NAFCILLIN SODIUM injection, powder, for solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Sandoz Inc

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 Testing ). 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 selec

Περίληψη προϊόντος:

Nafcillin for Injection, USP in ADD-Vantage vials for intravenous injection contains nafcillin sodium as the monohydrate equivalent to 1 gram or 2 grams nafcillin per vial. NDC 0781-3128-92, 1 gram ADD-Vantage Vial, packed in 10s NDC 0781-3129-92, 2 gram ADD-Vantage Vial, packed in 10s Store dry powder at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. ADD-Vantage® is a registered trademark of Hospira Inc. 46279501 Revised: November 2020 Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

NAFCILLIN SODIUM- NAFCILLIN SODIUM INJECTION, POWDER, FOR SOLUTION
SANDOZ INC
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NAFCILLIN FOR INJECTION, USP
RX ONLY
FOR INTRAVENOUS INJECTION ONLY
ADD-VANTAGE VIALS
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 ADD-Vantage is a sterile 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 SODIUM
MOLECULAR FORMULA: C H N NAO S • H O
MOLECULAR WEIGHT: 454.47
Nafcillin for injection, USP ADD-Vantage Vials, intended for
intravenous administration only, contain
nafcillin sodium as a sterile white to slightly yellowish 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
ADD-Vantage vial and is buffered with
approximately 40 mg sodium citrate per gram of nafcillin. The sodium
content is 66.1 mg [2.9 mEq] for
the 1 g vial and 132.2 mg [5.8 mEq] for the 2 g vial.
®
21
21
2
5
2
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 stud