RIBAVIRIN

Antiviral

Brand names: RIBAVIRIN

Respiratory (inhalation)

Mechanism of Action

Mechanism of Action In cell cultures the inhibitory activity of ribavirin for respiratory syncytial virus (RSV) is selective. The mechanism of action is unknown. Reversal of the in vitro antiviral activity by guanosine or xanthosine suggests ribavirin may act as an analogue of these cellular metabolites.

Indications

INDICATIONS AND USAGE Ribavirin for inhalation solution

USP. The vast majority of infants and children with RSV infection have disease that is mild

self-limited

USP aerosol (3 to 7 days) and should not be treated with the drug. Thus the decision to treat with ribavirin for inhalation solution

USP should be based on the severity of the RSV infection. The presence of an underlying condition such as prematurity

immunosuppression or cardiopulmonary disease may increase the severity of clinical manifestations and complications of RSV infection. Use of aerosolized ribavirin for inhalation solution

Contraindications

• CONTRAINDICATIONS Ribavirin for inhalation solution
• USP is contraindicated in individuals who have shown hypersensitivity to the drug or its components
• although clinical studies have not been performed
• it should be assumed that ribavirin for inhalation solution

FDA Warnings

WARNINGS: 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 )
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 )

Known Side Effects

13 documented side effects by frequency

Fatigue

>10%

Nausea

>10%

Rash

1-10%

Headache

1-10%

Itching

1-10%

Vomiting

1-10%

Diarrhea

1-10%

Weakness

1-10%

Fever

1-10%

Insomnia

0.1-1%

Shortness of Breath

0.1-1%

Decreased Appetite

0.1-1%

Drug Not Working

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Respiratory (inhalation)