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ritonavir (Rx)Brand and Other Names:Norvir

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 100mg

tablet

  • 100mg

oral solution

  • 80mg/mL
more...

HIV Infection

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

300 mg PO q12hr intially; increase by 100 mg q12hr to 600 mg PO q12hr over 5 days as tolerated

Use as booster with another protease inhibitor: 100-400 mg PO qDay or divided q12hr

Administration

Gradually increase to dose to avoid nausea/vomiting

Tablet: Take with food

Capsule and oral solution: Take with food if possible (may improve tolerability)

May mix capsules/oral solution with chocolate milk, Ensure

Tablets may be stored at room temperature

Capsules must be stored in refrigerator; may be left at room temperature for up to 30 days

Hepatic Impairment

Monitor therapy carefully in moderate and severe hepatic impairment

Dosage Forms & Strengths

capsule

  • 100mg

tablet

  • 100mg

oral solution

  • 80mg/mL
more...

HIV Infection

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

Age <1 month: Safety and efficacy not established

Age >1 month: 250 mg/m² PO q12hr initially; increase by 50 mg/m² q2-3days to 350-450 mg/m² q12hr; not to exceed 600 mg q12hr 

Adolescents: 300 mg PO q12hr intially; increase by 100 mg q12hr to 600 mg PO q12hr over 5 days as tolerated

Administration

Gradually increase to dose to avoid nausea/vomiting

Tablet: Take with food

Capsule and oral solution: Take with food if possible (may improve tolerability)

May mix capsules/oral solution with chocolate milk, Ensure

Tablets may be stored at room temperature

Capsules must be stored in refrigerator; may be left at room temperature for up to 30 days

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Interactions

Interaction Checker

ritonavir 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%

            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%)

            1-10%

            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%)

            Diaphoresis (2-3%)

            Paresthesia (3-7)

            Pharyngitis (1-3%)

            Rash (<4%)

            Somnolence (2-3%)

            Pharyngitis (1-3%)

            <1%

            Adrenal suppression

            Cerebral ischemia

            Dementia

            Edema

            Leukopenia

            Tachycardia

            Ulcerative colitis

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            Warnings

            Black Box Warnings

            Coadministration with sedative-hypnotics, antiarrhythmics, or ergot alkaloids may result in serious and/or life-threatening adverse events due to ritonavir’s effect on hepatic metabolism

            Ritonavir inhibits CYP450 3A; drugs that are extensively metabolized by CYP3A and have high first pass metabolism are most susceptible to increased serum levels when coadministered

            Contraindications

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

            Co-administration with drugs highly dependent on CYP3A for clearance or that significantly reduce ritonavir

            Cautions

            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

            Total cholesterol and triglycerides elevations may occur; monitor prior to therapy and periodically thereafter

            Patients may develop new onset or exacerbations of diabetes mellitus, hyperglycemia

            Patients may develop redistribution/accumulation of body fat

            Spontaneous bleeding may occur; additional factor VIII may be required

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            Pregnancy & Lactation

            Pregnancy Category: B

            Lactation: HIV+ women shouldn't breastfeed

            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; typically used to boost levels of other protease inhibitors

            Pharmacokinetics

            Absorption: variable, with or without food

            Vd: 0.16-0.66 L/kg (high concentrations in serum & lymph nodes)

            Protein Bound: 98-99%

            Metabolism: Hepatic; five metabolites, low concentration of an active metabolite achieved in plasma (oxidative)

            Half-life: 3-5 hr

            Peak plasma time: 2 hr (oral solution)

            Excretion: Urine (11%); feces (86%)

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            Images

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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.
            • Manage and view all your plans together – even plans in different states.
            • 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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