Drug Notebook

FDA Alerts

Special Alerts:

[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.

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ritonavir
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(ri TOE na veer)

What is the most important information I should know about ritonavir?

Do not take ritonavir with alfuzosin (Uroxatral), amiodarone (Cordarone, Pacerone), bepridil (Vascor), flecainide (Tambocor), propafenone (Rythmol), quinidine (Quinaglute, Quinidex), voriconazole (Vfend), astemizole (Hismanal), terfenadine (Seldane), cisapride (Propulsid), pimozide (Orap), midazolam (Versed), triazolam (Halcion), or an ergot medicine such as Ergomar, Cafergot, Wigraine, D.H.E. 45, Migranal, Methergine. These drugs can cause life-threatening side effects if you use them while you are taking ritonavir.

There are many other medicines that can interact with ritonavir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Taking ritonavir will not prevent you from passing HIV to other people through unprotected sex or sharing of needles. Talk with your doctor about safe methods of preventing HIV transmission during sex, such as using a condom and spermicide. Sharing drug or medicine needles is never safe, even for a healthy person.

What is ritonavir?

Ritonavir is an antiviral medication in a group of HIV medicines called protease (PRO-tee-ayz) inhibitors. Ritonavir prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

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

Ritonavir may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking ritonavir?

Do not take this medication if you are allergic to ritonavir.

Do not take ritonavir with any of the following medications:
  • alfuzosin (Uroxatral);

  • amiodarone (Cordarone, Pacerone);

  • astemizole (Hismanal);

  • bepridil (Vascor);

  • cisapride (Propulsid);

  • flecainide (Tambocor);

  • midazolam (Versed) or triazolam (Halcion);

  • pimozide (Orap);

  • propafenone (Rythmol);

  • quinidine (Cardioquin, Quinidex, Quinaglute);

  • terfenadine (Seldane);

  • voriconazole (Vfend); or

  • ergot medicines such as ergotamine (Ergomar, Cafergot), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), or methylergonovine (Methergine).

These drugs can cause life-threatening side effects if you use them while you are taking ritionavir.

Before taking ritonavir, tell your doctor if you are allergic to any drugs, or if you have:

If you have any of these conditions, you may not be able to use ritonavir, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby, but HIV can be passed to the baby if the mother is not properly treated during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection while you are pregnant. Ritionavir 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 ritonavir. You should not breast-feed while you are using ritonavir. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.
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