Generic Name: lopinavir and ritonavir (loe PIN a vir and ri TOE na veer)
Brand Names: Kaletra

What is Kaletra?

Kaletra contains a combination of lopinavir and ritonavir. Lopinavir and ritonavir are antiviral medications that prevent human immunodeficiency virus (HIV) cells from multiplying in your body

Kaletra is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). This medicine is not a cure for HIV or AIDS.

Kaletra may also be used for purposes not listed in this medication guide.

Important information

You should not use Kaletra if you have ever had a severe allergic reaction to lopinavir or ritonavir.

Some medicines can interact with Kaletra and should not be used at the same time, especially: alfuzosin, cisapride, lovastatin, simvastatin, St. John's wort, pimozide, midazolam, triazolam, rifampin, sildenafil (Revatio for pulmonary arterial hypertension), or an ergot medicine (ergotamine, dihydroergotamine, methylergonovine).

Slideshow: Flashback: FDA Drug Approvals 2013

Before taking this medicine

You should not use Kaletra if you have ever had a severe allergic reaction to lopinavir or ritonavir.

Some medicines can cause unwanted or dangerous effects when used with Kaletra. Your doctor may need to change your treatment plan if you use any of the following drugs:

  • alfuzosin;

  • cisapride;

  • pimozide;

  • rifampin;

  • lovastatin, simvastatin;

  • midazolam, triazolam;

  • sildenafil (Revatio for pulmonary arterial hypertension);

  • St. John's wort; or

  • an ergot medicine (ergotamine, dihydroergotamine, methylergonovine).

To make sure Kaletra is safe for you, tell your doctor if you have:

  • liver disease (especially hepatitis B or C);

  • heart disease or a heart rhythm disorder;

  • a personal or family history of Long QT Syndrome;

  • pancreas problems;

  • diabetes;

  • low levels of potassium in your blood;

  • a bleeding disorder such as hemophilia;

  • high cholesterol or triglycerides; or

  • if you have ever used a protease inhibitor in the past.

FDA pregnancy category C. It is not known whether Kaletra will harm an unborn baby. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

See also: Pregnancy and breastfeeding warnings (in more detail)

Kaletra can make birth control pills or patches less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking Kaletra.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Do not give Kaletra to a child younger than 14 days old without medical advice. Premature infants should not receive the medication until it has been 14 days after their original due date.

How should I take Kaletra?

Take Kaletra exactly as prescribed by your doctor. Follow all directions on your prescription label, especially when giving the medicine to a child. Do not take this medicine in larger or smaller amounts or for longer than recommended.

If a child is taking this medication, tell your doctor if the child has any changes in weight. Kaletra doses are based on weight in children.

Do not crush, chew, or break a Kaletra tablet. Swallow the pill whole. The tablets can be taken with or without food.

Kaletra liquid should be taken with food. Measure liquid medicine with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

While using Kaletra, you may need frequent blood tests at your doctor's office.

Use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

Store Kaletra liquid in the refrigerator or at room temperature. If you store the liquid at room temperature you must use it within 60 days.

Store the tablets at room temperature, away from heat and moisture. Keep the pills in their original container with the cap tightly closed.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Kaletra oral liquid could be fatal to a child.

What should I avoid?

If you take Kaletra liquid and you also take didanosine (Videx), take the didanosine at least 1 hour before or 2 hours after you take the liquid.

The liquid medicine contains alcohol. Avoid drinking alcohol while using this medicine.

Taking this medication will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Kaletra side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Kaletra: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking Kaletra and call your doctor at once if you have:

  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

  • severe pain in your upper stomach spreading to your back, nausea and vomiting;

  • itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • high blood sugar (increased thirst, increased urination);

  • penis erection that is painful or lasts 4 hours or longer (if you take Kaletra with erectile dysfunction medication);

  • diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;

  • swelling in your neck or throat (enlarged thyroid);

  • muscle weakness, tired feeling, joint or muscle pain, feeling short of breath;

  • problems with walking, breathing, speech, swallowing, or eye movement;

  • weakness or prickly feeling in your fingers or toes, severe lower back pain, loss of bladder or bowel control; or

  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Kaletra side effects may include:

  • mild nausea, upset stomach;

  • headache, weakness;

  • mild stomach pain; or

  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Kaletra?

Many drugs can interact with Kaletra. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Kaletra, especially:

  • atovaquone;

  • bosentan;

  • colchicine;

  • disulfiram (Antabuse);

  • lamotrigine;

  • salmeterol with or without fluticasone;

  • an antibiotic--clarithromycin, metronidazole, rifabutin;

  • an antidepressant--bupropion, trazodone;

  • antifungal medication--itraconazole, ketoconazole, voriconazole;

  • a blood thinner such as rivaroxaban, warfarin, Coumadin;

  • cancer medications;

  • cholesterol medicine--atorvastatin, rosuvastatin;

  • medicines for pulmonary arterial hypertension or erectile dysfunction--avanafil, sildenafil (Viagra), tadalafil, vardenafil;

  • heart or blood pressure medicine such as amiodarone, felodipine, lidocaine, nicardipine, nifedipine, quinidine;

  • the hepatitis C medications boceprevir or telaprevir;

  • medicines to prevent organ transplant rejection;

  • narcotic medicine--fentanyl, methadone;

  • other HIV or AIDS medications, including efavirenz, nevirapine, nelfinavir;

  • seizure medicine--carbamazepine, phenobarbital, phenytoin, valproic acid; or

  • steroid medicine such as budesonide, dexamethasone, fluticasone, prednisone.

This list is not complete and many other drugs can interact with lopinavir and ritonavir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about Kaletra.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Kaletra only for the indication prescribed.
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