Rebetol

Generic Name: ribavirin (RYE-ba-VIR-in)
Brand Name: Examples include Rebetol and Ribasphere

Rebetol may cause serious birth defects and/or fetal death when used during pregnancy. It should not be used by women who are pregnant or by men whose female partners are pregnant. Women of childbearing potential who either take Rebetol or are sexual partners of men who take Rebetol must:

  • have a negative pregnancy test immediately before therapy with Rebetol is started.
  • avoid becoming pregnant during therapy with Rebetol or within the first 6 months after Rebetol is stopped.

At least 2 reliable forms of effective birth control must be used during treatment with Rebetol and for 6 months after treatment with Rebetol is stopped. If you or your sexual partner becomes pregnant while taking Rebetol or within 6 months after Rebetol is stopped, contact your doctor right away.

Use of Rebetol alone is not effective for treating chronic hepatitis C infection. Rebetol must be used with another medicine (interferon) in order to treat hepatitis C infection.

Rebetol may cause serious blood problems (hemolytic anemia). This blood problem can worsen any heart problems you have and cause you to have a heart attack, which can be fatal. Tell your doctor if you have ever had heart problems. Do not take Rebetol if you have a history of serious or uncontrolled heart problems. Call your doctor right away if you have chest pain while taking Rebetol.


Rebetol is used for:

Treating chronic hepatitis C infection in certain patients when used in combination with interferon. It may also be used for other conditions as determined by your doctor.

Rebetol is an antiviral medicine. Exactly how it works to treat hepatitis C is not known.

Do NOT use Rebetol if:

  • you are allergic to any ingredient in Rebetol or have had a severe allergic reaction (eg, red, swollen, blistered, or peeling skin) to ribavirin or any other ingredient in Rebetol
  • you are pregnant or planning to become pregnant while you take Rebetol or within 6 months after you stop taking it
  • you are a man with a female sexual partner who is pregnant or planning to become pregnant while you take Rebetol or within 6 months after you stop taking it
  • you have certain blood disorders (eg, hemolytic anemia, sickle-cell anemia, thalassemia major), a history of serious or uncontrolled heart problems, severe kidney problems, or inflammation of the pancreas (acute pancreatitis)
  • you have autoimmune hepatitis (liver problems caused by your body instead of a virus)
  • you are taking didanosine

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Rebetol:

Some medical conditions may interact with Rebetol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you have a female sexual partner who is of childbearing age
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of cancer, heart problems or a heart attack, high blood pressure, kidney problems, diabetes, pancreas problems, lung or breathing problems, sarcoidosis, blood problems (eg, anemia, spherocytosis), stomach or bowel bleeding, thyroid problems, HIV infection or other immune system problems, or eye or vision problems
  • if you have liver problems other than hepatitis C infection (eg, hepatitis B infection), cirrhosis of the liver, or decreased liver function
  • if you have a history of anxiety or other mood or mental disorders (eg, depression), thoughts of suicide, or suicidal behavior
  • if you have used interferon before to treat hepatitis C and it did not work
  • if you had an organ transplant
  • if you have a history of drug or alcohol abuse

Some MEDICINES MAY INTERACT with Rebetol. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Didanosine or other nucleoside reverse transcriptase inhibitors (NRTIs) (eg, lamivudine), other antiretroviral medicines for HIV infection, or thiopurines (eg, azathioprine) because serious side effects, including risk of infection, nerve problems (peripheral neuropathy), pancreas problems, bone marrow suppression, lactic acidosis, and severe or fatal liver failure, may be increased by Rebetol
  • Anticoagulants (eg, warfarin) or certain NRTIs (eg, lamivudine, stavudine, zidovudine) because their effectiveness may be decreased by Rebetol

This may not be a complete list of all interactions that may occur. Ask your health care provider if Rebetol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Rebetol:

Use Rebetol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Rebetol comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Rebetol refilled.
  • Take Rebetol by mouth with food.
  • Swallow Rebetol whole. Do not break, crush, or chew before swallowing.
  • Drinking extra fluids while you are taking Rebetol is recommended. Check with your doctor for instructions.
  • Taking Rebetol at the same time each day will help you remember to take it.
  • Take Rebetol on a regular schedule to get the most benefit from it.
  • Continue to use Rebetol even if you feel well. Do not miss any doses.
  • If you miss a dose of Rebetol, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Rebetol.

Important safety information:

  • Rebetol may cause dizziness or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Rebetol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Avoid drinking alcohol, including beer, wine, and liquor, because it could worsen liver disease.
  • At least 2 reliable forms of effective birth control must be used during treatment by men and women who take Rebetol and for 6 months after Rebetol is stopped. Men who take Rebetol should use a condom with spermicide as 1 of the 2 forms of birth control.
  • Women of childbearing potential who either take Rebetol or are sexual partners of men who take Rebetol must have a pregnancy test before therapy with Rebetol is started, monthly during therapy, and monthly for 6 months after Rebetol is stopped.
  • Children and teenagers who take Rebetol may be at increased risk of suicidal thoughts or actions. Adults may also be affected. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Rebetol closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood, aggression, anger, anxiety, nervousness, irritable behavior, or any unusual changes in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
  • Rebetol may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Rebetol may cause dry mouth and increase the risk of teeth and gum problems. Proper dental care is important while you are taking Rebetol. Brush and floss your teeth carefully at least twice a day and visit the dentist regularly.
  • If vomiting occurs while you are taking Rebetol, be sure to rinse your mouth and clean your teeth afterwards.
  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • Diabetes patients - Rebetol may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Lab tests, including pregnancy; complete blood cell counts; hemoglobin or hematocrit levels; heart, liver, kidney, thyroid, and lung function; and eye exams, may be performed while you use Rebetol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Rebetol with caution in the ELDERLY; they may be more sensitive to its effects, especially anemia.
  • Rebetol may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take Rebetol.
  • Use Rebetol with extreme caution in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use Rebetol if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Rebetol is found in breast milk. Do not breast-feed while taking Rebetol.

Possible side effects of Rebetol:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; cough; diarrhea; dizziness; dry mouth; dry skin; loss of appetite; mild headache, nausea, or vomiting; sinus problems; tiredness; upset stomach; weakness or fatigue.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; itching; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in hearing, taste, or vision; chest pain; dark, tarry, or bloody stools; dark urine; decrease in the amount of urine; fainting; fever, chills, or sore throat; hair loss; joint pain; menstrual problems; mood or mental problems (eg, agitation, aggression, anger, anxiety, decreased concentration, depression, irritability, nervousness); muscle pain or weakness; numbness of an arm or leg; pale stools; prolonged nausea and vomiting; rapid breathing; red, swollen, blistered, or peeling skin; severe headache; severe or persistent diarrhea; severe stomach or back pain; shortness of breath; suicidal thoughts or actions; trouble sleeping; unusual bruising or bleeding; unusual or severe tiredness, weakness, or fatigue; weight loss; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Rebetol:

Store Rebetol at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Rebetol out of the reach of children and away from pets.

General information:

  • If you have any questions about Rebetol, please talk with your doctor, pharmacist, or other health care provider.
  • Rebetol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Rebetol or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Rebetol. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Rebetol. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Rebetol.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

Hide
(web4)