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a nucleoside analogue that acts as a broad-spectrum antiviral; used in treatment of severe viral pneumonia caused by respiratory syncytial virus, particularly in high-risk infants with underlying conditions such as cardiopulmonary disease; administered by oral inhalation. It is also used in conjunction with interferon alfa-2b in the treatment of chronic hepatitis C, administered orally.


Pharmacologic class: Synthetic nucleoside analog

Therapeutic class: Antiviral

Pregnancy risk category X

FDA Box Warning

• Ribavirin monotherapy isn't effective in treating chronic hepatitis C infection and shouldn't be used alone for this indication.

• Drug's main clinical toxicity is hemolytic anemia, which may worsen cardiac disease and lead to fatal and nonfatal myocardial infarctions. Don't administer to patients with history of significant or unstable cardiac disease.

• Drug is contraindicated in pregnant women and their male partners. Caution female patients and female partners of male patients receiving ribavirin to use extreme care to avoid pregnancy during therapy and for 6 months afterward.


Unknown. Thought to inhibit RNA and DNA synthesis by depleting nucleotides and blocking replication and maturation of viral cells.


Capsules: 200 mg

Powder to be reconstituted for inhalation (Virazole): 6 g in 100-ml glass vial

Tablets: 200 mg

Indications and dosages

Chronic hepatitis C infection

Note: Dosage calculated solely on basis of patient's weight.

Adults and children weighing 75 kg (165 lb) or more: 600 mg P.O. q morning and evening, given with interferon alfa-2b

Adults weighing less than 75 kg (165 lb) and children weighing more than 61 kg (134 lb): 400 mg P.O. q morning and 600 mg P.O. q evening, given with interferon alfa-2b

Children weighing 50 to 61 kg (110 to 134 lb): 400 mg P.O. b.i.d., given with interferon alfa-2b

Children weighing 37 to 49 kg (81 to 108 lb): 200 mg P.O. every morning and 400 mg P.O. every evening, given with interferon alfa-2b

Children weighing 25 to 36 kg (55 to 79 lb): 200 mg P.O. b.i.d., given with interferon alfa-2b

Hospitalized children with severe lower respiratory infection caused by respiratory syncytial virus

Infants and young children: 20 mg/ml by inhalation as a starting solution in Viratek Small Particle Aerosol Generator (SPAG-2) for 12 to 18 hours daily for 3 to 7 days. Give by oxygen hood from SPAG-2 unit to infant who isn't mechanically ventilated.

Dosage adjustment

• Cardiovascular disease
• Chronic obstructive pulmonary disease (COPD)
• Renal impairment
• Hemoglobin below 10 g/dl

Off-label uses

• Influenza A or B
• Pneumonia caused by adenovirus
• Severe lower respiratory tract infection in adults
• Genital herpes
• Hemorrhagic fever


• Hypersensitivity to drug or its components
• Autoimmune hepatitis (oral combination therapy)
• Creatinine clearance below 50 ml/minute
• Significant or unstable cardiac disease
• Hemoglobinopathy (such as sickle cell anemia, thalassemia major)
• Females of childbearing age (inhalation form)
• Pregnancy, pregnant partner of male patient (oral drug)
• Breastfeeding


Use cautiously in:
• decompensated hepatic disease, coinfection with hepatitis B or human immunodeficiency virus, COPD
• liver or other transplant recipients
• patients who don't respond to interferon.


Be aware that oral form must be given with interferon alfa-2b injection.
• Give aerosol by Viratek SPAG-2 only. Don't use other aerosol-generating equipment.
• Dilute powder in sterile water for injection. Don't use solutions with antimicrobial ingredients.
• Know that drug may be given by oral or nasal inhalation.
• Discard solution in SPAG-2 every 24 hours before adding new solution.

Avoid prolonged contact with aerosol, which can cause headache or eye irritation.

Adverse reactions

CNS: fatigue, headache, nervousness, depression, suicidal ideation

CV: hypotension, bradycardia (with inhalation form), cardiac arrest

EENT: conjunctivitis, eyelid erythema or rash

GI: nausea, dyspepsia, anorexia, pancreatitis

Hematologic: reticulocytosis, hemolytic anemia

Respiratory: bacterial pneumonia, pneumothorax, bronchospasm, pulmonary edema, apnea, worsening respiratory status (with inhalation form)

Skin: rash, pruritus


Drug-drug.Abacavir, didanosine, lamivudine, stavudine, zalcitabine, zidovudine: potentially fatal lactic acidosis

Stavudine, zidovudine: decreased antiviral activity

Drug-diagnostic tests.Alanine aminotransferase, aspartate aminotransferase, bilirubin: increased levels

Hemoglobin: decreased level

Reticulocytes: increased count

Patient monitoring

Carefully monitor patient's respiratory status. Check ventilator often to ensure that drug precipitates don't impede function.

Monitor ECG and vital signs. Watch for hypotension, bradycardia, and other signs of impending cardiac arrest or worsening respiratory condition.

Assess neurologic status. Stay alert for depression and suicidal ideation.
• Monitor liver function tests and CBC with white cell differential.

Patient teaching

• Explain drug delivery system and precautions carefully to patient or to parents of children receiving inhalation form.

Tell patient or parents that drug may cause depression or suicidal thoughts, which should be reported immediately.

Instruct patient or parents to immediately report new or worsening respiratory symptoms.
• Counsel sexually active patients (both males and females) about appropriate birth control. Tell them to use extreme care to avoid pregnancy. Stress importance of using two forms of effective contraception during and for 6 months after treatment (when using oral ribavirin).
• Advise female patient not to breastfeed.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.


/ri·ba·vi·rin/ (ri″bah-vi´rin) a broad-spectrum antiviral used in the treatment of severe viral pneumonia caused by respiratory syncytial virus, particularly in high-risk infants; also used in conjunction with interferon alfa-2b in the treatment of chronic hepatitis C.


A synthetic antiviral ribonucleoside that inhibits DNA and RNA replication.


an aerosol antiviral drug.
indications It is prescribed for the treatment of respiratory syncytial virus infections for the lower respiratory tract in infants and small children.
contraindications It is not recommended for infants requiring assisted ventilation.
adverse effects Reported side effects include bacterial pneumonia, pneumothorax, apnea, hypotension, and cardiac arrest, conditions that may also have resulted from the patient's underlying disease; deteriorated respiratory function; rash; conjunctivitis; and reticulocytosis.


Rebetol® Virology An oral ribavirin, a synthetic nucleoside analogue and broad-spectrum antiviral. See Rebetron.


An antiviral drug effective against a range of both DNA and RNA viruses including the herpes group and those causing hepatitis, and several strains of influenza.


A drug that is used to combat viral infections.
Mentioned in: Hemorrhagic Fevers

ribavirin (rī´bəvir´in),

n an antiviral agent that acts against many ribonucleic acid and deoxyribonucleic acid viruses by inhibiting protein synthesis and replication. Used in the United States only for aerosol therapy for infants to treat acute lower respiratory infections resulting from respiratory syncitial virus.


a broad-spectrum, non-interferon inducing, antiviral nucleoside.
References in periodicals archive ?
Approval in HIV-coinfected patients was based on the APRICOT study, a trial of 868 coinfected patients, which found the SVR rate after 48 weeks was 40% in those treated with Pegasys-Copegus, versus 20% in those on Pegasys alone and 12% in those on conventional interferon and Copegus.
Ribavirin is a teratogen and should be avoided during pregnancy Roche has set up a Copegus pregnancy registry; call 800-526-6367 to enroll patients.
In another study of 1,284 patients, SVR rates were 51% in patients with genotype 1, treated with 1,000-1,200 mg of Copegus per day for 48 weeks, and 82% among those who did not have genotype 1, treated with 800 mg of Copegus for 24 weeks.
In the study, about 200 chronically infected genotype 1 hepatitis C patients are expected to receive ANA598 200 mg twice a day (bid) in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin, USP) (a current standard of care, or SOC) with a loading dose of 800 mg bid on day 1, while approximately 66 patients are to receive placebo and SOC.
Two of the treatment arms are fully enrolled and are evaluating four-drug combinations of telaprevir (1,125 mg), VX-222 (400 mg or 100 mg), Pegasys (pegylated-interferon alfa-2a) and Copegus (ribavirin).
Other products launched in 2005 include fexofenadine hydrochloride tablets, AB rated and bioequivalent to Aventis' Allegra; azithromycin tablets, AB rated and bioequivalent to Pfizer's Zithromax; oxycodone hydrochloride extended-release tablets, AB rated and bioequivalent to Purdue Pharma's OxyContin; paroxetine tablets USP, AB rated and bioequivalent to GlaxoSmithKiine PLC's Paxil; and ribavirin tablets, AB rated and bioequivalent to Roche's Copegus.
Copegus has not been directly compared with Schering-Plough's combination of Peg-Intron (peginterferon alfa-2b) and Rebetol, approved in 2001 to treat HCV in interferon-[alpha]-naive adults with compensated liver disease.
26 October 2010 - Japanese drug maker Chugai (TYO: 4519), a subsidiary of Swiss Roche (VTX: ROG), said on Tuesday it has filed an application with the Ministry of Health, Labour and Welfare of Japan seeking approval of an additional indication, "improvement of viraemia associated with compensated cirrhosis related to hepatitis C" for the combination therapy of Pegasys and Copegus.
Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) are currently marketed for the indication of improvement of viraemia associated with chronic hepatitis C (CHC).
Pharmasset recently completed dosing in a 28 day Phase IIa trial to evaluate PSI-7977 in combination with Pegasys (pegylated interferon) plus Copegus (ribavirin) in treatment-naive patients chronically infected with HCV genotype 1.
Roche has said that the proposed acquisition would boost its own portfolio of hepatitis C drugs, which include Pegasys and Copegus.
The current armamentarium for treating HCV is relatively modest and consists of pegylated interferon (peg-IFN) products--Roche's Pegasys (peg-IFN-alpha-2a) and Merck's PegIntron/ViraferonPeg (peg-IFN-alpha-2b)--as well as equivalent branded ribavirin products: Roche's Copegus, Merck's Rebetol and generic ribavirin.