolysis, Stevens- Johnson syndrome)

    Coadministration with drugs highly dependent on CYP3A for clearance or that significantly reduce ritonavir

    Coadministration of ritonavir with the following drugs is contraindicated: alfuzosin, amiodarone, flecainide, propafenone, quinidine, voriconazole, rifampin, dihydroergotamine, ergotamine, methylergonovine, cisapride, lomitapide, lovastatin, simvastatin, lurasidone, apalutamide, pimozide, sildenafil for pulmonary arterial hypertension, triazolam, oral midazolam, carbamazepine, ranolazine, dronedarone, flecainide, colchicine, phenobarbital, phenytoin, and St. John’s wort

    • Increased triglycerides (17-34%)
    • Diarrhea (15-23%)
    • Nausea (26-30%)
    • Taste perversion (7-11%)
    • Vomiting (14-17%)
    • Weakness (10-15%)
    • Increased GGT (5-20%)
    • Increased creatinine phosphokinase (9-12%)
    • Abdominal pain (6%)
    • Anorexia (2-8%)
    • Dizziness (3-4%)
    • Dyspepsia (6%)
    • Eosinophilia
    • Fever (1-2%)
    • Flatulence (1-2%)
    • Headache (6-7%)
    • Insomnia (2-3%)
    • Increased uric acid (4%)
    • Increased LFTs (6-10%)
    • Local throat irritation (2-3%)
    • Malaise (1-2%)
    • Myalgia (2%)

    Do not administer with antacids; separate from didanosine by 2 hr

    Potent inhibitor of CYP3A4 (but also induces CYP450 enzymes)

    Monitor: monthly neurologic evaluation

    Risk of immune reconstitution syndrome if used in combination with other antiretroviral drugs

    Risks of hemolytic anemia and hyperbilirubinemia if used in combination with other antiretroviral drugs

    Capsules must be kept refrigerated

    Allergic reactions have been reported and include anaphylaxis, toxic epidermal necrolysis, Stevens-Johnson Syndrome, bronchospasm and angioedema; discontinue treatment if severe reactions develop

    Consider drug-drug interaction potential to reduce risk of serious or life-threatening adverse reactions

    Oral solution not for administration in preterm neonates in the immediate postnatal period; may cause toxicity; safety and efficacy not established

    Monitor liver function before and during therapy, especially in patients with underlying hepatic disease, including hepatitis B and hepatitis C, or marked transaminase elevations; fatalities resulting from hepatic reactions reported

    Fatalities resulting from pancreatitis reported; suspend therapy as clinically appropriate

    PR interval prolongation reported in some patients; cases of second and third degree heart block reported; use with caution with patients with preexisting conduction system disease, ischemic heart disease, cardiomyopathy, underlying structural heart disease or when administering with other drugs that may prolong the PR interval

    Advise pregnant women not to use oral solution during pregnancy owing to its alcohol content

    Excreted in human milk

    NOTE: The following maximum dosage limits apply for typical ritonavir use; maximum dosage limits may be altered based on certain individual patient circumstances, such as in the case of specific drug interactions.

    Adults

    1200 mg/day PO.

    Geriatric

    1200 mg/day PO.

    Adolescents

    Refer to dosage recommendations when used as a pharmacokinetic enhancer (specific dose varies significantly depending on patient age/weight and concomitant protease inhibitor); 800 mg/m2/day PO (Max: 1200 mg/day) when used as the sole protease inhibitor.

    Children

    Refer to dosage recommendations when used as a pharmacokinetic enhancer (specific dose varies significantly depending on patient age/weight and concomitant protease inhibitor); 800 mg/m2/day PO (Max: 1200 mg/day) when used as the sole protease inhibitor.

    Infants

    1 month and older: Refer to dosage recommendations when used as a pharmacokinetic enhancer (specific dose varies significantly depending on patient age/weight and concomitant protease inhibitor); 800 mg/m2/day PO when used as the sole protease inhibitor.
    Postmenstrual age less than 44 weeks: Use not recommended.

    Neonates

    Safety and efficacy have not been established.

    Ritonavir

    capsule

    • 100mg

    tablet

    • 100mg

    oral solution

    • 80mg/mL

    oral powder

    • 100mg/packet