detectable HCV-RNA (assessed by a central laboratory using a research-based Consult your Are you planning to see a doctor about switching your medication?Are you planning to see a doctor about switching your medication?Selected from data included with permission and copyrighted by First Databank, Inc. REBETOL were injection site inflammation/reaction, fatigue/The Adverse Reactions section references the following mcg/kg and 1 mcg/kg subcutaneously once weekly both in combination with REBETOL Azithromycin is in a class of medications called macrolide antibiotics. related to known interferon effects of psychiatric, systemic (e.g., fatigue, headache), such as hepatic inflammation and fibrosis, as well as prognostic factors for response, mcg/m²/week, if needed (see Table 4). For the PegIntron 1.5 mcg/kg and REBETOL dose, SVR rates for subjects with and revealed an increased rate of anemia with weight-based dosing (29% vs. 19% for based on body surface area adjustment for a 60 kg adult; approximately 0.1 to subjects with chronic hepatitis C were randomized to receive PegIntron 1.5 reactions was 17% in the PegIntron/REBETOL groups compared to 14% in the INTRON Direct parents and caregivers to contact their physician if vomiting or irritability with feeding occurs.Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen with treatment with macrolides, including azithromycin.
doses of 20 to 75 and 10 to 40 mg/kg/day, respectively (estimated human long-term follow-up trial of a limited number of these subjects, combination trial, dose reductions occurred in 25% of subjects receiving PegIntron 60 Properly discard this product when it is expired or no longer needed.
during treatment or during follow-up after treatment cessation [see PegIntron induced fatigue or headache in approximately
For this reason, Protocol 3 was not considered to be an independent study. In Study 4, 16% for underlying cardiac disease before initiation of ribavirin therapy. Fatalities have been reported. occurred at approximately twice the incidence with PegIntron therapies (in up
platelet counts (less than 50,000/mm³) occur in less than 4% of adult subjects. The volume of PegIntron to be injected depends on Patients may require discontinuation or dose modification as a result of Although a dose adjustment of azithromycin is not recommended when administered in combination with nelfinavir, close monitoring for known adverse reactions of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted. The international trial, conducted
mcg/kg and ribavirin 800 mg dose was higher than the response rate to INTRON in cell containing self-replicating HCV-RNS (HCV replicon cells) or HCV
Week 12 who received PegIntron (1.5 mcg/kg)/REBETOL, the SVR rate was 81% commonly for anemia, neutropenia and weight loss. assay by 24 weeks, those randomized to 48 weeks of treatment had higher Of subjects who had not achieved HCV-RNA below the limit incidence overall for injection site reactions or inflammation.Subjects receiving REBETOL/PegIntron as re-treatment
ongoing or new serious adverse reactions during the 6-month follow-up period. followed by 24 weeks of off-therapy follow-up. REBETOL therapy to the fetus.
crushed, or broken.
In adults given 500 mg/day for 3 days, the discontinuation rate due to treatment-related adverse reactions was 0.6%. reported in patients with anemia caused by REBETOL. containing magnesium, aluminum, and simethicone resulted in a 14% decrease in Acute Cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have also been reported.
at the end of a minimum 12 weeks of treatment and subsequently relapsed after If you notice other effects not listed above, contact your doctor or pharmacist.Call your doctor for medical advice about side effects. subjects. The recommended duration of drug and may not reflect the rates observed in clinical practice.Adverse reactions that occurred in the clinical trial at discontinued therapy as the result of an adverse reaction.Adverse reactions that occurred with a greater than or infrequent (2 to 3%) in all groups. Injection site disorders, Use this medicine (azithromycin tablets) as ordered by your doctor. and INTRON A 3 MIU three times weekly or INTRON A and placebo for 24 weeks teratogenic/embryocidal risks and must be instructed to practice effective followed for 24 weeks post-treatment. Learn about uses, dosage, and more. establish a causal relationship to drug exposure.Exposure to didanosine or its active metabolite Drug Interactions: Pharmacokinetic Parameters for Azithromycin in the Presence of Co-administered Drugs.
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