SAFETY PROFILE
SEVEN PHASE 3 COMPARATOR-CONTROLLED CLINICAL TRIALS CONSISTING OF 2046 ADULT PATIENTS SUPPORT THE SAFETY PROFILE OF ZYVOX
ZYVOX offers a demonstrated safety profile in:
* Renally insufficient patients
* Patients with mild-to-moderate hepatic impairment
* Elderly patients
* Pediatric patients
* In these 7 trials, 85% of reported adverse events were mild to moderate
* ZYVOX had a treatment-related discontinuation rate of 2.1% to 3.5%, and comparators had a 1.7% to 2.4% treatment-related discontinuation rate
Lactic acidosis has been reported with the use of ZYVOX. In reported cases, patients experienced repeated episodes of nausea and vomiting. Patients who develop recurrent nausea or vomiting, unexplained acidosis, or a low bicarbonate level while receiving ZYVOX should receive immediate medical evaluation.
Spontaneous reports of serotonin syndrome associated with the co-administration of ZYVOX and serotonergic agents, including antidepressants such as selective serotonin reuptake inhibitors (SSRIs), have been reported. Where administration of ZYVOX and concomitant serotonergic agents is clinically appropriate, patients should be closely observed for signs and symptoms of serotonin syndrome such as cognitive dysfunction, hyperpyrexia, hyperreflexia, and incoordination. If signs or symptoms occur, physicians should consider discontinuation of either one or both agents.
ZYVOX offers a demonstrated safety profile in:
* Renally insufficient patients
* Patients with mild-to-moderate hepatic impairment
* Elderly patients
* Pediatric patients
* In these 7 trials, 85% of reported adverse events were mild to moderate
* ZYVOX had a treatment-related discontinuation rate of 2.1% to 3.5%, and comparators had a 1.7% to 2.4% treatment-related discontinuation rate
Lactic acidosis has been reported with the use of ZYVOX. In reported cases, patients experienced repeated episodes of nausea and vomiting. Patients who develop recurrent nausea or vomiting, unexplained acidosis, or a low bicarbonate level while receiving ZYVOX should receive immediate medical evaluation.
Spontaneous reports of serotonin syndrome associated with the co-administration of ZYVOX and serotonergic agents, including antidepressants such as selective serotonin reuptake inhibitors (SSRIs), have been reported. Where administration of ZYVOX and concomitant serotonergic agents is clinically appropriate, patients should be closely observed for signs and symptoms of serotonin syndrome such as cognitive dysfunction, hyperpyrexia, hyperreflexia, and incoordination. If signs or symptoms occur, physicians should consider discontinuation of either one or both agents.