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:

Wockhardt USA LLC.

Administration route:

INTRAVENOUS

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 strongl

Product summary:

Oxacillin for Injection, USP, is available in a Pharmacy Bulk Package bottle which contains oxacillin sodium monohydrate equivalent to 10 grams oxacillin. NDC 64679-700-01    10 grams Pharmacy Bulk Package bottle, Packaged in carton of ten Pharmacy Bulk Package bottles. NDC 64679-700-03    10 grams Pharmacy Bulk Package bottle, Packaged in carton of one Pharmacy Bulk Package bottle. Storage Store the dry powder at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Manufactured by: Mitim S.r.l. Via Cacciamali n°34-36-38 25125 Brescia (BS), Italy Distributed by: Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA Rev.121118

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OXACILLIN - OXACILLIN INJECTION, POWDER, FOR SOLUTION
WOCKHARDT USA LLC.
----------
OXACILLIN FOR INJECTION, USP
PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION
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 semisynthetic antibiotic substance
derived from 6-amino-
penicillanic acid. It is the sodium salt in a parenteral dosage form.
The pharmacy bulk
package contains oxacillin sodium monohydrate equivalent to 10 grams
oxacillin. The
sodium content is 64 mg (2.8 mEq) per gram of oxacillin. The product
is buffered with
21 mg dibasic sodium phosphate per gram of oxacillin.
The chemical name of oxacillin sodium is
4-Thia-1azabicyclo[3.2.0]heptane-2-carboxylic
acid,
3,3-dimethyl-6-[[(5-methyl-3-phenyl-4isoxazolyl)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.
A pharmacy bulk package is a container of a sterile preparation for
parenteral use that
contains many single doses. The contents of this pharmacy bulk package
are intended
for use by a pharmacy admixture service for addition to suitable
parenteral fluids in the
preparation of admixtures for intravenous infusion (See DOSAGE AND
ADMINISTRATION, Directions for Proper Use of Pharmacy Bulk Package.)
FURTHER
DILUTION IS REQUIRED. NOT FOR DIRECT INFUSION.
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
cerebros