NAFCILLIN- nafcillin sodium injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NAFCILLIN SODIUM (UNII: 49G3001BCK) (NAFCILLIN - UNII:4CNZ27M7RV)

Available from:

Eugia US LLC

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see CLINICAL PHARMACOLOGY - Susceptibility Test Methods ) . Nafcillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to methicillin-resistant Staphylococcus sp., therapy with Nafcillin for Injection, USP should be discontinued and alternative therapy provided. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nafcillin for Injection, USP and other antibacterial drugs, Nafcillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. A history of a hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication.

Product summary:

Each vial of Nafcillin for Injection, USP contains nafcillin sodium equivalent to 1 gram or 2 grams of nafcillin. Nafcillin for Injection, USP is a sterile, white to yellowish-white powder supplied in vials as follows: Nafcillin for Injection USP, 1 g vials in a Box of 10                    NDC 55150-122-15 Nafcillin for Injection USP, 2 g vials in a Box of 10                    NDC 55150-123-15 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. The vial stopper is not made with natural rubber latex. Distributed by: Eugia US LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India Revised: December 2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NAFCILLIN - NAFCILLIN SODIUM INJECTION, POWDER, FOR SOLUTION
EUGIA US LLC
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NAFCILLIN FOR INJECTION, USP
RX ONLY
FOR INTRAMUSCULAR OR INTRAVENOUS INJECTION
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Nafcillin for Injection and other antibacterial drugs, Nafcillin for
Injection should be used
only to treat or prevent infections that are proven or strongly
suspected to be caused
by bacteria.
DESCRIPTION
Nafcillin for Injection, USP is semisynthetic penicillin derived from
the penicillin nucleus, 6-
aminopenicillanic acid. The chemical name of nafcillin sodium is
Monosodium (2S,5R,6R)-
6-(2-ethoxy-1-naphthamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-
carboxylate monohydrate. It is resistant to inactivation by the enzyme
penicillinase (beta-
lactamase). The structural formula is as follows:
Nafcillin for Injection, USP for the intramuscular or intravenous
route of administration,
contains nafcillin sodium as a sterile white to yellowish-white powder
for reconstitution.
The pH of the reconstituted solution is 6 to 8.5. Nafcillin for
Injection, USP contains
nafcillin sodium as the monohydrate equivalent to 1 gram or 2 grams of
nafcillin per vial
and is buffered with 40 mg sodium citrate per gram. The sodium content
is 65.78 mg
[2.9 mEq] per gram.
CLINICAL PHARMACOLOGY
In a study of five healthy adults administered a single 500 mg dose of
nafcillin by
intravenous injection over seven minutes, the mean plasma
concentration of the drug
was approximately 30 mcg/mL at 5 minutes after injection. The mean
area under the
plasma concentration-versus-time curve (AUC) for nafcillin in this
study was 18.06
mcg•h/mL.
The serum half-life of nafcillin administered by the intravenous route
ranged from 33 to
61 minutes as measured in three separate studies.
In contrast to the other penicillinase-resistant penicillins, only
about 30% of nafcillin is
excreted as unchanged drug in the urine of normal volunteers, and most
within the first
six hours. Nafcillin is primar