Lopinavir (loe-PIN-a-vir), Ritonavir (rit-OH-na-vir)
Treats human immunodeficiency virus (HIV) infection. HIV causes acquired immune deficiency syndrome (AIDS). This medicine does not cure HIV or AIDS. It is used with other medicines to slow the progress of the disease.
There may be other brand names for this medicine.
When This Medicine Should Not Be Used
You should not use this medicine if you have had a severe allergic reaction to lopinavir or ritonavir. Do not use this medicine if you are also using alfuzosin (Uroxatral®), cisapride (Propulsid®), dihydroergotamine (Migranal®), ergonovine, ergotamine (Cafergot®), lovastatin (Advicor®, Altoprev®, Mevacor®), methylergonovine (Methergine®), oral midazolam (Versed®), pimozide (Orap®), rifampin (Rifadin®), salmeterol (Advair®, Serevent®), sildenafil (Revatio®), simvastatin (Simcor®, Vytorin®, Zocor®), St. John's wort, or triazolam (Halcion®). Kaletra® should not be used once a day in children. Kaletra® oral liquid should not be given to premature infants.
How to Use This Medicine
- Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
- This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.
- You may take the Kaletra® tablet with or without food. The liquid medicine must be taken with food.
- Swallow the tablet whole. Do not crush, break, or chew it.
- Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
- Take all other medicines your doctor has prescribed as part of your combination treatment. Do not stop using your medicine unless your doctor tells you to. The amount of virus in your blood may increase and become harder to treat.
- This medicine works best if there is a constant amount in the blood. To keep blood levels constant, take this medicine at the same time each day and do not miss any doses. Also, when your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.
If a dose is missed:
- If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.
How to Store and Dispose of This Medicine
- Store the Kaletra® liquid in the refrigerator or at room temperature in a closed container. If stored at room temperature, use the medicine within 2 months. Keep away from excessive heat. The tablets should be stored in a closed container at room temperature, away from heat, moisture, and direct light.
- Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
- Keep all medicine away from children and never share your medicine with anyone.
Drugs and Foods to Avoid
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.
- Make sure your doctor knows if you are using other medicines to treat HIV/AIDS (such as abacavir, amprenavir, atazanavir, delavirdine, efavirenz, fosamprenavir, indinavir, maraviroc, nelfinavir, nevirapine, saquinavir, tenofovir, tipranavir, zidovudine, Agenerase®, Aptivus®, Atripla®, Crixivan®, Lexiva®, Reyataz®, Selzentry?, Sustiva®, Viracept®, or Viramune®), medicine for heart rhythm problems (such as amiodarone, bepridil, digoxin, lidocaine, quinidine, Cardioquin®, Cordarone®, or Lanoxin®), medicine to treat seizures (such as carbamazepine, phenobarbital, phenytoin, Dilantin®, or Tegretol®), medicine to treat a fungus infection (such as itraconazole, ketoconazole, voriconazole, Nizoral®, Sporanox®, or Vfend®), certain blood pressure medicines (such as atenolol, felodipine, metoprolol, nicardipine, nifedipine, Adalat®, Cardene®, Plendil®, or Toprol®), certain cancer medicines (such as vinblastine, vincristine, Oncovin®, or Vincasar®), or a blood thinner (such as warfarin or Coumadin®).
- Tell you doctor if you are also using medicines that weaken the immune system (such as cyclosporine, sirolimus, tacrolimus, Gengraf®, Neoral®, Protopic®, Rapamune®, or Sandimmune®), a steroid medicine (such as dexamethasone, fluticasone, Decadron®, or Flonase®), medicine to lower cholesterol (such as atorvastatin, rosuvastatin, Crestor®, or Lipitor®), atovaquone (Mepron®), bosentan (Tracleer®), bupropion (Wellbutrin®), clarithromycin (Biaxin®), colchicine (Colcrys®), fentanyl (Duragesic®), methadone (Dolophine®), midazolam injection (Dormicum®), rifabutin (Mycobutin®), sildenafil (Viagra®), tadalafil (Adcirca®, Cialis®), trazodone (Desyrel®), vardenafil (Levitra®), or birth control pills (such as Loestrin®, Ortho-Novum®, or Ovcon®).
- If you also use didanosine (Videx®), take it one hour before or two hours after taking Kaletra® liquid. Didanosine can be taken (without food) at the same time as Kaletra® tablets.
Warnings While Using This Medicine
- Make sure your doctor knows if you are pregnant, or if you or your child have a history of pancreatitis, diabetes, liver disease (such as cirrhosis, hepatitis B or C), or hemophilia (a bleeding disorder). Your doctor needs to know if you have high cholesterol or triglycerides in your blood, or if you have a family history of these problems. Tell your doctor if you have a history of heart disease (such as cardiomyopathy, heart attack, ischemic heart disease) or heart rhythm problems (such as a prolonged PR or QT interval, congenital long QT syndrome), or have low potassium in the blood.
- You should not breastfeed if you have HIV or AIDS, because you might give the infection to your baby through your breast milk.
- This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex, even if your partner also has HIV. Do not share needles with anyone.
- Birth control pills that contain estrogen may not work as well while you are using this medicine. To keep from getting pregnant, use another form of birth control together with your pills. Other forms include condoms, diaphragms, or contraceptive foams or jellies.
- Pancreatitis may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
- Check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.
- If you or your child are taking the oral liquid, you should limit the amount of alcohol you drink. The Kaletra® oral liquid contains 42% alcohol. Talk to your doctor if you or your child are taking, or plan on taking, metronidazole (Flagyl®) or disulfiram (Antabuse®).
- This medicine can cause changes in heart rhythms, such as a condition called PR or QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you or your child have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.
- When you start taking HIV medicines, your immune system may get stronger. If you have infections that are hidden in your body, such as pneumonia or tuberculosis, you or your child may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor immediately.
- This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area; or a loss of fat from the legs, arms, and face.
- This medicine may increase the level of cholesterol and fats in your blood. If this condition occurs, your doctor may give you a medicine to lower the cholesterol and fats. Talk to your doctor if you or your child have concerns.
- Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects.
Possible Side Effects While Using This Medicine
Call your doctor right away if you notice any of these side effects:
- Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
- Blistering, peeling, or red skin rash.
- Chest pain.
- Dark-colored urine or pale stools.
- Fast, pounding, or uneven heartbeat.
- Fever or chills.
- Increased hunger or thirst, and frequent urination.
- Lightheadedness, dizziness, or fainting.
- Nausea, vomiting, loss of appetite, or pain in your upper stomach.
- Numbness or weakness in your arm or leg, or on one side of your body.
- Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
- Pain in your lower leg (calf).
- Rapid weight gain.
- Sudden and severe stomach pain, nausea, or vomiting.
- Sudden or severe headache, or problems with vision, speech, balance, or walking.
- Swelling in your hands, ankles, or feet.
- Twitching or muscle movements you cannot control.
- Unusual bleeding, bruising, or weakness.
- Yellowing of your skin or the whites of your eyes.
If you notice these less serious side effects, talk with your doctor:
- Diarrhea, stomach pain or upset.
- Gaining weight around your neck, upper back, breast, face, or waist.
- Mild headache.
- Mild skin rash.
- Unusual or bad taste in your mouth.
If you notice other side effects that you think are caused by this medicine, tell your doctor
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
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