Virazole (Inhalation)

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

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

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

In deciding to use a medicine, you must consider the risks against the benefits. This decision will be made between you and your doctor. For this medicine, the following factors should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies so far have not shown specific problems that would limit the use of ribavirin in infants and young children.

Geriatric

Studies on how age affects the use of ribavirin have not been conducted in older adults. This medicine is not recommended for use in adults and the elderly.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others can be used together even if interactions might occur. In these cases, your doctor may need to adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below while you are receiving this medicine. The following interactions are significant and may not include all possibilities.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose 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 it may be necessary in some cases. If both medicines are prescribed, 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 increase the risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed, your doctor may change the dose or how often you use one or both of the medicines.

• Interferon Alfa-2b

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around meal times or with certain foods, as interactions may happen. Using alcohol or tobacco with certain medicines can also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Anemia or
• Heart disease or
• Lung disease—these may worsen side effects.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, 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.

In the U.S.

• Virazole

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antiviral

Pharmacologic Class: Viral RNA Polymerase Inhibitor

Chemical Class: Guanosine Nucleoside Analog

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.

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