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Ribavirin Solution
Generic Name: Ribavirin Oral Solution (rye-ba-VYE-rin)
Brand Name: Rebetol
Ribavirin Solution 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 Ribavirin Solution or are sexual partners of men who take Ribavirin Solution must:
- Have a negative pregnancy test immediately before therapy with Ribavirin Solution is started.
- Avoid becoming pregnant during therapy with Ribavirin Solution or within the first 6 months after Ribavirin Solution is stopped.
At least 2 reliable forms of effective birth control must be used during treatment with Ribavirin Solution and for 6 months after treatment with Ribavirin Solution is stopped.
Use of Ribavirin Solution alone is not effective
for treating chronic hepatitis C infection. Ribavirin Solution must be used with another medicine (interferon)
in order to treat hepatitis C infection.
Ribavirin Solution may cause serious blood problems (hemolytic anemia), which can cause serious and sometimes fatal heart attacks in patients who have heart disease. Do not take Ribavirin Solution you have a history of serious or uncontrolled heart problems.
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Ribavirin Solution is used for:Treating 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.
Ribavirin Solution is an antiviral medicine. How Ribavirin Solution works to treat hepatitis C is not completely understood.
Do NOT use Ribavirin Solution if:
- you are pregnant
- your female sexual partner is pregnant or could become pregnant within the next 6 months
- you have certain blood
disorders (eg, sickle-cell anemia, thalassemia major), a history of serious heart problems, severe kidney problems, or inflammation of your pancreas (acute pancreatitis)
- you have autoimmune hepatitis (liver problems caused by your own body instead of a virus) or severely decreased liver function
- you are taking didanosine
Contact your doctor or health care provider right away if any of these apply to you.
Before using Ribavirin Solution:Some medical conditions may interact with Ribavirin Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you plan to become pregnant or are breast-feeding
- 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 female sexual partner who is of childbearing age
- if you have a history of cancer, heart problems or heart attack, high blood pressure, kidney problems, diabetes, pancreas problems, lung or breathing problems, sarcoidosis, blood problems (eg, anemia), thyroid problems, or HIV infection
- if you have liver problems (other than hepatitis C infection) such as hepatitis B infection, cirrhosis of the liver, or decreased liver function
- if you have a history of anxiety or other mood or mental disorders, thoughts of suicide, or suicidal behavior
- if you have used interferon before to treat hepatitis C and it did not work
- if you have a history of drug or alcohol abuse
Some MEDICINES MAY INTERACT with Ribavirin Solution. 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), immunosuppressants (eg, cyclosporine), or other antiretroviral medicines for HIV infection because serious side effects, including risk of infection, nerve problems (peripheral neuropathy), pancreas problems, lactic acidosis, and severe or fatal liver failure, may be increased by Ribavirin Solution
- Anticoagulants (eg, warfarin) because the effectiveness of Ribavirin Solution may be decreased.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Ribavirin Solution 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 Ribavirin Solution:Use Ribavirin Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Ribavirin Solution comes with an additional patient information sheet called a Medication
Guide. Read it carefully and reread it each time you get Ribavirin Solution refilled.
- Ribavirin Solution should be taken with food.
- Drinking extra fluids while you are taking Ribavirin Solution is recommended. Check with your doctor for instructions.
- Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
- Take Ribavirin Solution regularly to receive the most benefit from it. Taking Ribavirin Solution at the same times each day will help you remember to take it.
- Continue to use Ribavirin Solution even if you feel well. Do not miss any doses.
- If you miss a dose of Ribavirin Solution, 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 Ribavirin Solution.
Important safety information:
- Ribavirin Solution may cause dizziness, drowsiness, tiredness, confusion, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Ribavirin Solution. Using Ribavirin Solution alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
- Avoid drinking alcohol, including beer, wine, and liquor, because it could worsen liver disease.
- LAB TESTS, including pregnancy tests; blood counts; hemoglobin levels; and heart, liver, kidney, thyroid, and lung function tests may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
- At least 2 reliable forms of effective birth control must be used during treatment with Ribavirin Solution and for 6 months after treatment with Ribavirin Solution is stopped.
- Women of childbearing potential who either take Ribavirin Solution or are sexual partners of men who take Ribavirin Solution must have a pregnancy test before therapy with Ribavirin Solution is started, monthly during therapy, and monthly for 6 months after Ribavirin Solution is stopped.
- Use Ribavirin Solution with extreme caution in CHILDREN younger than 3 years of age. Safety and effectiveness in this age group have not been confirmed.
- Use Ribavirin Solution with caution in the ELDERLY because they may be more sensitive to its effects.
- PREGNANCY and BREAST-FEEDING: Do not use Ribavirin Solution if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. It is unknown if Ribavirin Solution is excreted in breast milk. Do not breast-feed while taking Ribavirin Solution.
Possible side effects of Ribavirin Solution: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: Cough; diarrhea; dizziness; dry mouth; dry skin; loss of appetite; mild headache, nausea, or vomiting; mild pain, redness, or swelling at the injection site; tiredness; upset stomach; weakness or fatigue Seek medical attention right away if any of these SEVERE side effects occur: Severe allergic reactions (rash; hives; difficulty breathing; itching;
tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; changes in hearing, taste, or vision; chest pain; dark urine;
decrease in the amount of urine; fever, chills, or sore throat; hair loss;
irregular heartbeat; joint pain; loss of appetite; muscle pain or weakness;
numbness or tingling of arms or legs; prolonged nausea and vomiting; rapid breathing; severe headache; severe stomach or back pain; shortness of breath;
sinus problems; thoughts of suicide; trouble sleeping; unusual bruising or bleeding; unusual mental or mood changes; unusual or severe tiredness and fatigue; vomit
that looks like coffee grounds; weight loss; yellowing of eyes or skin.
This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.
Proper storage of Ribavirin Solution:Store Ribavirin Solution at 77 degrees F (25 degrees C) or in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ribavirin Solution out of the reach of children and away from pets.
General information:
- If you have any questions about Ribavirin Solution, please talk with your doctor, pharmacist, or other health care provider.
- Ribavirin Solution 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.
This information is a summary only. It does not contain all information about Ribavirin Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.
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