Lopinavir (with ritonavir)

Pronunciation: loh-PIN-a-veer.

Generic name
lopinavir/ritonavir
Drug class
HIV-1 protease inhibitor combination (antiretroviral)
Form
Film-coated tablet or oral solution (fixed-dose combination with ritonavir)
Route
Oral
Legal status
Prescription-only

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Kaletra (5) · Full directory

What lopinavir/ritonavir is and how it works

Lopinavir/ritonavir (Kaletra) is a prescription-only combination antiretroviral medicine used, together with other HIV medicines, to treat HIV-1 infection. Ritonavir does not treat HIV at this dose -- it boosts and maintains lopinavir's levels in the blood. (1)

Take lopinavir/ritonavir exactly as your prescriber directs, as part of a combination HIV treatment regimen. Your exact dose, and whether it can be taken once or twice daily, depends on your individual treatment plan and other medicines -- it is not a fixed dose for everyone.

Mechanism of action: how lopinavir/ritonavir works

Lopinavir is an HIV-1 (and HIV-2) protease inhibitor that blocks cleavage of the viral gag-pol polyprotein, producing immature, non-infectious viral particles. Ritonavir is co-formulated at a low, sub-therapeutic-for-HIV dose specifically to inhibit CYP3A-mediated metabolism of lopinavir, substantially raising and sustaining lopinavir plasma concentrations (a pharmacokinetic 'boosting' effect). (1) (6)

What lopinavir/ritonavir is used for

HIV-1 infection

Used together with other antiretroviral medicines to treat HIV-1 infection in adults and children aged 14 days and older (label age threshold varies slightly by country). (1)

Before taking lopinavir/ritonavir

Do not take / not appropriate for

  • Do not take lopinavir/ritonavir if you have had a serious allergic reaction to it or any of its ingredients, including reactions such as severe skin reactions, hives, or swelling. (all countries) (1)
  • Do not take lopinavir/ritonavir together with certain other medicines -- including certain heart rhythm medicines, some cholesterol medicines (such as lovastatin or simvastatin), some migraine medicines (ergot derivatives), the sedative midazolam or triazolam taken by mouth, the antipsychotic pimozide, colchicine in some situations, and sildenafil when used for pulmonary hypertension -- because combining them can cause serious or life-threatening effects. Always give your prescriber and pharmacist a complete list of your medicines. (all countries) (1) (2)
  • Do not take lopinavir/ritonavir with rifampicin or St John's Wort, as these can substantially reduce its effectiveness and increase the risk of HIV treatment resistance. (all countries) (1)

Tell your clinician about

  • Any history of pancreatitis, liver problems (including hepatitis B or C), or high cholesterol/triglycerides.
  • Any heart rhythm problems or a family history of them.
  • All other medicines you take, including over-the-counter medicines and herbal products such as St John's Wort.
  • Pregnancy, plans for pregnancy, or breastfeeding.
  • If the person being treated is a premature baby, since the oral solution needs special caution in very young infants.
(1) (2)

How to take lopinavir/ritonavir

  • Take exactly as your prescriber directs, as part of a combination HIV treatment plan.
  • Swallow tablets whole -- do not chew, break, or crush them.
  • The oral solution should be taken with food; it contains alcohol and propylene glycol, so tell your prescriber if it is intended for a young infant.
  • Do not stop or change your HIV treatment without discussing it with your prescriber first, since this can affect how well the treatment continues to work.
(1)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

Contact your prescriber or HIV care team for specific guidance if you miss a dose, since missing doses of antiretroviral treatment can affect how well it continues to work.

Overdose

Seek urgent medical attention if you think too much has been taken. There is no specific antidote; treatment focuses on supportive care and monitoring. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Diarrhoea -- the most common side effect.

What to notice: Diarrhoea -- the most common side effect.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Nausea or vomiting.

What to notice: Nausea or vomiting.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Raised cholesterol or triglyceride levels, found on blood tests.

What to notice: Raised cholesterol or triglyceride levels, found on blood tests.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Abdominal pain or headache.

What to notice: Abdominal pain or headache.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Serious warnings

Signs of pancreatitis — emergency

Symptoms: Severe abdominal pain, often spreading to the back, with nausea and vomiting.

Action: Seek urgent medical attention. Pancreatitis has occurred with this medicine, including fatal cases, particularly with marked triglyceride elevation. (1)

Signs of liver problems (hepatotoxicity) — high caution

Symptoms: Yellowing of the skin or eyes, dark urine, unusual tiredness, or loss of appetite.

Action: Tell your prescriber promptly. Liver function is monitored before and during treatment, especially in people with hepatitis B or C or existing liver disease. (1)

Signs of a heart rhythm problem — high caution

Symptoms: Fainting, a very fast, slow, or irregular heartbeat, or palpitations.

Action: Tell your prescriber promptly. This medicine can prolong certain heart electrical intervals (PR and, rarely, QT), and rare cases of atrioventricular block have been reported, particularly in people with existing heart conduction problems. (1) (2)

Signs of a serious allergic or severe skin reaction — emergency

Symptoms: Widespread rash or blistering, skin peeling, mouth sores, swelling of the face, lips, tongue, or throat, or difficulty breathing.

Action: Seek emergency medical help immediately. (1)

Interactions

  • Because it contains ritonavir, this medicine strongly affects how many other medicines are broken down (via the CYP3A liver enzyme). It must never be combined with certain medicines -- examples include some cholesterol medicines (lovastatin, simvastatin), some heart rhythm medicines, some migraine medicines, and midazolam or triazolam taken by mouth -- because levels can rise to dangerous levels. (1) (2)
  • Rifampicin and St John's Wort can greatly reduce lopinavir levels and are not recommended together with this medicine, as this risks treatment failure and resistance. (1)
  • Medicines for erectile dysfunction (such as sildenafil, tadalafil, or vardenafil) need specific dose limits and caution when combined, due to a risk of low blood pressure or visual changes. (2)
  • Other HIV medicines such as efavirenz or nevirapine may mean your prescriber increases your lopinavir/ritonavir dose. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Data from pregnancy exposure registries covering thousands of pregnancies, including over a thousand in the first trimester, have not shown an increased risk of major birth defects. Twice-daily dosing only is used in pregnancy, and the oral solution is generally avoided due to its alcohol content -- discuss with your prescriber. (1) (2) (3) (4) (5) (6)

Breastfeeding

Breastfeeding is generally not recommended for people with HIV, to help prevent transmitting HIV to the infant. Discuss feeding options with your prescriber. (1) (2) (3) (4) (5) (6)

Children

Approved for children from 14 days of age in some countries (twice-daily dosing only), with dosing based on body weight or body surface area; age thresholds vary slightly by country. (1) (2) (3) (4) (5) (6)

Elderly

No specific dose adjustment based on age alone is described in the source reviewed, but individual monitoring applies regardless of age. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

Use with caution, and avoid in severe liver impairment in some markets -- liver function is closely monitored during treatment. (1) (2) (3) (4) (5) (6)

Renal_impairment

Not specifically restricted in the source reviewed, but tell your prescriber about any kidney problems. (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Baseline liver function tests
  • Baseline lipid panel (cholesterol and triglycerides)
  • Review of all other medicines for CYP3A interactions
  • ECG if there are risk factors for heart conduction problems

During treatment

  • Periodic liver function testing, especially with hepatitis B or C.
  • Periodic lipid panel monitoring.
  • Blood glucose monitoring.
  • CD4 count and HIV viral load monitoring as part of routine HIV care.
  • Watching for symptoms of pancreatitis.
(1)

Storage

Store tablets at controlled room temperature. The oral solution should be stored as directed on the label and used with food; check the expiry date and follow pharmacy instructions closely, especially for infant use.

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information; verify against the current full label before prescribing.

United States

Indication: HIV-1 infection (combination antiretroviral therapy)

Dose summary: Adults: 400/100mg twice daily, or 800/200mg once daily in selected patients without specific resistance-associated mutations. Pregnancy: twice-daily dosing only. Paediatric (14 days-18 years): twice-daily dosing only, weight/BSA-based. Increase to 500/125mg twice daily when co-administered with efavirenz, nevirapine, or nelfinavir.

Renal context: Not specifically restricted in the source reviewed for renal impairment; hepatic impairment requires caution and, in some markets, is a contraindication when severe. (1)

Mechanism of action

Hepatic guidance

Principally hepatically metabolised; caution required in hepatic impairment, with postmarketing reports of hepatic dysfunction including fatalities.

Overdose note

No specific antidote exists; management is supportive with monitoring of cardiac, hepatic, and pancreatic status as clinically indicated. (1) (6)

Frequently asked questions

Is lopinavir/ritonavir (Kaletra) available in the US, UK, Europe, Canada, Australia, and New Zealand?

Yes, it is approved and available in all of these regions, either as Kaletra or, in New Zealand, as a generic lopinavir/ritonavir product. (1) (2) (3) (4) (5) (6)

Why does lopinavir/ritonavir interact with so many other medicines?

The ritonavir component strongly inhibits an important liver enzyme (CYP3A) used to break down many other medicines. This is deliberately used to boost lopinavir's own levels, but it also means levels of many other medicines can rise to unsafe levels if combined -- always give your prescriber and pharmacist your complete medicine list, including over-the-counter and herbal products. (1) (2)

What warning signs during lopinavir/ritonavir treatment need urgent attention?

Seek prompt medical attention for severe abdominal pain (possible pancreatitis), yellowing of the skin or eyes or dark urine (possible liver problems), or an irregular or fast heartbeat or fainting (possible heart rhythm effects). Report any of these to your clinician right away rather than waiting for a routine appointment. (1)

What is the mechanism of action of lopinavir/ritonavir?

Lopinavir is an HIV-1 (and HIV-2) protease inhibitor that blocks cleavage of the viral gag-pol polyprotein, producing immature, non-infectious viral particles. Ritonavir is co-formulated at a low, sub-therapeutic-for-HIV dose specifically to inhibit CYP3A-mediated metabolism of lopinavir, substantially raising and sustaining lopinavir plasma concentrations (a pharmacokinetic 'boosting' effect). (1) (6)

What is the generic name of Lopinavir (with ritonavir)?

The generic name is lopinavir/ritonavir. (1)

What class of drug is lopinavir/ritonavir?

Lopinavir (with ritonavir) is classed as: HIV-1 protease inhibitor combination (antiretroviral). (1)

References

  1. KALETRA (lopinavir and ritonavir) tablets and oral solution -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, AbbVie Inc. · United States · accessed 2026-07-29 · source 1
  2. Kaletra (lopinavir/ritonavir) -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- AbbVie · United Kingdom · accessed 2026-07-29 · source 2
  3. Kaletra European Public Assessment Report (EPAR)European Medicines Agency (EMA) · European Union · accessed 2026-07-29 · source 3
  4. KALETRA (lopinavir/ritonavir) Product MonographHealth Canada product monograph / Drug Product Database · Canada · accessed 2026-07-29 · source 4
  5. KALETRA lopinavir/ritonavir tablets and oral solution -- ARTG registrationsTherapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-29 · source 5
  6. Lopinavir/Ritonavir Mylan -- New Zealand Data SheetMedsafe (New Zealand regulator) · New Zealand · accessed 2026-07-29 · source 6

Brand names by country

Single-ingredient lopinavir/ritonavir names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Kaletra (1)FDA approved currently labeled · 200mg/50mg tablet, 100mg/25mg tablet, 80mg/20mg per mL oral solution · AbbVie Inc.

United Kingdom

  • Kaletra (2)MHRA licensed emc smpc confirmed · 100mg/25mg tablet, 200mg/50mg tablet, 80mg/20mg per mL oral solution · AbbVie

Canada

  • Kaletra (4)Health Canada approved confirmed · not specified in fetched source · AbbVie Corporation

Australia

  • Kaletra (5)TGA ARTG registered 2006-05-24 confirmed · 200mg/50mg tablet, oral solution · AbbVie Pty Ltd

New Zealand

  • Lopinavir/Ritonavir Mylan (6)Medsafe approved confirmed · 100mg/25mg tablet, 200mg/50mg tablet · Mylan (Viatris)
View brands in additional countries.

European Union

Kaletra (3)

This page provides general reference information about lopinavir/ritonavir and is not a substitute for advice from the prescriber managing your treatment. All dosing and treatment decisions should be made with your prescriber.

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