Brand Names: Kaletra

Generic Name: lopinavir and ritonavir (Pronunciation: loe PIN a veer and ri TOE na veer)

• What is lopinavir and ritonavir (Kaletra)?
• What are the possible side effects of lopinavir and ritonavir (Kaletra)?
• What is the most important information I should know about lopinavir and ritonavir (Kaletra)?
• What should I discuss with my healthcare provider before taking lopinavir and ritonavir (Kaletra)?
• How should I take lopinavir and ritonavir (Kaletra)?
• What happens if I miss a dose (Kaletra)?
• What happens if I overdose (Kaletra)?
• What should I avoid while taking lopinavir and ritonavir (Kaletra)?
• What other drugs will affect lopinavir and ritonavir (Kaletra)?
• Where can I get more information?

What is lopinavir and ritonavir (Kaletra)?

Lopinavir and ritonavir is a combination of two antiviral medications in a group of HIV medicines called protease (PRO-tee-ayz) inhibitors. This medication prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Lopinavir and ritonavir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Lopinavir and ritonavir is not a cure for HIV or AIDS.

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

Kaletra

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What are the possible side effects of lopinavir and ritonavir (Kaletra)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking ritonavir and call your doctor at once if you have any of these serious side effects:

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
• increased urination or extreme thirst;
• easy bruising or bleeding;
• signs of a new infection, such as fever or chills, cough, or flu symptoms;
• severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate; or
• low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• mild nausea, vomiting, diarrhea, stomach pain, bloating;
• numbness or tingling, especially around your mouth;
• mild skin rash;
• headache, weakness, mood changes; or
• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about lopinavir and ritonavir (Kaletra)?

Do not take lopinavir and ritonavir with cisapride (Propulsid), lovastatin (Mevacor, Altocor), oral midazolam (Versed), pimozide (Orap), rifampin (Rifadin, Rimactane, Rifater), simvastatin (Zocor), St. John's wort, triazolam (Halcion), or an ergot medicine such as Ergomar, Cafergot, Wigraine, D.H.E. 45, Migranal, Methergine.

These drugs can cause life-threatening side effects if you use them while you are taking lopinavir and ritonavir.

There are many other medicines that can interact with lopinavir and ritonavir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Taking lopinavir and ritonavir will not prevent you from passing HIV to other people through unprotected sex or sharing of needles. Talk with your doctor about safe methods of preventing HIV transmission during sex, such as using a condom and spermicide. Sharing drug or medicine needles is never safe, even for a healthy person.

What should I discuss with my healthcare provider before taking lopinavir and ritonavir (Kaletra)?

Do not take lopinavir and ritonavir with cisapride (Propulsid), lovastatin (Mevacor, Altocor), oral midazolam (Versed), pimozide (Orap), rifampin (Rifadin, Rimactane, Rifater), simvastatin (Zocor), St. John's wort, triazolam (Halcion), or an ergot medicine such as Ergomar, Cafergot, Wigraine, D.H.E. 45, Migranal, Methergine.

These drugs can cause life-threatening side effects if you take them together with lopinavir and ritonavir.

Before taking lopinavir and ritonavir, tell your doctor if you are allergic to any drugs, or if you have:

• liver disease (especially hepatitis B or C);
• pancreas problems;
• diabetes;
• a bleeding disorder such as hemophilia;
• high cholesterol or triglyceride levels in your blood; or
• if you have ever used a protease inhibitor in the past.

FDA pregnancy category C. This medication may be harmful to an unborn baby. HIV can be passed to the baby if the mother is not properly treated during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection while you are pregnant.

Lopinavir and ritonavir can make birth control pills or patches less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking lopinavir and ritonavir.

You should not breast-feed while you are using lopinavir and ritonavir. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.

Do not give this medication to a child younger than 14 days old.

How should I take lopinavir and ritonavir (Kaletra)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Lopinavir and ritonavir tablets may be taken with or without food.

Do not crush, chew, or break a lopinavir and ritonavir tablet. Swallow the pill whole.

Lopinavir and ritonavir capsules or liquid should be taken with food.

Measure the liquid form (oral solution) of lopinavir and ritonavir with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

Store the liquid medicine in the refrigerator or at room temperature, away from heat or moisture. If you store the medicine at room temperature you must use it within 60 days.

Store the tablets or capsules at room temperature, away from heat and moisture. Keep the pills in their original container with the cap tightly closed.

What happens if I miss a dose (Kaletra)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Kaletra)?

Seek emergency medical attention if you think you have used too much of this medication. An overdose of lopinavir and ritonavir oral liquid could be fatal to a child.

What should I avoid while taking lopinavir and ritonavir (Kaletra)?

If you take lopinavir and ritonavir liquid and you also take didanosine, take the didanosine at least 1 hour before or 2 hours after you take lopinavir and ritonavir liquid.

Lopinavir and ritonavir oral liquid contains a large portion of alcohol. Avoid drinking alcohol while using this medicine. Tell your doctor if you also take metronidazole (Flagyl) or disulfiram (Antabuse), which can cause severe nausea and vomiting when taken with lopinavir and ritonavir liquid.

Taking this medication will not prevent you from passing HIV to other people through unprotected sex or sharing of needles. Talk with your doctor about safe methods of preventing HIV transmission during sex, such as using a condom and spermicide. Sharing drug or medicine needles is never safe, even for a healthy person.

What other drugs will affect lopinavir and ritonavir (Kaletra)?

Many drugs can interact with lopinavir and ritonavir. Below is just a partial list. Tell your doctor if you are using:

• fluticasone (Advair, Flonase, Flovent);
• antibiotics such as itraconazole (Sporanox), ketoconazole (Nizoral), rifabutin (Mycobutin);
• an antidepressant such as trazodone (Desyrel) and others;
• a blood thinner such as warfarin (Coumadin);
• a calcium channel blocker such as amlodipine (Caduet, Lotrel, Norvasc), diltiazem (Tiazac, Cartia, Dilacor), felodipine (Plendil), nifedipine (Procardia, Adalat), or verapamil (Calan, Covera, Isoptin, Verelan);
• cholesterol-lowering medicine such as atorvastatin (Lipitor), or rosuvastatin (Crestor);
• drugs that weaken the immune system, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf);
• heart rhythm medications such as amiodarone (Cordarone) or quinidine (Quinaglute, Quinidex);
• other HIV /AIDS medicine such as amprenavir (Agenerase), atazanavir (Reyataz), efavirenz (Sustiva), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), saquinavir (Invirase), and others;
• insulin or diabetes medication you take by mouth;
• medicines to treat erectile dysfunction, such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra); or
• seizure medications such as carbamazepine (Carbatrol, Tegretol), phenobarbital (Luminal, Solfoton), or phenytoin (Dilantin).

This list is not complete and there are many other medicines that can interact with lopinavir and ritonavir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about lopinavir and ritonavir.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Last Updated: April 12, 2009