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:

Liberty Pharmaceuticals, Inc.

INN (International Name):

DICLOXACILLIN SODIUM

Composition:

DICLOXACILLIN 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

The penicillinase-resistant penicillins are indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drugs. Cultures and susceptibility tests should be performed initially to determine the causative organism and their sensitivity to the drug (see CLINICAL PHARMACOLOGY – Susceptibility Testing ). The penicillinase-resistant penicillins 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. To reduce the development of drug-resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules and other antibacterial drugs, dic

Product summary:

Dicloxacillin sodium capsules, USP 250 mg Light blue opaque cap/body capsule printed with GG854 containing dicloxacillin sodium equivalent to 250 mg dicloxacillin. Bottle of 40 capsules NDC 00440-1380-40 Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DICLOXACILLIN SODIUM- DICLOXACILLIN SODIUM CAPSULE
LIBERTY PHARMACEUTICALS, INC.
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DICLOXACILLIN SODIUM CAPSULES, USP
250 MG AND 500 MG
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.
Dicloxacillin sodium is chemically designated as 4-Thia-1-azabicyclo
[3.2.0]heptane-2-carboxylic
acid,
6-[[[3-(2,6-dichlorophenyl)-5-methyl-4-isoxazolyl]-carbonyl]-amino]-3,3-dimethyl-7-oxo-,
monosodium salt, monohydrate, [2S-(2α5α,6β)] and has the following
structural formula:
Each capsule for oral administration contains dicloxacillin sodium
equivalent to 250 or 500 mg of
dicloxacillin. The inactive ingredient is magnesium stearate. The
capsule shells contain FD&C Blue 1,
titanium dioxide, and gelatin.
CLINICAL PHARMACOLOGY
MICROBIOLOGY
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.
Dicloxacillin sodium has been shown to be active against most strains
of the following microorganisms,
both _in vitro_ and in clinical infections as described in the
INDICATIONS AND USAGE section.
Aerobic Gram-Positive Microorganisms
_Staphylococcus_ spp. (penicillinase producing)
SUSCEPTIBILITY TESTING
Diffusion Techniques
Quantitative methods that require measurement of zone diameters
provide reproducible estimates of the
susceptibility of bacteria to antimicrobial compounds. One such
standardized procedure
that has been
recommended for use with disks to test the susceptibility of
microorganisms to dicloxacillin, uses the