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:

Sandoz 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, d

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 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP OUT OF THE REACH OF CHILDREN Revised: November 2020 46276383 Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DICLOXACILLIN SODIUM- DICLOXACILLIN SODIUM CAPSULE
SANDOZ INC
----------
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.
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:
MOLECULAR FORMULA: C
H CL
N NAO S ·H O
MOLECULAR WEIGHT: 510.32
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
CAS – 13412 64-1
19
16
2
3
5
2
microorganisms, both _in vitro_ and in clinical infections as
described in the INDICATIONS AND
USAGE section.
_AEROBIC GRAM-POSITIVE MICROORGANISMS:_
_Staphylococcus_ spp.
SUSCEPTIBILITY TESTING
For specific information regarding susceptibility test interpretive
criteria and associated test methods
and quality control standards recognized by FDA fo