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KALETRA
LOPINAVIR/RITONAVIR CAPSULES - ORAL

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

LOPINAVIR/RITONAVIR CAPSULES - ORAL

(low-PIN-uh-veer/rye-TAWN-uh-veer)

COMMON BRAND NAME(S): 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.

How To Use

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 this drug 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). This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. Find out about other drugs that should not be taken with this product (see Drug Interactions section).

Side Effects

Diarrhea, headache, nausea, vomiting, 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. Tell your doctor immediately if you have any of these highly unlikely but very serious side effects: severe stomach pain, yellowing eyes and skin, dark urine, persistent fever, fatigue. Changes in body fat may occur while you are taking this medication (e.g., increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of therapy with your doctor, as well as the possible role of exercise to reduce this side effect. This medication 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 this medication. Consult your doctor or pharmacist for more information. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Tell your doctor your medical history, including: any allergies, liver disease, diabetes, pancreatitis, high cholesterol, bleeding problems (e.g., hemophilia), any other previous illnesses. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Because breast-feeding can transmit HIV, do not breast-feed.

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, amprenavir, zidovudine, abacavir, nevirapine), 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, oral contraceptives (e.g., ethinyl estradiol). This product may decrease the effectiveness of hormone-type birth control (oral contraceptives). Consult your doctor or pharmacist about using other birth control methods. 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 taking this medication. 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.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include change in amount of urine; or numbness or tingling in the arms, hands, legs, or feet.

Notes

This medication does not cure HIV. Patients treated with this medication 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 this medication with others. Laboratory and/or medical tests will be performed to monitor your progress.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is within 2 hours of the next dose, skip the missed dose and resume your usual dosing schedule. It is important not to miss doses of this drug. Remember to refill your medication on time to avoid missing doses.

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. Avoid exposure to excessive heat.

Medical Alert

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).