Generic Name: ribavirin (Oral route)
Use caution when administering aerosolized ribavirin to patients requiring mechanical ventilator assistance. Sudden deterioration of respiratory function has been associated with initiation of aerosolized ribavirin use in infants. Monitor respiratory function during treatment. Ribavirin is not indicated for use in adults. Ribavirin has been shown to produce testicular lesions in rodents and to be teratogenic in all animal species in which adequate studies have been conducted (rodents and rabbits) .Oral routeTabletCapsuleSolution
Ribavirin is not effective for monotherapy treatment of chronic hepatitis C virus infection. The primary toxicity is hemolytic anemia which may result in worsening of cardiac disease and fatal and nonfatal myocardial infarctions. Avoid use in patients with significant or unstable cardiac disease. Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. Ribavirin is contraindicated in women who are pregnant and in male partners of women who are pregnant. Use 2 reliable forms of contraception and avoid pregnancy during therapy and for 6 months after completion of treatment in both female patients and in female partners of male patients who are taking ribavirin .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antiviral
Pharmacologic Class: Viral RNA Polymerase Inhibitor
Chemical Class: Guanosine Nucleoside Analog
Ribavirin is used in combination with injectable interferon alfa-2b, peginterferon alfa-2a, or peginterferon alfa-2b to treat chronic hepatitis C infection. The combination of ribavirin and peginterferon alfa-2b is used to treat adults and children 3 years of age and older who show symptoms of liver damage. Ribavirin is an antiviral agent that treats hepatitis C virus.
This medicine is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of ribavirin tablets in the pediatric population. Appropriate studies have also not been performed on the relationship of age to the effects of ribavirin capsules and oral liquid in children below 3 years of age. The safety and efficacy of ribavirin tablets, capsules, and oral liquid have not been established in these age groups.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ribavirin in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving ribavirin.
|All Trimesters||X||Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain ribavirin. It may not be specific to Copegus. Please read with care.
To help clear up your infection completely, ribavirin must be given for the full time of treatment, even if you or your child begins to feel better after a few days. Also, it is important to keep the amount of medicine in your body at a steady level. To help keep the amount constant, ribavirin must be given on a regular schedule.
You should take this medicine with food.
Swallow the capsule whole. Do not crush, break, or open it.
Measure the oral liquid with a marked measuring cup or spoon. Wash the cup or spoon after each use.
This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the medication guide if you do not have one.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the capsules and tablets in a closed container at room temperature, away from heat, moisture, and direct light.
Store the oral liquid in the refrigerator or at room temperature, away from heat and direct light. Do not freeze.
It is very important that your doctor check the progress of you or your child at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. The medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If a pregnancy occurs while you are using this medicine, tell your doctor right away.
A negative pregnancy test is needed in women who are of childbearing age before starting treatment with this medicine. Two forms of birth control must be used together during treatment and for six months after treatment ends. You will need to have pregnancy tests done regularly to make sure you are not pregnant while being treated with this medicine and after your treatment ends.
Ribavirin may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child's doctor right away.
Check with your doctor right away if you or your child have back, leg, or stomach pains; bleeding gums; chills; dark urine; difficulty breathing; fatigue; fever; general body swelling; headache; loss of appetite; nausea or vomiting; nosebleeds; pale skin; sore throat; or yellowing of the eyes or skin. These could be symptoms of a blood disorder called anemia.
This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop taking this medicine and call your doctor right away if you or your child have itching, hives, hoarseness, trouble with breathing, trouble with swallowing, or any swelling of the hands, face, or mouth while you are using this medicine.
You or your teenager should not drink alcoholic beverages while you are taking this medicine.
This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you or your teenager drive, operate machinery, or do anything else that could be dangerous if you are not alert.
Check with your doctor if blurred vision, decreased vision, or any other change in vision occurs while you or your child are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
Peginterferon injection combined with ribavirin can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets in the blood, which are necessary for proper blood clotting. If this occurs, there are certain precautions you or your child can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
This medicine may cause teeth and gum problems. This medicine may cause dryness of the mouth, and a dry mouth may damage your teeth and gums if you take the medicine for a long time. To help prevent this condition, carefully brush your teeth at least two times a day and have regular visits with your dentist. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute.
Some patients who have used this medicine have had vomiting. If you vomit during your treatment, rinse your mouth out with water. This may also help prevent damage to your teeth and gums.
Ribavirin used together with injectable peginterferon alfa-2b may affect your child's growth. Your doctor may need to check your child's height and weight during and after treatment with these medicines.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:More common
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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