DICLOXACILLIN SODIUM- 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 USP and other antibacterial drugs, dicloxacillin sodium capsules 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. 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 Plate Testing ). Dicloxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal in

Product summary:

Product: 50090-1894 Product: 50090-2276 NDC: 50090-2276-0 28 CAPSULE in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DICLOXACILLIN SODIUM- DICLOXACILLIN SODIUM CAPSULE
A-S MEDICATION SOLUTIONS
----------
DICLOXACILLIN SODIUM CAPSULES USP
3123
3125
RX ONLY
To reduce the development of drug resistant bacteria and maintain the
effectiveness of dicloxacillin
sodium capsules USP and other antibacterial drugs, dicloxacillin
sodium capsules USP 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 a semisynthetic antibiotic substance which
resists destruction by the
enzyme penicillinase (beta - lactamase). 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.
Dicloxacillin is administered orally via capsule form or powder for
reconstitution. Structurally,
dicloxacillin sodium USP may be represented as follows:
C
H Cl
N NaO S·H O MW 510.32
INACTIVE INGREDIENTS
_Capsules_
Magnesium Stearate.
_Capsule Shell and Print Constituents_
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.
19
16
2
3
5
2
_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 AND
USAGE section.
Gram-positive Bacteria
_Staphylococcus_ spp.
_Susceptibility Test Methods_
Susceptibility of staphylococcal isolates to dicloxacillin may be
inferred by testing penicillin and either
oxacillin or cefoxitin . For staphylococcal iso