SIVEXTRO- tedizolid phosphate tablet, film coated SIVEXTRO- tedizolid phosphate injection, powder, lyophilized, for solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

tedizolid phosphate (UNII: O7DRJ6R4DW) (tedizolid - UNII:97HLQ82NGL)

Доступна с:

Merck Sharp & Dohme LLC

ИНН (Международная Имя):

tedizolid phosphate

состав:

tedizolid phosphate 200 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

SIVEXTRO® is an oxazolidinone-class antibacterial indicated in adult and pediatric patients 12 years of age and older 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 . 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 epidemio

Обзор продуктов:

SIVEXTRO tablets are yellow film-coated oval tablets containing 200 mg of tedizolid phosphate; each tablet is debossed with "TZD" on one side and "200" on the other side. They are supplied as follows: HDPE bottles of 30 tablets with child-resistant closure (NDC 67919-041-04) Unit dose blister packs of 6 tablets (NDC 67919-041-05) SIVEXTRO is supplied as a sterile, lyophilized powder for injection in single-dose 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. They are supplied as follows: Package of ten 200 mg single-dose vials (NDC 67919-040-02) SIVEXTRO tablets and SIVEXTRO for injection should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Discard any unused portion of the single-dose vials.

Статус Авторизация:

New Drug Application

Характеристики продукта

SIVEXTRO- TEDIZOLID PHOSPHATE TABLET, FILM COATED
SIVEXTRO- TEDIZOLID PHOSPHATE INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
MERCK SHARP & DOHME LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SIVEXTRO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SIVEXTRO.
SIVEXTRO (TEDIZOLID PHOSPHATE) FOR INJECTION, FOR INTRAVENOUS USE
SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FOR ORAL USE
INITIAL U.S. APPROVAL: 2014
INDICATIONS AND USAGE
SIVEXTRO is an oxazolidinone antibacterial indicated in adult and
pediatric patients 12 years of age and
older for the treatment of acute bacterial skin and skin structure
infections (ABSSSI) caused by designated
susceptible bacteria. (1.1)
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 or
prevent infections that are proven or
strongly suspected to be caused by susceptible bacteria.
DOSAGE AND ADMINISTRATION
200 mg administered once daily orally or as an intravenous (IV)
infusion over 1 hour for six (6) days in
adult and pediatric patients 12 years of age and older. (2.1)
DOSAGE FORMS AND STRENGTHS
For injection: 200 mg, sterile, lyophilized powder in single-dose vial
for reconstitution for intravenous
infusion. (3)
Tablet: 200 mg (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Patients with neutropenia: The safety and efficacy of SIVEXTRO in
patients with neutropenia (neutrophil
counts <1000 cells/mm ) have not been adequately evaluated. In an
animal model of infection, the
antibacterial activity of SIVEXTRO was reduced in the absence of
granulocytes. Consider alternative
therapies in neutropenic patients. (5.1)
_Clostridioides difficile_-associated diarrhea: Evaluate if diarrhea
occurs. (5.2)
ADVERSE REACTIONS
The most common adverse reactions (≥2%) in adults are nausea,
headache, diarrhea, infusion- or
injection-related adverse reactions, vomiting, and dizziness. The most
common adv