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:

RedPharm Drug, Inc.

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, dicl

Product summary:

Dicloxacillin sodium capsules, USP 250 mg Light blue opaque cap/body capsule printed with GG854 containing dicloxacillin sodium, USP equivalent to 250 mg dicloxacillin. Bottle of 100 capsules NDC 0781-2248-01 500 mg Light blue opaque cap/body capsule printed with GG855 containing dicloxacillin sodium, USP equivalent to 500 mg dicloxacillin. Bottle of 100 capsules NDC 0781-2258-01 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DICLOXACILLIN SODIUM- DICLOXACILLIN SODIUM CAPSULE
REDPHARM DRUG, INC.
----------
SPL UNCLASSIFIED SECTION
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, USP 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:
[Dicloxacillin sodium chemical structure]
Each capsule for oral administration contains dicloxacillin sodium,
USP 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. The capsule
ink contains
shellac, propylene glycol, black iron oxide, ammonium hydroxide and
potassium
hydroxide
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 isolates
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.
Susceptibility Testing:
Susceptibility of staphylococcal isolates to dicloxacillin may be
inferred by testing
penicillin and either oxacillin or cefoxitin1. For staphylococcal
isolates, penicillin
susceptibility implies susceptibility to other β-la