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(rye-buh-VIE-rin)
Virazole
Lyophilized powder for aerosol reconstitution: 6 g ribavirin/100 mL vial. Contains 20 mg/mL when reconstituted with 300 mL sterile water.
Class: Anti-infective, Antiviral

 Action Has antiviral inhibitory activity against respiratory syncytial virus (RSV), influenza virus, and herpes simplex virus. Exact mechanism is unknown.

 Indications

Aerosol

Treatment of carefully selected hospitalized infants and young children with severe lower respiratory tract infections caused by RSV.

Capsule

In combination with recombinant interferon alfa-2b injection for the treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with alpha interferon or who have relapsed following alpha interferon therapy.

 Contraindications Infants requiring assisted ventilation because drug may precipitate in the equipment, interfering with safe and effective ventilation; women who are or may become pregnant.

 Route/Dosage

RSV

INFANTS & CHILDREN: Inhalation 6 g reconstituted with 300 mL Sterile Water aerosolized and administered over 12 to 18 hr/day for 3 to 7 days.

Capsules

ADULTS: PO Patients £ 75 kg: two 200 mg capsules in the morning and three 200 mg capsules in the evening. Patients > 75 kg: three 200 mg capsules in the morning and evening. In patients whose hemoglobin levels fall < 10 g/dL, reduce the ribavirin dose to 600 mg/day (one 200 mg capsule in the morning and two 200 mg capsules in the evening). Permanently discontinue ribavirin in patients whose hemoglobin levels fall < 8.5 g/dL. In patients with a history of stable cardiovascular disease, a permanent dose reduction of ribavirin to 600 mg/day is required if the hemoglobin decreased by ³ 2 g/dL during any 4-wk treatment period. Permanently discontinue ribavirin therapy in patients with cardiac history if the hemoglobin remains < 12 g/dL after 4 wk on a reduced ribavirin dose.

 Interactions None well documented.

 Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Cardiac arrest, hypotension, digitalis toxicity (aerosol). CNS: Headache, dizziness, insomnia, irritability, depression, emotional lability, impaired concentration, nervousness, fatigue (capsules). DERMATOLOGIC: Rash; alopecia, pruritus, injection site inflammation and reaction (capsules). EENT: Conjunctivitis (aerosol); sinusitis, taste perversion, hearing disorders, vertigo (capsules). GI: Nausea, anorexia, dyspepsia, vomiting (capsules). HEMATOLOGIC: Anemia (aerosol); hemolytic anemia, changes in hemoglobin, WBC, neutrophil, and platelet values (capsules). RESPIRATORY: Worsening of respiratory status, bacterial pneumonia, pneumothorax, apnea, ventilator dependence (aerosol); dyspnea (capsules). OTHER: Myalgia, arthralgia, musculo-skeletal pain, rigors, fever, flu-like symptoms, asthenia, chest pain (capsules).

 Precautions

Pregnancy: Category X. Lactation: Undetermined. Children: Safety and efficacy of ribavirin capsules not established. Elderly: Administer ribavirin capsules with caution, reflecting greater frequency of decreased hepatic, renal, or cardiac function and comorbidity. Monotherapy: Ribavirin monotherapy is not effective for treatment of chronic hepatitis C virus infection. Renal Function Impairment: Do not use in patients with Ccr < 50 mL/min.

PATIENT CARE CONSIDERATIONS

 Administration/Storage

  • Administer by aerosol using only Small Particle Aerosol Generator (SPAG-2). Refer to manufacturer instructions for use of device.
  • Reconstitute with 100 mL of preservative-free Sterile Water for Injection, then transfer solution to reservoir.
  • Dilute to final volume of 300 mL with Sterile Water for Injection. Concentration should be 20 mg/mL.
  • Do not administer with other aerosol medications.
  • Discard solutions placed in SPAG-2 unit ³ q 24 hr and when liquid level is low before adding newly reconstituted solution.
  • Store reconstituted solution at room temperature and discard after 24 hr.
  • Store powder form of drug at room temperature.
  • Minimize environmental exposure to ribavirin by use of an aerosol delivery hood or other shielding techniques. Do not allow pregnant women near patient when aerosol is being delivered.

 Assessment/Interventions

  • Obtain patient history, including drug history and any known allergies.
  • Obtain baseline reticulocyte count and monitor daily.
  • Monitor I&O.
  • Obtain baseline vital signs and monitor at regular intervals during administration.
  • Assess respiratory status prior to starting drug and monitor closely during treatment.
  • If respiratory status deteriorates rapidly, discontinue treatment and notify health care provider.
  • Obtain baseline digoxin levels on patients who are concomitantly receiving digoxin and monitor for digoxin toxicity.
  • Assess skin prior to starting drug and observe for changes.

 Patient/Family Education

  • Caution patient that this medication must not be taken during pregnancy or when pregnancy is possible.
  • Tell family to notify health care provider if change in respiratory status or rash occurs.

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