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Lopinavir and Ritonavir

(loe pin' a veer) (ri toe' na veer)

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IMPORTANT WARNING:   Return to top

[Posted 03/12/2008] FDA and Tibotec Therapeutics notified healthcare professionals of changes to the WARNINGS section of the prescribing information for darunavir (Prezista) tablets regarding the risk of hepatotoxicity. In clinical trials and postmarketing experience, drug induced hepatitis has been reported in patients receiving combination therapy with darunavir/ritonavir. Appropriate laboratory testing should be conducted prior to initiating therapy with darunavir/ritonavir and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases, especially during the first several months of darunavir/ritonavir treatment. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Prezista, http://www.fda.gov/medwatch/safety/2008/prezista_DHCP.pdf and http://www.fda.gov/cder/foi/label/2008/021976s003s004lbl.pdf.

[Posted 08/14/2007] Abbott Laboratories disseminated a Dear Healthcare Provider Letter throughout the world to physicians and pharmacists that prescribe/distribute lopinavir and ritonavir (Kaletra Oral Solution). The letter informed healthcare professionals of an accidental overdose that occurred with a pediatric patient taking lopinavir and ritonavir oral solution. The infant received a significantly large dose of lopinavir and ritonavir oral solution and subsequently died. Healthcare professionals should pay special attention to accurate calculation of the dose of lopinavir and ritonavir oral solution, transcription of the medication order, dispensing information and dosing instructions to minimize the risk for medication errors. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#kaletra, http://www.fda.gov/medwatch/safety/2007/Kaletra_DHCP.pdf and http://www.fda.gov/medwatch/safety/2007/Mar_PI/Kaletra_PI_200703.pdf.

Why is this medication prescribed?   Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

The combination of lopinavir and ritonavir is used with other antiviral medications to treat human immunodeficiency virus (HIV) in patients with acquired immunodeficiency syndrome (AIDS). Lopinavir is in a class of medications called protease (pro' tee ace) inhibitors. It works by slowing the spread of HIV in the body. In this combination, ritonavir is used to increase the amount of lopinavir in the body so it can work better. Lopinavir and ritonavir is not a cure and may not decrease the number of HIV-related illnesses. Lopinavir and ritonavir does not prevent the spread of HIV to other people.

How should this medicine be used?   Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

The combination of lopinavir and ritonavir comes as a capsule and a solution (liquid) to take by mouth. It is usually taken twice a day with food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take lopinavir and ritonavir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take lopinavir and ritonavir even if you feel well. Do not stop taking lopinavir and ritonavir without talking to your doctor.

Other uses for this medicine   Return to top

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?   Return to top

Before taking lopinavir and ritonavir,

What special dietary instructions should I follow?   Return to top

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?   Return to top

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?   Return to top

Lopinavir and ritonavir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

Lopinavir and ritonavir may cause high blood sugar. If you experience any of the following symptoms, call your doctor immediately:

Lopinavir and ritonavir may cause increases in levels of cholesterol and other fats (triglycerides) in the blood.

Lopinavir and ritonavir may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?   Return to top

Keep this medication in the container it came in, tightly closed, and out of reach of children. If you store lopinavir and ritonavir capsules or solution in the refrigerator, they can be used until the expiration date printed on the label. If you store them at room temperature, the capsules or solution should be used within 2 months. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose   Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?   Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to lopinavir and ritonavir.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names of combination products   Return to top

  • Kaletra®

Last Revised - 09/01/2007
Last Reviewed - 08/01/2007


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