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:

Sagent Pharmaceuticals

INN (International Name):

oxacillin sodium

Composition:

oxacillin 1 g

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 Testing ). 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 suspected

Product summary:

Each vial of Oxacillin for Injection, USP contains oxacillin sodium monohydrate equivalent to 1 gram or 2 grams of oxacillin and is supplied as: Store dry powder at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. SAGENT® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in India ©2018 Sagent Pharmaceuticals, Inc. Revised: February 2018 SAGENT Pharmaceuticals®

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OXACILLIN- OXACILLIN SODIUM INJECTION, POWDER, FOR SOLUTION
SAGENT PHARMACEUTICALS
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OXACILLIN FOR INJECTION, USP
(FOR INTRAVENOUS OR INTRAMUSCULAR INJECTION)
SAGENT
Rx only
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 penicillin antibiotic
derived from the penicillin nucleus,
6-amino-penicillanic acid. It is resistant to inactivation by the
enzyme penicillinase (beta-lactamase). It is
the sodium salt in parenteral dosage form for intramuscular or
intravenous use.
Each vial of Oxacillin for Injection, USP contains oxacillin sodium
monohydrate equivalent to 1 gram or
2 grams of oxacillin. The sodium content is 63.77 mg (2.77 mEq) per
gram oxacillin. The product is
buffered with 20 mg dibasic sodium phosphate per gram oxacillin.
Oxacillin for Injection, USP is white
to off-white powder and gives an essentially clear and colorless to
yellow 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 fluid