Copegus

DRUG DESCRIPTION

COPEGUS, ribavirin, is a nucleoside analogue with antiviral activity. The chemical name of ribavirin is 1-?-Dribofuranosyl-1H-1,2,4-triazole-3-carboxamide and has the following structural formula:

COPEGUS® (ribavirin) Structural Formula Illustration

The empirical formula of ribavirin is C8H12N4O5 and the molecular weight is 244.2. Ribavirin is a white to off-white powder. It is freely soluble in water and slightly soluble in anhydrous alcohol.

COPEGUS (ribavirin) is available as a light pink to pink colored, flat, oval-shaped, film-coated tablet for oral administration. Each tablet contains 200 mg of ribavirin and the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, cornstarch, and magnesium stearate. The coating of the tablet contains Chromatone-P® or Opadry® Pink (made by using hydroxypropyl methyl cellulose, talc, titanium dioxide, synthetic yellow iron oxide, and synthetic red iron oxide), ethyl cellulose (ECD-30), and triacetin.

What are the possible side effects of ribavirin (Copegus, Rebetol, RibaPak, Ribasphere, RibaTab)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using ribavirin and call your doctor at once if you have any of these serious side effects:

  • pale or yellowed skin, dark colored urine, easy bruising or bleeding, confusion, or unusual weakness;
  • severe depression, hallucinations, thoughts of suicide or hurting yourself;
  • fever, chills, body aches, flu...

Read All Potential Side Effects and See Pictures of Copegus »

What are the precautions when taking ribavirin (Copegus)?

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),...

Read All Potential Precautions of Copegus »


Copegus Consumer (continued)

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 unusually tired 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. It is not known if this will affect final adult height. Monitor your child's height 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 this medication is started, during treatment, and for 6 months after this drug is stopped. If you become pregnant or think you may be pregnant, inform your doctor immediately. See Warnings for additional information.

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.


Copegus Patient Information Including Side Effects

Brand Names: Copegus, Rebetol, RibaPak, Ribasphere, RibaTab

Generic Name: ribavirin (oral) (Pronunciation: rye ba VYE rin)

  • What is ribavirin (Copegus)?
  • What are the possible side effects of ribavirin (Copegus)?
  • What is the most important information I should know about ribavirin (Copegus)?
  • What should I discuss with my healthcare provider before taking ribavirin (Copegus)?
  • How should I take ribavirin (Copegus)?
  • What happens if I miss a dose (Copegus)?
  • What happens if I overdose (Copegus)?
  • What should I avoid while taking ribavirin (Copegus)?
  • What other drugs will affect ribavirin (Copegus)?
  • Where can I get more information?

What is ribavirin (Copegus)?

Ribavirin is an antiviral medication.

Ribavirin must be used together with an interferon alfa product (such as Peg-Intron or Intron A) to treat chronic hepatitis C.

Ribavirin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of ribavirin (Copegus)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using ribavirin and call your doctor at once if you have any of these serious side effects:

  • pale or yellowed skin, dark colored urine, easy bruising or bleeding, confusion, or unusual weakness;
  • severe depression, hallucinations, thoughts of suicide or hurting yourself;
  • fever, chills, body aches, flu symptoms, trouble breathing;
  • severe blistering, peeling, and red skin rash;
  • blood diarrhea, or black tarry stools;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate.

Less serious side effects may include:

  • feeling tired or irritable;
  • dry mouth, cough;
  • headache, dizziness;
  • hearing or vision problems;
  • hair loss, dry skin, rash, itching;
  • joint or muscle pain; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ribavirin (Copegus)?

Ribavirin is not effective when used alone to treat hepatitis C. Ribavirin must be used together with an interferon alfa product (such as Peg-Intron or Intron A) to treat chronic hepatitis C.

This medication can cause birth defects or death in an unborn baby.

  • If you are a woman, do not take ribavirin if you are pregnant.
  • If you are a man, do not take ribavirin if your female sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin.
  • Use at least two effective forms of birth control while either sexual partner is taking ribavirin, and for at least 6 months after treatment ends.
  • Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking ribavirin.

Ribavirin may decrease the number of red blood cells in your body. This is called anemia and it can be life-threatening in people who have heart disease or circulation problems. To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Call your doctor at once if you have pale or yellowed skin, dark colored urine, fever, confusion, chest pain, shortness of breath, or weakness. These may be signs of serious anemia.

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