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Abbott's Kaletra(R) Tablet Dosed Once-Daily or Twice-Daily Demonstrated Similar Clinical Results Across Race and Gender Lines
Date:8/5/2008

ipitor(R) (atorvastatin), Crestor(R) (rosuvastatin), Viagra(R) (sildenafil), Cialis(R) (tadalafil), Levitra(R) (vardenafil), oral contraceptives ("the pill") or the contraceptive patch, Mycobutin(R) (rifabutin), inhaled Flonase(R) (fluticasone), metronidazole, or disulfiram. Patients should talk with their doctor about all medicines they are taking or planning to take, including those without a prescription and herbal products.

KALETRA should not be given once-daily in combination with Sustiva(R) (efavirenz), Viramune(R) (nevirapine), Agenerase(R) (amprenavir), fosamprenavir, Viracept(R) (nelfinavir), phenobarbital, Dilantin(R) (phenytoin) or Tegretol(R) carbamazepine.

Patients and/or their care providers should pay special attention to accurate administration of the KALETRA dose to reduce the risk of accidentally giving too much or too little medicine.

The most commonly reported side effects of moderate severity that are thought to be drug related are abdominal pain, abnormal bowel movements, diarrhea, feeling weak/tired, headache and nausea. Children taking KALETRA may sometimes get a skin rash. Other side effects may occur.

Pancreatitis and liver problems, which can be fatal, have been reported in patients receiving KALETRA. 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.

Some patients have had large increases in triglycerides and cholesterol. Changes in body fat have been seen in some patients taking anti-HIV therapy. The long-term health effects of these conditions are not known at this time.

Diabetes and high blood sugar have occurred in patients taking protease inhibitors, such as KALETRA.

Some patients with hemophilia have increased bleeding with protease inhibitors.

The effects of KALETRA on pregnant women or their unborn babies are not known. Mothers taking KALET
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SOURCE Abbott
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