Rx Item-Sivextro 200Mg Tab 30 By Merck

SIVEXTRO- tedizolid phosphate tablet, film coated
SIVEXTRO- tedizolid phosphate injection, powder, lyophilized, for solution
Merck Sharp & Dohme Corp.
1 INDICATIONS AND USAGE
1.1 Acute Bacterial Skin and Skin Structure Infections

SIVEXTRO� is an oxazolidinone-class antibacterial indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Streptococcus pyogenes , Streptococcus agalactiae , Streptococcus anginosus Group (including Streptococcus anginosus , Streptococcus intermedius , and Streptococcus constellatus), and Enterococcus faecalis.
1.2 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of SIVEXTRO and other antibacterial drugs, SIVEXTRO should be used only to treat ABSSSI 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.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage

The recommended dosage of SIVEXTRO is 200 mg administered once daily for six (6) days either orally (with or without food) or as an intravenous (IV) infusion in patients 18 years of age or older.
DOSAGE FORMS AND STRENGTHS

SIVEXTRO 200 mg tablet is a yellow film-coated oval tablet; each tablet is debossed with "TZD" on one side and "200″ on the other side.

SIVEXTRO for injection is a sterile, white to off-white lyophilized powder for injection in single-use vials of 200 mg. Each 200 mg vial must be reconstituted with Sterile Water for Injection and subsequently diluted only with 0.9% Sodium Chloride Injection, USP.
DESCRIPTION

SIVEXTRO (tedizolid phosphate), a phosphate prodrug, is converted to tedizolid in the presence of phosphatases.

Tedizolid phosphate has the chemical name [(5R)-(3-{3-Fluoro-4-[6-(2-methyl-2H -tetrazol- 5-yl) pyridin-3-yl]phenyl}-2-oxooxazolidin- 5-yl]methyl hydrogen phosphate.

Its empirical formula is C17 H16 FN6 O6 P and its molecular weight is 450.32.
CLINICAL PHARMACOLOGY
12.1 Mechanism of Action

Tedizolid phosphate is the prodrug of tedizolid, an antibacterial agent.

RX ITEM-Sivextro 200Mg Tab 30 By Merck
NDC 67919-0041-01 UPC/GTIN No.3-67919-04101-3 Mfg.Part No.4101

Sivextro 200Mg Tab 30 By Merck
BRAND: SIVEXTRO NDC: 67919-0041-01,67919004101 UPC: 3-67919-04101-3,367919041013 Merck & Co.

TEDIZOLID PHOSPHATE ORAL
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