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REBETRON 1000
RIBAVIRIN (ORAL) AND INTERFERON ALPHA-2B (INJECTION)

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

RIBAVIRIN (ORAL) AND INTERFERON ALPHA-2B (INJECTION)

(rye-buh-VYE-rin/in-ter-FEER-on)

COMMON BRAND NAME(S): Rebetron

WARNING: Because the ribavirin in this combination product has cause birth defects and fetal death, it must not be used during pregnancy. Men and women of childbearing potential must avoid pregnancy and use 2 forms of effective birth control (contraception) during treatment with this product and for 6 months after this medication has been stopped. The interferon can cause or worsen some serious medical conditions including psychiatric conditions (e.g., depression), immune system problems (autoimmune conditions such as lupus or rheumatoid arthritis), circulation problems (e.g., cardiovascular disease/blood clots), or infections (bone marrow suppression). If your medical history includes these conditions, inform your doctor promptly. Also, tell your doctor immediately if any serious symptoms or side effects occur (see Side Effects section). These conditions occur infrequently, but some can be fatal.

Uses

This combination of medications is used to treat certain viral infections.

How To Use

Take the ribavirin by mouth, usually twice daily with or without food; or as directed by your doctor. It is important to take this medication consistently either with food or without food. Taking it inconsistently (sometimes with food, sometimes without food) may decrease the effectiveness and/or increase your risk of side effects. It may be best to take this medicine with food (more medicine might be absorbed into your bloodstream). The interferon is injected under the skin (SC) three times a week or as directed. Use at bedtime may minimize flu-like side effects. Learn all the preparation and administration instructions in the product package and ask your doctor or pharmacist if you are unclear on any information. Dosage is based on your condition and response to treatment. Drink plenty of fluids while using these drugs unless otherwise directed. Antiviral medications work best when the amount of medicine in your body is kept at a constant level. Do this by taking the medication at about the same time each day as directed. Continue to use these products until the full prescribed amount is finished even if symptoms disappear after a short time. Do not use if the liquid contains particles or is discolored. Make sure needles and any medical supplies are stored safely and disposed of properly. Consult your pharmacist or nurse.

Side Effects

This product may cause flu-like symptoms such as fever, headache, nausea, fatigue, muscle/joint aches, or diarrhea. Redness, pain or swelling at the injection site, dizziness, hair thinning and change in taste sensation may also occur. If these effects persist or worsen, inform your doctor promptly. Unlikely but report promptly: severe fatigue, one-sided weakness (arm/leg), vision changes, poor coordination, cold or heat intolerance, fast/slow/irregular heartbeat. Very unlikely but report promptly: black stools, persistent sore throat, chest discomfort, unusual bleeding or bruising, tingling of hands or feet, difficulty hearing, seizures, rapid breathing, dark urine, yellowing of the eyes/skin, change in the amount of urine, unusual increase in thirst. If you notice any of the following unlikely but serious side effects, stop your treatment with this medicine and consult your doctor immediately: unusual or severe mental/mood changes (e.g., suicidal thoughts or severe depression), bloody diarrhea. Rare, possibly fatal cases of swelling of the pancreas (pancreatitis) have occurred. Tell your doctor immediately if you have symptoms such as stomach pain and vomiting. In the unlikely event you have an allergic reaction to this drug, seek immediate medical attention. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

This medication is not recommended for use if you have the following medical conditions: other severe liver conditions (e.g., autoimmune hepatitis, decompensated liver disease), immune system suppression for organ transplants. Tell your doctor your medical history, especially of: psychiatric conditions (e.g., depression), low blood counts (e.g., red cells, white cells, or platelets), heart problems, breathing problems, thyroid problems, lung diseases (e.g., COPD, asthma, pneumonia), intestinal disease (e.g., colitis), pancreatitis, immune system diseases (e.g., lupus, rheumatoid arthritis), eye problems, diabetes, kidney disease, high blood pressure, brain tumors, seizures, any allergies. Avoid alcohol intake as it may intensify drug side effects. Since these products may cause dizziness, caution is advised when performing tasks requiring alertness (e.g., driving). Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug. These products must not be used during pregnancy by either the pregnant woman or her male partner. Two reliable forms of birth control must be used whenever at least one sexual partner is using these medicines, and for six months after stopping treatment. If you (or your partner) become pregnant or think you/partner may be pregnant, inform your doctor immediately. It is unknown whether these products are excreted into breast milk. Because of the potential risk to the infant, breast-feeding while using these products is not recommended. Consult your doctor before breast-feeding.

Drug Interactions

Tell your doctor of all over-the-counter and prescription medications you may use, including: zidovudine, zalcitabine, didanosine, barbiturates (e.g., phenobarbital), theophylline, vidarabine, drugs that can depress the immune system (e.g., anti-cancer type). Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately.

Notes

These products have been prescribed for your current condition only. Do not use them later for another infection or give them to others. A different medication may be needed in those cases. Laboratory and/or medical tests will be performed to monitor for pregnancy, side effects or response to treatment (e.g., blood counts such as CBC, platelets).

Missed Dose

If you miss a dose, contact your doctor or pharmacist to establish a new dosing schedule.

Storage

Store this product in a refrigerator between 36 and 46 degrees F (2-8 degrees C). The capsules of ribavirin may be stored separately at room temperature between 59-86 degrees F (15-30 degrees C). Properly discard of any unused medications after the expiration date.

Medical Alert

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).