RibaPak is distributed by Par Pharmaceutical

If you would like additional information, please contact PAR Pharmaceutical at 1-800-828-9393 (www.parpharm.com) or Three Rivers Pharmaceuticals® at 800.405.8506.

RibaPak
(ribavirin) Tablets

Hepatitis C is a viral infection of the liver. It’s often chronic, and can lead to cirrhosis and liver cancer. It’s difficult to treat, and harder to cure. Diagnosis is based on the antibodies your body produces in response to hepatitis C infection, liver biopsy, and/or a PCR test that directly measures the hep C viral activity in your blood. You can be a carrier, or have a persistent infection. When to treat and the best way to treat hepatitis C is not yet known.

Who should get tested for hepatitis C?

  • persons who ever injected illegal drugs, including those who injected once or a few times many years ago
  • persons who were treated for clotting problems with a blood product made before 1987 when more advanced methods for manufacturing the products were developed
  • persons who were notified that they received blood from a donor who later tested positive for hepatitis C
  • persons who received a blood transfusion or solid organ transplant before July 1992 when better testing of blood donors became available
  • long-term hemodialysis patients
  • persons who have signs or symptoms of liver disease (e.g., abnormal liver enzyme tests)
  • healthcare workers after exposures (e.g., needle sticks or splashes to the eye ) to HCV-positive blood on the job
  • children born to HCV-positive women RibaPak (ribavirin) in combination with peginterferon alfa-2a is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A).

Now just two tablets a day instead of up to six

  • The first 400mg ribavirin tablets for chronic hepatitis C virus (HCV) infection
  • Up to 66% fewer tablets required than with Copegus® (ribavirin, USP)
  • Seven-day dose-at-a-glance package minimizes confusion
  • Simpler to dose, convenient for patients—and cost-effective

 

RibaPak is therapeutically equivalent to Copegus®

  • Each RibaPak 400mg tablet is bioequivalent to two 200mg tablets of Copegus®
  • Each RibaPak 600mg tablet is bioequivalent to three 200mg tablets of Copegus®

 

IMPORTANT SAFETY INFORMATION:
The most serious possible side effects of RibaPak (ribavirin) are:

  • Harm to unborn children. RibaPak (ribavirin) may cause birth defects or death of an unborn child.
  • Anemia. Anemia is a reduction in the number of red blood cells you have. Anemia can be dangerous, especially if you have heart or breathing problems. Tell your healthcare provider right away if you feel tired, have chest pain or shortness of breath. These may be signs of low red blood cell counts.
  • Liver Problems. Some patients may develop worsening of liver function. Some of the symptoms may include stomach bloating, confusion, brown urine, and yellow eyes. Tell your healthcare provider immediately if any of these symptoms occur.

Call your healthcare provider right away if you have any of the following symptoms. They may be signs of a serious side effect of RibaPak (ribavirin) and peginterferon alfa-2a treatment.

  • trouble breathing
  • hives or swelling
  • chest pain
  • severe stomach pain or low back pain
  • bloody diarrhea or bloody stools (bowel movements). These may look like black tar.
  • bruising or unusual bleeding
  • change in your vision
  • high fever (temperature greater than 100.5∞F)
  • you have psoriasis (a skin disease) and it gets worse
  • you become very depressed or think about suicide (ending your life)

The most common side effects of RibaPak (ribavirin) are likely to be the same as for other ribavirin products. These are:

  • feeling tired
  • nausea and appetite loss
  • rash and itching
  • cough

These are not all the possible side effects of RibaPak (ribavirin) treatment. For more information, ask your doctor or pharmacist and see the PEGASYS Medication Guide.

HOW SUPPLIED
RibaPak (ribavirin) is available as tablets for oral administration.

RibaPak Dose Package Contents
RibaPak
400 mg-400 mg
400 mg AM
400 mg PM
400 mg tablets (56)
for 28 days
RibaPak
400 mg-600 mg
600 mg AM
400 mg PM
400 mg and 600 mg tablets
(28 each) for 28 days
RibaPak
600 mg-600 mg
600 mg AM
600 mg PM
600 mg tablets (56)
for 28 days

 

Storage Conditions
Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F)
[see USP Controlled Room Temperature].

1 PEGASYS® is a registered trademark of Hoffmann-La Roche
2 REBETRON™ is a trademark of Schering Corporation

Please download the PACKAGE INSERT for complete prescribing information.

RibaPak is distributed by Par Pharmaceutical

If you would like additional information, please contact PAR Pharmaceutical at 1-800-828-9393 (www.parpharm.com) or Three Rivers Pharmaceuticals at 800.405.8506.

Please download the
PACKAGE INSERT

for complete prescribing information.

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