Virazole (inhalation)

Virazole (inhalation)

Virazole (inhalation) Inhalation route (powder for solution)

The use of ribavirin in aerosol form in patients requiring mechanical ventilation should only be carried out by physicians and support personnel who are familiar with the ventilator used and this method of administration of the drug. Strict attention must be paid to procedures proven to minimize the accumulation of drug precipitation, which can lead to mechanical ventilator dysfunction and associated increased pulmonary pressure.

Sudden deterioration in respiratory function has been associated with the initiation of aerosolized ribavirin in infants. During treatment, respiratory function should be carefully monitored. If initiation of treatment with aerosolized ribavirin appears to cause a sudden deterioration in respiratory function, treatment should be discontinued and restarted only with extreme caution, continued 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 cause testicular lesions in rodents and to be teratogenic in all animal species in which relevant studies have been conducted (rodents and rabbits).

Uses for Virazole

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

Before using Virazol

When deciding whether to use a medicine, the risks of taking the medicine must be weighed against the benefits it produces. This is a decision that you and your doctor will make. The following should be noted with this medicine:

Allergies

Tell your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also tell your doctor 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.

Pediatrics

Studies conducted to date have not shown any pediatric-specific problems that would limit the benefit of ribavirin in infants and young children.

geriatrics

Appropriate studies of the association of age with the effects of ribavirin have not been conducted in the geriatric population. The use of this medicine in adults and the elderly is not recommended.

Breastfeeding

There are insufficient studies in women to determine the risk to infants when using this drug while breast-feeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug interactions

Although certain medicines should not be used together at all, in other cases two different medicines can be used together, although interactions may occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. If you are receiving this medicine, it is particularly important that your doctor knows whether you are taking any of the medicines listed below. The following interactions were selected for their potential significance and are not necessarily exhaustive.

The use of this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or to change some of the other medications you are taking.

• Didanosin

Using this medicine with any of the following medicines is not usually recommended but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Abacavir
• Azathioprin
• Levoketoconazol
• Mercaptopurin
• Methotrexat
• Stavudin
• Warfarin
• Zalcitabin
• Zidovudin

Using this medicine with any of the following medicines may result in an increased risk of certain side effects, but using both medicines 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 medicines.

• Interferon Alfa-2b

Interactions with food/tobacco/alcohol

Certain medicines should not be taken during or near food or consumption of certain foods because interactions may occur. Consuming alcohol or tobacco with certain medications can also lead to interactions. Discuss using your medicine with food, alcohol or tobacco with your doctor.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Anämie bzw
• Herzkrankheit bzw
• Lungenerkrankung – kann dazu führen, dass sich die Nebenwirkungen verschlimmern.

Correct use of Virazole

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

To help your child's infection heal completely, ribavirin must be given throughout the course of treatment, even if your child feels better after a few days. Additionally, inhaled ribavirin works best when there is a constant amount in the lungs. To keep the amount constant, ribavirin must be administered regularly or continuously.

Precautions when using Virazole

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

If a woman is pregnant, exposure to this medicine may harm the unborn child. It is very important that all pregnant women who will be in the hospital with their child contact the doctor immediately.

Virazole side effects

In addition to the necessary effects, a medicine may also have some undesirable effects. Although not all of these side effects may occur, medical attention may be required if they occur.

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

Incident not known

• Rücken-, Bein- oder Bauchschmerzen
• Zahnfleischbluten
• bläuliche Farbe von Fingernägeln, Lippen, Haut, Handflächen oder Nagelbetten
• verschwommene Sicht
• Brustschmerzen oder Unwohlsein
• Verwirrung
• Husten
• Husten, der manchmal einen rosafarbenen, schaumigen Auswurf erzeugt
• dunkler Urin
• schwieriges, schnelles, lautes Atmen, manchmal mit pfeifender Atmung
• Schwindel, Ohnmacht oder Benommenheit beim plötzlichen Aufstehen aus einer liegenden oder sitzenden Position
• extrem flache oder langsame Atmung
• schneller, langsamer, hämmernder oder unregelmäßiger Herzschlag oder Puls
• Ermüdung
• Fieber oder Schüttelfrost
• allgemeine Schwellung des Körpers
• Kopfschmerzen
• vermehrtes Schwitzen
• Benommenheit, Schwindel oder Ohnmacht
• Appetitverlust
• niedriger Blutdruck oder Puls
• Übelkeit oder Erbrechen
• Nasenbluten
• nicht atmen
• blasse Haut
• starke Schmerzen in der Brust
• Kurzatmigkeit
• niesen
• Halsentzündung
• Herzstillstand
• Plötzliches Auftreten schwerer Atemprobleme
• Schwitzen
• Schwellungen in den Beinen und Knöcheln
• Engegefühl in der Brust
• Atembeschwerden beim Bewegen oder Gehen
• Bewusstlosigkeit
• ungewöhnliche Blutungen oder Blutergüsse
• ungewöhnliche Müdigkeit oder Schwäche
• gelbe Augen oder Haut

Some side effects may occur that usually do not require medical attention. These side effects may disappear during treatment as your body gets used to the medicine. Your doctor may also be able to give you ways to prevent or reduce some of these side effects. If any of the following side effects persist or are bothersome, or if you have any questions, contact your doctor:

Incident not known

• Brennende, trockene oder juckende Augen
• Augenausfluss oder übermäßiger Tränenfluss
• Ausschlag
• Rötung, Schmerzen, Schwellung des Auges, des Augenlids oder der inneren Augenlidschleimhaut

Some patients may also experience other side effects not listed. If you notice other side effects, contact your doctor.

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

Commonly used brand names

In the USA

• Virazol

Available dosage forms:

• Pulver zur Lösung

Therapeutic Class: Antiviral

Pharmacological class: Viral RNA polymerase inhibitor

Chemical Class: Guanosine Nucleoside Analogue

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