Loxenil Warnings

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 pre-treatment levels. Complete blood counts should be monitored weekly in patients who receive linezolid, particularly in those who receive linezolid for >2 weeks, those with preexisting 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 Mortality Imbalance in an lnvestigational 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 vancornycin / dicloxacillin / oxacillin in an open-label study in seriously ill patients with intravascular catheter-related infections [78/363 (21.5%) vs 58/363 (16%); odds ratio 1.426, 95% CI 0.97, 2.098]. While causality has not been established, this observed imbalance occurred primarily in linezolid-treated patients in whom either gram-negative pathogens, mixed gram-negative and gram-positive pathogens, or no pathogen were identified at baseline, but was not seen in patients with gram-positive infections only. Linezolid is not approved and should not be used for the treatment of patients with catheter-related bloodstream infections or catheter-site infections. Linezolid has no clinical activity against gram-negative pathogens and is not indicated for the treatment of gram-negative infections. It is critical that specific gram-negative therapy be initiated immediately if a concomitant gram-negative pathogen is documented or suspected (see Indications). Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Zyvox, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile and surgical evaluation should be instituted as clinically indicated. Hypoglycemia: Postmarketing cases of symptomatic hypoglycemia have been reported in patients with diabetes mellitus receiving insulin or oral hypoglycemic agents when treated with linezolid, a reversible, nonselective MAO inhibitor. Some MAO inhibitors have been associated with hypoglycemic episodes in diabetic patients receiving insulin or hypoglycemic agents. While a causal relationship between linezolid and hypoglycemia has not been established, diabetic patients should be cautioned of potential hypoglycemic reactions when treated with linezolid. If hypoglycemia occurs, a decrease in the dose of insulin or oral hypoglycemic agent, or discontinuation of oral hypoglycemic agent insulin or linezolid may be required.