This combination product contains two medications, lopinavir and ritonavir. This product is used in combination with other medications to help control your HIV infection, thereby improving your quality of life. It also lowers your risk of getting HIV disease complications (e.g., opportunistic infections, cancer). Both lopinavir and ritonavir belong to a class of drugs known as HIV protease inhibitors. The ritonavir in this product helps the lopinavir to stay in your body. This effect builds up the amount of lopinavir in your body, increasing its effectiveness.

This lopinavir/ritonavir product is not a cure for HIV infection, and it does not prevent the spread of HIV to others through sexual contact or blood contamination (e.g., sharing used needles).

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using lopinavir/ritonavir and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

Take this product by mouth with or without food, usually once or twice daily or as directed by your doctor. Swallow the tablets whole. Do not crush, break or chew the tablets.

Dosage is based on your medical condition, response to therapy, and any other anti-HIV medications you may be taking.

Taking this product once a day is not recommended if you have previously taken other drugs to treat your HIV infection. Consult your doctor for more details.

If you are taking didanosine in addition to this product, you can take it at the same time as this product, but take them both without food.

It is very important to continue taking this medication (and other anti-HIV medications) exactly as prescribed by your doctor.

This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. Remember to use it at the same time(s) each day. Do not skip any doses.

Do not take more or less of this drug than prescribed, or stop taking it (or other HIV medicines) even for a short time, unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.

Find out about other drugs that should not be taken with this product (see Drug Interactions section).

Diarrhea, nausea, vomiting, stomach upset, gas, headache, and trouble sleeping may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: joint/muscle pain, increased thirst, increased urination, blurred vision, confusion, persistent nausea/vomiting, severe stomach pain, yellowing of skin/eyes, dark urine, persistent fever, unusual tiredness.

Seek immediate medical attention if any of these rare but very serious side effects occur: severe dizziness, fainting, slow/fast/irregular heartbeat.

Changes in body fat may occur while you are taking this medication (e.g., increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of therapy with your doctor, as well as the possible role of exercise to reduce this side effect.

This medication may cause an increase in blood fat levels (cholesterol and triglycerides). Cholesterol and triglyceride testing should be done before and occasionally during treatment with this medication. Consult your doctor or pharmacist for more information.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this product, tell your doctor or pharmacist if you are allergic to either lopinavir or ritonavir; or to other HIV protease inhibitors such as amprenavir, indinavir or saquinavir; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, diabetes, pancreatitis, high blood fat levels (cholesterol/triglycerides), bleeding problems (e.g., hemophilia), previous infection with certain diseases (e.g., hepatitis B infection, hepatitis C infection, tuberculosis).

Lopinavir/ritonavir may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using lopinavir/ritonavir, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using lopinavir/ritonavir safely.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

See also How to Use section.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Lopinavir/ritonavir interacts with many medications. Other medications can affect the removal of lopinavir/ritonavir from your body, which may affect how lopinavir/ritonavir works. In addition, lopinavir/ritonavir can slow down or speed up the removal of other medications from your body, which may affect how they work. Before taking lopinavir/ritonavir, tell your doctor or pharmacist about all medications and products you may use.

This drug should not be used with the following medications because very serious interactions may occur: alfuzosin, certain non-drowsy antihistamines, bosentan, cisapride, conivaptan, eletriptan, eplerenone, ergot drugs (e.g., dihydroergotamine, ergonovine, methylergonovine, ergotamine), ivabradine, pimozide, ranolazine, rifampin, certain sedatives (midazolam, triazolam), certain "statins" (lovastatin, simvastatin), St John's wort, voriconazole.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting lopinavir/ritonavir.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other HIV drugs (e.g., efavirenz, amprenavir, zidovudine, abacavir, nevirapine, atazanavir, tipranavir/ritonavir), antidepressants (e.g., bupropion, trazodone), atovaquone, other azole antifungals (ketoconazole, itraconazole), "blood thinners" (e.g., warfarin), calcium channel blockers (e.g., felodipine, nifedipine, nicardipine), some cancer drugs (e.g., dasatinib, lapatinib, sunitinib, vinblastine, vincristine), dexamethasone, drugs for erectile dysfunction (e.g., sildenafil, tadalafil, vardenafil), fluticasone, garlic supplements, heart rhythm medication (e.g., amiodarone, bepridil, lidocaine, quinidine), drugs that suppress the immune system (e.g., cyclosporine, tacrolimus, rapamycin), macrolide antibiotics (e.g., clarithromycin), narcotic pain medications (e.g., methadone), rifabutin, other sedatives (alprazolam, zolpidem), seizure medication (e.g., phenytoin, carbamazepine, phenobarbital), solifenacin, certain other "statins" (atorvastatin, rosuvastatin), temsirolimus.

Many drugs besides lopinavir/ritonavir may affect the heart rhythm (QT prolongation), including dofetilide, procainamide, sotalol, among others.

This medication may decrease the effectiveness of combination-type birth control pills. This can result in pregnancy. You may need to use an additional form of reliable birth control while using this medication. Consult your doctor or pharmacist for details.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: change in amount of urine; or numbness or tingling in the arms, hands, legs, or feet.

To decrease your risk of spreading HIV disease, always use an effective barrier method (e.g., latex condoms/dental dams) during sexual activity. Consult your doctor or pharmacist for more details.

Do not share this medication with others.

Keep all medical and laboratory appointments. Laboratory and/or medical tests (e.g., liver function, blood counts, blood cholesterol/triglyceride levels, blood sugar) should be performed from time to time to monitor your progress or check for side effects. Consult your doctor for more details.

Lopinavir/ritonavir is available in tablets, capsules and oral solution. Do not switch types of this medication without instructions on how to do so by your doctor.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Avoid exposure to high heat. Also, in high humidity, avoid storing this product for more than 2 weeks outside of the manufacturer's original container. If this does occur, consult your pharmacist for instructions on what to do with your medication. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised September 2009 Copyright(c) 2009 First DataBank, Inc.