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Drugs reference index «Virazole»

Virazole


Virazole

Generic Name: ribavirin (Inhalation route)

rye-ba-VYE-rin

Inhalation, oral/nebulization routePowder for Solution
  • INHALATION
    • 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.
    • 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) .

Use caution when administering aerosolized ribavirin to patients requiring mechanical ventilator assistance. Sudden deterioration of respiratory function has been associated with initiation of aerosolized ribavirin use in infants. Monitor respiratory function during treatment. Ribavirin is not indicated for use in adults. 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) .

Oral routeTabletCapsuleSolution
  • ORAL
    • Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication.
    • The primary toxicity of ribavirin is hemolytic anemia. The anemia associated with ribavirin therapy may result in worsening of cardiac disease that led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with ribavirin.
    • Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. In addition, ribavirin has multiple-dose half-life of 12 days, and so it may persist in non-plasma compartments for as long as 6 months. Therefore, ribavirin therapy is contraindicated in women who are pregnant and in male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of treatment in both female patients and in female partners of male patients who are taking ribavirin therapy. At least two reliable forms of effective contraception must be utilized during treatment and during the 6-month posttreatment follow-up period .

Ribavirin is not effective for monotherapy treatment of chronic hepatitis C virus infection. The primary toxicity is hemolytic anemia which may result in worsening of cardiac disease and fatal and nonfatal myocardial infarctions. Avoid use in patients with significant or unstable cardiac disease. Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. Ribavirin is contraindicated in women who are pregnant and in male partners of women who are pregnant. Use 2 reliable forms of contraception and avoid pregnancy during therapy and for 6 months after completion of treatment in both female patients and in female partners of male patients who are taking ribavirin .

Commonly used brand name(s):

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

Uses For Virazole

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 Virazole

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.

Pediatric

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

Geriatric

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 .

Pregnancy

Pregnancy CategoryExplanation
All TrimestersXStudies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

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.

Interactions with Medicines

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
  • Lamivudine
  • Stavudine
  • 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

Interactions with Food/Tobacco/Alcohol

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 Virazole

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 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 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 .

Virazole 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 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.

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  • Virazole Solution MedFacts Consumer Leaflet (Wolters Kluwer)
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  • Ribavirin Detailed Consumer Information (PDR)
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  • Rebetol MedFacts Consumer Leaflet (Wolters Kluwer)
  • Rebetol Prescribing Information (FDA)
  • Rebetol Detailed Consumer Information (PDR)
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  • Ribasphere Prescribing Information (FDA)

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