KALETRA

Drug Name: KALETRA

KALETRA DESCRIPTION:
LOPINAVIR/RITONAVIR SOLUTION - ORAL (low-PIN-uh-veer/rye-TAWN-uh-veer)

COMMON KALETRA BRAND NAME(S):
Kaletra

KALETRA SIDE EFFECTS:
Diarrhea, headache, nausea, vomiting, drowsiness, dizziness, weakness, rash, and trouble sleeping may occur. If these effects persist or worsen, notify your doctor. Tell your doctor immediately if you have any of these serious side effects: increased thirst or urination, blurred vision, swelling, stomach pain, chills, joint or muscle pain. Tell your doctor immediately if you have any of these unlikely but serious side effects: leg pain, mouth sores, persistent sore throat or fever, weight loss, change in body fat, mental/mood changes, trouble breathing, vision changes, urination problems, decreased sexual ability. KALETRA may cause an increase in cholesterol or fat levels (triglycerides) in the blood. Cholesterol and triglyceride testing should be done before taking, and occasionally during treatment with, KALETRA. Consult your doctor or pharmacist for more information. If you notice other effects not listed above, contact your doctor or pharmacist.

HOW TO USE KALETRA:
KALETRA: Take this product by mouth, usually twice daily with food; or as directed by your doctor. The amount of drug prescribed is based on your medical condition and response to therapy. Do not take more or less of KALETRA than prescribed, or stop taking it (or other HIV medicines), even for a brief time, unless directed to do so by your doctor. This may cause the amount of the virus to increase or may make the virus more difficult to treat (develop resistance). KALETRA works best when the amount of drug in your body is kept at a constant level. Therefore, take KALETRA at evenly spaced intervals. Find out about other drugs that should not be taken with this product (see Drug Interactions section).

KALETRA USES:
This combination product is used, along with other medications, to treat Human Immunodeficiency Virus (HIV) infection. These medications belong to a class of drugs called protease inhibitors that block an enzyme needed for HIV to multiply. Decreasing the amount of HIV in your body helps reduce complications, such as infections (opportunistic types such as pneumocystis pneumonia). This product does not cure HIV.

KALETRA PRECAUTIONS:
Tell your doctor your medical history, including any allergies, liver disease, diabetes, pancreatitis, high cholesterol, bleeding problems (e.g., hemophilia), heart disease, or any other previous illnesses. This product contains a large amount of alcohol and may make you dizzy or drowsy. Use caution engaging in activities requiring alertness. Limit alcoholic beverages. Caution is advised when using this product in children. This product contains a large amount of alcohol and accidental overdose could be serious. KALETRA should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether KALETRA passes into breast milk. Because breast-feeding can transmit HIV, do not breast-feed.

KALETRA DRUG INTERACTIONS:
Certain medications taken with this product could result in serious, or even fatal, drug interactions. This drug is not recommended for use with: certain heart medications (e.g., antiarrhythmics such as flecainide, propafenone); astemizole, terfenadine, rifampin, ergot drugs (e.g., dihydroergotamine, ergonovine, methylergonovine, ergotamine); cisapride, certain "statins" (e.g., lovastatin, simvastatin); St John's wort, pimozide, certain sedatives (e.g., midazolam, triazolam). Tell your doctor if you are taking any of these other prescription or non-prescription medications: all other HIV drugs (e.g., efavirenz, nevirapine, amprenavir, zidovudine, abacavir); other heart rhythm medication (e.g., amiodarone, bepridil, lidocaine, quinidine); "blood thinners" (e.g., warfarin); seizure medication (e.g., phenytoin, carbamazepine, phenobarbital); macrolide antibiotics (e.g., clarithromycin); antifungals (e.g., ketoconazole, itraconazole); rifabutin, atovaquone, calcium channel blockers (e.g., felodipine, nifedipine, nicardipine); dexamethasone, sildenafil, other "statins" (atorvastatin, cerivastatin); cyclosporine, tacrolimus, rapamycin, methadone, disulfiram, metronidazole, drugs used to produce sleep, sedatives, tranquilizers, anti-anxiety drugs, narcotic pain relievers (e.g., codeine), psychiatric medicines, muscle relaxants, antihistamines that cause drowsiness (e.g., diphenhydramine). This product may decrease the effectiveness of hormone-type birth control (oral contraceptives). Consult your doctor or pharmacist about using other birth control methods. Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask you pharmacist about the safe use of those products. Do not eat grapefruit or drink grapefruit juice unless your doctor instructs you otherwise. If you are taking didanosine in addition to this product, take it one hour before or two hours after KALETRA. This product may interfere with certain laboratory tests (e.g., cholesterol, triglycerides, GGT, aminotransferases, glucose). Do not start or stop any medicine without doctor or pharmacist approval.

KALETRA OVERDOSE:
If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include numbness or tingling in the arms, hands, legs, or feet; or change in amount of urine, drowsiness, dizziness, loss of consciousness, or shallow breathing.

KALETRA NOTES:
KALETRA does not cure HIV. Patients treated with KALETRA may continue to acquire "opportunistic" infections associated with HIV. This product also does not prevent the spread of HIV to others through sexual contact or blood. Do not share KALETRA with others. Laboratory and/or medical tests will be performed to monitor your progress.

MISSED KALETRA DOSE:
It is very important to take KALETRA exactly as prescribed. However, if you miss a dose, use 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. Remember to refill your medication on time to avoid missing doses.

KALETRA STORAGE:
Store at refrigerated temperature between 36 and 46 degrees F (2 to 8 degrees C) away from light and moisture. If stored at room temperature (77 degrees F or 25 degrees C), this product should be used within 2 months. Your condition can cause complications in a medical emergency. For information on enrollment call Medic Alert (TM) at 1-800-854-1166. In Canada call 1-800-668-1507.