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Drugs & Medications

REBETOL

RIBAVIRIN SOLUTION

GENERIC NAME(S): RIBAVIRIN

WARNINGS:

Ribavirin may cause birth defects and/or death in unborn babies that are exposed to it during pregnancy. If you or your sexual partner are or may be pregnant, do not take ribavirin, and contact your doctor immediately. Women and men who are taking ribavirin must avoid pregnancy by using two forms of reliable birth control (such as latex condoms and birth control pills) during treatment with this drug and for 6 months after this medication has been stopped. Consult your doctor or pharmacist for more information.

Patients with certain types of heart disease should not use ribavirin because it can lower your red blood cell level (anemia). This may worsen your condition and can lead to a possibly fatal heart attack. Before using this medication, tell your doctor if you have had any heart problems or chest pain.

Ribavirin should never be used alone to treat hepatitis C infections.

Who should not take REBETOL?
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Uses

This medication is an antiviral used in combination with interferon to treat ongoing hepatitis C. Long-term hepatitis C infection causes liver swelling that can lead to serious liver conditions such as scarring, cancer, and organ failure. Ribavirin works by reducing the amount of hepatitis C virus in your body, which may help your liver recover. However, this drug is not a cure for hepatitis C infection, and it does not prevent the spread of Hepatitis C to others through sexual contact or blood contamination (e.g., sharing used needles).

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to treat severe acute respiratory syndrome (SARS).

How to use REBETOL

Read the Medication Guide provided by your pharmacist before you start using ribavirin and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

Measure the dose out carefully with a medication spoon/cup. Take this medication by mouth as directed by your doctor, usually twice daily with food for 24 to 48 weeks.

The dosage and length of treatment is based on your age, weight, medical condition, and response to therapy.

Antiviral medications work best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, use it at the same times each day.

Drink plenty of water while being treated with this medication. Doing so will decrease the risk of serious side effects.

Side Effects

Nausea, diarrhea, stomach upset, headache, dizziness, blurred vision, trouble sleeping, flu-like symptoms (e.g., fever, chills, sore throat, muscle aches), cough, hair loss, low appetite, weight loss or gain, dry skin, and changes in taste/hearing may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tooth and gum problems may sometimes occur during ribavirin/interferon treatment. Dry mouth can worsen this side effect. Prevent dry mouth by drinking plenty of water or by using a saliva substitute. Brush your teeth well at least twice daily and see your dentist regularly. If you experience vomiting during treatment, rinse out your mouth afterwards to reduce tooth and gum problems.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual tiredness/weakness, fast/pounding/irregular heartbeat, trouble breathing, mental/mood changes (e.g., severe depression, suicidal thoughts), muscle/joint pain, vision changes, easy bruising/bleeding, dark urine, yellowing of eyes/skin.

Seek immediate medical attention if any of these unlikely but very serious side effects occurs: chest pain, jaw/left arm pain, stomach/lower back pain, black/bloody stools.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking ribavirin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: other types of hepatitis (e.g., autoimmune hepatitis), blood disorders (e.g., sickle cell anemia, low hemoglobin, thalassemia), kidney disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other liver problems, heart disease, high blood pressure, breathing problems, pancreas problems (e.g., pancreatitis), diabetes.

This drug may make you dizzy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for anemia while using this drug.

Children may be at greater risk for mental/mood changes, including severe depression or suicidal thoughts, while using this drug. Ribavirin/interferon treatment may also slow down a child's rate of growth. Normal weight gain and rate of growth usually return after treatment is completed but the final adult height may be lower than expected. Monitor your child's height and weight periodically during treatment.

Ribavirin must not be used during pregnancy. It is recommended that female patients or female partners of male patients take a pregnancy test before starting this medication. A pregnancy test should also be taken every month while using this medication and for 6 months after this medication is stopped. If you become pregnant or think you may be pregnant, tell your doctor right away. See also Warning section.

It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this medication is not recommended.

Interactions

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal medication you may use, especially of: antacids, certain anti-HIV drugs (e.g., NRTIs such as lamivudine, stavudine, zidovudine), didanosine.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (e.g., pregnancy, blood counts/hemoglobin, liver function, thyroid function, heart function/EKG, eye exams) should be performed periodically to monitor your progress or check for side effects.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in those cases. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature at 77 degrees F (25 degrees C) or in the refrigerator at 36-46 degrees F (2-8 degrees C) away from light and moisture. Do not freeze. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised December 2013. Copyright(c) 2013 First Databank, Inc.

Images

REBETOL 200 MG CAPSULE
REBETOL 200 MG CAPSULE
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REBETOL dp, 200mg
REBETOL 200 MG CAPSULE
REBETOL 200 MG CAPSULE

Identification

color
white
shape
oblong
imprint
REBETOL dp, 200mg
This medicine is a white, oblong capsule imprinted with "REBETOL dp" and "200mg".

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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