Lopinavir and ritonavir is a combination antiviral medicine used to treat human immunodeficiency virus (HIV), the virus that can cause acquired immunodeficiency syndrome (AIDS). lopinavir and ritonavir is not a cure for HIV or AIDS.

Lopinavir and ritonavir is for use in adults and children who are at least 14 days old.

Lopinavir and ritonavir may also be used for purposes not listed in this medication guide.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Lopinavir and ritonavir can cause a serious heart problem. Call your doctor at once if you have fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out).

Tell your doctor if you have signs of liver or pancreas problems: loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

The combination of lopinavir and ritonavir comes as a tablet and a solution (liquid) to take by mouth. It is usually taken twice a day, but may be taken once a day by certain adults. The solution must be taken with food. The tablets may be taken with or without food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take lopinavir and ritonavir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

If you are using the solution, shake it well before each use to mix the medication evenly. Use a dose-measuring spoon or cup to measure the correct amount of liquid for each dose, not a regular household spoon.

Continue to take lopinavir and ritonavir even if you feel well. Do not stop taking lopinavir and ritonavir without talking to your doctor. If you miss doses, take less than the prescribed amount, or stop taking lopinavir and ritonavir, your condition may become more difficult to treat.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed, especially when giving the medicine to a child

Swallow the tablet whole and do not crush, chew, or break it.

The tablets can be taken with or without food.

Lopinavir and ritonavir liquid should be taken with food. Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Ask your doctor before giving lopinavir and ritonavir liquid through a feeding tube.

Lopinavir and ritonavir doses are based on weight in children. Your child's dose needs may change if the child gains or loses weight.

You will need frequent medical tests.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with HIV should remain under the care of a doctor.

Store lopinavir and ritonavir liquid in the refrigerator or at room temperature.

Store the tablets at room temperature, away from heat and moisture. Keep the pills in their original container. If you store the liquid at room temperature you must use it within 60 days.

You should not use lopinavir and ritonavir if you have ever had a severe allergic reaction to lopinavir or ritonavir.

Some medicines can cause unwanted or dangerous effects when used with lopinavir and ritonavir. Your doctor may change your treatment plan if you also use:

• apalutamide;

• alfuzosin;

• cisapride;

• colchicine;

• dronedarone;

• elbasvir/grazoprevir;

• lomitapide;

• lurasidone, pimozide;

• ranolazine;

• rifampin;

• lovastatin, simvastatin;

• triazolam, or oral midazolam;

• sildenafil (Revatio for pulmonary arterial hypertension);

• St. John's wort; or

• an ergot medicine (ergotamine, dihydroergotamine, methylergonovine).

Tell your doctor if you have ever had:

• liver disease (especially hepatitis B or C);

• heart problems;

• long QT syndrome (in you or a family member);

• pancreas problems;

• diabetes;

• high cholesterol;

• low levels of potassium in your blood; or

• a bleeding disorder such as hemophilia.

Tell your doctor if you are pregnant, and use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

Lopinavir and ritonavir oral solution (liquid) contains alcohol and propylene glycol. Do not use the liquid form of this medicine if you become pregnant.

Lopinavir and ritonavir can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using lopinavir and ritonavir, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.

Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Missing doses may increase the risk of your virus becoming resistant to medication.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of lopinavir and ritonavir oral liquid could be fatal to a child.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets at room temperature and protect them from excess moisture. It is best to keep the tablets in the container they came in; if you must take them out of the container, you should use them within 2 weeks. You may keep the oral solution in the refrigerator until the expiration date printed on the label, or you may store it at room temperature for up to 2 months.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Lopinavir and ritonavir liquid contains alcohol and propylene glycol. Avoid drinking alcohol while using lopinavir and ritonavir.

Using this medicine will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Lopinavir and ritonavir may cause serious side effects. Call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

• signs of a kidney stone--pain in your side or lower back, blood in your urine, painful or difficult urination;

• high blood sugar--increased thirst, increased urination, fruity breath odor, weight loss; or

• signs of liver or pancreas problems--loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Lopinavir and ritonavir affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Lopinavir and ritonavir liquid contains alcohol and propylene glycol, which may cause drowsiness or slow breathing in a baby taking this medicine. Tell your doctor if you notice these symptoms in your baby.

Lopinavir and ritonavir can cause changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

Common side effects of lopinavir and ritonavir may include:

• nausea, vomiting, diarrhea; or

• high cholesterol or triglycerides.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Lopinavir and ritonavir can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Some medicines can make lopinavir and ritonavir less effective when taken at the same time. If you take lopinavir and ritonavir liquid and you also take didanosine (Videx), take the didanosine at least 1 hour before or 2 hours after you take lopinavir and ritonavir liquid.

Many drugs can affect lopinavir and ritonavir, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to lopinavir and ritonavir.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Kaletra® (containing Lopinavir, Ritonavir)