DICLOXACILLIN SODIUM capsule

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

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Download 제품 특성 요약 (SPC)
09-01-2012

유효 성분:

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

제공처:

Physicians Total Care, Inc.

INN (국제 이름):

DICLOXACILLIN SODIUM

구성:

DICLOXACILLIN 250 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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

제품 요약:

Dicloxacillin sodium capsules, USP Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

                                DICLOXACILLIN SODIUM - DICLOXACILLIN SODIUM CAPSULE
PHYSICIANS TOTAL CARE, INC.
----------
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 ingredients are gelatin, FD&C Blue #1,
magnesium stearate, and titanium
dioxide.
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 1
mcg oxacillin disk. Int
                                
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