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:: Overview :: Precautions :: Side Effects Search results last updated: 5/9/2009

Generic & Brand Name : Source: (RXList)

Brand Name : Zyvox
Generic Name : Linezolid

Overview (Source: MedicineNet)
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Precautions (Source: RXList)
Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported in patients receiving linezolid. In cases where the outcome is known, when linezolid was discontinued, the affected hematologic parameters have risen toward pretreatment levels. Complete blood counts should be monitored weekly in patients who receive linezolid, particularly in those who receive linezolid for longer than two weeks, those with pre-existing myelosuppression, those receiving concomitant drugs that produce bone marrow suppression, or those with a chronic infection who have received previous or concomitant antibiotic therapy. Discontinuation of therapy with linezolid should be considered in patients who develop or have worsening myelosuppression. In adult and juvenile dogs and rats, myelosuppression, reduced extramedullary hematopoiesis in spleen and liver , and lymphoid depletion of thymus , lymph nodes, and spleen were observed (see ANIMAL PHARMACOLOGY ). Mortality Imbalance in an Investigational Study in Patients with Catheter-Related Bloodstream Infections, including those with catheter-site infections An imbalance in mortality was seen in patients treated with linezolid relative to vancomycin/dicloxacillin/oxacillin in an open-label study in seriously ill patients with intravascular catheter-related infections [78/363 (21.5%) vs. 58/363 (16.0%); odds ratio 1.426, 95% CI 0.970, 2.098]. While causality has not been established, this observed imbalance occurred p ...
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Side Effects (Source: RXList)
Adult Patients The safety of ZYVOX formulations was evaluated in 2046 adult patients enrolled in seven Phase 3 comparator-controlled clinical trials , who were treated for up to 28 days. In these studies, 85% of the adverse events reported with ZYVOX were described as mild to moderate in intensity. Table 6 shows the incidence of adverse events reported in at least 2% of patients in these trials. The most common adverse events in patients treated with ZYVOX were diarrhea (incidence across studies: 2.8% to 11.0%), headache (incidence across studies: 0.5% to 11.3%), and nausea (incidence across studies: 3.4% to 9.6%). Table 6. Incidence (%) of Adverse Events Reported in ≥ 2% of Adult Patients in Comparator-Controlled Clinical Trials with ZYVOX Event ZYVOX (n=2046) All Comparators * (n=2001) Diarrhea 8.3 6.3 Headache 6.5 5.5 Nausea 6.2 4.6 Vomiting 3.7 2.0 Insomnia 2.5 1.7 Constipation 2.2 2.1 Rash 2.0 2.2 Dizziness 2.0 1.9 Fever 1.6 2.1 *Comparators included cefpodoxime proxetil 200 mg PO q12h; ceftriaxone 1 g IV q12h; clarithromycin 250 mg PO q12h; dicloxacillin 500 mg PO q6h; oxacillin 2 g IV q6h; vancomycin 1 g IV q12h. Other adverse events reported in Phase 2 and Phase 3 studies included oral moniliasis, vaginal moniliasis, hypertension , dyspepsia , localized abdominal pain , pruritus , and tongue discoloration. Table 7 shows the incidence of drug-related adverse events reported in at least 1% of adult patients in these trials by dose of ZYVOX. Table 7. Incidence (%) of Dru ...
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