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:

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 stron

Product summary:

Oxacillin for injection, USP contains oxacillin sodium equivalent to 1 or 2 grams oxacillin per vial. NDC 64679-698-01    1 gram vial, packaged in carton of ten vials NDC 64679-698-03    1 gram vial, packaged in carton of one vial NDC 64679-699-01    2 grams vial, packaged in carton of ten vials NDC 64679-699-03    2 grams vial, packaged in carton of one vial Store 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.
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OXACILLIN FOR INJECTION, USP (SDV)
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, USP 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 64 mg (2.8 mEq) per gram of oxacillin. The product is buffered with
21 mg dibasic
sodium phosphate per gram of oxacillin. Oxacillin for injection, USP
is white to off white
powder and gives a clear solution upon reconstitution.
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, [2S(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 t