RibaTab

Ribavirin is a prescription medicine used with either interferon alfa-2b (Intron A) or peginterferon alfa-2b (PegIntron) to treat chronic (lasting a long time) hepatitis C infection in people 3 years and older with liver disease.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Ribavirin may cause serious side effects, including:

See "Drug Precautions".

• Swelling and irritation of your pancreas (pancreatitis). You may have stomach pain, nausea, vomiting, or diarrhea.
• Serious breathing problems. Difficulty breathing may be a sign of a serious lung infection (pneumonia) that can lead to death.
• Serious eye problems that may lead to vision loss or blindness.
• Dental problems. Your mouth may be very dry, which can lead to problems with your teeth and gums.
• Severe depression
• Suicidal thoughts and attempts. Adults and children who take ribavirin, especially teenagers, are more likely to have suicidal thoughts or attempt to hurt themselves while taking ribavirin. Call your healthcare provider right away or go to the nearest hospital emergency room if you have new or worse depression or thoughts about suicide or dying.
• Severe blood disorders. An increased risk when used in combination with pegylated alpha interferons and azathioprine
• Weight loss and slowed growth in children

Tell your health care provider right away if you have any side effect that bothers you or that does not go away.

The most common side effects of ribavirin include:

• flu-like symptoms - feeling tired, headache, shaking along with high temperature (fever), nausea, and muscle aches.
• mood changes, feeling irritable.

The most common side effects of ribavirin in children include:

• a decrease in the blood cells that fight infection (neutropenia).
• a decrease in appetite.
• stomach pain and vomiting.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of ribavirin. For more information ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription medicines, vitamins, and herbal supplements. Ribavirin may affect the way other medicines work.

Especially tell your healthcare provider if you take didanosine (Videx) or azathioprine (Imuran and Azasan).

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

1. Do Not take ribavirin alone to treat chronic hepatitis C infection. Ribavirin should be used in combination with either interferon alfa-2b (Intron A) or peginterferon alfa-2b (PegIntron) to treat chronic hepatitis C infection.
2. Ribavirin may cause a significant drop in your red blood cell count and cause anemia in some cases. Anemia has been associated with worsening of heart problems, and in rare cases can cause a heart attack and death. Tell your healthcare provider if you have ever had any heart problems. Ribavirin may not be right for you. Seek medical attention right away if you experience chest pain.
3. Ribavirin may cause birth defects or the death of your unborn baby. Do not take ribavirin if you or your sexual partner is pregnant or plan to be come pregnant. Do not become pregnant within 6 months after discontinuing ribavirin therapy. You must use 2 forms of birth control when you take ribavirin and for the 6 months after treatment.
   • Females must have a pregnancy test before starting ribavirin, every month while taking ribavirin, and every month for the 6 months after the last dose of ribavirin.
   • If you or your female sexual partner becomes pregnant while taking ribavirin or within 6 months after you stop taking ribavirin, tell your healthcare provider right away. You or your healthcare provider should contact the ribavirin pregnancy registry by calling 1-800-593-2214. The ribavirin pregnancy registry collects information about what happens to mothers and their babies if the mother takes ribavirin while she is pregnant.

Do not take ribavirin if you have:

• or ever had serious allergic reactions to the ingredients in ribavirin.
• certain types of hepatitis (autoimmune hepatitis).
• certain blood disorders (hemoglobinopathies).
• severe kidney disease.
• take didanosine (Videx).

Talk to your healthcare provider before taking ribavirin if you have any of these conditions.

Before you take ribavirin, tell your healthcare provider if you have or ever had:

• treatment for hepatitis C that did not work for you.
• breathing problems. Ribavirin may cause or worsen breathing problems you already have.
• vision problems. Ribavirin may cause eye problems or worsen eye problems you already have. You should have an eye exam before you start treatment with ribavirin.
• certain blood disorders such as anemia (low red blood cell count).
• high blood pressure, heart problems, or have had a heart attack. Your healthcare provider should check your blood and heart before you start treatment with ribavirin.
• thyroid problems
• liver problems other than hepatitis C infection
• human immunodeficiency virus (HIV) or any immunity problems
• mental health problems, including depression or thoughts of suicide
• kidney problems
• an organ transplant
• diabetes. Ribavirin may make your diabetes worse or harder to treat.
• any other medical condition
• are breastfeeding. It is not known if ribavirin passes into your breast milk. You and your healthcare provider should decide if you will take ribavirin or breast feed.

Tell your healthcare provider about all the medicines you take, including prescription medicines, vitamins, and herbal supplements. Ribavirin may affect the way other medicines work.

• Store ribavirin capsules between 59°F to 86°F (15°C to 30°C).
• Store ribavirin oral solution between 59°F to 86°F (15°C to 30°C) or in the refrigerator between 36°F to 46°F (2°C to 8°C).

Keep ribavirin and all medicines out of the reach of children.

Avoid drinking alcohol. It may increase your risk of liver damage.

Using this medicine will not prevent you from passing hepatitis to other people. Follow your doctor's instructions about how to prevent passing the disease to another person.

In the U.S.

• Copegus
• Rebetol
• RibaPak
• Ribasphere
• Ribasphere Ribapak
• RibaTab

Available Dosage Forms:

• Tablet
• Solution
• Capsule

Therapeutic Class: Antiviral

Pharmacologic Class: Viral RNA Polymerase Inhibitor

Chemical Class: Guanosine Nucleoside Analog

Ribavirin is used in combination with injectable interferon alfa-2b, peginterferon alfa-2a, or peginterferon alfa-2b to treat chronic hepatitis C infection. The combination of ribavirin and peginterferon alfa-2b is used to treat adults and children 3 years of age and older who show symptoms of liver damage. Ribavirin is an antiviral agent that treats hepatitis C virus.

This medicine is available only with your doctor's prescription.

This section provides information on the proper use of a number of products that contain ribavirin. It may not be specific to RibaTab. Please read with care.

To help clear up your infection completely, ribavirin must be given for the full time of treatment, even if you or your child begins to feel better after a few days. Also, it is important to keep the amount of medicine in your body at a steady level. To help keep the amount constant, ribavirin must be given on a regular schedule.

You should take this medicine with food.

Swallow the capsule whole. Do not crush, break, or open it.

Measure the oral liquid with a marked measuring cup or spoon. Wash the cup or spoon after each use.

This medicine should come with a Medication Guide. Read and follow the information carefully. Ask your doctor if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For hepatitis C virus infection, in combination with interferon alfa-2b:
  • For oral dosage form (capsules):
    • Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 1000 to 1200 milligrams (mg) per day, given as two or three capsules in the morning and three capsules at night.
    • Children 3 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 15 milligrams (mg) per kilogram (kg) of body weight per day, given in 2 divided doses and taken in the morning and evening.
    • Children younger than 3 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (solution):
    • Adults—Dose is based on body weight and must be determined by your doctor. The oral solution form of this medicine is not usually prescribed for adults and teenagers.
    • Children 3 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 15 milligrams (mg) per kilogram (kg) of body weight per day, given in 2 divided doses and taken in the morning and evening.
    • Children younger than 3 years of age—Use and dose must be determined by your doctor.
• For hepatitis C virus infection, in combination with peginterferon alfa-2b:
  • For oral dosage form (capsules):
    • Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 800 to 1400 milligrams (mg) per day, given as two to three capsules in the morning and two to four capsules at night.
    • Children 3 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 15 milligrams (mg) per kilogram (kg) of body weight per day, given in 2 divided doses and taken in the morning and evening.
    • Children younger than 3 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (solution):
    • Adults—Dose is based on body weight and must be determined by your doctor. The oral solution form of this medicine is not usually prescribed for adults and teenagers.
    • Children 3 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 15 milligrams (mg) per kilogram (kg) of body weight per day, given in two divided doses and taken in the morning and evening.
    • Children younger than 3 years of age—Use and dose must be determined by your doctor.
• For hepatitis C virus infection, in combination with peginterferon alfa-2a:
  • For oral dosage form (tablets):
    • Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 800 to 1200 milligrams (mg) per day, given in 2 divided doses and taken in the morning and evening.
    • Children 5 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 400 to 1200 mg per day, given in 2 divided doses and taken in the morning and evening.
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.
• For hepatitis C with HIV virus coinfection, in combination with peginterferon alfa-2a:
  • For oral dosage form (tablets):
    • Adults—800 milligrams (mg) per day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the capsules and tablets in a closed container at room temperature, away from heat, moisture, and direct light.

Store the oral liquid in the refrigerator or at room temperature, away from heat and direct light. Do not freeze.