NORVIR (ritonavir)

Indication:

NORVIR® (ritonavir) is a class of medicines called the HIV protease (PRO-tee-ase) inhibitors. NORVIR is used in combination with other anti-HIV medicines to treat people with human immunodeficiency virus (HIV) infection. NORVIR is for adults and for children age one month and older.

 

Important Safety Information

NORVIR does not cure HIV infection or AIDS and does not reduce the risk of passing HIV to others.

Patients should not take NORVIR if they have had a serious allergic reaction to NORVIR or any of its ingredients.

Certain medicines should not be taken with NORVIR because the combination can cause serious or life-threatening problems such as irregular heartbeat, breathing difficulties or excessive sleepiness. Norvir should not be taken with Cordarone®, ergotamine, ergonovine, methylergonovine, and dihydroergotamines such as Cafergot®, Migranal®, D.H.E. 45® and others, as well as Halcion®, Hismanal®, Orap®, Propulsid®, Quinidine, also known as Quinaglute®, Cardioquin®, Quinidex®and others, Rythmol®, Seldane®, Tambocor®, Uroxatral®, Vascor®, Versed® , and Vfend®.

In addition, NORVIR should not be taken with inhaled Flonase®, or products containing St. John’s wort (Hypericum Perforatum). Particular caution should be used when taking Viagra®, Cialis®, or Levitra® since the interaction with NORVIR may result in an increase in these drug -related side effects such as low blood pressure, dizziness , changes in vision and prolonged erection. Patients should discuss all medicines, including those without a prescription and herbal preparations they are taking or plan to take, with their doctor or pharmacist.

Do not take NORVIR with the cholesterol-lowering medicines Mevacor® or Zocor® because of possible serious reactions. There is also an increased risk of drug interactions between NORVIR when taken with Lipitor or Crestor; talk to your doctor before you take any of these cholesterol-lowering medicines with NORVIR.

For patients taking didanosine (Videx) and NORVIR, the dose of these medicines should be separated by at least 2.5 hours Rifampin and saquinavir should not be taken with NORVIR. Patients should tell their doctor if they are taking rifampin and saquinavir.

Patients should tell their doctor if they are taking rifampin (also know as Rimactane®, Rifadin®, Rifater® or Rifamate®) as these medicines can reduce the levels of NORVIR.

Tipranavir given with 200 mg of ritonavir has been associated with reports of hepatitis and decreased liver function, including some deaths. Patients with chronic hepatitis B or C are at increased risk for liver toxicity.

Pancreatitis and liver problems, which may cause death, have been reported in patients receiving NORVIR. Patients should tell their doctor if they have nausea, vomiting, or abdominal pain, which may be signs of pancreatitis, or if they have or have had liver disease such as hepatitis B or C.

In patients taking protease inhibitors, increased bleeding (in patients with hemophilia) and diabetes/high blood sugar have occurred. Some patients receiving Norvir have had large increases in triglycerides and cholesterol.

Changes in body fat have been seen in some patients receiving antiretroviral therapy. The cause and long-term health effects of these conditions are not known at this time.

Varying degrees of cross-resistance among protease inhibitors have been observed.

The most commonly reported side effects are: feeling weak or tired, nausea, vomiting, diarrhea, loss of appetite, abdominal pain, changes in taste, tingling feeling or numbness in hands or feet or around the lips, headache, and dizziness. This is not a complete list of reported side effects.

Norvir oral solution contains alcohol.