Lopinavir and Ritonavir
Lopinavir and ritonavir is a combination HIV-1 protease inhibitor used alongside other antiretroviral medicines to treat HIV-1 infection in adults and children.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 6 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Lopinavir and Ritonavir: Patient Information Guide
A plain-language walkthrough of Lopinavir and Ritonavir — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Lopinavir and ritonavir treats HIV-1 infection as part of a combination antiretroviral regimen. It is always used with at least one other HIV medicine.
- Kaletra tablets are indicated for HIV-1 infection in adults and pediatric patients 14 days and older
- Kaletra oral solution is indicated for HIV-1 infection in adults and pediatric patients 14 days and older
- Lopinavir and ritonavir tablets are indicated for HIV-1 infection in adults and pediatric patients 14 days and older
- Resistance testing is recommended before starting treatment, as the number of lopinavir resistance-associated mutations in the virus affects how well the medicine works
⚙️How it works▾
Lopinavir works by blocking HIV-1 protease — an enzyme the virus depends on to assemble new, functional copies of itself. Without this enzyme, HIV produces immature, non-infectious particles that cannot spread infection. Ritonavir is paired with lopinavir not primarily for its own antiviral effect, but to block the liver enzyme (CYP3A) that would otherwise break lopinavir down too quickly, keeping lopinavir at levels high enough to suppress the virus.
Because HIV can mutate and develop resistance to protease inhibitors, and because there is potential for cross-resistance among drugs in this class, resistance testing before and during treatment helps guide therapy decisions.
💊How it's taken▾
Lopinavir and ritonavir is taken by mouth and is available as a tablet and an oral solution. Tablets may be taken once or twice daily in adults, based on your prescriber's recommendation; in pediatric patients, twice-daily dosing is standard, with the amount calculated from body weight or body surface area. Once-daily dosing is not recommended in children, in pregnant women, or in certain clinical situations (such as when taken with efavirenz, nevirapine, nelfinavir, or certain seizure medicines).
- Tablets (Kaletra and lopinavir and ritonavir): may be taken with or without food; swallow whole — never chew, break, or crush
- Kaletra oral solution: must be taken with food every time
- Never skip doses or stop on your own — missing doses can allow the virus to develop resistance
🤒Side effects — in detail▾
The most common side effects include diarrhea (very frequently reported, and more common with once-daily than twice-daily dosing), nausea, vomiting, abdominal pain, fatigue, and increases in blood cholesterol and triglycerides. Rash and headache are also reported. These digestive side effects tend to happen early in treatment, while changes in blood fats may develop over time.
Seek medical attention right away if you develop severe stomach pain, yellowing of the skin or eyes, irregular heartbeat or fainting, severe skin blistering or peeling, or signs of a serious infection — these may signal pancreatitis, liver damage, a heart-rhythm problem, or a serious skin reaction.
⚠️Warnings & precautions▾
- Liver damage (hepatotoxicity): Serious and sometimes fatal liver injury has been reported, especially in people with pre-existing hepatitis B or C. Liver tests should be done before and during treatment.
- Pancreatitis: Inflammation of the pancreas — sometimes fatal — has occurred, particularly in people with high triglycerides or advanced HIV. Stop the medicine and call your doctor if you develop severe abdominal pain, nausea, or vomiting.
- Heart rhythm changes: This medicine can prolong the QT interval and PR interval in the heart's electrical system, rarely leading to dangerous arrhythmias. Use with extra caution if you have heart disease, a conduction disorder, low potassium, or take other drugs that affect heart rhythm.
- Drug interactions: Lopinavir and ritonavir strongly affects the metabolism of many other medications. Some combinations are outright dangerous; others require dose adjustments. Review all medications with your prescriber before starting.
- Toxicity in premature newborns: Kaletra oral solution contains alcohol and propylene glycol and has caused life-threatening events — including fatal heart and kidney problems — in preterm newborns. It should not be used in this group without specialist oversight.
- Other risks: New or worsening diabetes, high cholesterol and triglycerides, body fat changes, increased bleeding in hemophilia patients, and immune reconstitution syndrome (a flare of inflammation as immunity recovers) have all been reported.
🔀What it interacts with▾
Lopinavir and ritonavir has a very long list of significant drug interactions because it both inhibits and, for some pathways, induces the liver enzymes that process hundreds of medications.
- Completely contraindicated (never combine): lovastatin, simvastatin (cholesterol), triazolam and oral midazolam (sedatives), dronedarone (heart rhythm), alfuzosin (prostate), pimozide and lurasidone (psychiatric), colchicine (gout, in patients with liver or kidney problems), ranolazine (chest pain), sildenafil/Revatio (pulmonary hypertension), lomitapide, elbasvir/grazoprevir (hepatitis C), ergot derivatives, rifampin (tuberculosis), apalutamide (cancer), and St. John's Wort
- Other HIV medicines: Efavirenz, nevirapine, and nelfinavir lower lopinavir levels and may require a dose increase; tipranavir and fosamprenavir/ritonavir combinations are not recommended
- Seizure medicines: Carbamazepine, phenobarbital, and phenytoin reduce lopinavir levels — once-daily dosing must not be used with these; phenytoin blood levels should be monitored
- Blood thinners: Warfarin levels can fluctuate — monitor INR frequently; avoid rivaroxaban
- Antifungals: High doses of ketoconazole or itraconazole are not recommended; avoid voriconazole if possible
- Certain cancer drugs: Several agents (ibrutinib, venetoclax, neratinib, vincristine, vinblastine, and others) should be avoided or used with extreme caution
- Cholesterol-lowering drugs: Some statins (other than lovastatin/simvastatin) may be used with close monitoring and possible dose limits — discuss with your doctor
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Tell your doctor if you have liver disease, hepatitis B, or hepatitis C — your liver will need close monitoring
- Tell your doctor if you have heart disease, a heart rhythm disorder, cardiomyopathy, or are taking any medicine that affects the heart's electrical system
- Tell your doctor if you have ever had pancreatitis or have high triglycerides
- Tell your doctor if you have hemophilia — increased bleeding has been reported with protease inhibitors
- Tell your doctor if you are pregnant — once-daily dosing is not recommended during pregnancy; lopinavir levels are naturally lower in the second and third trimester
- Breastfeeding is not recommended while taking this medication
- Kaletra oral solution is not recommended in premature newborns due to serious toxicity risk from alcohol and propylene glycol in the formulation
- Renal impairment: lopinavir is not significantly cleared by the kidneys, so kidney disease alone is unlikely to require dose adjustment — but follow your doctor's guidance
- Liver impairment: lopinavir levels are modestly higher in mild-to-moderate liver impairment; the medicine has not been studied in severe liver impairment and extra caution is warranted
🚑If you take too much▾
Overdoses with lopinavir and ritonavir oral solution have been life-threatening — including one report of a fatal heart failure in an infant who received far more than the recommended amount. In premature newborns, overdose has been associated with complete heart block, cardiomyopathy, lactic acidosis (dangerous acid buildup in the blood), and acute kidney failure. Kaletra oral solution is highly concentrated, and doses must be measured precisely, especially in infants.
There is no specific antidote. Treatment focuses on supportive care, monitoring vital signs, and if needed, removing unabsorbed drug with gastric lavage or activated charcoal. Dialysis does not effectively remove lopinavir (which binds tightly to proteins), but dialysis can help remove the alcohol and propylene glycol components found in the oral solution.
📡Pharmacodynamics — effects in the body▾
In studies of Kaletra's effect on the heart's electrical system, the drug was shown to prolong both the QT interval (a measure of ventricular repolarization) and the PR interval (the time for an electrical signal to travel from the upper to lower chambers of the heart). These effects were dose-related — higher-than-approved doses produced larger changes. In rare cases reported after the drug reached the market, these electrical changes have been linked to serious rhythm disturbances, including torsade de pointes (a specific dangerous arrhythmia) and second- or third-degree heart block (where signals between heart chambers are delayed or blocked).
🔬Pharmacokinetics — how your body processes it▾
After swallowing, lopinavir reaches peak blood levels in about 4 to 5 hours. Taking the tablet with food increases absorption by about 19%; taking the oral solution with food increases it by much more — about 130% compared to fasting — which is why the oral solution must always be taken with food. Once in the bloodstream, lopinavir binds tightly to plasma proteins (over 98%), and its half-life (the time it takes the body to clear half the drug) is roughly 7 hours. It is broken down mainly by the liver enzyme CYP3A, and most of the drug leaves the body through the stool, with a small amount in urine. Ritonavir, co-formulated in each dose, slows this breakdown and keeps lopinavir levels therapeutically effective throughout the dosing period.
📦How to store it▾
Tablets Store KALETRA tablets at 20°- 25°C (68°- 77°F); excursions permitted to 15°- 30°C (59°- 86°F) . Dispense in original container or USP equivalent tight container. Store KALETRA oral solution at 2°- 8°C (36°- 46°F) until dispensed.
📄 Written from Lopinavir and Ritonavir’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Lopinavir and Ritonavir — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly does this medication do, and will it cure my HIV? ▾
Does it matter when I take it, and do I need to take it with food? ▾
What side effects should I expect, and which ones should make me call my doctor? ▾
I take several other medications. Is that a problem? ▾
Is it safe to take this if I'm pregnant or trying to get pregnant? ▾
My child has been prescribed Kaletra oral solution. Is there anything I should know as a caregiver? ▾
Is Lopinavir and Ritonavir available over the counter? ▾
When was Lopinavir and Ritonavir first available? ▾
Who makes Lopinavir and Ritonavir? ▾
💬 Answers drafted from Lopinavir and Ritonavir’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Lopinavir and Ritonavir comes
Lopinavir and Ritonavir is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Kaletra tablets are used to treat HIV-1 infection in adults and pediatric patients 14 days and older, in combination with other antiretroviral medicines
- Lopinavir and ritonavir tablets are used to treat HIV-1 infection in adults and pediatric patients 14 days and older, in combination with other antiretroviral medicines
- Kaletra tablets and lopinavir and ritonavir tablets may be taken with or without food
- Tablets must be swallowed whole — do not chew, break, or crush them
- Kaletra tablets can be taken once daily or twice daily in adults depending on the prescriber's recommendation; once-daily dosing is not recommended in pediatric patients
- Lopinavir and ritonavir tablets once-daily dosing is not recommended in pregnant women, in patients with certain resistance mutations, or when taken with efavirenz, nevirapine, nelfinavir, carbamazepine, phenobarbital, or phenytoin
Oral solution
How this form is used
- Kaletra oral solution is used to treat HIV-1 infection in adults and pediatric patients 14 days and older, in combination with other antiretroviral medicines
- Kaletra oral solution must always be taken with food
- Kaletra oral solution should not be used with polyurethane feeding tubes; silicone or PVC feeding tubes are compatible
- Kaletra oral solution should not be given to premature newborns before they reach a postmenstrual age of 42 weeks and a postnatal age of at least 14 days
- Kaletra oral solution contains alcohol and propylene glycol — measure doses carefully, especially in infants and young children
📊 Lopinavir and Ritonavir across the U.S. market
How Lopinavir and Ritonavir appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Lopinavir and Ritonavir is used
A general measure of how commonly Lopinavir and Ritonavir is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Lopinavir and Ritonavir is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Lopinavir and Ritonavir prescribed? Of the 1,596 medications we measure, Lopinavir and Ritonavir ranks #1,423 by Medicaid prescriptions — more than 11% of them.
Utilization by Lopinavir and Ritonavir product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
lopinavir 200 MG / ritonavir 50 MG Oral Tablet Most dispensed
Summed across the 3 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 597730
lopinavir 80 MG/ML / ritonavir 20 MG/ML Oral Solution
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311369
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Lopinavir and Ritonavir, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 4 of 17 listed Lopinavir and Ritonavir NDCs with Medicaid activity.
🔍 Compare Lopinavir and Ritonavir products
A representative set of FDA-listed product records for Lopinavir and Ritonavir — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Oral solution | ||||
| LOPINAVIR 80 mg/mL; RITONAVIR 20 mg/mL | Oral | AbbVie Inc. × 2 listings | NDA | View NDC → |
| 80; 20 mg/mL; mg/mL | Oral | AbbVie Inc. × 2 listings | NDA | View NDC → |
| 💊Tablet | ||||
| RITONAVIR 50 mg/1; LOPINAVIR 200 mg | — | AbbVie Deutschland GmbH & Co Kg | DRUG FOR FURTHER PROCESSING | View NDC → |
| LOPINAVIR 100 mg/1; RITONAVIR 25 mg | — | AbbVie Deutschland GmbH & Co Kg × 3 listings | DRUG FOR FURTHER PROCESSING | View NDC → |
| LOPINAVIR 200 mg/1; RITONAVIR 50 mg | — | AbbVie Deutschland GmbH & Co Kg × 2 listings | DRUG FOR FURTHER PROCESSING | View NDC → |
| LOPINAVIR 100 mg/1; RITONAVIR 25 mg | Oral | AbbVie Inc. × 3 listings | NDA | View NDC → |
| LOPINAVIR 200 mg/1; RITONAVIR 50 mg | Oral | AbbVie Inc. × 3 listings | NDA | View NDC → |
| 100; 25 mg/1; mg | Oral | AbbVie Inc. × 4 listings | NDA | View NDC → |
| 200; 50 mg/1; mg | Oral | AbbVie Inc. × 4 listings | NDA | View NDC → |
| LOPINAVIR 100 mg/1; RITONAVIR 25 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| LOPINAVIR 200 mg/1; RITONAVIR 50 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| LOPINAVIR 100 mg/1; RITONAVIR 25 mg | Oral | Laurus Labs Limited | ANDA | View NDC → |
| LOPINAVIR 200 mg/1; RITONAVIR 50 mg | Oral | Laurus Labs Limited | ANDA | View NDC → |
| 100; 25 mg/1; mg | Oral | Laurus Labs Limited | ANDA | View NDC → |
| 200; 50 mg/1; mg | Oral | Laurus Labs Limited | ANDA | View NDC → |
| LOPINAVIR 100 mg/1; RITONAVIR 25 mg | Oral | Macleods Pharmaceuticals Limited × 2 listings | ANDA | View NDC → |
| LOPINAVIR 200 mg/1; RITONAVIR 50 mg | Oral | Macleods Pharmaceuticals Limited × 2 listings | ANDA | View NDC → |
| 200; 50 mg/1; mg | Oral | NuCare Pharmaceuticals,Inc. | ANDA | View NDC → |
| 200; 50 mg/1; mg | Oral | NuCare Pharmaceuticals,Inc. × 2 listings | NDA | View NDC → |
| 200; 50 mg/1; mg | Oral | Remedyrepack Inc. | NDA | Find on DailyMed ↗ |
Showing 38 of 38 products — FDA National Drug Code Directory. See every product, package size and price: browse all 38 Lopinavir and Ritonavir NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Lopinavir and Ritonavir — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Lopinavir and Ritonavir in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Lopinavir and Ritonavir went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.
RxCUI 284640 3 dose forms · 4 strengths
-
Dose form (SCDF) Oral Capsule RxCUI 374642No current FDA listingClinical drug / strength (SCD) lopinavir 133 MG / ritonavir 33.3 MGRxCUI 311368 -
Dose form (SCDF) Oral Solution RxCUI 374643In current FDA listingsClinical drug / strength (SCD) lopinavir 80 MG/ML / ritonavir 20 MG/MLRxCUI 311369 -
Dose form (SCDF) Oral Tablet RxCUI 597729In current FDA listingsClinical drug / strength (SCD) lopinavir 100 MG / ritonavir 25 MGRxCUI 746645lopinavir 200 MG / ritonavir 50 MGRxCUI 597730
Look up RxCUI 284640 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Lopinavir and Ritonavir is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Lopinavir and Ritonavir belongs to the Protease Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 6 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. NuCare Pharmaceuticals,Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.