Important Safety Information
Do not take KALETRA if you are allergic to KALETRA or any of its ingredients, including lopinavir or ritonavir. Skin rashes, some of them severe, can occur in people who take KALETRA. Tell your doctor if you had a rash when you took another medicine for HIV or if you notice any skin rash when you take KALETRA.
Drug Interactions:
The list of drug interactions below is not complete. You must tell your doctor 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®); sildenafil (Revatio®) only when used to treat pulmonary arterial hypertension; alfuzosin (Uroxatral®); 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, nilotinib (Tasigna®) and dasatinib (Sprycel®), atorvastatin (Lipitor®), rosuvastatin (Crestor®), efavirenz (Atripla® and Sustiva®), nevirapine (Viramune®), amprenavir (Agenerase®), fosamprenavir (Lexiva®), nelfinavir (Viracept®), phenytoin (Dilantin®), carbamazepine (Tegretol®), phenobarbital, sildenafil (Viagra®), tadalafil (Cialis®, Adcirca®), vardenafil (Levitra®), rifabutin (Mycobutin®), inhaled fluticasone (Flonase®), salmeterol (Serevent®) and salmeterol in combination with fluticasone propionate (Advair®), colchicine (Colcrys®), bosentan (Tracleer®), fentanyl (Duragesic®, IonsysTM, Fentora®) and methadone.
KALETRA should not be taken once daily if you take carbamazepine (Tegretol® and Epitol®), phenobarbital (Luminal®), or phenytoin (Dilantin®).
There is an increased risk of certain problems when you take medicines used for the treatment of erectile problems such as sildenafil (Viagra®), 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 (dizziness or fainting), vision changes, and/or erections lasting more than 4 hours. Tell your doctor right away if you experience any of these side effects.
KALETRA oral solution contains a large amount of alcohol. Talk with your doctor if you take or plan to take metronidazole (Flagyl®) or disulfiram (Antabuse®). You can have severe nausea and vomiting if you take these medicines with KALETRA.
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 doctor right away if you experience dizziness, lightheadedness, fainting, and/or a sensation of abnormal heartbeats.
Liver problems, including death, can happen in people who take KALETRA. Blood tests in people who take KALETRA may show possible liver problems. People with liver disease such as hepatitis B or C who take KALETRA may have worsening liver disease. People should tell their doctor right away if they have any of the following signs and symptoms: loss of appetite, yellowing of skin or eyes (jaundice), dark-colored urine, pale-colored stools, itchy skin, and/or stomach area (abdominal) pain.
Inflammation of the pancreas (pancreatitis), which may be serious and cause death, has occurred in some people who take KALETRA. You have a higher chance of having pancreatitis if you have had it before. Tell your doctor if you have nausea, vomiting, and/or abdominal pain, as these may be signs of pancreatitis.
Immune reconstitution syndrome may occur after starting anti-HIV medicines, including KALETRA. This happens when you develop signs and symptoms of serious infections you already have, which may require additional treatment.
Large increases 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 and high blood sugar (hyperglycemia) have occurred in some people who take protease inhibitors, including KALETRA. Tell your doctor 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 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.
If you are taking birth control pills or using patches to prevent pregnancy, you should use an extra form or a different type of birth control, since birth control pills or patches may not work as well while you take KALETRA. Talk to your doctor about how to prevent pregnancy while taking KALETRA.
It is not known if KALETRA will harm your unborn baby. If you are pregnant or planning to become pregnant, you should tell your doctor.
If you take KALETRA during pregnancy, you should talk with your doctor about how you can take part in an Antiretroviral Pregnancy Registry. The purpose of the pregnancy registry is to follow the health of you and your baby.
Do not breast-feed while taking KALETRA. There is a chance HIV can be passed to your baby through breast milk and your baby may have serious side effects from KALETRA.
Common side effects of KALETRA include diarrhea, nausea, stomach area (abdominal) pain, feeling weak, vomiting, headache, or upset stomach. These are not all of the possible side effects of KALETRA.
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