Copegus Generic Name: Ribavirin
Examples include Copegus and Ribasphere
Copegus 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 Copegus or are sexual partners of men who take Copegus must:
- Have a negative pregnancy test immediately before therapy with Copegus is started.
- Avoid becoming pregnant during therapy with Copegus or within the first 6 months after Copegus is stopped.
At least 2 reliable forms of effective birth control must be used during treatment with Copegus and for 6 months after treatment with Copegus is stopped.
Use of Copegus alone is not effective for treating chronic hepatitis C infection. Copegus must be used with another medicine (interferon) in order to treat hepatitis C infection.
Copegus 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 Copegus you have a history of serious or uncontrolled heart problems.
Copegus is used for:
Treating hepatitis C infection in certain patients when used in combination with peginterferon. It may also be used for other conditions as determined by your doctor.
Copegus is an antiviral medicine. How Copegus works to treat hepatitis C is not completely understood.
Do NOT use Copegus if:
- you are allergic to any ingredient in Copegus
- you are pregnant or could become pregnant
- your sexual partner is pregnant or could become pregnant
- 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 are also using peginterferon and 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 Copegus :
Some medical conditions may interact with Copegus . 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 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 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, psoriasis, 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 an organ transplant
- if you have a history of drug or alcohol abuse
Some MEDICINES MAY INTERACT with Copegus . 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 Copegus
- Anticoagulants (eg, warfarin) because their effectiveness may be decreased by Copegus
This may not be a complete list of all interactions that may occur. Ask your health care provider if Copegus 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 Copegus :
Use Copegus as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Copegus comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Copegus refilled.
- Take Copegus by mouth with food.
- Drinking extra fluids while you are taking Copegus is recommended. Check with your doctor for instructions.
- Take Copegus on a regular schedule to get the most benefit from it. Taking Copegus at the same times each day will help you remember to take it.
- Continue to use Copegus even if you feel well. Do not miss any doses.
- If you miss a dose of Copegus and you remember the same day, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once. If you do not remember until the next day, contact your doctor.
Ask your health care provider any questions you may have about how to use Copegus .
Important safety information:
- Copegus may cause dizziness, drowsiness, tiredness, confusion, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Copegus 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.
- Copegus may cause dry mouth and increase the risk of teeth and gum problems. Proper dental care is important while you are taking it. Brush and floss your teeth carefully at least twice a day. Be sure to have regular dental check-ups.
- If vomiting occurs while you are taking Copegus , be sure to rinse your mouth and clean your teeth afterwards.
- Copegus 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.
- Diabetes patients - Copegus 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 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 Copegus and for 6 months after treatment with Copegus is stopped.
- Women of childbearing potential who either take Copegus or are sexual partners of men who take Copegus must have a pregnancy test before therapy with Copegus is started, monthly during therapy, and monthly for 6 months after Copegus is stopped.
- Use Copegus with caution in the ELDERLY; they may be more sensitive to its effects.
- Copegus should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been determined.
- PREGNANCY and BREAST-FEEDING: Do not use Copegus if you are pregnant. It has been shown to cause harm to the fetus. 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 Copegus is found in breast milk. Do not breast-feed while taking Copegus .
Possible side effects of Copegus :
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:
Blurred vision; cough; diarrhea; dizziness; dry mouth; dry skin; hair loss; joint pain; loss of appetite; mild headache, nausea, or vomiting; tiredness; trouble sleeping; 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; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; changes in vision or speech; chest pain; confusion; dark urine; decrease in the amount of urine; depression; fever, chills, or sore throat; irregular heartbeat; memory problems; muscle pain or weakness; numbness or tingling of arms or legs; one-sided weakness; prolonged nausea and vomiting; rapid breathing; severe headache, dizziness, or vomiting; severe stomach or back pain; shortness of breath; sinus problems; thoughts of suicide; 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 about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), or emergency room immediately.Proper storage of Copegus :
Store Copegus 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 Copegus out of the reach of children and away from pets.
- If you have any questions about Copegus , please talk with your doctor, pharmacist, or other health care provider.
- Copegus 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 Copegus . 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.
- Copegus Prescribing Information (FDA)
- Copegus Advanced Consumer (Micromedex) - Includes Dosage Information
- Ribavirin Prescribing Information (FDA)
- Ribavirin Professional Patient Advice (Wolters Kluwer)
- Ribavirin Detailed Consumer Information (PDR)
- Rebetol Consumer Overview
- Rebetol Prescribing Information (FDA)
- Rebetol Detailed Consumer Information (PDR)
- Ribasphere Consumer Overview
- Ribasphere Prescribing Information (FDA)
- Virazole Prescribing Information (FDA)
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