OXACILLIN injection, solution

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

OXACILLIN SODIUM (UNII: G0V6C994Q5) (OXACILLIN - UNII:UH95VD7V76)

Prieinama:

Baxter Healthcare Corporation

INN (Tarptautinis Pavadinimas):

OXACILLIN SODIUM

Sudėtis:

OXACILLIN 1 g in 50 mL

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Oxacillin is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug. (See CLINICAL PHARMACOLOGY - Susceptibility Test Methods.) Oxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. Oxacillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant Staphylococcus , therapy should not be continued with oxacillin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Oxacillin Injection, USP and other antibacterial drugs, Oxacillin Injection, USP 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. A history of a hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

Produkto santrauka:

Oxacillin Injection, USP is supplied as a premixed frozen iso-osmotic solution in 50 mL single dose GALAXY plastic containers as follows: 2G3538 NDC 0338-1013-41 1 gram oxacillin 2G3539 NDC 0338-1015-41 2 grams oxacillin Store at or below -20°C/-4°F. [See DIRECTIONS FOR USE OF GALAXY PLASTIC CONTAINER] Handle frozen product containers with care. Product containers may be fragile in the frozen state.

Autorizacija statusas:

New Drug Application

Prekės savybės

OXACILLIN- OXACILLIN INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
----------
OXACILLIN INJECTION, USP
IN PLASTIC CONTAINER
FOR INTRAVENOUS USE ONLY
GALAXY CONTAINER (PL 2040)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Oxacillin
Injection, USP and other antibacterial drugs, Oxacillin Injection, USP
should be used only to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
DESCRIPTION
Oxacillin Injection, USP is a sterile injectable product containing
oxacillin which is added as oxacillin
sodium, a semisynthetic penicillin derived from the penicillin
nucleus, 6-aminopenicillanic acid. The
chemical name of oxacillin sodium is
4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, 3,3-
dimethyl-6-[[(5-methyl-3-phenyl-4- isoxazolyl)carbonyl]-amino]-7-oxo-,
monosodium salt,
monohydrate, [2S-(2α,5α,6ß)]-. It is resistant to inactivation by
the enzyme penicillinase (beta-lactamase).
The molecular formula of oxacillin sodium is C
H N NaO S•H O. The molecular weight is 441.44.
The structural formula of oxacillin sodium is as follows:
Oxacillin Injection, USP is a frozen, iso-osmotic, sterile,
nonpyrogenic premixed 50 mL solution
containing 1 g or 2 g of oxacillin added as oxacillin sodium.
Dextrose, USP has been added to the
above dosages to adjust osmolality (approximately 1.5 g and 300 mg as
dextrose hydrous to the 1 g and
2 g dosages respectively). Sodium Citrate Hydrous, USP has been added
as a buffer (approximately 150
mg and 300 mg to the 1 g and 2 g dosages, respectively). The pH has
been adjusted with hydrochloric
acid and may have been adjusted with sodium hydroxide. The pH is 6.5
(6.0 to 8.5). The solution is
intended for intravenous use after thawing to room temperature.
This GALAXY container (PL 2040) is fabricated from a specially
designed multilayer plastic (PL
2040). Solutions are in contact with the polyethylene layer of this
container and can leach out certain
chemical components of the plastic in very small amounts