Key facts
- Active ingredient
- Ribavirin
- Drug class
- Nucleoside Analog Antiviral
- Form
- Powder
- Strength
- Ribavirin 6GM/VIAL
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Bausch
- FDA application
- NDA018859
- Availability
- Discontinued (per FDA)
- FDA boxed warning
- Yes — see the boxed warning
What is Virazole?
From the FDA label:Ribavirin is a synthetic nucleoside with antiviral activity. Ribavirin for inhalation solution, USP is a sterile, lyophilized powder to be reconstituted for aerosol administration. Each 100 mL glass vial contains 6 grams of ribavirin, and when reconstituted to the recommended volume of 300 mL with Sterile Water for Injection, USP or Sterile Water for Inhalation (no preservatives added), will contain 20 mg of ribavirin per mL, pH approximately 5.5. Aerosolization is to be carried out in a Small Particle Aerosol Generator (SPAG ® -2) nebulizer only. Ribavirin is 1-beta-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide, with the following structural formula: Ribavirin is a stable, white crystalline compound with a maximum solubility in water of 142 mg/mL at 25°C and with only a slight solubility in ethanol. The empirical formula is C 8 H 12 N 4 O 5 and the molecular weight is 244.21.
How to use
The recommended treatment regimen is 20 mg/mL Ribavirin for Inhalation Solution, USP as the starting solution in the drug reservoir of the SPAG-2 unit, with continuous aerosol administration for 12-18 hours per day for 3 to 7 days. Using the recommended drug concentration of 20 mg/mL the average aerosol concentration for a 12 hour delivery period would be 190 mcg/L of air. Aerosolized Ribavirin for Inhalation Solution, USP should not be administered in a mixture for combined aerosolization or simultaneously with other aerosolized medications. Non-Mechanically Ventilated Infants Ribavirin for Inhalation Solution, USP should be delivered to an infant oxygen hood from the SPAG ® -2 aerosol generator. Administration by face mask or oxygen tent may be necessary if a hood cannot be employed (see SPAG-2 Instructions for Use). However, the volume and condensation area are larger in a tent and this may alter delivery dynamics of the drug. Mechanically Ventilated Infants The recommended dose and administration schedule for infants who require mechanical ventilation is the same as for those who do not. Either a pressure or volume cycle ventilator may be used in conjunction with the SPAG-2. In either case, patients should have their endotracheal tubes suctioned every 1-2 hours, and their pulmonary pressures monitored frequently (every 2-4 hours). For both pressure and volume ventilators,…
Side effects
The description of adverse reactions is based on events from clinical studies (approximately 200 patients) conducted prior to 1986, and the controlled trial of aerosolized Ribavirin for Inhalation Solution, USP conducted in 1989-1990. Additional data from spontaneous post-marketing reports of adverse events in individual patients have been available since 1986. Deaths Deaths during or shortly after treatment with aerosolized Ribavirin for Inhalation Solution, USP have been reported in 20 cases of patients treated with Ribavirin for Inhalation Solution, USP (12 of these patients were being treated for RSV infections). Several cases have been characterized as "possibly related" to Ribavirin for Inhalation Solution, USP by the treating physician; these were in infants who experienced worsening respiratory status related to bronchospasm while being treated with the drug. Several other cases have been attributed to mechanical ventilator malfunction in which Ribavirin for Inhalation Solution, USP precipitation within the ventilator apparatus led to excessively high pulmonary pressures and diminished oxygenation. In these cases the monitoring procedures described in the current package insert were not employed (see Description of Studies , WARNINGS , and DOSAGE AND ADMINISTRATION ). Pulmonary and Cardiovascular Pulmonary function significantly deteriorated during aerosolized…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
USE OF AEROSOLIZED RIBAVIRIN FOR INHALATION SOLUTION, USP 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 (SEE WARNINGS ). SUDDEN DETERIORATION OF RESPIRATORY FUNCTION HAS BEEN ASSOCIATED WITH INITIATION OF AEROSOLIZED RIBAVIRIN FOR INHALATION SOLUTION, USP USE IN INFANTS. RESPIRATORY FUNCTION SHOULD BE CAREFULLY MONITORED DURING TREATMENT. IF INITIATION OF AEROSOLIZED RIBAVIRIN FOR INHALATION SOLUTION, USP 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 (SEE WARNINGS ). RIBAVIRIN FOR INHALATION SOLUTION, USP 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) (SEE CONTRAINDICATIONS ).
Warnings
Important safety information
Respiratory function should be carefully monitored during treatment. If initiation of aerosolized Ribavirin for Inhalation Solution, USP 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. Use with Mechanical Ventilators USE OF AEROSOLIZED RIBAVIRIN FOR INHALATION SOLUTION, USP IN PATIENTS REQUIRING MECHANICAL VENTILATOR ASSISTANCE SHOULD BE UNDERTAKEN ONLY BY PHYSICIANS AND SUPPORT STAFF FAMILIAR WITH THIS MODE OF ADMINISTRATION AND THE SPECIFIC VENTILATOR BEING USED. 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. These procedures include the use of bacteria filters in series in the expiratory limb of the ventilator circuit with frequent changes (every 4 hours), water column pressure release valves to indicate elevated ventilator pressures, frequent monitoring of these devices and verification that ribavirin crystals have not accumulated within the ventilator circuitry, and frequent suctioning and monitoring of the patient (see Description of Studies ). Those administering aerosolized Ribavirin for Inhalation Solution, USP in conjunction with mechanical ventilator use should be thoroughly familiar with detailed descriptions of these procedures as outlined in the SPAG-2 Instructions for Use.
Who should not take Virazole
Ribavirin for Inhalation Solution, USP is contraindicated in individuals who have shown hypersensitivity to the drug or its components, and in women who are or may become pregnant during exposure to the drug. Ribavirin has demonstrated significant teratogenic and/or embryocidal potential in all animal species in which adequate studies have been conducted (rodents and rabbits). Therefore, although clinical studies have not been performed, it should be assumed that Ribavirin for Inhalation Solution, USP may cause fetal harm in humans. Studies in which the drug has been administered systemically demonstrate that ribavirin is concentrated in the red blood cells and persists for the life of the erythrocyte.
Overdose — what happens if you take too much
No overdosage with Ribavirin for Inhalation Solution, USP by aerosol administration has been reported in humans. The LD50 in mice is 2 g orally and is associated with hypoactivity and gastrointestinal symptoms (estimated human equivalent dose of 0.17 g/kg, based on body surface area conversion). The mean plasma half-life after administration of aerosolized Ribavirin for Inhalation Solution, USP for pediatric patients is 9.5 hours. Ribavirin for Inhalation Solution, USP is concentrated and persists in red blood cells for the life of the erythrocyte (see Pharmacokinetics ).
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Clinical studies of interactions of Ribavirin for Inhalation Solution, USP 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 Ribavirin for Inhalation Solution, USP with laboratory tests has not been evaluated.
Drug class
May treat (source: NIH RxClass)
Dosage forms
Powder
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Virazole treat?
- Virazole (Ribavirin) may be used to treat human adenovirus infections, west nile fever, respiratory syncytial virus infections, chronic hepatitis c, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Virazole?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Virazole. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Virazole?
- Virazole is marketed by Bausch. You can see Bausch's full profile, rating, and other products on pharmaranks.
- Is Virazole a brand-name or generic drug?
- Virazole is a brand-name product with the active ingredient Ribavirin. Lower-cost generic equivalents containing Ribavirin are available — ask your pharmacist.
- Is Virazole available over the counter?
- No. Virazole is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Virazole come in?
- Virazole is currently marketed as powder, per the FDA's National Drug Code Directory.
- What class of drug is Virazole?
- Virazole is classified as nucleoside analog antiviral, per the FDA's Established Pharmacologic Class.
- Is Virazole FDA-registered?
- Virazole is on record with the U.S. FDA under application number NDA018859. You can verify this on its official FDA label.
- Is Virazole safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Virazole. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Virazole?
- Virazole's side effects are taken directly from its FDA label. From the label: The description of adverse reactions is based on events from clinical studies (approximately 200 patients) conducted prior to 1986, and the controlled trial of aerosolized Ribavirin for Inhalation Solution, USP conducted in 1989-1990.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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