No

Antiviral Agent

Inhalation: Treatment of patients with respiratory syncytial virus (RSV) infections; may also be used in other viral infections including influenza A and B and adenovirus; specially indicated for treatment of severe lower respiratory tract RSV infections in patients with an underlying compromising condition (prematurity, bronchopulmonary dysplasia and other chronic lung conditions, congenital heart disease, immunodeficiency, immunosuppression), and recent transplant recipients

X

Females of childbearing age; hypersensitivity to ribavirin; patients with autoimmune hepatitis

Use with caution in patients requiring assisted ventilation because precipitation of the drug in the respiratory equipment may interfere with safe and effective patient ventilation; monitor carefully in patients with COPD and asthma for deterioration of respiratory function. Ribavirin is potentially mutagenic, tumor-promoting, and gonadotoxic. Anemia has been observed in patients receiving the interferon/ribavirin combination. Severe psychiatric events have also occurred including depression and suicidal behavior during combination therapy; avoid use in patients with a psychiatric history.

Inhalation:

1% to 10%:

Central nervous system: Fatigue, headache, insomnia

Gastrointestinal: Nausea, anorexia

Hematologic: Anemia

<1%: Hypotension, cardiac arrest, digitalis toxicity, rash, skin irritation, conjunctivitis, mild bronchospasm, worsening of respiratory function, apnea

Note: Incidence of adverse effects in healthcare workers approximate 51% headache; 32% conjunctivitis; 10% to 20% rhinitis, nausea, rash, dizziness, pharyngitis, and lacrimation

Oral: (All adverse reactions are documented while receiving combination therapy with interferon alpha-2b)

>10%:

Cardiovascular: Chest pain

Central nervous system: Dizziness, headache, fatigue, fever, insomnia, irritability, depression, emotional lability, impaired concentration

Dermatologic: Alopecia, rash, pruritus

Gastrointestinal: Nausea, anorexia, dyspepsia, vomiting

Hematologic: Decreased hemoglobin and WBC

Neuromuscular & skeletal: Myalgia, arthralgia, musculoskeletal pain, weakness, rigors

Respiratory: Dyspnea, sinusitis

Miscellaneous: Flu-like syndrome

1% to 10%:

Central nervous system: Nervousness

Endocrine & metabolic: Thyroid function test abnormalities

Gastrointestinal: Taste perversion

Decreased effect of zidovudine

Do not use any water containing an antimicrobial agent to reconstitute drug; reconstituted solution is stable for 24 hours at room temperature

Inhibits replication of RNA and DNA viruses; inhibits influenza virus RNA polymerase activity and inhibits the initiation and elongation of RNA fragments resulting in inhibition of viral protein synthesis

Absorption: Absorbed systemically from the respiratory tract following nasal and oral inhalation; absorption is dependent upon respiratory factors and method of drug delivery; maximal absorption occurs with the use of the aerosol generator via an endotracheal tube; highest concentrations are found in the respiratory tract and erythrocytes

Metabolism: Occurs intracellularly and may be necessary for drug action

Half-life, plasma:

Children: 6.5-11 hours

Adults: 24 hours, much longer in the erythrocyte (16-40 days), which can be used as a marker for intracellular metabolism

Time to peak serum concentration: Inhalation: Within 60-90 minutes

Elimination: Hepatic metabolism is major route of elimination with 40% of the drug cleared renally as unchanged drug and metabolites

Infants, Children, and Adults:

Aerosol only: 12-18 hours/day for 3 days, up to 7 days in length

Ribavirin should be administered in well-ventilated rooms (at least 6 air changes/hour)

Respiratory function, CBC, reticulocyte count, I & O

May cause drowsiness or insomnia

None reported

No information available to require special precautions

No effects or complications reported

Take as directed, for full course of therapy; do not discontinue even if feeling better. Use aerosol device as instructed. Maintain adequate fluid intake and report any swelling of ankles or feet, difficulty breathing, persistent lethargy, acute headache, insomnia, severe nausea or anorexia, confusion, fever, chills, sore throat, easy bruising or bleeding, mouth sores, or worsening of respiratory condition. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Do not get pregnant during or for 1 month following therapy. Male: Do not cause a pregnancy. Male/female: Consult prescriber for instruction on appropriate barrier contraceptive measures. This drug may cause severe fetal defects. Consult prescriber if breast-feeding.

Keep accurate I & O record, discard solutions placed in the SPAG-2 unit at least every 24 hours and before adding additional fluid; healthcare workers who are pregnant or who may become pregnant should be advised of the potential risks of exposure and counseled about risk reduction strategies including alternate job responsibilities; ribavirin may adsorb to contact lenses

Capsule: 200 mg; available only in Rebetron® combination package

Powder for aerosol: 6 g (100 mL)

American Academy of Pediatrics Committee on Infectious Diseases, "Reassessment of the Indications for Ribavirin Therapy in Respiratory Syncytial Virus Infections," Pediatrics, 1996, 97(1):137-40.

American Academy of Pediatrics Committee on Infectious Diseases, "Use of Ribavirin in the Treatment of Respiratory Syncytial Virus Infection," Pediatrics, 1993, 92(3):501-4.

Barry M, Russi M, Armstrong L, et al, "Brief Report: Treatment of a Laboratory-Acquired Saria Virus Infection," N Engl J Med, 1995, 333(5):294-6.

Davis GL, Esteban-Mur R, Rustgi V, et al, "Interferon Alfa-2b Alone or in Combination With Ribavirin for the Treatment of Relapse of Chronic Hepatitis C. International Hepatitis Interventional Therapy Group," N Engl J Med, 1998, 339(21):1493-9.

"Drugs for Non-HIV Viral Infections," Med Lett Drugs Ther, 1994, 36(919):27.

Englund JA, Piedra PA, Ahn YM, et al, "High-Dose, Short-Duration Ribavirin Aerosol Therapy Compared With Standard Ribavirin Therapy in Children With Suspected Respiratory Syncytial Virus Infection," J Pediatr, 1994, 125:635-41.

Janai HK, Marks MI, Zaleska M, et al, "Ribavirin: Adverse Drug Reactions 1986 to 1988," Pediatr Infect Dis J, 1990, 9(3):209-11.

Keating MR, "Antiviral Agents," Mayo Clin Proc, 1992, 67(2):160-78.

Kramer TH, Gaar GG, Ray CG, et al, "Hemodialysis Clearance of Intravenously Administered Ribavirin," Antimicrob Agents Chemother, 1990, 34(3):489-90.

McHutchison JG, Gordon SC, Schiff ER, et al, "Interferon Alfa-2b Alone or in Combination With Ribavirin as Initial Treatment for Chronic Hepatitis C. Hepatitis Interventional Therapy Group," N Engl J Med, 1998, 339(21):1485-92.

Meert KL, Sarnaik AP, Gelmini MJ, et al, "Aerosolized Ribavirin in Mechanically Ventilated Children With Respiratory Syncytial Virus Lower Respiratory Tract Disease: A Prospective, Double-Blind, Randomized Trial," Crit Care Med, 1994, 22(4):566-72.

Morris DJ, "Adverse Effects and Drug Interactions of Clinical Importance With Antiviral Drugs," Drug Saf, 1994, 10(4):281-91.

Nicholson KG, "Properties of Antiviral Agents," Lancet, 1984, 2(8401):503-6 and 2(8402):562-4.

Ottolini MG and Hemming VG, "Prevention and Treatment Recommendations for Respiratory Syncytial Virus Infection. Background and Clinical Experience 40 Years After Discovery," Drugs, 1997, 54(6):867-84.

Smith DW, Frankel LR, Mathers LH, et al, "A Controlled Trial of Aerosolized Ribavirin in Infants Receiving Mechanical Ventilation for Severe Respiratory Syncytial Virus Infection," N Engl J Med, 1991, 325(1):24-9.

Van Bever HP, Desager KS, Van Hoeck K, et al, "Water Intoxication After Nebulised Tribavirin," Lancet, 1995, 345(8947):451.

Vogt MW, Hartshorn KL, Furman PA, et al, "Ribavirin Antagonizes the Effect of Azidothymidine on HIV Replication," Science, 1987, 235(4794):1376-9.