pharmacopeia
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/api/v1/drug/ribavirin

Boxed warning

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 ).

Mechanism of action

Sourced from openFDA

In cell cultures the inhibitory activity of ribavirin for respiratory syncytial virus (RSV) is selective. The mechanism of action is unknown.

Enzyme

Indications

Sourced from openFDA
  • Ribavirin for inhalation solution, USP is indicated for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus. Treatment early in the course of severe lower respiratory tract infection may be necessary to achieve efficacy.

Contraindications

Sourced from openFDA
  • 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).contraindicated

Dosage & administration

Sourced from openFDA

BEFORE USE, READ THOROUGHLY THE VALEANT SMALL PARTICLE AEROSOL GENERATOR SPAG-2 OPERATOR'S MANUAL FOR SMALL PARTICLE AEROSOL GENERATOR OPERATING INSTRUCTIONS. AEROSOLIZED RIBAVIRIN FOR INHALATION SOLUTION, USP SHOULD NOT BE ADMINISTERED WITH ANY OTHER AEROSOL GENERATING DEVICE. 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 micrograms/liter 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 manual). 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.

Warnings & precautions

Sourced from openFDA

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. 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 Clinical Studies).

Adverse reactions

Sourced from openFDA

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 ribavirin for inhalation solution, USP treatment in six of six adults with chronic obstructive lung disease and in four of six asthmatic adults.

Pharmacokinetics

Sourced from openFDA
Metabolism
Assay for ribavirin for inhalation solution, USP in human materials is by a radioimmunoassay which detects ribavirin and at least one metabolite. Ribavirin for inhalation solution, USP, when administered by aerosol, is absorbed systemically.

Overdosage

Sourced from openFDA

No overdosage with ribavirin for inhalation solution, USP by aerosol administration has been reported in humans. The LD 50 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 ).

Approval history

Sourced from openFDA
  • Dec 31, 1985NDANDA018859Bausch
  • Sep 17, 2009ANDAANDA079117Aurobindo Pharma
  • Sep 17, 2009ANDAANDA079111Aurobindo Pharma
  • Oct 6, 2016ANDAANDA207366Navinta Llc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
63,876 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Fatigue9,55315%
  2. 2Anaemia8,36213%
  3. 3Nausea7,42812%
  4. 4Rash5,3578.4%
  5. 5Headache4,7867.5%
  6. 6Pruritus4,6427.3%
  7. 7Vomiting3,8066.0%
  8. 8Diarrhoea3,7455.9%
  9. 9Asthenia3,6125.7%
  10. 10Pyrexia3,5805.6%
  11. 11White Blood Cell Count Decreased3,4435.4%
  12. 12Insomnia3,4365.4%
  13. 13Dyspnoea3,3275.2%
  14. 14Decreased Appetite3,2715.1%
  15. 15Drug Ineffective3,2115.0%

Literature

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Recent PubMed references pinned to Ribavirin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 1,100 ClinicalTrials.gov registrations naming Ribavirin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Ribavirin. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • VDRCPIC D (provisional)ClinPGx 3

Frequently asked questions

How does Ribavirin work?
In cell cultures the inhibitory activity of ribavirin for respiratory syncytial virus (RSV) is selective. The mechanism of action is unknown.
What is Ribavirin used for?
According to FDA labeling, Ribavirin carries indications including: Ribavirin for inhalation solution, USP is indicated for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus. Treatment early in the course of severe lower respiratory tract infection may be necessary to achieve efficacy.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Ribavirin?
Ribavirin is classified as Antivirals for treatment of HCV infections, Nucleoside Analog Antiviral, Enzyme Inhibitors, Decreased DNA Replication, Decreased RNA Replication.
What are the brand names for Ribavirin?
Ribavirin is marketed under brand names including Moderiba, RibaTab, Ribasphere, Virazole.
What are the contraindications for Ribavirin?
Ribavirin labeling lists contraindications including: 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).. Always consult the full prescribing information and a clinician.
Note. Data for ribavirin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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