Ribavirin monotherapy is not effective for treatment of chronic hepatitis C virus (HCV) infection and should not be used alone for this indication.
The principal toxicity of oral ribavirin is hemolytic anemia which may result in worsening of cardiac disease and has resulted in fatal and nonfatal MI. Patients with a history of substantial or unstable cardiac disease should not be given ribavirin.
Teratogenic and/or embryocidal effects demonstrated. Ribavirin has a long half-life and may persist in nonplasma compartments for as long as 6 months. Contraindicated in pregnant women and in male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during and for 6 months following ribavirin therapy in female patients and in female partners of male patients receiving ribavirin. At least 2 reliable forms of contraception must be used during and for 6 months following completion of treatment.
Initiation of aerosolized ribavirin (given by nasal or oral inhalation) in infants has resulted in sudden deterioration of respiratory function. Monitor respiratory function carefully. If sudden deterioration of respiratory function occurs, discontinue therapy. Reinstitute with extreme caution and continuous monitoring; consider concomitant administration of a bronchodilator.
Ribavirin for nasal or oral inhalation is not indicated in adults.
Administer aerosolized ribavirin under the supervision of and by qualified clinicians and support staff experienced with the specific ventilator and mode of administration. Attention must be directed to procedures that minimize accumulation of drug precipitate, which can result in mechanical ventilator dysfunction and associated increased pulmonary pressure.
REMS:
FDA approved a REMS for ribavirin to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
Take this medicine by mouth. Follow the directions on the prescription label. Use a specially marked spoon or container to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. You can take this medicine with or without food, but you should take it the same way every day. Take your medicine at regular intervals. Do not take your medicine more often than directed. Take all of your medicine as directed even if you think you are better. Do not skip doses or stop your medicine early.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 3 years of age for selected conditions, precautions do apply.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose and remember the same day, take it as soon as you remember. If the whole day has passed, ask your healthcare provider what to do. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with the following medication:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
See your doctor or health care professional for a follow-up visit as directed. You may need to have tests done to check your progress. Tell your doctor if your symptoms do not improve or if they get worse.
This medicine may cause birth defects or death to an unborn child. Women taking this medicine must avoid pregnancy while taking this medicine and for 6 months after stopping this medicine. Men who are taking this medicine must avoid getting a woman pregnant while taking this medicine and for 6 months after stopping this medicine. Use 2 forms of birth control. Women who can still have children must have a negative pregnancy test before starting treatment. Take monthly pregnancy tests while you are taking this medicine and for 6 months after this medicine is stopped. Talk to your doctor if you think that you or your partner are pregnant or are trying to become pregnant.
Do not drink alcohol, including beer, wine, and liquor. This may make your liver disease worse.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.
Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe. Brush your teeth thoroughly twice daily and have regular dental examinations. Also, if you vomit, rinse out your mouth.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
cough
difficulty hearing or ringing in the ears
increased hunger or thirst
increased urination
itchy skin
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store in the refrigerator at 2 to 8 degrees C (36 to 46 degrees F). Or, store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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