Lopinavir/ ritonavir solution

Generic Name: lopinavir/ritonavir (loe-PIN-a-vir/ri-TOE-na-vir)
Brand Name: Kaletra

Lopinavir/ ritonavir solution is used for:

Treating HIV infection. It is used along with other medicines for HIV.

Lopinavir/ritonavir solution is a combination of 2 HIV protease inhibitors. It works by stopping the HIV virus from multiplying.

Do NOT use lopinavir/ ritonavir solution if:

  • you are allergic to any ingredient in lopinavir/ritonavir solution
  • you have a certain type of irregular heartbeat (congenital long QT syndrome) or low blood potassium levels
  • you are taking alfuzosin, avanafil, boceprevir, bosutinib, cabazitaxel, cisapride, conivaptan, crizotinib, enzalutamide, an ergot derivative (eg, dihydroergotamine, ergotamine, methylergonovine), lomitapide, lovastatin, lurasidone, meperidine, metronidazole, oral midazolam, pimozide, regorafenib, rifampin, rivaroxaban, salmeterol, simvastatin, St. John's wort, telaprevir, tolvaptan, triazolam, or vincristine
  • you are taking sildenafil to treat pulmonary arterial hypertension (PAH)
  • you have taken or will be taking eletriptan within 72 hours of taking lopinavir/ritonavir solution
  • you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using lopinavir/ ritonavir solution:

Some medical conditions may interact with lopinavir/ritonavir solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver problems (eg, hepatitis B or C) or abnormal liver function tests
  • if you have high cholesterol or triglyceride levels, or hemophilia or another bleeding disorder
  • if you have a history of kidney problems, pancreas problems (eg, pancreatitis), diabetes or high blood sugar (hyperglycemia), or low potassium or magnesium blood levels
  • if you have a history of alcohol abuse
  • if you have a history of heart problems (eg, heart failure, conduction abnormalities), heart blood vessel problems, or irregular heartbeat (eg, QT prolongation), or if you have a family member with a history of irregular heartbeat
  • if you take another HIV protease inhibitor (eg, atazanavir, tipranavir)

Some MEDICINES MAY INTERACT with lopinavir/ritonavir solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many prescription and nonprescription medicines (eg, used for abortion, aches or pain, alcoholism, allergies, asthma or other lung or breathing problems, birth control, blood thinning, blood vessel problems, bone marrow problems, cancer, Cushing syndrome, cystic fibrosis, depression or other mental or mood problems, diabetes, enlarged prostate, erectile dysfunction, gout, hepatitis C, high blood pressure, high cholesterol, HIV infection, immune suppression, infection, inflammation, irregular heartbeat or other heart problems, low blood sodium levels, migraines, PAH, seizures, sleep disorders, smoking cessation), multivitamin products, and herbal or dietary supplements (eg, garlic) because they may interact with lopinavir/ritonavir solution. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with lopinavir/ritonavir solution.

This may not be a complete list of all interactions that may occur. Ask your health care provider if lopinavir/ritonavir solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use lopinavir/ ritonavir solution:

Use lopinavir/ritonavir solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Lopinavir/ritonavir solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get lopinavir/ritonavir solution refilled.
  • Take lopinavir/ritonavir solution by mouth with food.
  • Use the dosing cup that comes with lopinavir/ritonavir solution to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
  • Lopinavir/ritonavir solution must be taken with other HIV medicines to be effective.
  • If you are also taking didanosine, take it at least 1 hour before or 2 hours after you take lopinavir/ritonavir solution.
  • Taking lopinavir/ritonavir solution at the same time each day will help you remember to take it.
  • Continue to take lopinavir/ritonavir solution even if you feel well. Do not miss any doses. Do not stop taking lopinavir/ritonavir solution without checking with your doctor.
  • If you miss a dose of lopinavir/ritonavir solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use lopinavir/ritonavir solution.

Important safety information:

  • Lopinavir/ritonavir solution may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start lopinavir/ritonavir solution.
  • Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking lopinavir/ritonavir solution. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
  • If the patient is a child, tell the child's doctor if his or her weight changes. The dose of lopinavir/ritonavir solution may need to be changed.
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking lopinavir/ritonavir solution, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
  • Do NOT change your dose or stop taking lopinavir/ritonavir solution without checking with your doctor.
  • Lopinavir/ritonavir solution is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
  • Lopinavir/ritonavir solution does not stop the spread of HIV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HIV to others.
  • Patients taking certain medicines for erectile dysfunction (eg, sildenafil, tadalafil, vardenafil) may experience low blood pressure, prolonged erections, and vision changes while taking lopinavir/ritonavir solution. Talk to your doctor before taking these medicines with lopinavir/ritonavir solution.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are taking lopinavir/ritonavir solution. To prevent pregnancy, use an extra form of birth control (eg, condoms).
  • Hemophilia patients - Some people with hemophilia have developed increased bleeding while taking protease inhibitors, such as lopinavir/ritonavir solution. Report all bleeding episodes to your doctor.
  • Lopinavir/ritonavir solution may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
  • Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Lab tests, including cholesterol and triglyceride levels, liver function, and blood glucose levels, may be performed while you use lopinavir/ritonavir solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Caution is advised when using lopinavir/ritonavir solution in CHILDREN; they may be more sensitive to its effects, especially skin rash.
  • Caution is advised when using lopinavir/ritonavir solution in BABIES; they may be more sensitive to its effects, especially drowsiness and breathing problems.
  • Lopinavir/ritonavir solution has alcohol and propylene glycol in it. Do not use it in PREMATURE NEWBORNS immediately after birth or in newborns younger than 14 days old, unless your doctor has directed you otherwise. It may cause serious and possibly fatal side effects, such as heart problems (eg, heart muscle problems, slow or irregular heartbeat), high blood lactic acid levels, severe kidney problems, and severe drowsiness or breathing problems. Discuss any questions or concerns with your doctor.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking lopinavir/ritonavir solution while you are pregnant. It is not known if lopinavir/ritonavir solution is found in breast milk. Do not breast-feed while taking lopinavir/ritonavir solution. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or lopinavir/ritonavir solution to the baby.

Possible side effects of lopinavir/ ritonavir solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache; mild stomach pain or upset; nausea; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dizziness or light-headedness; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; loss of consciousness; red, swollen, blistered, or peeling skin; severe or persistent nausea or vomiting; symptoms of high blood sugar (eg, confusion; flushed face; fruit-like breath odor; increased thirst, hunger, or urination; unusual drowsiness); symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, loss of appetite, stomach pain, unusual fatigue); symptoms of pancreatitis (eg, severe stomach or back pain, with or without nausea or vomiting); unusual bleeding or bruising.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of lopinavir/ritonavir solution:

Store lopinavir/ritonavir solution in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. If stored in the refrigerator, lopinavir/ritonavir solution may be used until the expiration date printed on the label. Lopinavir/ritonavir solution may also be stored at room temperature up to 77 degrees F (25 degrees C). If stored at room temperature, throw away any medicine that is left after 2 months. Store away from heat, moisture, and light. Do not store in the bathroom. Keep lopinavir/ritonavir solution out of the reach of children and away from pets.

General information:

  • If you have any questions about lopinavir/ritonavir solution, please talk with your doctor, pharmacist, or other health care provider.
  • Lopinavir/ritonavir solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take lopinavir/ritonavir solution or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about lopinavir/ritonavir solution. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to lopinavir/ritonavir solution. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using lopinavir/ritonavir solution.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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