NAFCILLIN- nafcillin 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:

Methapharm Inc.

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. 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). 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 should be discontinued and alternative therapy provided. 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 susceptible bacteria. When culture and susceptibility information are available, they should be considered in s

Product summary:

Nafcillin for Injection, USP contains nafcillin sodium as the monohydrate equivalent to 1 gram or 2 grams of nafcillin per vial and is supplied as follows: Store dry powder at 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature] Manufactured for: Methapharm, Inc.  Coral Springs, FL 33065 USA  Made in Romania Last Revised: December 2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NAFCILLIN- NAFCILLIN INJECTION POWDER, FOR SOLUTION
METHAPHARM INC.
----------
FOR INTRAMUSCULAR OR INTRAVENOUS INJECTION
RX ONLY
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-
amino-penicillanic 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 of nafcillin
sodium is as follows:
C
H
N NaO S ●H O MW=454.47
Nafcillin for Injection, USP for the intramuscular or intravenous
route of administration,
contains nafacilin sodium as a sterile white to off-white crystalline
dry powder for
reconstitution. The reconstituted solution is a clear and colorless
solution. The pH of the
reconstituted solution is 6 - 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 approximately 38 mg sodium citrate per gram. The sodium content
is about 66 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 unch