OXACILLIN- oxacillin injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz Inc

INN (International Name):

OXACILLIN SODIUM

Composition:

OXACILLIN 1 g

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 for Injection, USP and other antibacterial drugs, Oxacillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly susp

Product summary:

Oxacillin for Injection, USP contains oxacillin sodium equivalent to 1 or 2 grams oxacillin per vial. NDC 0781-9109-95 1 gram vial packaged in 10s NDC 0781-9111-95 2 grams vial packaged in 10s Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OXACILLIN- OXACILLIN INJECTION, POWDER, FOR SOLUTION
SANDOZ INC
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OXACILLIN FOR INJECTION, USP
FOR INTRAMUSCULAR OR INTRAVENOUS INJECTION
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Oxacillin for
Injection and other antibacterial drugs, Oxacillin for Injection
should be used only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Oxacillin for Injection, USP is a sterile product for intramuscular or
intravenous administration.
Oxacillin for Injection contains oxacillin sodium, a semisynthetic
penicillin derived from the penicillin
nucleus, 6-aminopenicillanic acid. It is resistant to inactivation by
the enzyme penicillinase (beta-
lactamase). Each vial contains oxacillin sodium monohydrate equivalent
to 1 gram or 2 grams of
oxacillin. The sodium content is 63.5 mg (2.8 mEq) per gram of
oxacillin. The product is buffered with
19 mg dibasic sodium phosphate per gram of oxacillin.
OXACILLIN SODIUM
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,
[2_S_(2α,5α,6β)]. 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 441.43.
CLINICAL PHARMACOLOGY
Intravenous administration provides peak serum levels approximately 5
minutes after the injection is
completed. Slow I.V. administration of 500 mg gives a peak serum level
of 43 mcg/mL after 5 minutes
with a half-life of 20 to 30 minutes.
Oxacillin sodium, with normal doses, has insignificant concentrations
in the cerebrospinal and ascitic
fluids. It is found in therapeutic concentrations in the pleural,
bile, and amniotic fluids.
Oxacillin sodium is rapidly excreted as unchanged drug in the urine by
glomerular filtration and active
tubular secretion. The elimination half-life for oxacillin is about
0.5 hour