Classifications: antiretroviral agent; protease inhibitor; Therapeutic: antiretroviral; protease inhibitor
Pregnancy Category: B
100 mg capsules; 80 mg/mL solution
HIV protease is an enzyme required to produce the polyprotein procurers of functional proteins in infectious HIV. Protease
inhibitors prevent cleavage of the viral polyproteins, resulting in the formation of immature noninfectious virus particles.
Protease inhibitor of both HIV-1 and HIV-2 resulting in the formation of noninfectious viral particles.
Alone or in combination with other antiretroviral agents or protease inhibitors for treatment of HIV infection. Often used
to increase the effect of other ANTIRETROVIRALS.
Hypersensitivity to ritonavir; antimicrobial resistance to protease inhibitors; pancreatitis; lactation. Safe use in children
<1 mo has not been established.
Pregnancy (category B); hepatic diseases, hepatic insufficiency, liver enzyme abnormalities, or hepatitis, jaundice, advanced
HIV disease; diabetes mellitus, diabetic ketoacidosis, hyperglycemia, hyperlipidemia, hypertriglyceridemia; hemophilia A
or B, renal insufficiency, concurrent administration with HMG-Coa reductase inhibitors.
Route & Dosage
Adult: PO 600 mg b.i.d. 1 h before or 2 h after meal (may take with a light snack)
Child (>1 mo): PO 300400 mg/m2 b.i.d. (max: 600 mg b.i.d.), start with 250 mg/m2 b.i.d., increase by 50 mg/m2 q23d
- Give preferably with food; oral solution may be mixed with chocolate milk within 1 h of dosing to improve taste.
- Do not give concurrently with any of the following drugs: alprazolam, amiodarone, bepridil, bupropion, clozapine, clorazepate,
diazepam, dihydroergotamine, ergotamine, encainide, estazolam, flecainide, flurazepam, meperidine, midazolam, piroxicam,
propafenone, propoxyphene, quinidine, rifabutin, triazolam, zolpidem.
- Store refrigerated at 2°8° C (36°46° F). Protect from light in tightly closed container.
Adverse Effects (≥1%)Body as a Whole:
Myalgia, allergic reaction, bronchitis
, cough, rhinitis, taste alterations, visual disturbances, dysuria, hyperglycemia,
. CNS: Asthenia, fatigue
, headache, fever, malaise
, circumoral or peripheral paresthesia
, dizziness, somnolence, abnormal thinking,
amnesia, agitation, anxiety, confusion, convulsions, aphasia, ataxia, diplopia
, emotional lability, euphoria, hallucinations,
decreased libido, nervousness, neuralgia
, peripheral neuropathy
, paralysis, tremor, vertigo. CV:
Palpitations, vasodilation, hypotension, postural hypotension, syncope, tachycardia. Hematologic: Anemia
, lymphadenopathy. GI: Nausea, diarrhea, vomiting,
abdominal pain, dyspepsia, stomatitis
, anorexia, dry mouth, constipation
, flatulence, cholecystitis, cholestasis, abnormal
liver function tests, hepatitis
Rash, sweating, acne
, contact dermatitis, pruritus, urticaria, skin ulceration, dry skin.
InteractionsDrug: Carbamazepine, dexamethasone, phenobarbital, phenytoin, rifabutin, rifampin,
smoking can decrease ritonavir levels. Ritonavir
may increase serum
levels and toxicity
especially in patients with renal
insufficiency (reduce clarithromycin
dose in patients with Clcr
<60 mL/min); desipramine; saquinavir, amiodarone, bepridil, bupropion, clozapine, dihydroergotamine, flecainide, meperidine, pimozide, piroxicam, propoxyphene, quinidine, rifabutin, trazodone, alfuzosin, fluticasone. Ritonavir
decreases levels of oral contraceptives
may increase ergotamine toxicity
with dihydroergotamine, ergotamine;
may increase systemic steroid exposure with fluticasone.
Liquid formulation may cause disulfiram-like reaction with alcohol
See the complete prescribing information for a comprehensive table of potential, but not studied, drug interactions. Herbal: St. John's wort, garlic
may decrease antiretroviral
Rapidly from GI tract. Peak:
24 h. Distribution:
9899% protein bound. Metabolism:
In liver (CYP3A4). Elimination:
Primarily in feces (>80%).
Assessment & Drug Effects
- Lab tests: Monitor periodically CBC with differential and platelet count, liver function, kidney function, serum albumin,
lipid profile, CPK, serum amylase, electrolytes, blood glucose HbA1C, and alkaline phosphatase.
- Withhold drug and notify physician in the presence of abnormal liver function.
- Assess for S&S of GI distress, peripheral neuropathy, and other potential adverse effects.
Patient & Family Education
- Learn potential adverse reactions and drug interactions; report to physician use of any OTC or prescription drugs.
- Take this drug exactly as prescribed. Do not skip doses. Take at same time each day.