OXACILLIN - oxacillin sodium 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:

AuroMedics Pharma LLC

INN (International Name):

OXACILLIN SODIUM

Composition:

OXACILLIN 2 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 str

Product summary:

Each vial of Oxacillin for Injection, USP contains oxacillin sodium monohydrate equivalent to 2 grams of oxacillin.          Oxacillin for Injection USP, 2 g vials in a Box of 10           NDC 55150-128-25 Oxacillin for Injection, USP is a sterile, white to off-white powder and after reconstitution it becomes light yellow colored clear liquid. Store dry powder at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] The vial stopper is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OXACILLIN - OXACILLIN SODIUM INJECTION, POWDER, FOR SOLUTION
AUROMEDICS PHARMA LLC
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OXACILLIN FOR INJECTION, USP
RX ONLY
FOR INTRAMUSCULAR OR INTRAVENOUS INJECTION
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 suspected to be caused
by bacteria.
DESCRIPTION
Oxacillin for Injection, USP is a semisynthetic penicillin antibiotic
derived from 6-amino-penicillanic
acid. It is the sodium salt in a parenteral dosage form. Each vial of
Oxacillin for Injection, USP contains
oxacillin sodium monohydrate equivalent to 2 grams of oxacillin. The
sodium content is 57.30 mg [2.5
mEq] per gram oxacillin. The product is buffered with 20 mg sterile
disodium hydrogen phosphate per
gram oxacillin.
Oxacillin for Injection, USP is a sterile, white to off-white powder
supplied in vials.
Oxacillin sodium, C
H N NaO S • H O molecular weight 441.43, is designated as 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)] and has the following structural
formula:
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.
The penicillinase-resistant penicillins bind to serum protein, mainly
albumin. The degree of protein
binding reported for oxacillin is 94.2% ± 2.1%. Reported values vary
with the method of study and the
investigator.
The penicillinase-resistant penicillins vary in the extent to which
they are distributed in the body fluids.
With normal doses, insignificant concentrations are found in the
cerebrospinal fluid and aqueous humor.
All the drugs in this class are found in therapeutic concent