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Ritonavir Oral solution

It is used with other medicines to treat HIV

Generic Name: ritonavir

Brand Names: Norvir

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[Posted 10/21/2010] ISSUE: FDA notified healthcare professionals of new risk information added to the Warnings and Precautions, Contraindications, and Clinical Pharmacology sections of the antiviral drug saquinavir (Invirase), describing a potential change in the electrical activity of the heart when saquinavir is used with another antiviral medication, ritonavir (Norvir). Changes in the electrical activity of the heart may lead to abnormal heart rhythms, known as prolonged QT or PR intervals. A prolonged QT interval can lead to a serious abnormal rhythm called torsades de pointes, which can be fatal. A prolonged PR interval can lead to a serious abnormal rhythm called complete heart block. Torsades de pointes and complete heart block have been reported in patients taking saquinavir with ritonavir

BACKGROUND: The medications saquinavir and ritonavir are given together to treat HIV infection. Ritonavir must be given at a low dose with saquinavir in order to increase the level of saquinavir in the body. In February 2010, FDA announced it was reviewing clinical trial data about a potentially serious effect on the heart from the use of saquinavir in combination with ritonavir. This new information was derived from a clinical study designed to study a drug’s impact on the electrical activity of the heart.

RECOMMENDATION: Patients at particular risk are those with underlying heart conditions or those who have existing heart rate or rhythm problems. An electrocardiogram should be performed prior to initiation of treatment. Physicians consider whether ongoing EKG monitoring is appropriate for patients and when it should be done. The Data Summary in the Drug Safety Communication provides more details.

FDA will require that a Medication Guide be given to patients when picking up a prescription for Invirase. The Medication Guide will include information on the risk of abnormal heart rhythms. For more information visit the FDA website at: [Web] and [Web].

[Posted 02/23/2010] FDA notified healthcare professionals and patients that it is reviewing clinical trial data about a potentially serious effect on the heart from the use of saquinavir (Invirase) in combination with ritonavir (Norvir), antiviral medications given together to treat HIV infection.

The data suggest that together the two drugs may affect the electrical activity of the heart, known as prolonged QT or PR intervals. A prolonged QT interval can increase the risk for a serious abnormal rhythm called torsades de pointes. A prolonged PR interval can cause the electrical signal responsible for generating a heart beat to slow or even stop, known as heart block.

FDA's analysis of these data is ongoing. The agency will update the public as soon as this review is complete. However, healthcare professionals should be aware of this potential risk for changes to the electrical activity of the heart. Saquinavir and ritonavir should not be used in patients already taking medications known to cause QT interval prolongation such as Class IA (such as quinidine,) or Class III (such as amiodarone) antiarrhythmic drugs, or in patients with a history of QT interval prolongation.

Patients should not stop taking their prescribed antiviral medications. Patients who are concerned about possible risks associated with using saquinavir and ritonavir should talk to their healthcare professional.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Online: [Web]
  • Phone: 1-800-332-1088
  • Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch “Download Forms” page ([Web]), to address on the pre-addressed form
For more information visit the FDA website at: [Web] and [Web].

REMS:

FDA approved a REMS for ritonavir to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

What is this medicine?

RITONAVIR (ri TOE na veer) is an antiretroviral medicine. It is used with other medicines to treat HIV. This medicine is not a cure for HIV. It will not stop the spread of HIV to others.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • diabetes
  • hemophilia
  • high cholesterol or triglycerides
  • liver disease
  • an unusual or allergic reaction to ritonavir, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine with food. Shake well before using. Use a specially marked spoon or dropper to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. You can mix the dose with chocolate milk, Ensure, or Advera to make it taste better. Take the medicine within 1 hour if you mix it with these items. Throw it away if you cannot take it within 1 hour. Take your medicine at regular intervals. Do not take your medicine more often than directed. For your anti-HIV therapy to work as well as possible, take each dose exactly as prescribed. Do not skip doses or stop your medicine even if you feel better. Skipping doses may make the HIV virus resistant to this medicine and other medicines. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 1 month old for selected conditions, precautions do apply.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • alfuzosin
  • medicines for irregular heart beat like amiodarone, bepridil, dofetilide, encainide, flecainide, propafenone, quinidine
  • cerivastatin
  • cisapride
  • conivaptan
  • disulfiram
  • eplerenone
  • lovastatin
  • medicines for headaches like dihydroergotamine, ergonovine, ergotamine, methylergonovine
  • meperidine
  • metronidazole
  • midazolam
  • pimozide
  • ranolazine
  • red yeast rice
  • rifapentine
  • simvastatin
  • St. John's wort
  • triazolam
  • voriconazole

This medicine may also interact with the following medications:

  • atovaquone
  • birth control pills, patches, rings, or injections
  • clarithromycin
  • cyclosporine
  • dronabinol
  • itraconazole
  • ketoconazole
  • medicines for blood pressure, heart disease, irregular heart beat
  • medicines for cholesterol like atorvastatin
  • medicines for depression, anxiety, or psychotic disturbances
  • medicines for erectile dysfunction
  • medicines for seizures
  • medicines for sleep
  • methamphetamine
  • other medicines for HIV
  • propoxyphene
  • rifabutin
  • rifampin
  • rivaroxaban
  • sirolimus
  • steroid medicines like budesonide, dexamethasone, fluticasone, prednisone
  • tacrolimus
  • theophylline
  • tramadol
  • warfarin

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine.

HIV is spread to others through sexual or blood contact. Talk to your doctor about how to stop the spread of HIV.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control. Women who can still have children must use a reliable form of barrier contraception, like a condom or diaphragm.

This medicine may affect blood sugar levels. If you have diabetes, check with your doctor or health care professional before you change your diet or the dose of your diabetic medicine.


Last Updated: November 28, 2012
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