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The clinical and hematologic status of patients with creatinine clearance less than or equal to 50 mL/min receiving Ribavirin should be carefully monitored. Ribavirin was also not oncogenic in a rat 2 year carcinogenicity study at doses up to the maximum tolerated dose of 60 mg/kg/day. The significance of these findings to human administration is unknown.Ribavirin for Inhalation Solution, USP is indicated for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to RSV.
be taken to avoid pregnancy in female patients and in female partners of male patients. If there is any deterioration of cardiovascular status, therapy should be suspended or discontinued [see After initiation of therapy, hematological tests should be performed at 2 weeks and 4 weeks and biochemical tests should be performed at 4 weeks. This site is provided for educational and informational purposes only, in accordance with our 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. After aerosol treatment, peak plasma concentrations of ribavirin are 85% to 98% less than the concentration that reduced RSV plaque formation in tissue culture. 2 DOSAGE AND ADMINISTRATION . Peginterferon alfa-2a in combination with Ribavirin resulted in a higher SVR compared to peginterferon alfa-2a alone or interferon alfa-2b and Ribavirin (In Study NV15942, all patients received peginterferon alfa-2a 180 mcg subcutaneous once weekly and were randomized to treatment for either 24 or 48 weeks and to a Ribavirin dose of either 800 mg or 1000 mg/1200 mg (for body weight less than 75 kg/ greater than or equal to 75 kg). No maternal toxicity or effects on offspring were observed in a peri/postnatal toxicity study in rats dosed orally at up to 1 mg/kg/day (approximately 0.01 times the maximum recommended daily human dose of Ribavirin).Ribavirin is known to accumulate in intracellular components from where it is cleared very slowly. Female patients of childbearing potential and male patients with female partners of childbearing potential should not receive Ribavirin unless the patient and his/her partner are using effective contraception (two reliable forms) during therapy and for 6 months post therapy [see A Ribavirin Pregnancy Registry has been established to monitor maternal-fetal outcomes of pregnancies of female patients and female partners of male patients exposed to Ribavirin during treatment and for 6 months following cessation of treatment. The recommended dose of COPEGUS tablets is provided in Table 1. There may be new information. In these trials, one or more serious adverse reactions occurred in 10% of CHC monoinfected subjects and in 19% of CHC/HIV subjects receiving peginterferon alfa-2a alone or in combination with Ribavirin. In the pediatric clinical trial, hematological and chemistry assessments were at 1, 3, 5, and 8 weeks, then every 4 weeks. A total of 114 subjects were randomized to receive either combination treatment of Ribavirin plus peginterferon alfa-2a or peginterferon alfa-2a monotherapy; subjects failing peginterferon alfa-2a monotherapy at 24 weeks or later could receive open-label Ribavirin plus peginterferon alfa-2a. Patients with pre-existing cardiac disease should have electrocardiograms administered before treatment, and should be appropriately monitored during therapy.
Ribavirin tablets should not be used for these indications. Ribavirin plasma exposures were approximately 20% lower in subjects with ESRD on HD compared to subjects with normal renal function receiving the standard 1000/1200 mg Ribavirin daily dose.Subjects with moderate (n=17) or severe (n=14) renal impairment did not tolerate 600 mg or 400 mg daily doses of Ribavirin, respectively, due to Ribavirin-related adverse reactions, mainly anemia, and exhibited 20% to 30% higher Ribavirin plasma exposures (despite frequent dose modifications) compared to subjects with normal renal function (creatinine clearance greater than 80 mL/min) receiving the standard dose of Ribavirin. In rats, retinal degeneration occurred in controls, but the incidence was increased in Ribavirin-treated rats.The safety and effectiveness of peginterferon alfa-2a in combination with Ribavirin for the treatment of hepatitis C virus infection were assessed in two randomized controlled clinical trials. See Slideshow. Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. COPEGUS should be given in combination with PEGASYS; it is important to note that COPEGUS should never be given as monotherapy.
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