RibaTab

Generic Name: ribavirin (oral) (rye ba VYE rin)

What is ribavirin?

Ribavirin is an antiviral medication.

Ribavirin must be used together with an interferon alfa product (such as Peg-Intron or Intron A) to treat chronic hepatitis C.

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

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

Ribavirin is not effective when used alone to treat hepatitis C. Ribavirin must be used together with an interferon alfa product (such as Peg-Intron or Intron A) to treat chronic hepatitis C. This medication can cause birth defects or death in an unborn baby.

If you are a woman, do not take ribavirin if you are pregnant.

If you are a man, do not take ribavirin if your female 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 two effective forms of birth control while either sexual partner is taking ribavirin, and 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.

Ribavirin may decrease the number of red blood cells in your body. This is called anemia and it can be life-threatening in people who have heart disease or circulation problems. To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Call your doctor at once if you have pale or yellowed skin, dark colored urine, fever, confusion, chest pain, shortness of breath, or weakness. These may be signs of serious anemia.

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

You should not take this medication if you are allergic to ribavirin, or if you have:

severe liver disease;

autoimmune hepatitis;

a hemoglobin disorder such as anemia, thalassemia (Mediterranean anemia), or sickle-cell anemia; or

if you are pregnant woman, or a man whose female sexual partner is pregnant.

If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before using ribavirin, tell your doctor if you have:

hepatitis B infection;

a blood cell disorder;

cancer;

psoriasis;

diabetes;

sarcoidosis;

a thyroid disorder;

hepatitis B virus or human immunodeficiency virus (HIV or AIDS);

a history of heart disease, high blood pressure, or a heart attack;

a history of depression or suicide attempt;

a history of drug or alcohol addiction; or

a history of a liver or other organ transplant.

Tell your doctor if you have been treated with interferon in the past and it did not work well in treating your hepatitis C.

If you are a woman, do not take ribavirin if you are pregnant. You will need frequent pregnancy tests to make sure you are not pregnant while taking ribavirin.

If you are a man, do not take ribavirin if your female sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin. Your sexual partner will need frequent pregnancy tests to make sure she is not pregnant while you are taking ribavirin.

Use at least two effective forms of birth control while either sexual partner is taking ribavirin, and 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.

Your name may need to be listed on a ribavirin pregnancy registry if you become pregnant while you or your male sexual partner are taking this medication or during the 6 months after treatment ends. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether ribavirin had any effect on the baby.

It is not known whether ribavirin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take ribavirin?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Ribavirin is not effective when used alone to treat hepatitis C. It must be used together with an interferon alfa product (such as Peg-Intron or Intron A) to treat chronic hepatitis C. Take this medicine with food.

Measure the liquid form of ribavirin with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Ribavirin may decrease the number of red blood cells in your body. This is called anemia and it can be life-threatening in people who have heart disease or circulation problems. To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your liver and thyroid function may also need to be checked. Do not miss any scheduled visits to your doctor.

Call your doctor at once if you have pale or yellowed skin, dark colored urine, fever, confusion, chest pain, shortness of breath, or weakness. These may be signs of serious anemia.

It is important to use ribavirin regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. You may need to take this medication for many months.

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 and capsules at room temperature away from moisture, heat, and light. Store ribavirin liquid (oral solution) in the refrigerator. Do not allow it to freeze.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. If you have not taken the medication for longer than 24 hours, call your doctor for instructions. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include easy bruising or bleeding, urinating less than usual or not at all, chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, or a general ill feeling.

What should I avoid while taking ribavirin?

Treatment with ribavirin does not prevent spread of the hepatitis C virus to other people. Follow your doctor’s instructions about how to prevent passing the disease to another person.

Do not drink alcohol while taking ribavirin. Alcohol can increase the risk of damage to your liver. Ribavirin can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Ribavirin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using ribavirin and call your doctor at once if you have any of these serious side effects:

pale or yellowed skin, dark colored urine, easy bruising or bleeding, confusion, or unusual weakness;

severe depression, hallucinations, thoughts of suicide or hurting yourself;

fever, chills, body aches, flu symptoms, trouble breathing;

severe blistering, peeling, and red skin rash;

blood diarrhea, or black tarry stools;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or

severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate.

Less serious side effects may include:

feeling tired or irritable;

dry mouth, cough;

headache, dizziness;

hearing or vision problems;

hair loss, dry skin, rash, itching;

joint or muscle pain; or

sleep problems (insomnia).

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 other drugs will affect ribavirin?

Before taking ribavirin, tell your doctor if you are using any of the following drugs:

abacavir (Ziagen);

didanosine (Videx);

lamivudine (Combivir, Epivir, Epzicom, Trizivir);

stavudine (Zerit);

tenofovir (Viread);

zalcitabine (Hivid); or

zidovudine (Retrovir, AZT).

This list is not complete and there may be other drugs that can interact with ribavirin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.