Virazole

Virazole is a prescription medication used to treat Respiratory Syncytial Virus (RSV) in children. Virazole belongs to a group of antiviral drugs called nucleoside analogues that work by reducing viral replication in the body. 

This medication comes as a solution inhaled through a machine. Virazole is typically given over 12-18 hours per day over 3-7 days.

Common side effects of Virazole include difficulty breathing, low blood pressure, and rash. 

Virazole is a prescription medication used to treat Respiratory Syncytial Virus (RSV) in children. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Valeant Pharmaceuticals North America LLC

Virazole may cause serious side effects. See "Drug Precautions".

Common side effects include:

• Difficulty breathing
• Low blood pressure
• Rash

Tell our health care provider right away if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Virazole. For more information ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription medicines, vitamins, and herbal supplements. Virazole may affect the way other medicines work.

Clinical studies of interactions of Virazole with other drugs commonly used to treat infants with RSV infections, such as digoxin, bronchodilators, other antiviral agents, antibiotics or anti-metabolites, have not been conducted. Interference by Virazole with laboratory tests has not been evaluated.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

1. Difficulty breathing. This may be more common or severe if you have COPD or asthma.
2. Genetic mutations. Genetic mutations have been see in animals tested with Virazole. The risk of genetic mutations and possible cancer has not been fully evaluated in humans.
3. Male reproductive damage. Virazole has shown to cause harm to male reproductive organs in animals. The risk for damage in humans has not been fully evaluated.
4. Low blood pressure. This may be more common or sever if you have inherited heart disease.
5. Virazole may cause birth defects or the death of your unborn baby. Do not take Virazole if you or your sexual partner is pregnant or plan to be come pregnant. It is not known when it is safe to become pregnant after taking Virazole.

Do not take Virazole if you:

• have or ever had serious allergic reactions to the ingredients in Virazole.
• are pregnant or planning to become pregnant
• are breastfeeding or planning to breastfeed
• certain types of hepatitis (autoimmune hepatitis).
• certain blood disorders (hemoglobinopathies).
• severe kidney disease.
• take didanosine (Videx).

Talk to your healthcare provider before taking Virazole if you have any of these conditions.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Virazole, there are no specific foods that you must exclude from your diet when receiving this medication.

Before you take Virazole, tell your healthcare provider if you have or ever had:

• allergy to Virazole or to any of its ingredients
• breathing problems. Virazole may cause or worsen breathing problems you already have.
• high blood pressure, heart problems, or have had a heart attack. Your healthcare provider should check your blood and heart before you start treatment with Virazole.
• any other medical condition
• are breastfeeding. It is not known if Virazole passes into your breast milk. You and your healthcare provider should decide if you will take Virazole or breast feed.
• Tell your healthcare provider about all the medicines you take, including prescription medicines, vitamins, and herbal supplements. Virazole may affect the way other medicines work.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy. Virazole falls into category X.

It has been shown that women taking ribavirin during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women. Although studies have not been performed, Virazole may cause harm to your unborn baby.

It is not known when it is safe to become pregnant after taking Virazole.

It is not known if Virazole crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Virazole.

Take Virazole exactly as prescribed. Virazole comes in inhalation form and is typically given over 12-18 hours per day for 3-7 days.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose is 20 mg/mL Virazole in the drug reservoir of the SPAG-2 unit, with continuous administration for 12-18 hours per day for 3 to 7 days. Using the recommended dose of 20 mg/mL, the average aerosol concentration for a 12 hour delivery period would be 190 micrograms/liter of air.

If you take too much Virazole, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Virazole is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Vials containing the lyophilized Virazole powder should be stored in a dry place at 25°C (77°F); excursions are permitted to 15°C-30°C (59°F- 86°F). Reconstituted solutions may be stored, under sterile conditions, at room temperature (20-30°C, 68-86°F) for 24 hours.

• Vials containing the lyophilized Virazole inhalation powder should be stored in a dry place at 25°C (77°F); excursions are permitted to 15°C-30°C (59°F- 86°F). Reconstituted solutions may be stored, under sterile conditions, at room temperature (20-30°C, 68-86°F) for 24 hours.
• Keep Virazole and all medicines out of the reach of children.

USE OF AEROSOLIZED VIRAZOLE 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 VIRAZOLE USE IN INFANTS. RESPIRATORY FUNCTION SHOULD BE CAREFULLY MONITORED DURING TREATMENT. IF INITIATION OF AEROSOLIZED VIRAZOLE 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. VIRAZOLE 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.