DICLOXACILLIN SODIUM capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DICLOXACILLIN SODIUM (UNII: 4HZT2V9KX0) (DICLOXACILLIN - UNII:COF19H7WBK)

Available from:

A-S Medication Solutions

INN (International Name):

DICLOXACILLIN SODIUM

Composition:

DICLOXACILLIN 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules and other antibacterial drugs, dicloxacillin sodium capsules 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. Dicloxacillin 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 organisms and their sensitivity to the drug (see CLINICAL PHARMACOLOGY – Susceptibility  Testing ). Dicloxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of laboratory test results. The penicillinase-resistant penicillins 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 a penicillinase-resistant penicillin. Dicloxacillin sodium is contraindicated in persons who have shown hypersensitivity to any of the penicillins or any component of the formulations.

Product summary:

Product: 50090-0116 NDC: 50090-0116-1 40 CAPSULE in a BOTTLE NDC: 50090-0116-0 28 CAPSULE in a BOTTLE NDC: 50090-0116-4 20 CAPSULE in a BOTTLE Product: 50090-0310

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DICLOXACILLIN SODIUM- DICLOXACILLIN SODIUM CAPSULE
A-S MEDICATION SOLUTIONS
----------
DICLOXACILLIN SODIUM CAPSULES USP
RX ONLY
To reduce the development of drug resistant bacteria and maintain the
effectiveness of
dicloxacillin sodium capsules and other antibacterial drugs,
dicloxacillin sodium capsules
should be used only to treat or prevent infections that are proven or
strongly suspected
to be caused by bacteria.
DESCRIPTION
Dicloxacillin sodium, USP is an antibacterial agent of the isoxazolyl
penicillin series. It is a
penicillinase resistant, acid resistant semisynthetic penicillin
suitable for oral
administration.
It is monosodium
(2_S_,5_R_,6_R_)-6-[3-(2,6-dichlorophenyl)-5-methyl-4-
isoxazolecarboxamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo
[3.2.0]heptane-2-
carboxylate monohydrate, and has following structural formula:
C
H
Cl
N NaO S·H O MW 510.32
Each capsule for oral administration contains dicloxacillin sodium,
USP equivalent to 250
mg or 500 mg of dicloxacillin. The inactive ingredient is Magnesium
Stearate. The capsule
shells and print constituents contains D&C Yellow #10 Aluminum Lake,
FD&C Blue #1
Aluminum Lake, FD&C Blue #1, FD&C Blue #2 Aluminum Lake, FD&C Red #40
Aluminum
Lake, D&C Yellow #10, Gelatin, Shellac, Sodium Lauryl Sulfate,
Sorbitan Monolaurate,
Black Iron Oxide, Titanium Dioxide, Propylene Glycol.
CLINICAL PHARMACOLOGY
MICROBIOLOGY
_Mechanism of Action_
Penicillinase-resistant penicillins exert a bactericidal action
against penicillin-susceptible
microorganisms during the state of active multiplication. All
penicillins inhibit the
biosynthesis of the bacterial cell wall.
_Antibacterial Activity_
Dicloxacillin sodium has been shown to be active against most isolates
of the following
microorganisms, both _in vitro_ and in clinical infections as
described in the INDICATIONS
19
16
2
3
5
2
AND USAGE section.
Gram-positive Bacteria
_Staphylococcus_ spp.
_Susceptibility Testing_
For specific information regarding susceptibility test interpretive
criteria and associated
test methods and