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Zyvox 600 Mg Tablets 20 Ct. By Pfizer USA

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Zyvox 600 Mg Tablets 20 Ct. By Pfizer USA

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Zyvox 600 Mg Tablets 20 Ct. By Pfizer USA. Item Number.:RXD2957421/RXB10023598
Size : 20
ABC Selling UoM : EA
NDC: 00009-5135-02
UPC Barcode :
Supplier: 0050000308 PFIZER PHARM
Supplier Material : 1931
Generic Code : 045131 LINEZOLID ORAL TABLET 600 MG
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : BRX Branded RX

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Product Description.:

Prescribing Information for Zyvox



https://media.pfizer.com/files/products/uspi_zyvox.pdf

ZYVOX is indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms:

Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains) or Streptococcus pneumoniae (including multidrug-resistant strains [MDRSP]).

Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains), Streptococcus pyogenes, or Streptococcus agalactiae. ZYVOX has not been studied in the treatment of decubitus ulcers.

IMPORTANT SAFETY INFORMATION

ZYVOX use is contraindicated in patients with known hypersensitivity to linezolid or any of the other product components.

ZYVOX should not be used in patients taking any medicinal product which inhibits monoamine oxidases A or B (e.g. phenelzine, isocarboxazid) or within 2 weeks of taking any such product.

Unless patients are monitored for potential increases in blood pressure, ZYVOX should not be administered to patients with uncontrolled hypertension, pheochromocytoma, thyrotoxicosis and/or patients taking any of the following: directly and indirectly acting sympathomimetic, vasopressive, and dopaminergic agents.

Unless patients are carefully observed for signs and/or symptoms of serotonin syndrome, ZYVOX should not be administered to patients with carcinoid syndrome and/or patients taking any of the following medications: serotonin reuptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists, meperidine, or buspirone.

Spontaneous reports of serotonin syndrome have been reported with the coadministration of ZYVOX and serotonergic agents. If signs or symptoms of serotonin syndrome, such as cognitive dysfunction, hyperpyrexia, hyperreflexia, and incoordination occur, discontinuation of one or both agents should be considered.

Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported in patients receiving ZYVOX. In cases where the outcome is known, when ZYVOX was discontinued, the affected hematologic parameters returned to pretreatment levels. Complete blood counts should be monitored weekly, particularly in patients who receive ZYVOX for longer than 2 weeks.

ZYVOX is not approved and should not be used for the treatment of patients with catheter-related bloodstream infections or catheter-site infections.

ZYVOX Indications

ZYVOX is indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms:

Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains) or Streptococcus pneumoniae (including multidrug-resistant strains [MDRSP]).

Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains), Streptococcus pyogenes, or Streptococcus agalactiae. ZYVOX has not been studied in the treatment of decubitus ulcers.

Important Safety Information

ZYVOX use is contraindicated in patients with known hypersensitivity to linezolid or any of the other product components.

ZYVOX should not be used in patients taking any medicinal product which inhibits monoamine oxidases A or B (e.g. phenelzine, isocarboxazid) or within 2 weeks of taking any such product.

Unless patients are monitored for potential increases in blood pressure, ZYVOX should not be administered to patients with uncontrolled hypertension, pheochromocytoma, thyrotoxicosis and/or patients taking any of the following: directly and indirectly acting sympathomimetic, vasopressive, and dopaminergic agents.

Unless patients are carefully observed for signs and/or symptoms of serotonin syndrome, ZYVOX should not be administered to patients with carcinoid syndrome and/or patients taking any of the following medications: serotonin reuptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists, meperidine, or buspirone.

Spontaneous reports of serotonin syndrome have been reported with the coadministration of ZYVOX and serotonergic agents. If signs or symptoms of serotonin syndrome, such as cognitive dysfunction, hyperpyrexia, hyperreflexia, and incoordination occur, discontinuation of one or both agents should be considered.

Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported in patients receiving ZYVOX. In cases where the outcome is known, when ZYVOX was discontinued, the affected hematologic parameters returned to pretreatment levels. Complete blood counts should be monitored