Virazole is an antiviral medicine that is used to treat babies and young children with severe lung infections caused by respiratory syncytial virus (RSV).

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

Your child may have sudden breathing problems while being treated with this medicine. Your child's lung function will be tested often.

A healthcare provider will give your baby this medicine in a hospital.

Virazole is given with a machine that releases the medicine as an aerosol into an oxygen hood or tent, or a face mask. This allows your child to gently inhale the medicine over a long period of time.

Virazole is usually given for 12 to 18 hours per day for 3 to 7 days.

Small amounts of ribavirin may be released into the nearby air while this medicine is being given to your child. Anyone in close contact with the child may be exposed to Virazole released into the air.

Your child's lung function will be tested often. The doctor may prescribe bronchodilator medication to help improve your child's breathing.

You may need to follow special precautions to avoid exposure to airborne Virazole while your baby is being treated with this medicine. Carefully follow all directions about handling or being near your child.

Women who are able to become pregnant should avoid close contact with the child. Otherwise, take all safety precautions needed to reduce your exposure to Virazole.

Being near a child who has RSV may increase your risk of becoming infected with the virus. Seek medical attention if you have symptoms such as headache, stuffy nose, sore throat, cough, fever, hoarseness, and wheezing.

Virazole is for use only in babies and young children and should not be used by an adult.

Your child should not be treated with Virazole if the child is allergic to Virazole (such as Rebetol, RibaPak, Ribasphere, RibaTab).

This medicine is for use only in young children, but Virazole can harm an unborn baby or cause birth defects.

Virazole should not be used by a woman who is pregnant or may become pregnant, or a man whose sex partner is pregnant.

Because your child will receive Virazole in a clinical setting, a missed dose is not likely.

Since Virazole is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions you should follow while caring for a child being treated with this medicine.

Get emergency medical help if your baby has signs of an allergic reaction: hives; difficult breathing; swelling of the face, lips, tongue, or throat.

Your baby will remain under constant supervision during treatment with Virazole. Any problems the baby has during this time may require further treatment by healthcare professionals.

Sudden breathing problems may occur. Tell your baby's caregivers at once if the baby has any of these side effects:

• fever, cough;

• shallow breathing;

• limpness or severe weakness;

• wheezing, gasping for breath;

• blue-colored lips, cold and clammy skin;

• cough with mucus; or

• other worsened breathing problems.

Although it may be unlikely, it is possible that Virazole could be released into the air in amounts high enough to cause side effects in people who have close contact with the child receiving Virazole. Tell your doctor if you have any of these side effects while caring for the child:

• chest pain, shortness of breath;

• runny nose, sore throat;

• headache, dizziness;

• nausea;

• rash; or

• eye redness, watery eyes.

Some symptoms of exposure to airborne Virazole in an adult may be similar to the symptoms of infection with RSV. Report any new symptoms to the doctor right away.

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.

Your child's caregivers will manage and monitor all medications given to the child during treatment with Virazole.

Do not give any medications to your child that have not been prescribed by your doctor. This includes vitamins, minerals, or herbal products.