Pronunciation:

rye-ba-VYE-rin

Brand Names:

• Virazole

Dosage Forms:

• Powder for Solution

Warnings:

Use of aerosolized ribavirin in patients requiring mechanical ventilator assistance should be undertaken only by physicians and support staff familiar with the specific ventilator being used and this mode of administration of the drug. Strict attention must be paid to procedures that have been shown to minimize the accumulation of drug precipitate, which can result in mechanical ventilator dysfunction and associated increased pulmonary pressures.Sudden deterioration of respiratory function has been associated with initiation of aerosolized ribavirin use in infants. Respiratory function should be carefully monitored during treatment. If initiation of aerosolized ribavirin treatment appears to produce sudden deterioration of respiratory function, treatment should be stopped and reinstituted only with extreme caution, continuous monitoring and consideration of concomitant administration of bronchodilators.Aerosolized ribavirin is not indicated for use in adults. Physicians and patients should be aware that 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) .

Classifications:

Therapeutic—

Antiviral

Pharmacologic—

Viral RNA Polymerase Inhibitor

Chemical—

Guanosine Nucleoside Analog

Uses of This Medicine:

Ribavirin for inhalation is used to treat severe pneumonia in infants and young children that is caused by the respiratory syncytial virus (RSV). It is given by oral inhalation, which means breathing the medicine as a fine mist through the mouth. Your child will use a special nebulizer (sprayer) that is attached to an oxygen hood, oxygen tent, or face mask .

This medicine is available only with your doctor's prescription .

Before Using This Medicine:

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:

Allergies—

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.

Children—

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of ribavirin in infants and young children .

Older adults—

Appropriate studies on the relationship of age to the effects of ribavirin have not been performed in the geriatric population. This medicine is not recommended for use in adults and the elderly .

Breast-feeding—

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.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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.

• Didanosine

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.

• Abacavir
• Azathioprine
• Levoketoconazole
• Mercaptopurine
• Methotrexate
• Stavudine
• Warfarin
• Zalcitabine
• Zidovudine

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.

• Interferon Alfa-2b

Other interactions—

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.

Other medical problems—

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:

• Anemia or
• Heart disease or
• Lung disease—May cause side effects to become worse .

Proper Use of This Medicine:

This medicine will be given by a nurse or other trained health professional, and only while your child is in the hospital .

To help clear up your child's infection completely, ribavirin must be given for the full time of treatment, even if your child begins to feel better after a few days. Also, ribavirin for inhalation works best when there is a constant amount in the lungs. To help keep the amount constant, ribavirin must be given on a regular or continuous schedule .

Precautions While Using This Medicine:

It is very important that your doctor check your child's progress to make sure this medicine is working properly and to check for unwanted effects. Your child will be monitored very closely while this medicine is given .

If a woman is pregnant, being exposed to this medicine can harm the unborn baby. It is very important that all pregnant women who will be with your child in the hospital contact the doctor immediately .

Side Effects of This Medicine:

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 or nurse immediately if any of the following side effects occur:

Incidence not known

Back, leg, or stomach pains

bleeding gums

bluish color of fingernails, lips, skin, palms, or nail beds

blurred vision

chest pain or discomfort

confusion

cough

coughing that sometimes produces a pink frothy sputum

dark urine

difficult, fast, noisy breathing, sometimes with wheezing

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

extremely shallow or slow breathing

fast, slow, pounding, or irregular heartbeat or pulse

fatigue

fever or chills

general body swelling

headache

increased sweating

lightheadedness, dizziness, or fainting

loss of appetite

low blood pressure or pulse

nausea or vomiting

nosebleeds

not breathing

pale skin

severe pain in chest

shortness of breath

sneezing

sore throat

stopping of heart

sudden onset of severe breathing problems

sweating

swelling in the legs and ankles

tightness in the chest

trouble with breathing when moving or walking

unconsciousness

unusual bleeding or bruising

unusual tiredness or weakness

yellow eyes or skin

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:

Incidence not known

Burning, dry, or itching eyes

eye discharge or excessive tearing

rash

redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

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.