"Swelling and irritation of your pancreas (pancreatitis).Call your healthcare provider or get medical help right away if you have any of the symptoms listed above. Upon cessation of treatment, total recovery occurred after 1 spermatogenesis cycle. Do not take ribavirin if you or your sexual partner is pregnant or plan to become pregnant. You will take ribavirin pills twice daily by mouth with food (dose is based on your weight). Ribavirin demonstrated increased incidences of mutation and cell transformation in multiple genotoxicity assays. By the end of the 6-month follow-up period, the incidence of ongoing adverse reactions by body class in the PegIntron 1.5/ ribavirin group was 33% (psychiatric), 20% (musculoskeletal), and 10% (for endocrine and for GI). 0000027415 00000 n
Pharmacokinetic modeling and simulation indicate that a dose of 200 mg daily in patients with severe renal impairment and a dose of 200 mg daily alternating with 400 mg the following day in patients with moderate renal impairment will provide plasma Ribavirin exposure similar to patients with normal renal function receiving the approved regimen of Ribavirin. 0000005225 00000 n
The international trial, conducted in Europe, Israel, Canada, and Australia, enrolled 192 subjects (64% male, 95% Caucasian, mean Knodell score 6.6, and 56% genotype 1). Adverse events consisted of bacterial pneumonia in one case, staphylococcus bacteremia in one case and two cases of post-extubation stridor. Ribavirin dose may be adjusted based on your tolerance of this medication. Ribavirin has direct antiviral activity in tissue culture against many RNA viruses. Several cases of bronchospasm and/or chest pain were also reported, usually in individuals with known underlying reactive airway disease. The safety and efficacy of ribavirin tablets therapy for the treatment of adenovirus, RSV, parainfluenza or influenza infections have not been established. Patients with pre-existing cardiac disease should have electrocardiograms administered before treatment, and should be appropriately monitored during therapy. The majority of adverse reactions were mild or moderate in severity. Ribavirin should be administered with caution to patients with pre-existing cardiac disease. Subjects who were negative at Week 12 were treated for 48 weeks and followed for 24 weeks post-treatment. Refer to Intron A labeling for interferon dosing information. In the pediatric trial, the most prevalent adverse reactions were pyrexia (80%), headache (62%), neutropenia (33%), fatigue (30%), anorexia (29%), injection-site erythema (29%) and vomiting (27%). The minimum interval following exposure to VIRAZOLE before pregnancy may be safely initiated is unknown (see VIRAZOLE has been shown to be toxic to lactating animals and their offspring. The most common reason for dose modification of Ribavirin in CHC and CHC/HIV patients was anemia (22% and 16%, respectively).Peginterferon alfa-2a dose was reduced in 12% of patients receiving 1000 mg to 1200 mg Ribavirin for 48 weeks and in 7% of patients receiving 800 mg Ribavirin for 24 weeks. If you are a consumer or patient please visit Labeling for INTRON A and PegIntron should be reviewed in their entirety for additional safety information prior to initiation of combination treatment.Clinical trials with ribavirin in combination with PegIntron or INTRON A have been conducted in over 7,800 subjects from 3 to 76 years of age. Copy the URL below and paste it into your RSS Reader application. 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). It is not known if Ribavirin is safe and will work in children under 5 years of age.Especially tell your healthcare provider if you take any medicines to treat HIV, including didanosine (Videx or Videx EC), or if you take azathioprine (Imuran or Azasan).Know the medicines you take. In addition, ribavirin has a multiple-dose half-life of 12 days and may persist in non-plasma compartments for as long as 6 months. In animal studies, these effects were mostly reversible within a few months after drug cessation Long-term follow-up data in pediatric subjects indicates that ribavirin in combination with PegIntron or with INTRON A may induce a growth inhibition that results in reduced height in some patients Ribavirin is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Ribavirin and its triazole carboxamide and triazole carboxylic acid metabolites are excreted renally. 0000008449 00000 n
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