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Zyvoxid

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Indications:

indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms Linezolid is not indicated for the treatment of Gram-negative infections. It is critical that specific Gramnegative therapy be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected Vancomycin-Resistant Enterococcus faecium infections, including cases with concurrent bacteremia . Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains), or Streptococcus pneumonia Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, caused by Staphylococcus aureus Streptococcus pyogenes, or Streptococcus agalactiae. This drug has not been studied in the treatment of decubitus ulcers. Uncomplicated skin and skin structure infections caused by Staphylococcus aureus or Streptococcus pyogenes. Community-acquired pneumonia caused by Streptococcus pneumonia including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible strains only). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Linezolid and other antibacterial drugs, Linezolid should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Contraindications:

contraindicated for use in patients who have known hypersensitivity to linezolid or any of the other product components. Monoamine Oxidase Inhibitors Linezolid should not be used in patients taking any medicinal product which inhibits monoamine oxidases A or B (e.g., phenelzine, isocarboxazid) or within two weeks of taking any such medicinal product. Potential Interactions Producing Elevation of Blood Pressure Unless patients are monitored for potential increases in blood pressure, linezolid should not be administered to patients with uncontrolled hypertension, pheochromocytoma, thyrotoxicosis and/or patients taking any of the following types of medications: directly and indirectly acting sympathomimetic agents (e.g., pseudoephedrine), vasopressive agents (e.g., epinephrine, norepinephrine), dopaminergic agents (e.g., dopamine, dobutamine) Interactions). Potential Serotonergic Interactions Unless patients are carefully observed for signs and/or symptoms of serotonin syndrome, linezolid should not be administered to patients with carcinoid syndrome and/or patients taking any of the following medications: serotonin re-uptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), meperidine or buspirone.

Adverse reactions:

is well tolerated and the adverse events were described as mild to moderate in intensity. The most common adverse events were diarrhea, headache, and nausea, the other adverse events were include oral moniliasis, vaginal moniliasis, hypertension, dyspepsia, localized abdominal pain, pruritus, and tongue discoloration.

Interactions:

Monoamine Oxidase Inhibition: Linezolid is a reversible, nonselective inhibitor of monoamine oxidase. Therefore, linezolid has the potential for interaction with adrenergic and serotonergic agents. Adrenergic Agents: Some individuals receiving Linezolid may experience a reversible enhancement of the pressor response to indirect-acting sympathomimetic agents, vasopressor or dopaminergic agents. Commonly used drugs such as phenylpropanolamine and pseudoephedrine have been specifically studied. Initial doses of adrenergic agents, such as dopamine or epinephrine, should be reduced and titrated to achieve the desired response. Serotonergic Agents: Co-administration of linezolid and serotonergic agents was not associated with serotonin syndrome in Phase 1, 2 or 3 studies. Spontaneous reports of serotonin syndrome associated with co-administration of Linezolid and serotonergic agents, including antidepressants such as selective serotonin reuptake inhibitors (SSRIs), have been reported. Patients who are treated with Linezolid and concomitant serotonergic agents should be closely observed as described in the PRECAUTIONS, General Section. Strong CYP450 Inducers: In a study in healthy volunteers, co-administration of rifampin with oral linezolid resulted in a 21% decrease in linezolid Cmax and a 32% decrease in linezolid AUC0-12. The clinical significance of this interaction is unknown. Other strong inducers of hepatic enzymes (e.g. carbamazepine, phenytoin, phenobarbital) could cause a similar or smaller decrease in linezolid exposure.

Warnings:

General Lactic Acidosis Lactic acidosis has been reported with the use of Linezolid. 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 Linezolid should receive immediate medical evaluation. Serotonin Syndrome Spontaneous reports of serotonin syndrome associated with the co-administration of Linezolid and serotonergic agents, including antidepressants such as selective serotonin reuptake inhibitors (SSRIs), have been reported ). Where administration of Linezolid 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. If the concomitant serotonergic agent is withdrawn, discontinuation symptoms can be observed ) for a description of the associated discontinuation symptoms). Peripheral and Optic Neuropathy Peripheral and optic neuropathy have been reported in patients treated with Linezolid, primarily those patients treated for longer than the maximum recommended duration of 28 days. In cases of optic neuropathy that progressed to loss of vision, patients were treated for extended periods beyond the maximum recommended duration. Visual blurring has been reported in some patients treated with Linezolid for less than 28 days. If patients experience symptoms of visual impairment, such as changes in visual acuity, changes in color vision, blurred vision, or visual field defect, prompt ophthalmic evaluation is recommended. Visual function should be monitored in all patients taking Linezolid for extended periods (? 3 months) and in all patients reporting new visual symptoms regardless of length of therapy with Linezolid. If peripheral or optic neuropathy occurs, the continued use of Linezolid in these patients should be weighed against the potential risks. Convulsions have been reported in patients when treated with linezolid. In some of these cases, a history of seizures or risk factors for seizures was reported. The use of antibiotics may promote the overgrowth of nonsusceptible organisms. Should superinfection occur during therapy, appropriate measures should be taken. ZYVOX has not been studied in patients with uncontrolled hypertension, pheochromocytoma, carcinoid syndrome, or untreated hyperthyroidism. The safety and efficacy of ZYVOX formulations given for longer than 28 days have not been evaluated in controlled clinical trials. Prescribing ZYVOX in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

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