Copegus

Copegus

     * Generic Name: ribavirin
     * Brand Name: Copegus


     * What is ribavirin?
     * What are the possible side effects of ribavirin?
     * What is the most important information I should know about
       ribavirin?
     * What should I discuss with my healthcare provider before taking
       ribavirin?
     * How should I take ribavirin?
     * What happens if I miss a dose?
     * What happens if I overdose?
     * What should I avoid while taking ribavirin?
     * What other drugs will affect ribavirin?
     * Where can I get more information?

What is ribavirin?

   Ribavirin is an antiviral medication.

   Ribavirin must be used together with an interferon alfa product (such
   as Pegasys, PegIntron, Sylatron, or Intron A) to treat
   chronic hepatitis C.

   Ribavirin may also be used for purposes not listed in this medication
   guide.

What are the possible side effects of ribavirin?

   Get emergency medical help if you have signs of an allergic reaction:
   hives; difficulty breathing; swelling of your face, lips, tongue, or
   throat.

   Ribavirin can cause anemia. In rare cases, this can lead to fatal
   heart problems. Get emergency medical attention if you have chest pain.

   Call your doctor at once if you have:
     * problems with your vision;
     * severe pain in your upper stomach spreading to your back, nausea,
       vomiting, diarrhea;
     * stabbing chest pain, wheezing, feeling short of breath;
     * severe depression, thoughts about suicide, or thoughts about
       hurting someone else;
     * signs of serious anemia--pale or yellowed skin, dark colored urine,
       confusion or weakness; or
     * other signs of low blood cell counts--fever, chills, flu-like
       symptoms, swollen gums, mouth sores, skin sores, easy bruising,
       unusual bleeding, feeling light-headed.

   Common side effects may include:
     * nausea, flu-like symptoms, tiredness;
     * fever, chills or shaking;
     * headache;
     * mood changes, feeling irritable;
     * muscle pain; or
     * stomach pain, vomiting, loss of appetite.

   This is not a complete list of side effects and others may occur. Call
   your doctor for medical advice about side effects. You may report side
   effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ribavirin?

   You should not use ribavirin if you have autoimmune hepatitis,
   severe kidney disease, or a hemoglobin blood cell disorder.

   Ribavirin is not effective when used alone. It must be used together
   with an interferon alfa product. You should not take ribavirin with
   didanosine.

   Ribavirin can cause birth defects or death in an unborn baby. Do not
   use this medicine if you are pregnant, or if you are a man and your
   sexual partner is pregnant. Use 2 forms of birth control to prevent
   pregnancy while either sexual partner is taking ribavirin, and for at
   least 6 months after treatment ends.

   In rare cases, ribavirin can cause fatal heart problems. Get emergency
   medical attention if you have chest pain.

   Copegus Patient Information including How Should I Take
   Hepatitis:A Visual Guide to Hepatitis

   A Visual Guide to Hepatitis Slideshow
 

   Hepatitis C Quiz
   Infectious Mononucleosis:Learn About the 'Kissing Disease' Caused
   by EBV

   Infectious Mononucleosis Slideshow

What should I discuss with my healthcare provider before taking ribavirin?

   You should not take ribavirin if you are allergic to it, or if you
   have:
     * a hemoglobin blood cell disorder such as sickle-cell anemia or
       thalassemia;
     * autoimmune hepatitis;
     * severe kidney disease;
     * if you are also taking didanosine (Videx); or
     * if you are pregnant, or if you are a man whose sexual partner is
       pregnant.

   You should not take ribavirin with peginterferon alfa-2a if you have:
     * autoimmune hepatitis; or
     * severe liver disease (especially cirrhosis).

   To make sure ribavirin is safe for you, tell your doctor if you have:
     * heart disease;
     * a blood cell disorder such as anemia (low red blood cells);
     * breathing problems;
     * vision problems;
     * liver problems other than hepatitis C;
     * a thyroid disorder;
     * kidney disease;
     * human immunodeficiency virus (HIV or AIDS);
     * diabetes;
     * a history of depression, mental illness, or suicide attempt;
     * a history of organ transplant; or
     * if you have ever received treatment for hepatitis C that did not
       work well.

   Ribavirin can cause birth defects or death in an unborn baby. You may
   need to have a negative pregnancy test before taking this medicine
   and every month during your treatment.
     * If you are a woman, do not take ribavirin if you are pregnant.
     * If you are a man, do not take ribavirin if your sexual partner is
       pregnant. An unborn baby could also be harmed if a man fathers the
       child while he is taking ribavirin.
     * Use at least 2 effective forms of birth control to prevent
       pregnancy while either sexual partner is taking ribavirin. Keep
       using 2 forms of birth control for at least 6 months after
       treatment ends.
     * Tell your doctor right away if a pregnancy occurs while either the
       mother or the father is taking ribavirin.

   If a pregnancy occurs, your name may be listed on a pregnancy registry.
   This is to track the outcome of the pregnancy and to evaluate any
   effects of ribavirin on the baby.

   It is not known whether ribavirin passes into breast milk or if it
   could harm a nursing baby. You should not breast-feed while using this
   medicine.

   Ribavirin is not approved for use by anyone younger than 3 years old.

   Ribavirin can affect growth in children. Tell your doctor if your child
   is not growing at a normal rate while using this medicine.

How should I take ribavirin?

   Follow all directions on your prescription label. Do not take this
   medicine in larger or smaller amounts or for longer than recommended.

   Ribavirin is not effective when used alone to treat hepatitis C. It
   must be used together with an interferon alfa product.

   Take ribavirin with food.

   Do not crush, chew, break, or open a ribavirin capsule. Swallow it
   whole. Tell your doctor if you have trouble swallowing the capsule.

   Measure liquid medicine with the dosing syringe provided, or with a
   special dose-measuring spoon or medicine cup. If you do not have a
   dose-measuring device, ask your pharmacist for one.

   Use ribavirin regularly to get the most benefit. Get your prescription
   refilled before you run out of medicine completely.

   Drink extra fluids while you are taking ribavirin to keep from getting
   dehydrated, especially during exercise or in hot weather.

   Ribavirin can cause dry mouth, which could lead to tooth decay or
   gum disease. If you vomit while taking ribavirin, rinse your mouth
   out with water to prevent damage to your teeth or gums. Be sure to have
   regular dental exams while you are taking this medication.

   Store ribavirin tablets or capsules at room temperature away from
   moisture, heat, and light.

   Store ribavirin liquid (oral solution) in the refrigerator. Do not
   allow it to freeze.

   Copegus Patient Information including If I Miss a Dose
   Hepatitis:A Visual Guide to Hepatitis

   A Visual Guide to Hepatitis Slideshow
 

   Hepatitis C Quiz
   Infectious Mononucleosis:Learn About the 'Kissing Disease' Caused
   by EBV

   Infectious Mononucleosis Slideshow

What happens if I miss a dose?

   Take the missed dose as soon as you remember. Skip the missed dose if
   it is almost time for your next scheduled dose. Do not take extra
   medicine to make up the missed dose.

What happens if I overdose?

   Seek emergency medical attention or call the Poison Help line at
   1-800-222-1222.

What should I avoid while taking ribavirin?

   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.

What other drugs will affect ribavirin?

   Tell your doctor about all your current medicines and any you start or
   stop using, especially:
     * azathioprine; or
     * medicines to treat HIV or AIDS.

   This list is not complete. Other drugs may interact with ribavirin,
   including prescription and over-the-counter medicines, vitamins, and
   herbal products. Not all possible interactions are listed in this
   medication guide.

Where can I get more information?

   Your pharmacist can provide more information about ribavirin.
     __________________________________________________________________

   Remember, keep this and all other medicines out of the reach of
   children, never share your medicines with others, and use this
   medication only for the indication prescribed.
   Every effort has been made to ensure that the information provided by
   Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete,
   but no guarantee is made to that effect. Drug information contained
   herein may be time sensitive. Multum information has been compiled for
   use by healthcare practitioners and consumers in the United States and
   therefore Multum does not warrant that uses outside of the United
   States are appropriate, unless specifically indicated otherwise.
   Multum's drug information does not endorse drugs, diagnose patients or
   recommend therapy. Multum's drug information is an informational
   resource designed to assist licensed healthcare practitioners in caring
   for their patients and/or to serve consumers viewing this service as a
   supplement to, and not a substitute for, the expertise, skill,
   knowledge and judgment of healthcare practitioners. The absence of a
   warning for a given drug or drug combination in no way should be
   construed to indicate that the drug or drug combination is safe,
   effective or appropriate for any given patient. Multum does not assume
   any responsibility for any aspect of healthcare administered with the
   aid of information Multum provides. The information contained herein is
   not intended to cover all possible uses, directions, precautions,
   warnings, drug interactions, allergic reactions, or adverse effects. If
   you have questions about the drugs you are taking, check with your
   doctor, nurse or pharmacist.