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KALETRA® (lopinavir/ritonavir) is a prescription anti-HIV medicine that contains two medicines. KALETRA is called a protease inhibitor and is used with other anti-HIV-1 medicines to treat people with human immunodeficiency virus (HIV-1) infection. KALETRA is for adults and for children age 14 days and older.

KALETRA does not cure HIV-1 infection or AIDS and does not reduce the risk of passing HIV-1 to others. People taking KALETRA may still get opportunistic infections or other conditions that happen with HIV-1.

Do not take KALETRA if you are allergic to KALETRA or any of its ingredients, including lopinavir or ritonavir. Do not take KALETRA with certain medicines, as they can cause serious problems or death or make KALETRA less effective against HIV. Some patients taking KALETRA can develop pancreas and liver problems, which can cause death. Patients may develop abnormal heart rhythms, large increases in triglycerides and cholesterol, diabetes, high blood sugar and/or changes in body fat. Some patients with hemophilia may have increased bleeding.

Click here for Important Safety Information about KALETRA.



Important Safety Information About KALETRA1

Do not take KALETRA if you are allergic to KALETRA or any of its ingredients, including lopinavir or ritonavir.

Drug Interactions:
The below list of drug interactions is not complete. You must tell your healthcare provider about all medicines you are taking or planning to take, including those without a prescription, vitamins, and herbal products.

Serious problems or death can happen if you take these medicines with KALETRA: ergot-containing medicines, including ergotamine (Cafergot® and others), dihydroergotamine (D.H.E. 45® and others), ergonovine (Ergotrate®), and methylergonovine (Methergine®); triazolam (Halcion®); midazolam oral syrup; pimozide (Orap®); lovastatin (Mevacor®); simvastatin (Zocor®); rifampin (Rimactane®, Rifadin®, Rifater®, or Rifamate®); or products containing St. John's wort (Hypericum perforatum).

The following medicines may need changes if you take KALETRA: birth control pills that contain estrogen ("the pill"), birth control (contraceptive) patches, atorvastatin (Lipitor®), rosuvastatin (Crestor®), efavirenz (Atripla® and Sustiva®), nevirapine (Viramune®), amprenavir (Agenerase®), fosamprenavir (Lexiva®), nelfinavir (Viracept®), phenytoin (Dilantin®), carbamazepine (Tegretol®), phenobarbital, sildenafil (Viagra®, Revatio®), tadalafil (Cialis®), vardenafil (Levitra®), rifabutin (Mycobutin®), inhaled fluticasone (Flonase®), metronidazole, and disulfiram.

KALETRA can cause serious side effects:
KALETRA may not be right for you. Tell your doctor about all your medical conditions.

Changes in your heart rhythm and the electrical activity of your heart can occur when taking KALETRA. These changes can lead to serious heart problems. Your risk for these problems may be higher if you already have a history of abnormal heart rhythm or other types of heart disease, or if you take other medicines that can affect your heart rhythm while you take KALETRA. Tell your healthcare provider if you experience dizziness, lightheadedness, fainting, and/or a sensation of abnormal heartbeats.

Liver problems, including death, can happen in people who take KALETRA. Tell your healthcare provider right away if you have a history of liver disease, such as hepatitis B or C, or if you have any of the following symptoms: loss of appetite, yellow skin and whites of eyes (jaundice), dark-colored urine, pale-colored stools, itchy skin, and/or abdominal pain.

Pancreas problems, which may be serious and cause death, have occurred in some people who take KALETRA. Tell your healthcare provider right away if you have nausea, vomiting, and/or abdominal pain.

Increase in certain fat (triglycerides and cholesterol) levels in the blood have occurred in some people receiving KALETRA. The long-term chance of getting complications such as heart attacks or strokes due to these increases in triglycerides and cholesterol caused by protease inhibitors is not known at this time.

New or more serious diabetes, or high blood sugar (hyperglycemia), have occurred in some people who take protease inhibitors, including KALETRA. Tell your healthcare provider if you notice an increase in thirst or urinate often while taking KALETRA.

Changes in body fat have been seen in some people who take antiretroviral (anti-HIV) therapy. The cause and long-term health effects of these conditions are not known at this time.

Increased bleeding has occurred in some people with hemophilia who take protease inhibitors, including KALETRA.

There is an increased risk of certain problems when you take medicines such as sildenafil (Viagra®, Revatio®), tadalafil (Cialis®), or vardenafil (Levitra®) with KALETRA , because the interaction with these medicines may result in an increase in their side effects, such as low blood pressure, vision changes, and/or erections lasting more than 4 hours.

Common side effects of KALETRA include diarrhea, nausea, abdominal pain, feeling weak, vomiting, headache, and upset stomach. These are not all of the possible side effects of KALETRA.

The effects of KALETRA on pregnant women or their unborn babies are not known. Mothers should not breast-feed if they are taking KALETRA or if they have HIV-1.

The long-term effects of KALETRA are not known at this time.

Use
KALETRA® (lopinavir/ritonavir) is a prescription anti-HIV medicine that contains two medicines. KALETRA is called a protease inhibitor and is used with other anti-HIV-1 medicines to treat people with human immunodeficiency virus (HIV-1) infection. KALETRA is for adults and for children age 14 days and older.

KALETRA does not cure HIV-1 infection or AIDS and does not reduce the risk of passing HIV-1 to others. People taking KALETRA may still get opportunistic infections or other conditions that happen with HIV-1.

Reference: 1. Kaletra [package insert]. North Chicago, IL: Abbott Laboratories.

Click here for full Prescribing Information and Medication Guide about KALETRA.



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